Crystalline forms of HDAC inhibitor and uses thereof

WO2025217209A3PCT designated stage Publication Date: 2025-11-20TANGO THERAPEUTICS INC
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Patent Information

Application Number
PCT/US2025/023734
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2025-01-10
Filing Date
2025-04-08
Publication Date
2025-11-20

AI Technical Summary

Technical Problem

Developing pharmaceutical compositions of HDAC inhibitors that address stability, solubility, and other considerations for effective treatment of diseases like cancer is challenging, particularly in human patients.

Method used

The development of crystalline forms of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, including anhydrous and solvate forms, which exhibit specific X-ray powder diffraction patterns and are used in pharmaceutical compositions to treat cancers with modified STK11 activity or expression, often in combination with immune checkpoint modulators.

Benefits of technology

These crystalline forms enhance the effectiveness of HDAC inhibitors by modulating the Teff to Treg cell ratio, reducing Treg cells, inducing anti-tumor cytokines, and reversing immune evasion phenotypes in cancers with STK11 mutations, while maintaining erythroid and myeloid cell viability.

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Abstract

The disclosure relates to crystalline forms of an HDAC inhibitor, pharmaceutical compositions thereof, and methods of treating cancers, including cancers having modified STK11 activity or expression, by administering an effective amount of the crystalline forms or compositions.
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Description

Attorney Docket No. TGO-025WO CRYSTALLINE FORMS OF HDAC INHIBITOR AND USES THEREOF CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of, and priority to, U.S. Provisional Patent Application No.63 / 631,137, filed on April 8, 2024, and to U.S. Provisional Patent Application No.63 / 744,127, filed on January 10, 2025; the content of each of which is hereby incorporated by reference herein in its entirety. BACKGROUND

[0002] Development of pharmaceutical compositions comprising one or more novel active ingredients requires a variety of considerations, such as route of administration (e.g., enteral, parenteral, topical, etc.), dosage form (e.g., solid - tablet, capsule, etc.; liquid - solution, suspension, syrup, etc.), strength of active ingredient(s) (e.g., 1 mg - 1,000 mg), non-therapeutic component(s) (e.g., excipients) and their respective amounts, and each of these considerations may involve additional considerations such as stability, degradation, sensitivity to light, solubility, taste if administered enterally, palatability, pH, skin irritability, microbial growth, etc. Advancing a novel active ingredient (e.g., a PRMT5 inhibitor) through rigorous regulatory entities requires discovering and developing a pharmaceutical composition that addresses these, or other, considerations.

[0003] Accordingly, there is a need for pharmaceutical compositions comprising compounds (e.g., HDAC inhibitors) that exhibit desirable properties treat diseases or disorders (e.g., cancers) in human patients. SUMMARY

[0004] In an embodiment, provided is an anhydrous crystalline form, Form A, of (R)-N-(4- amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Attorney Docket No. TGO-025WO wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2,15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2.

[0005] In an embodiment, provided is an ethyl acetate solvate crystalline form, Form B1, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2,11.8±0.2, 12.6±0.2, 14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2.

[0006] In an embodiment, provided is an acetonitrile solvate crystalline form, Form B2, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2,Attorney Docket No. TGO-025WO 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2.

[0007] In an embodiment, provided is an 1,3-dioxane solvate crystalline form, Form C, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2,15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2.

[0008] In an embodiment, provided is an anhydrous crystalline form, Form D, of (R)-N-(4- amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2,16.9±0.2, 17.3±0.2, 18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2.Attorney Docket No. TGO-025WO

[0009] In an embodiment, provided is a 1,3-dioxane solvate crystalline form, Form E, of (R)- N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 7.1±0.2, 10.7±0.2, 11.8±0.2,16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2.

[0010] In an embodiment, provided is an anhydrous crystalline form, Form F, of (R)-N-(4- amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2.

[0011] In an embodiment, provided is an anhydrous crystalline form, Form G, of (R)-N-(4- amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Attorney Docket No. TGO-025WOFormula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2,15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2.

[0012] In an embodiment, provided is a hydrate crystalline form, Form H, of (R)-N-(4- amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2,17.9±0.2, 18.7±0.2, 19±0.2, 19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2.

[0013] In an embodiment, provided is a crystalline form, Form I, of (R)-N-(4-amino-4'- fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Attorney Docket No. TGO-025WOFormula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2,15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2.

[0014] In an embodiment, provided is a pharmaceutical composition comprising a crystalline form as described in any of the embodiments herein.

[0015] In an embodiment, provided is a method of treating a subject having, or at risk of developing, a cancer, the method comprising administering to the subject an effective amount of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, wherein the cancer is identified as having modified STK11 activity or expression.

[0016] In an embodiment, provided is a method of treating a cancer in a subject comprising administering to the subject an immune checkpoint modulator and an effective amount of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, wherein the treatment modulates and / or improves the Teff cell to Treg cell ratio in the tumor or tumor microenvironment, wherein the cancer is identified as having modified STK11 activity or expression.

[0017] In an embodiment, provided is a method of treating a cancer in a subject comprising administering to the subject an immune checkpoint modulator and an effective amount of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, wherein the treatment reduces or depletes Treg cells in the tumor or tumor microenvironment, wherein the cancer is identified as having modified STK11 activity or expression.

[0018] In an embodiment, provided is a method of treating a cancer in a subject comprising administering to the subject an immune checkpoint modulator and an effective amount of aAttorney Docket No. TGO-025WO compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, wherein the treatment induces or increases the expression of cytokines that promote anti-tumor activity, wherein the cancer is identified as having modified STK11 activity or expression.

[0019] In an embodiment, provided is a method of treating a cancer in a subject comprising administering to the subject an immune checkpoint modulator and an effective amount of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, wherein the treatment reduces the expression of cytokines that promote Treg cell recruitment, wherein the cancer is identified as having modified STK11 activity or expression.

[0020] In an embodiment, provided is a method of treating a cancer in a subject comprising administering to the subject an effective amount of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, wherein the administering of the crystalline form or the composition does not reduce erythroid or myeloid cell viability, wherein the cancer is identified as having modified STK11 activity or expression.

[0021] In an embodiment, provided is a method of treating cancer in a subject, wherein the cancer presents an immune evasion phenotype characterized by STK11 mutant expression comprising: administering an effective amount of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, wherein the crystalline form, or the composition is capable of attenuating or reversing the immune evasion phenotype.

[0022] In an embodiment, provided is a method of treating a cancer in a subject comprising administering to the subject an effective amount of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, wherein an immune checkpoint modulator has been, is, or will be administered to the subject, wherein the cancer is identified as having modified STK11 activity or expression.

[0023] In an embodiment, provided is a method of treating a cancer in a subject comprising administering to the subject an immune checkpoint modulator, wherein an effective amount of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, is, or will be administered to the subject, wherein the cancer is identified as having modified STK11 activity or expression.Attorney Docket No. TGO-025WO

[0024] In an embodiment, provided is a method for ascertaining susceptibility of a subject having or having been diagnosed with cancer to treatment with a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein, the method comprising: determining: i) the presence or absence of a STK11 mutation; and / or ii) the level of STK11 activity or expression in the subject or a sample derived from the subject; wherein the presence of a STK11 mutation and / or a modified level of STK11 activity or expression is indicative of susceptibility to treatment with the crystalline form or composition.

[0025] In an embodiment, provided is a method for ascertaining susceptibility of a subject having or having been diagnosed with cancer to treatment with a combination of a compound of formula (I), crystalline form or pharmaceutical composition thereof as described in any of the embodiments herein and an immune checkpoint modulator, the method comprising: determining: i) the presence or absence of a STK11 mutation; and / or ii) the level of STK11 activity or expression in the subject or a sample derived from the subject; wherein the presence of a STK11 mutation and / or a modified level of STK11 activity or expression is indicative of susceptibility to treatment with a combination of an HDAC inhibitor and an immune checkpoint modulator. BRIEF DESCRIPTION OF THE DRAWINGS FIG.1A is an exemplary X-ray powder diffraction pattern of crystalline Form A of the compound of Formula (I). FIG.1B shows an exemplary thermogravimetric analysis (TGA) thermogram of crystalline Form A of the compound of Formula (I) showing about 0.3% weight loss at about 150°C. FIG.1C shows a differential scanning calorimetry (DSC) thermogram for crystalline Form A the compound of Formula (I), under a heat-cool-heat protocol, showing a melt peak at T onset of about 170.7 °C with an enthalpy of 95J / g. FIG.1D shows the change of water content as a function of relative humidity in an exemplary DVS experiment for crystalline Form A of the compound of Formula (I). FIG.1E shows a1H NMR spectrum for crystalline Form A of the compound of Formula (I). FIG.2A is an exemplary X-ray powder diffraction pattern of crystalline Form B1 of the compound of Formula (I).Attorney Docket No. TGO-025WO FIG.2B shows an exemplary thermogravimetric analysis (TGA) thermogram of crystalline Form B1 of the compound of Formula (I) showing about 0.6% weight loss at about 100°C and about 5.5% weight loss from about 100°C to 150°C. FIG.2C shows a differential scanning calorimetry (DSC) thermogram for crystalline Form B1 the compound of Formula (I), under a heat-cool-heat protocol, showing a desolvation peak from 110.7°C, an exothermic peak at Tonsetof 142.0°C and a melting peak at Tonsetof 203.4°C and an enthalpy of about 75 J / g. FIG.2D shows a1H NMR spectrum for crystalline Form B1 of the compound of Formula (I). FIG.3A is an exemplary X-ray powder diffraction pattern of crystalline Form B2 of the compound of Formula (I) showing . FIG.3B shows an exemplary thermogravimetric analysis (TGA) thermogram of crystalline Form B2 of the compound of Formula (I) showing about 1.1% weight loss at about 100°C and about 3.4% weight loss from about 100°C to 150°. FIG.3C shows a differential scanning calorimetry (DSC) thermogram for crystalline Form B2 the compound of Formula (I), under a heat-cool-heat protocol, showing a desolvation peak from 111.1°C, an exothermic peak at Tonsetof 138.1°C and a melting peak at Tonsetof 201.0°C with an enthalpy of about 79J / g. FIG.3D shows a1H NMR spectrum for crystalline Form B2 of the compound of Formula (I). FIG.4. is an exemplary X-ray powder diffraction pattern of crystalline Form C of the compound of Formula (I). FIG.5A is an exemplary X-ray powder diffraction pattern of crystalline Form D of the compound of Formula (I). FIG.5B shows an exemplary thermogravimetric analysis (TGA) thermogram of crystalline Form D of the compound of Formula (I) showing about 0.8% weight loss at about 150°. FIG.5C shows a differential scanning calorimetry (DSC) thermogram for crystalline Form D the compound of Formula (I), under a heat-cool-heat protocol, showing shows a melting peak at Tonsetof 160.2°C, an exothermic peak at Tonsetof 165.5°C and a melting peak at Tonsetof 181.7°C. FIG.5D shows a1H NMR spectrum for crystalline Form D of the compound of Formula (I). FIG.6A is an exemplary X-ray powder diffraction pattern of crystalline Form E of the compound of Formula (I).Attorney Docket No. TGO-025WO FIG.6B shows an exemplary thermogravimetric analysis (TGA) thermogram of crystalline Form E of the compound of Formula (I) showing about 1.5% weight loss at about 100°C and about 6.6% weight loss from about 100°C to 150°C. FIG.6C shows a differential scanning calorimetry (DSC) thermogram for crystalline Form E the compound of Formula (I), under a heat-cool-heat protocol, showing a desolvation peak from 89.7°C and 2 combined endothermic peaks at Tonsetof 155.0°C and 167.5°C, respectively. FIG.6D shows a1H NMR spectrum for crystalline Form E of the compound of Formula (I). FIG.7A is an exemplary X-ray powder diffraction pattern of crystalline Form F of the compound of Formula (I). FIG.7B shows an exemplary thermogravimetric analysis (TGA) thermogram of crystalline Form F of the compound of Formula (I) showing about 0.8% weight loss at about 150°C. FIG.7C shows a differential scanning calorimetry (DSC) thermogram for crystalline Form F the compound of Formula (I), under a heat-cool-heat protocol, showing a melting peak at Tonset of 203.9°C with an enthalpy of about 87J / g. FIG.7D shows a 1H NMR spectrum for crystalline Form F of the compound of Formula (I). FIG.8A is an exemplary X-ray powder diffraction pattern of crystalline Form G of the compound of Formula (I). FIG.8B shows an exemplary thermogravimetric analysis (TGA) thermogram of crystalline Form G of the compound of Formula (I) showing about 0.4% weight loss at about 150°C. FIG.8C shows a differential scanning calorimetry (DSC) thermogram for crystalline Form G the compound of Formula (I), under a heat-cool-heat protocol, showing a small melting peak at Tonset of 165.3°C and a melting peak at Tonset of 180.1°C with an enthalpy of about 78J / g. FIG.8D shows a 1H NMR spectrum for crystalline Form G of the compound of Formula (I). FIG.9A is an exemplary X-ray powder diffraction pattern of crystalline Form H of the compound of Formula (I). FIG.9B shows an exemplary thermogravimetric analysis (TGA) thermogram of crystalline Form H of the compound of Formula (I) about 1.8% weight loss at about 100°C. FIG.9C shows a differential scanning calorimetry (DSC) thermogram for crystalline Form H the compound of Formula (I), under a heat-cool-heat protocol, showing a dehydration formAttorney Docket No. TGO-025WO 20.5°C, an exothermic peak at 88.2°C, an endothermic peak at 133.4°C and a melting peak at Tonset of 197.2°C with an enthalpy of about 9J / g. FIG.9D shows a 1H NMR spectrum for crystalline Form H of the compound of Formula (I). FIG.9E shows an overlay of the results of the VT-XRPD experiments conducted with Form H. FIG.10A is an exemplary X-ray powder diffraction pattern of crystalline Form I of the compound of Formula (I). FIG.10B shows a differential scanning calorimetry (DSC) thermogram for crystalline Form I the compound of Formula (I), under a heat-cool-heat protocol, showing a dehydration endothermic peak from about 52°C and a melting peak at Tonset of 192.4°C with an enthalpy of about 55J / . FIG.10C shows a 1H NMR spectrum for crystalline Form H of the compound of Formula (I). FIG.11A is an exemplary X-ray powder diffraction pattern of tosylate salt crystalline Form A of the compound of Formula (I). FIG.11B shows an exemplary thermogravimetric analysis (TGA) thermogram of tosylate salt crystalline Form A of the compound of Formula (I) showing about 0.3% weight loss at about 150°C. FIG.11C shows a differential scanning calorimetry (DSC) thermogram for tosylate salt crystalline Form A the compound of Formula (I), under a heat-cool-heat protocol, showing a melt peak at T onset of about 170.7 °C with an enthalpy of 95J / g. FIG.11D shows the change of water content as a function of relative humidity in an exemplary DVS experiment for tosylate salt crystalline Form A of the compound of Formula (I). FIG.11E shows a1H NMR spectrum for tosylate salt crystalline Form A of the compound of Formula (I). FIG.12A is an exemplary X-ray powder diffraction pattern of mono-fumaric acid cocrystal Form A of the compound of Formula (I). FIG.12B shows an exemplary thermogravimetric analysis (TGA) thermogram of mono-fumaric acid cocrystal Form A of the compound of Formula (I) showing about 0.3% weight loss at about 150°C.Attorney Docket No. TGO-025WO FIG.12C shows a differential scanning calorimetry (DSC) thermogram for mono-fumaric acid cocrystal Form A the compound of Formula (I), under a heat-cool-heat protocol, showing a melt peak at T onset of about 170.7 °C with an enthalpy of 95J / g. FIG.12D shows the change of water content as a function of relative humidity in an exemplary DVS experiment for mono-fumaric acid cocrystal Form A of the compound of Formula (I). FIG.12E shows a1H NMR spectrum for mono-fumaric acid cocrystal Form A of the compound of Formula (I). FIG.13 is an exemplary X-ray powder diffraction pattern of hydrochloric acid salt Form A of the compound of Formula (I) FIG.14A depicts the tumor growth curve for mice bearing MC38_sgSTK11 tumors treated with a control antibody anti-IgG2a (10 mg / kg i.p. BIW), a combination of Compound I (3, 10, 30, 75 and 150 / 100 mg / kg p. o., QD) + the control antibody anti-IgG2a (10 mg / kg i.p. BIW), an anti- PD1 inhibitor (10 mg / kg i.p., BIW), and a combination of Compound I (3, 10, 30, 75 and 150 / 100 mg / kg p.o., QD) + anti-PD1 inhibitor (10 mg / kg i.p., BIW). The data is plotted according to the groups described in Example 1. FIG.14B depicts the tumor growth curve in the MC38 STK11 knockout mouse model treated with either anti-IgG2a (10 mg / kg i.p., BIW), Anti-PD1 (10 mg / kg i.p., BIW), Compound I (30 mg / kg p.o., QD), or Anti-PD1 (10 mg / kg i.p., BIW) + Compound I (30 mg / kg p.o., QD) was monitored over the course of treatment and plotted by individual animal. FIG.15A depicts the survival curve for mice bearing MC38_sgSTK11 tumors treated with a control antibody anti-IgG2a (10 mg / kg i.p., BIW), a combination of Compound I (3, 10, 30, 75 and 150 / 100 mg / kg p.o., QD) + the control antibody anti-IgG2a (10 mg / kg i.p. BIW), or an anti- PD1 inhibitor (10 mg / kg i.p., BIW). The data is plotted according to the groups described in Example 1. FIG.15B depicts the survival curve for mice bearing MC38_sgSTK11 tumors treated with a control antibody anti-IgG2a (10 mg / kg i.p., BIW), a combination of Compound I (3, 10, 30, 75 and 150 / 100 mg / kg p.o. QD) + anti-PD1 inhibitor (10 mg / kg i.p., BIW), or an anti-PD1 inhibitor (10 mg / kg i.p., BIW) The data is plotted according to the groups described in Example 1. FIG.15C shows a survival plot of mice with STK11-deleted MC38 tumors treated with Anti- IgG2a 10 mg / kg, i.p., BIW, Anti-IgG2a 10 mg / kg, i.p., BIW + Compound I, 30 mg / kg, p.o., QD,Attorney Docket No. TGO-025WO Anti-PD110 mg / kg, i.p., BIW, or Anti-PD110 mg / kg, i.p., BIW + Compound I, 30 mg / kg, p.o., QD as indicated. FIG.16A depicts the tumor growth curve for untreated control mice and mice that had survived treatment with either a combination of Compound I (75 mg / kg, p.o., QD) + a control antibody anti-IgG2a (10 mg / kg i.p. BIW) or a combination of Compound I (3, 10, 30, 75 and 150 / 100 mg / kg) + anti-PD1 inhibitor (10 mg / kg, i.p., BIW) and were rechallenged with MC38_sgSTK11 implants as described in Example 2. FIG.16B shows a plot of the tumor volume in mice that were re-challenged with STK11-deleted MC38 tumors as described in Example 2 (combined in a single group) in parallel with a control group of previously untreated mice. All animals remained off-treatment, and tumor size was plotted over time after re-challenge. FIG.17 depicts the tumor growth curve for mice bearing MC38_sgSTK11 tumors treated with a control antibody anti-IgG2a (10 mg / kg i.p. BIW), Compound I (30 mg / kg, p.o. QD), an anti-PD1 inhibitor (10 mg / kg i.p., BIW) and a combination of Compound I (30 mg / kg p.o., QD) and anti- PD1 inhibitor (10 mg / kg i.p., BIW). The mice with complete tumor regression in the initial experiment were rechallenged at day 69 with MC38_sgSTK11 implants. FIG.18A shows a volcano plot of an unbiased in vivo CRISPR screen identifying HDAC1 knockout as a sensitizer to anti-PD1 in STK11-deleted MC38 tumors. FIG.18B shows waterfall plots of the Project Achilles CRISPR scores for HDAC1, HDAC2, and HDAC3 in a panel of cell lines. Negative scores indicate depletion of cells with knockout of the indicated gene. FIG.19A shows a graph of a dose-dependent binding of Compound I to HDAC1, by cellular NanoBRET target engagement assay. FIG.19B show graphs of a dose-dependent binding of Compound I to HDAC2, by cellular NanoBRET target engagement assay. FIG.19C show graphs of a dose-dependent binding of Compound I inhibitor to HDAC3 by cellular NanoBRET target engagement assay. FIG.20A depicts the tumor growth curve in the CT26 STK11 knockout mouse model treated with either control antibody Anti-IgG2a (10 mg / kg, i.p., BIW), Anti-IgG2a (10 mg / kg, i.p., BIW) + Compound I (75 mg / kg, p.o., QD), Anti-PD1 (10 mg / kg, i.p., BIW), or (Anti-PD110 mg / kg, i.p., BIW) + Compound I (75 mg / kg, p.o., QD). The tumor volume was monitored overAttorney Docket No. TGO-025WO the course of treatment and plotted by individual animal. STK11 knockout renders CT26 tumors resistant to anti-PD1 treatment. FIG.20B shows a survival plot of mice with STK11-deleted CT26 tumors treated with control antibody Anti-IgG2a (10 mg / kg, i.p., BIW), Anti-IgG2a (10 mg / kg, i.p., BIW) + Compound I (75 mg / kg, p.o., QD), Anti-PD1 (10 mg / kg, i.p., BIW), or Anti-PD1 (10 mg / kg, i.p., BIW) + Compound I (75 mg / kg, p.o., QD) as indicated. FIG.21A depicts the tumor growth curve of STK11-deficient MC38 tumor cells in C57BL / 6 animals and athymic BALB / c Nude mice treated with Anti-IgG2a (10 mg / kg, i.p., BIW), Anti- IgG2a (10 mg / kg, i.p., BIW) + Compound I (30 mg / kg, p.o., QD), Anti-PD110 mg / kg, i.p., BIW, or Anti-PD110 mg / kg, i.p., BIW + Compound I, 30 mg / kg, p.o., QD as indicated. FIG.21B depicts the tumor growth curve of STK11-deficient MC38 tumor cells in C57BL / 6 animals and athymic BALB / c Nude mice treated with Anti-IgG2a (10 mg / kg, i.p., BIW), Anti- IgG2a (10 mg / kg, i.p., BIW) + Compound I (75 mg / kg, p.o., QD), Anti-PD1 (10 mg / kg, i.p., BIW), or Anti-PD1 (10 mg / kg, i.p., BIW) + Compound I (75 mg / kg, p.o., QD) as indicated. FIG.22A shows a graph depicting the change in gene expression for CXCL9, 10, and 11 as measured by Nanostring PanCancer IO 360 in STK11- / - MC38 tumors treated for 7 days with 30 mg / kg of Compound I or anti-PD1 alone or in combination. FIG.22B shows a graph depicting the change in gene expression for CCL1 and CCL22 as measured by Nanostring PanCancer IO 360 in STK11- / - MC38 tumors treated for 7 days with 30 mg / kg of Compound I or anti-PD1 alone or in combination. FIG.22C shows a graph depicting the change in gene expression for HLA genes as measured by Nanostring PanCancer IO 360 in STK11- / - MC38 tumors treated for 4 days with 0.2 uM of Compound I or solvent control. FIG.23A shows graphs of T cells, C4+ T cells, CD8+ Tcells and CD8+ TEM cells profiling by flow cytometry of STK11-deleted MC38 tumors treated for 7 days with 10 mg / kg of Compound I alone or in combination with anti-PD1. FIG.23B shows graphs of Treg cells and ratio of CD8+ / Treg cells by flow cytometry of STK11- deleted MC38 tumors treated for 7 days with 10 mg / kg of Compound I alone or in combination with anti-PD1. FIG.23C show graphs of IFNgamma expression by a tumor treated with Compound I alone or in combination with anti-PD1 for 72 hrs.Attorney Docket No. TGO-025WO FIG.23D shows graphs of IFNgamma expression in co-culture of human NSCLC cells with PBMCS and fibroblasts treated with Compound I alone or in combination with anti-PD1 for 72 hrs. FIG.23E shows graphs profiling the relative abundance of All T cells and T regulatory cells of STK11-deleted MC38 tumors from mice treated for 7 days with vehicle, 10 mg / kg of Compound I alone or in combination with anti-PD1. FIG.24A shows plots of gene expression changes in A549 cells treated with vorinostat using the PanCancer IO360 panel and the top three ranked gene ontology groups for each compound as determined from the Nanostring data in using the nSolver software. FIG.24B shows plots of gene expression changes in A549 cells treated with domatinostat using the PanCancer IO360 panel and the top three ranked gene ontology groups for each compound as determined from the Nanostring data in using the nSolver software. FIG.24C shows plots of gene expression changes in A549 cells treated with Compound I using the PanCancer IO360 panel and the top three ranked gene ontology groups for each compound as determined from the Nanostring data in using the nSolver software. FIG.25A shows plots for the erythroid and myeloid cell viability after treatment Compound I at different concentrations as indicated. The efficacious dose range of Compound I is also plotted (shaded area, 3 mg / kg to 75 mg / kg). FIG.25B depicts the tumor growth curves STK11-deleted MC38 tumors in a mouse model treated with a clinically relevant dose of vorinostat alone or in combination with anti-PD1 antibody. FIG.25C depicts the tumor growth curves STK11-deleted MC38 tumors in a mouse model treated with a clinically relevant dose of Compound I alone or in combination with anti-PD1 antibody. FIG.25D shows a plot comparing Compound I concentrations to HDAC1 or HDAC3 inhibition in vivo. Shaded boxes indicate tolerated and efficacious dose ranges of Compound I. FIG.26 shows a plot of the predicted plasma concentration (ng / mL) over time upon administration to humans and the predicted window between the efficacious and non-selective dose. FIG.27A shows a Western blot of acetylated histone 3 lysine 9 (H3K9Ac) from mouse MC38 tumor tissue after treatment with Compound I for 7 days at the indicated dose.Attorney Docket No. TGO-025WO FIG.27B shows a Quantification of the H3K9Ac western blot in (E) and normalized to total histone H3. FIG.27C shows the plasma concentration of Compound I administered at 30 mg / kg, 100 mg / kg and 300 mg / kg QD for two days, starting 1 hour after the last dose. FIG.27D shows a quantification of the levels of acetyl-histone H2B by flow cytometry in PBMC samples at the prescribed time points following administration of Compound I at 30 mg / kg, 100 mg / kg and 300 mg / kg QD for two days to MC38 tumor-bearing mice. FIG.27E shows a quantification of the levels of acetyl-histone H3B by Western Blot in tumor samples collected at the prescribed time points following administration of Compound I at 30 mg / kg, 100 mg / kg and 300 mg / kg QD for two days to MC38 tumor-bearing mice. FIG.28A depicts the tumor growth curve in a STK11-null CT26 (KRAS G12D mutant colon cancer) syngeneic mouse model. The mice were treated with either anti-IgG2, Anti-PD1 (10 mg / kg), Compound I (75 mg / kg), or Anti-PD1 (10 mg / kg ) + Compound I (75 mg / kg). Tumor volume was monitored over the course of treatment and plotted by individual animal. FIG.28B depicts the tumor growth curve in a STK11-null CT26 (KRAS G12D mutant colon cancer) model. Animals were treated with either anti-IgG2, Compound I (75 mg / kg), Anti-PD1 (10 mg / kg), or Anti-PD1 (10 mg / kg ) + Compound I (75 mg / kg). Tumor volume was monitored over the course of treatment and plotted by treatment group. FIG.28C depicts the survival curve for the KRAS G12D mutant CT26-STK11 knockout syngeneic mouse model treated with either anti-IgG2 , Anti-PD1 (10 mg / kg), Compound I (75 mg / kg), or Anti-PD1 (10 mg / kg ) + Compound I (75 mg / kg). FIG.28D depicts the tumor growth curve in a wild-type / parental CT26 (KRAS G12D mutant colon cancer) model. Animals were treated with either anti-IgG2, Compound I (75 mg / kg), Anti- PD1 (10 mg / kg), or Anti-PD1 (10 mg / kg ) + Compound I (75 mg / kg). Tumor volume was monitored over the course of treatment and plotted by treatment group. FIG.28E depicts the tumor growth curve in a wild-type / parental CT26 (KRAS G12D mutant colon cancer) model. Animals were treated with either anti-IgG2, Compound I (75 mg / kg), Anti- PD1 (10 mg / kg), or Anti-PD1 (10 mg / kg ) + Compound I (75 mg / kg). Tumor volume was monitored over the course of treatment and plotted by individual animal for group 1 and group 4. FIG.29A depicts the tumor growth curve in a wild-type / parental CT26 (KRAS G12D mutant colon cancer) model. Animals were treated with either anti-IgG2, Compound I (75 mg / kg), Anti-Attorney Docket No. TGO-025WO CTL4A (10 mg / kg), or Anti-CTL4A (10 mg / kg ) + Compound I (75 mg / kg). Tumor volume was monitored over the course of treatment and plotted by treatment group. FIG.29B depicts the tumor growth curve in a wild-type / parental CT26 (KRAS G12D mutant colon cancer) model. Animals were treated with either anti-IgG2, Compound I (75 mg / kg), Anti- CTL4A (10 mg / kg), or Anti-CTL4A (10 mg / kg ) + Compound I (75 mg / kg). Tumor volume was monitored over the course of treatment and plotted by individual animal for group 1 and group 4. FIG.29C depicts the tumor growth curve in a STK11-null CT26 (KRAS G12D mutant colon cancer) model treated with either anti-IgG2, Compound I (75 mg / kg), Anti-CTL4A (10 mg / kg), or Anti-CTL4A (10 mg / kg ) + Compound I (75 mg / kg). Tumor volume was monitored over the course of treatment and plotted by treatment group. FIG.29D depicts the tumor growth curve in a STK11-null CT26 (KRAS G12D mutant colon cancer) model treated with either anti-IgG2, Compound I (75 mg / kg), Anti-CTL4A (10 mg / kg), or Anti-CTL4A (10 mg / kg ) + Compound I (75 mg / kg). Tumor volume was monitored over the course of treatment and plotted by individual animal for group 1 and group 4. FIG.30A depicts the tumor growth curve in the STK11-null 3LL model treated with either anti- IgG2, Anti-PD1 (10 mg / kg), Compound I (75 mg / kg), or Anti-PD1 (10 mg / kg ) + Compound I (75 mg / kg) Tumor volume was monitored for the depicted duration and was plotted by treatment group. FIG.30B depicts the survival curve for the STK11-null 3LL model treated with either anti- IgG2, Anti-PD1 (10 mg / kg), Compound I (75 mg / kg), or Anti-PD1 (10 mg / kg ) + Compound I (75 mg / kg) Survival is plotted by treatment group. FIG.31A depicts the overall design of the first-in-human, non-randomized, open-labeled, phase 1 (dose escalation) and phase 2 (dose expansion) sequential assignment study for TNG260. FIG.31B depicts the overall results of phase 1 (dose escalation) in the study, with 80 mg QD as the dose for the highest exposure with maximal preclinical activity and 40 mg QD as the dose for the lowest exposure with maximal preclinical activity. FIG.31C depicts the patient flow in phase 1 of the study, which separates into three periods: screening (up to 28 days), treatment (cycle 1, cycle 2, cycle 3+) and follow up (EOT + 120 days).Attorney Docket No. TGO-025WO FIG.31D depicts the pharmacokinetics of TNG260 on day 15 in cycle 1 of the treatment period. Exposure increases with dose and 80 mg exposure approximates preclinical maximum efficacy exposure. Represented as arithmetic mean plasma concentration-time profiles FIG.31E depicts the correlation between the exposures of TNG260 in preclinical and human studies. Doses of TNG260 at 40 mg and 80 mg QD in the clinical study described in Example 27 achieved exposures that correspond to the exposures required for full efficacy in preclinical models, while higher doses resulted in exposures that in preclinical models were associated with diminished efficacy. FIG.32A depicts the tumor growth curve in the STK11-deficient, syngeneic MC38 mouse tumor model treated with anti-IgG2, Anti-PD1 (10 mg / kg, BIW), Compound I (30 mg / kg), dosed QD, QD (1 week on / 2 week off), QD (2 week on / 1 week off), QD (2 day on / 5 day off), QW (once a week) or BIW (twice a week). Tumor volume was monitored for the depicted duration and was plotted by treatment group. FIG.32B depicts the tumor growth curve in the STK11-deficient, syngeneic MC38 mouse tumor model treated with anti-IgG2, Anti-PD1 (10 mg / kg, BIW), Compound I (30 mg / kg), dosed QD vs QD (2 week on / 1 week off). Tumor volume was monitored for the depicted duration and was plotted for each individual animal. FIG.32C depicts the tumor growth curve in the STK11-deficient, syngeneic MC38 mouse tumor model treated with anti-IgG2, Anti-PD1 (10 mg / kg, BIW), Compound I (30 mg / kg), dosed QD vs QD (1 week on / 2 week off). Tumor volume was monitored for the depicted duration and was plotted for each individual animal. FIG.32D depicts the tumor growth curve in the STK11-deficient, syngeneic MC38 mouse tumor model treated with anti-IgG2, Anti-PD1 (10 mg / kg, BIW), Compound I (30 mg / kg), dosed QD vs QD (2 days on / 5 days off). Tumor volume was monitored for the depicted duration and was plotted for each individual animal. FIG.32E depicts the tumor growth curve in the STK11-deficient, syngeneic MC38 mouse tumor model treated with anti-IgG2, Anti-PD1 (10 mg / kg, BIW), Compound I (30 mg / kg), dosed QD vs QW (once a week). Tumor volume was monitored for the depicted duration and was plotted for each individual animal. FIG.32F depicts the tumor growth curve in the STK11-deficient, syngeneic MC38 mouse tumor model treated with anti-IgG2, Anti-PD1 (10 mg / kg, BIW), Compound I (30 mg / kg), dosed QDAttorney Docket No. TGO-025WO vs BIW (biweekly). Tumor volume was monitored for the depicted duration and was plotted for each individual animal. DETAILED DESCRIPTION

[0026] As generally described herein, provided are methods of treating a subject having, or at risk of developing, a cancer, the method comprising administering to the subject an effective amount of Compound I (e.g., a crystalline form described herein), wherein the cancer is identified as having modified STK11 activity or expression.

[0027] The disclosure herein sets forth exemplary methods, parameters and the like. It should be recognized, however, that such description is not intended as a limitation on the scope of the present disclosure but is instead provided as a description of exemplary embodiments to assist the reader as appropriate.

[0028] As used in the present disclosure, certain words and phrases (and grammatical equivalents such as conjugations, declensions, and the like) are generally intended to have the meanings defined herein unless expressly indicated otherwise or the context in which they are used indicates otherwise. STK11

[0029] Serine / threonine kinase 11 protein, abbreviated as STK11 and also referred to as PJS, liver kinase B1(LKB1), renal carcinoma antigen NY-REN-19 and hLKB1 protein, is a protein kinase that in humans is encoded by the STK11 gene (HGNC symbol STK11, Ensembl ID ENSG00000118046.16). As described in Koenig, M. et al Cancer Research (2021) 81(16): 4194–4204 (doi: 10.1158 / 0008-5472), which is hereby incorporated by reference in its entirety: “The serine / threonine kinase LKB1 belongs to the calcium calmodulin family, which is ubiquitously expressed in several tissues and highly conserved among eukaryotes. Over the past 15 years, LKB1 has been implicated in a number of essential biological processes such as: cell cycle control, cellular energy metabolism, angiogenesis, cell polarity, and DNA damage response. The sub-cellular localization and activity of LKB1 is controlled through its interaction with STRAD and the armadillo repeat-containing mouse protein 25 (Mo25). LKB1 regulates the activity of at least 14 downstream kinases related to the AMPK family and phosphorylates other substrates including STRAD, PTEN, and p21CDKN1A. LKB1 is phosphorylated on at least eight residues, and evidence suggests that LKB1 auto-phosphorylates itself on at least four of these, whereas the other four are phosphorylated by upstream kinases. While these post-Attorney Docket No. TGO-025WO translational modifications seem not to modify its kinase activity, they are involved in the different biological responses associated with LKB1, and likely in its interactions with other partners.”

[0030] The STK11 gene is located on human chromosome 19p 13. The gene includes nine coding exons and one noncoding exon and codes for the 433 amino acid serine / threonine-protein kinase STK11 protein, which is widely expressed in all tissues (Hemminki A, et al. Nature, 1998, 18,184-187; Alessi, D.R., et al. Annu. Rev. Biochem.2006, 75, 137-163; Sanchez- Cespedes M. Oncogene 2007, 26, 7825-7832). Somatic mutations or deletions of the STK11 gene are present in many cancers, including, but not limited to, lung adenocarcinomas (~15%), non-melanoma skin cancer (~5%), cholangiocarcinomas (~3%), ovarian carcinomas (approximately 3%) and pancreatic adenocarcinomas (~2%) (Sanchez-Cespedes M, et al. Cancer Res 2002, 62, 3659-62; Sanchez-Vega F, et al. Cell 2018, 173, 321-337.e10; Gurumurthy S, et al. Nature 2010, 468, 659-63; Ji H, et al. Nature 2007, 448, 807-10; Gill RK, et al. Oncogene 2011, 30, 3784-3791; Gao J, et al. Sci Signal 2013, 6 (269), pl 1; Cerami E, et al. Cancer Discov 2012, 2, 401-404; Zehir A, et al. Nat Med.2017, 23(6),703-713; Robinson DR, et al. Nature. 2017, 548, 297-303).

[0031] STK11 mutations found in cancer include point mutations (e.g., nonsense or frame shift mutations) predicted to be deleterious and oncogenic (Chakravarty D, et al. JCO Precis Oncol.2017, 2017) or small indels. Mutations in the STK11 gene frequently co-occur with other STK11 genomic alterations such as copy number alteration or gene deletions. These mutations and alterations result in loss of STK11 protein expression or loss of wild-type STK11 protein activity. Non-mutational mechanisms for modified expression (e.g., loss of expression) or modified activity (e.g., loss of wildtype activity) include genomic loss or promoter methylation.

[0032] As further described in Koenig, M. et al Cancer Research (2021) 81(16): 4194–4204 (doi: 10.1158 / 0008-5472), which is hereby incorporated by reference in its entirety: “Up to date, more than 400 unique mutations have been described for the STK11 gene, where ~70% of these mutations promote the truncation of the protein and the other 30% represent missense mutations (COSMIC and TCGA-Bioportal). As a tumor suppressor, a number of studies have shown the contributions of the genetic loss of LKB1 to tumorigenesis. It has been demonstrated that LKB1 controls cell cycle through the transcriptional regulation of Cyclin D1 and p21CDKN1A5, where re-expression of LKB1 leads to G1 cell cycle arrest. The role of LKB1 in controlling cell metabolism through AMPK signaling has been widely documented. We know that the LKB1- AMPK axis controls lipid and glucose metabolism, and acts as a negative regulator of theAttorney Docket No. TGO-025WO Warburg effect suppressing tumor growth. LKB1 is also important in the regulation of catabolic pathways leading to the increase of glucose uptake and modulation of glycolysis or the mobilization of lipid stores by stimulating lipases, such as adipose triglyceride lipase, to release fatty acids from triglyceride stores. LKB1-AMPK-stimulated pathways also include increased turnover of macromolecules by autophagy, allowing the turnover of old and damaged molecules, or the replenishment of nutrient stores under starvation. Additionally, several investigations have suggested the role of LKB1 in regulation of physiological and pathological angiogenesis through the regulation of VEGF, MMP-2, MMP-9, bFGF, and NOX1 expression, and its participation in neurophilin-1 degradation. Studies of LKB1 loss of function have also revealed its role in cell polarity and motility through the regulation of PAK115 and the modulation of the phosphorylation status of FAK and CDC42 activation. Together, these functions contribute to the induction of epithelial mesenchymal transition (EMT) and metastasis. In addition to this, in vivo experiments have shown evidence for the contribution of LKB1 to genotoxic DNA damage response and DNA damage repair.”

[0033] It has been reported that lung adenocarcinoma patients having cancer cells with STK11 loss of function mutations respond poorly to standard of care anti-PD-1 and anti-PD-L1 therapies. Skoulidis, F., et al Cancer Discovery 8(7): 822-835 (2018) (DOI: 10.1158 / 2159- 8290.CD-18-0099) and Skoulidis, F., et al Journal of Clinical Oncology 37(15): supp 102 (2019) (DOI: 10.1200 / JCO.2019.37.15_suppl.102), each of which is hereby incorporated by reference in their entirety. A pooled CRISPR-Cas9 based in vivo screen was performed and identified STK11 as an immune evasion context, where depletion of STK11 drives resistance to immune pressure in immune competent mice. Min, C., et al Cancer Research 81(Supp.13): 1905 (2021) (DOI: 10.1158 / 1538-7445.AM2021-1905), which is hereby incorporated by reference in its entirety.

[0034] STK11 mutations have been associated with low levels of T-cell inflammation and tumor PD-L1 expression. Biton J, et al. Clin Cancer Res 2018; 24:5710–23, which is hereby incorporated by reference in its entirety.

[0035] Similarly, STK11 mutations in NSCLC have been associated to poor responses to other treatment modalities including anti-VEGF therapies, platinum chemotherapies and additional single agent chemotherapies. Papillon-Cavanagh S. et al. ESMO Open, 2020, 5, E000706, which is hereby incorporated by reference in its entirety.

[0036] As used herein “modified expression” (e.g., STK11 modified expression) refers to a change in the expression levels (i.e., a decrease or increase in expression levels) of a protein in aAttorney Docket No. TGO-025WO cell (e.g., a cancer cell) in comparison to a reference cell (e.g., a healthy cell). In some embodiments, increased or decreased expression levels of a protein (e.g., STK11 protein) can be assessed by determining the copy number of the gene encoding the protein (e.g., the copy number of the STK11 gene) in a patient sample (e.g., a tumor sample) and comparing the levels with those present in a control sample (e.g., a healthy tissue sample). In some embodiments, increased or decreased expression levels of a protein (e.g., STK11 protein) can be assessed by determining the level of the protein (e.g., STK11 protein) or mRNA in a patient sample (e.g., a tumor sample) and comparing the levels with those present in a control sample (e.g., a healthy tissue sample).

[0037] As used herein “modified activity” (e.g., STK11 modified activity) refers to a change in the biological activity (e.g., enzyme activity) levels (i.e., a decrease or increase in the serine / threonine kinase activity levels of STK11) of a protein in a cell (e.g., a cancer cell) in comparison to a reference cell (e.g., a healthy cell). Mutations in the gene encoding the protein (e.g., STK11 mutations) can cause the expression of protein (e.g., mutant STK11 protein) with a level of enzymatic activity that is different from the enzymatic activity of the wild-type protein.

[0038] As used herein, an “STK11 mutation” is a mutation selected from: (i) a mutation in the nucleotide sequence encoding STK11; (ii) a mutation in a regulatory sequence controlling expression of the nucleotide sequence encoding STK11; (iii) a mutation in a nucleotide encoding a protein which interacts with the transcription product of the STK11 gene; (iv) a mutation in the translation product of the STK11 gene; and (v) a mutation in the transcription product of the STK11 gene.

[0039] In some embodiments, the STK11 mutation is a mutation selected from: (i) a mutation in the nucleotide sequence encoding STK11; (ii) a mutation in a regulatory sequence controlling expression of the nucleotide sequence encoding STK11; and (iii) a mutation in a nucleotide encoding a protein which interacts with the transcription product of the STK11 gene.Attorney Docket No. TGO-025WO

[0040] In some embodiments, the STK11 mutation is a mutation in the nucleotide sequence encoding STK11. In some embodiments, the STK11 mutation is a mutation in a regulatory sequence controlling expression of the nucleotide sequence encoding STK11. In some embodiments, the STK11 mutation is a mutation in a nucleotide encoding a protein which interacts with the transcription product of the STK11 gene. In some embodiments, the STK11 mutation is a mutation in the translation product of the STK11 gene. In some embodiments, the STK11 mutation is a mutation in the transcription product of the STK11 gene.

[0041] In some embodiments, the STK11 mutation is an inactivating or loss-of function mutation.

[0042] As used herein, a “loss-of-function mutation,” also referred to as “an inactivating mutation” refers to a mutation that results in expression of a mutant protein that exhibits reduced or absent biological activity or enzymatic activity compared to wild-type protein. A loss-of- function mutation in a gene (e.g., the STK11 gene) can also result in no expression of the wild- type protein, or the expression of only a fragment of the protein that exhibits reduced or absent biological or enzymatic activity compared to a wild-type protein. The mutation can be in a DNA nucleotide sequence, mRNA sequence, or protein sequence. In some embodiments, the mutation is a DNA mutation (e.g., a substitution, deletion, insertion, truncation, splice site, translation start site, fusion, or frameshift mutation).

[0043] In some embodiments, a loss-of-function mutation (e.g., a loss-of-function STK11 mutation) is one of the following: 1) a nonsense mutation (a genetic alteration that causes the premature termination of a protein). The altered protein may be partially or completely inactivated, resulting in a change or loss of protein function; 2) a frameshift mutation (an insertion or deletion involving a number of base pairs that is not a multiple of three, which consequently disrupts the triplet reading frame of a DNA sequence). Frameshift mutations generally cause the creation of a premature termination (stop) codon, and result in a truncated protein product; 3) a splice-site mutation (a genetic alteration in the DNA sequence that occurs at the boundary of an exon and an intron (splice site)). This change can disrupt RNA splicing resulting in the loss of exons or the inclusion of introns and an altered protein-coding sequence;Attorney Docket No. TGO-025WO 4) a translation start site mutation (a mutation that disrupts the translation initiation sequence, abolishing the initiation of translation at the normal start site, resulting in loss of mRNA translation or translation of an abnormal messenger RNA (mRNA)). Translation start site mutations result in loss of protein expression or in synthesis of a protein with an abnormal amino acid sequence; 5) a recurrent somatic mutation (having at least 5 instances recorded in the Catalogue of Somatic Mutations in Cancer (COSMIC) database) (Tate JG, et al. Nucleic Acids Res (2019) 47(D1), D941-D947); 6) a DNA fusion (a gene created by joining parts of two different genes; may be made when part of DNA from a chromosome moves to another chromosome); 7) any other mutation predicted to reduce the function of the encoded protein by the OncoKB algorithm (Chakravarty D, et al. JCO Precis Oncol.2017, 2017) or MutationAssessor (Reva B, Antipin Y, Sander C. Nucleic acids research.201 l;39(17):el 18);

[0044] In certain embodiments, the mutation is not a variant of unknown significance (a mutation for which the association with disease risk is unclear, also known as an unclassified variant, a variant of uncertain significance, or VUS (Richards S, et al. Standards and Guidelines for the Interpretation of Sequence Variants: A Joint Consensus Recommendation of the American College of Medical Genetics and Genomics and the Association for Molecular Pathology. Genet Med.2015 May; 17(5): 405-424.).

[0045] In some embodiments, the mutation is not a germline mutation (a gene change in a reproductive cell (egg or sperm) that becomes incorporated into the DNA of every cell in the body of the offspring), identified in the dbSNP (Sherry, S.T., et al.. Nucleic Acids Res, 2001, 29: 308-311).

[0046] Loss of function mutations of the STK11 gene (e.g., in a cancer cell) can result in the loss of expression of STK11 protein, the expression of only a fragment of the STK11 protein or the expression of a STK11 protein with reduced or absent enzymatic activity. (e.g., no serine / threonine kinase enzymatic activity).

[0047] Non-limiting examples of STK11 mutations that are loss-of-function mutations as defined herein are listed in Table 1 (adapted from WO2022087270). The mutations included in Table 1 were predicted to have deleterious function by OncoKB or had at least 5 occurrences inAttorney Docket No. TGO-025WO COSMIC, and excluded mutations and copy number alterations of unknown significance (i.e., VUS) and germline mutations.

[0048] One of skill in the art would appreciate that many STK11 mutations are known, or are otherwise identifiable. Table 1-Exemplary STK11 loss-of-function mutationsAttorney Docket No. TGO-025WOAttorney Docket No. TGO-025WOAttorney Docket No. TGO-025WOAttorney Docket No. TGO-025WOAttorney Docket No. TGO-025WOAttorney Docket No. TGO-025WO

[0049] One of skill in the art would also appreciate that STK11 mutations may co-occur with other mutations. Mutations in STK11 co-occur frequently with KRAS mutations. (Koivunen, J. et al. Br J Cancer 2008, 99, 245–252). STK11 somatic mutations also co-occur frequently with KEAP1 mutations (See Papillon-Cavanagh S. et al. ESMO Open, 2020, 5, E000706). Some authors report that the presence of STK11 and KEAP1 mutations have a bigger impact on immunotherapy resistance in patients with KRAS mutations than in patients with wild-type KRAS (See Ricciuti B. et al. Journal of Thoracic Oncology 2021, 17, 400-410).

[0050] In some embodiments provided herein, the cancer is identified as having modified STK11 activity or expression and as having modified KRAS activity or expression. In some embodiment, the modified KRAS activity or expression is the presence of a mutant KRAS. In some embodiment, the mutant KRAS is selected from KRASG12C, KRASG12D, KRASG12V, KRASG12A, KRASG12S, KRASG12R, KRASG13C, KRASG13D, KRASG13S, KRASQ61HandAttorney Docket No. TGO-025WO KRASQ61K. In some embodiments, the mutant KRAS is selected from KRASG12C, KRASG12Dand KRASG12V. In some embodiments provided herein, the cancer is identified as having modified STK11 activity or expression and as having wildtype KRAS activity or expression. In some embodiments provided herein, the cancer is identified as having modified STK11 activity or expression and as having modified KRAS (e.g., KRASG12C, KRASG12D, KRASG12V) activity or expression or wildtype KRAS activity or expression. In some embodiments, the cancer is further identified as having modified KEAP1 activity or expression (e.g., KEAP1 mutations).

[0051] One of skill in the art would also appreciate that STK11 mutations may frequently occur in certain diseases (e.g., cancer). Compound

[0052] In some embodiments, provided herein is histone deacetylase (HDAC) inhibitor (e.g., HDAC1,2-selective inhibitor, CoREST-selective deacetylase inhibitor) (R)-N-(4-amino-4'- fluoro-[1,1'-biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide , having Formula (I):Formula (I), or a pharmaceutically acceptable salt thereof.

[0053] The compound of Formula (I) is also known as TNG260. The compound of Formula (I) can be referred to as “Compound I” interchangeably.

[0054] In some embodiments, the compound of Formula (I) is a free base.

[0055] In certain embodiments, the compound of Formula (I) is a crystalline form of the free base of compound of formula (I) (e.g., a crystalline form selected from Form A, Form B1, Form B2, Form C, Form D, Form E, Form F, Form G, Form H and Form I). Crystalline Form A

[0056] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form A. Crystalline Form A is an anhydrous crystalline form of theAttorney Docket No. TGO-025WO compound of formula (I). References to “Form A” without additional modifiers refer to the free base crystalline Form A.

[0057] Form A has high crystallinity as evidenced by its X-ray Powder Diffraction pattern (XRPD) (FIG.1A). No solvent residue is observed by NMR (FIG.1D).

[0058] DSC (FIG.1C) shows a melting peak at Tonset of 170.7°C with an enthalpy of 95J / g. TGA (FIG.1B) shows about 0.3% weight loss at about 150°C.

[0059] Form A is the most stable anhydrate of the anhydrous forms disclosed herein atRH 40%. When RH is 50%, hydrate Form H is more stable.

[0060] Bulk stability of Form A was evaluated at 25°C / 92.5%RH in an open container, at 40°C / 75%RH in an open container and at 60°C in a tight container over 1 week, and it was determined that Form A is chemically stable under these conditions. Though Form A is only thermodynamically stable when RH is 40% at 25°C, it shows good kinetic stability in physical form under these conditions over 1 week, even in high RH (Example 8).

[0061] Hygroscopicity of Form A was evaluated by dynamic vapor sorption (DVS) test at 25°C. Form A is slightly hygroscopic in <70%RH, and it becomes hygroscopic and shows ~13% water uptake in 95%RH at 25°C (FIG.1D, Example 2). No change in crystalline form was observed after DVS experiment.

[0062] Solubility of the Form A was measured in 7 pH buffers and bio-relevant fluids including pH 1.2 HCl solution (0.2N), pH 4.5 acetate buffer (50mM), pH 6.8 phosphate buffer (50mM), pH 2.0 SGF, pH 6.5 FaSSIF-v1, pH 5.0 FeSSIF-v1 and pure water at 37°C for 1h and 24h, respectively, and was compared with the solubility of a crystalline tosylate salt (tosylate Form A) and a mono-fumaric acid cocrystal (fumaric cocrystal Form A). Residual solids after the solubility test were analyzed by XRPD.

[0063] Form A and the salt / cocrystal candidates showed comparable and pH dependent solubility in the aqueous media. Their solubility reached about 1.5- >2mg / mL in pH 1.2 HCl solution but decreased to about 30μg / mL in pH 6.8 phosphate buffer. Solubility in SGF (pH 2.0) and in water was slightly higher for Tosylate Form A (1.4mg / mL) and the fumaric cocrystal Form A (1mg / mL) compared to free base Form A (0.8mg / mL). However, the tosylate Form A, resulted in an HPLC-detectable degradation product in supernatant after solubility test in SGF (pH 2.0). The tosylate Form A and the mono-fumaric acid cocrystal Form A dissociated to crystalline free form in pH 4.5 buffer, pH 6.8 buffer, water, FaSSIF-v1 and FeSSIF-v1. Both theAttorney Docket No. TGO-025WO Form A and the salt / cocrystal candidates converted to an HCl salt crystalline form after the solubility test in pH 1.2 HCl solution.

[0064] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingat least one (e.g., one, two, three or four) characteristic peaks at values of 2 in degrees selectedfrom 13.1±0.2, 15±0.2, 22.3±0.2 and 24±0.2. In certain embodiments, Form A has an X-raypowder diffraction pattern comprising at least one characteristic peak at values of 2 in degreesselected from 13.1±0.2, 15±0.2, 22.3±0.2 and 24±0.2. In certain embodiments, Form A has anX-ray powder diffraction pattern comprising at least two characteristic peaks at values of 2 indegrees selected from 13.1±0.2, 15±0.2, 22.3±0.2 and 24±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least three characteristic peaks at values of2 in degrees selected from 13.1±0.2, 15±0.2, 22.3±0.2 and 24±0.2.

[0065] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 13.1±0.2, 15±0.2, 22.3±0.2 and 24±0.2.

[0066] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 13.1±0.2, 15±0.2, 22.3±0.2 and 24±0.2 and atleast one (e.g., one, two, three, four, five or six) additional characteristic peak at values of 2 indegrees selected from 5.3±0.2, 10.6±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.7±0.2, 22.8±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2.

[0067] In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2,18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least one characteristic peak at values of 2 indegrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-raypowder diffraction pattern comprising at least two characteristic peaks at values of 2 in degreesselected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powderdiffraction pattern comprising at least three characteristic peaks at values of 2 in degreesselected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2,Attorney Docket No. TGO-025WO 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powderdiffraction pattern comprising at least four characteristic peaks at values of 2 in degreesselected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction patterncomprising at least six characteristic peaks at values of 2 in degrees selected from 5.3±0.2,10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingat least seven characteristic peaks at values of 2 in degrees selected from 5.3±0.2, 10.6±0.2,13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks at values of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2,15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least nine characteristic peaks atvalues of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2,18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least ten characteristic peaks at values of 2 indegrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2.

[0068] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2,17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.2.Attorney Docket No. TGO-025WO

[0069] In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three or four) characteristic peaks between and including thefollowing values of 2 in degrees: 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 22.1to 22.5 (e.g., 22.3±0.2) and 23.8 to 24.2 (e.g., 24±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least one characteristic peak between andincluding the following values of 2 in degrees: 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g.,15±0.2), 22.1 to 22.5 (e.g., 22.3±0.2) and 23.8 to 24.2 (e.g., 24±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least two characteristic peaksbetween and including the following values of 2 in degrees: 12.9 to 13.3 (e.g., 13.1±0.2), 14.8to 15.2 (e.g., 15±0.2), 22.1 to 22.5 (e.g., 22.3±0.2) and 23.8 to 24.2 (e.g., 24±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least threecharacteristic peaks between and including the following values of 2 in degrees: 12.9 to 13.3(e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 22.1 to 22.5 (e.g., 22.3±0.2) and 23.8 to 24.2 (e.g., 24±0.2).

[0070] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 12.9 to 13.3(e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 22.1 to 22.5 (e.g., 22.3±0.2) and 23.8 to 24.2 (e.g., 24±0.2).

[0071] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 12.9 to 13.3(e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 22.1 to 22.5 (e.g., 22.3±0.2) and 23.8 to 24.2 (e.g., 24±0.2) and at least one (e.g., one, two, three, four, five or six) additional characteristic peaksbetween and including values of 2 in degrees selected from: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to10.8 (e.g., 10.6±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2).

[0072] In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2),Attorney Docket No. TGO-025WO 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least one characteristic peak between andincluding the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g.,10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least two characteristic peaks between andincluding the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g.,10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least three characteristic peaks betweenand including the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g.,10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least four characteristic peaks betweenand including the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g.,10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g.,Attorney Docket No. TGO-025WO 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least five characteristic peaks between andincluding the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g.,10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least six characteristic peaks between andincluding the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g.,10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least seven characteristic peaks betweenand including the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g.,10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2).

[0073] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 5.1 to 5.5 (e.g.,5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7Attorney Docket No. TGO-025WO (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks between and including the following values of 2 in degrees: 5.1 to 5.5 (e.g.,5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks between and including the following values of 2 in degrees: 5.1 to 5.5 (e.g.,5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least tencharacteristic peaks between and including the following values of 2 in degrees: 5.1 to 5.5 (e.g.,5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2) and 28.3 to 28.7 (e.g., 28.5±0.2).

[0074] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 13.1±0.2, 15±0.2, 22.3±0.2 and 24±0.2 and atleast one (e.g., one, two, three, four, five or six) additional characteristic peak at values of 2 indegrees selected from 5.3±0.2, 10.6±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.7±0.2, 22.8±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2.

[0075] In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atAttorney Docket No. TGO-025WOvalues of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2,18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powderdiffraction pattern comprising at least one characteristic peak at values of 2 in degrees selectedfrom 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least twocharacteristic peaks at values of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2,15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least three characteristic peaks at values of 2 indegrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction patterncomprising at least four characteristic peaks at values of 2 in degrees selected from 5.3±0.2,10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least fivecharacteristic peaks at values of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2,15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least six characteristic peaks at values of 2 indegrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction patterncomprising at least seven characteristic peaks at values of 2 in degrees selected from 5.3±0.2,10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2,Attorney Docket No. TGO-025WO 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks at values of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2,15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least nine characteristic peaks at values of 2 indegrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2. In certain embodiments, Form A has an X-ray powder diffraction patterncomprising at least ten characteristic peaks at values of 2 in degrees selected from 5.3±0.2,10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2.

[0076] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2,17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.2.

[0077] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 12.9 to 13.3(e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 22.1 to 22.5 (e.g., 22.3±0.2) and 23.8 to 24.2 (e.g., 24±0.2) and at least one (e.g., one, two, three, four, five or six) additional characteristic peaksbetween and including values of 2 in degrees selected from: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to10.8 (e.g., 10.6±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2).Attorney Docket No. TGO-025WO

[0078] In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least onecharacteristic peak between and including the following values of 2 in degrees: 5.1 to 5.5 (e.g.,5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingat least two characteristic peaks between and including the following values of 2 in degrees: 5.1to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least three characteristic peaks between and includingthe following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2),Attorney Docket No. TGO-025WO 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least four characteristic peaksbetween and including the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least fivecharacteristic peaks between and including the following values of 2 in degrees: 5.1 to 5.5 (e.g.,5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingat least six characteristic peaks between and including the following values of 2 in degrees: 5.1to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g.,Attorney Docket No. TGO-025WO 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least seven characteristic peaks between and includingthe following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2),12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least eight characteristic peaksbetween and including the following values of 2 in degrees: 5.1 to 5.5 (e.g., 5.3±0.2), 10.4 to10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks between and including the following values of 2 in degrees: 5.1 to 5.5 (e.g.,5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g.,Attorney Docket No. TGO-025WO 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2). In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingat least ten characteristic peaks between and including the following values of 2 in degrees: 5.1to 5.5 (e.g., 5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2).

[0079] In certain embodiments, Form A has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 5.1 to 5.5 (e.g.,5.3±0.2), 10.4 to 10.8 (e.g., 10.6±0.2), 12.9 to 13.3 (e.g., 13.1±0.2), 14.8 to 15.2 (e.g., 15±0.2), 15.6 to 16 (e.g., 15.8±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.4 to 19.8 (e.g., 19.6±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22.1 to 22.5 (e.g., 22.3±0.2), 22.5 to 22.9 (e.g., 22.7±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 25.6 to 26 (e.g., 25.8±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 29.1 to 29.5 (e.g., 29.3±0.2), 31.7 to 32.1 (e.g., 31.9±0.2), 37.1 to 37.5 (e.g., 37.3±0.2), 37.3 to 37.7 (e.g., 37.5±0.2), 37.1 to 37.5 (e.g., 37.3±0.2) and 37.3 to 37.7 (e.g., 37.5±0.2).

[0080] In some embodiments, Form A has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG. 1A.

[0081] In some embodiments, Form A has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine, or tencharacteristic peaks, in terms of 2 values in degrees shown in Table 2 (±0.2 degrees).

[0082] In some embodiments, Form A has an XRPD pattern (obtained using CuKa radiation)comprising at least 50% of the peaks at 2 values in degrees and with relative intensities shownin Table 2 allowing for variation due to experimental conditions.Attorney Docket No. TGO-025WO Table 2-XRPD peaks for Form A of a compound of Formula (I)Attorney Docket No. TGO-025WO

[0083] In certain embodiments, Form A is substantially characterized by the thermal gravimetric analysis (TGA) as shown in FIG.1B.

[0084] In certain embodiments, Form A is substantially characterized by the differential scanning calorimetry profile (DSC) shown in FIG.1C. In some embodiments, Form A can be characterized by the differential scanning calorimetry profile (DSC) shown in FIG.1C, showing DSC shows a melting peak at Tonset of 170.7°C with an enthalpy of 95J / g.

[0085] In certain embodiments, Form A is substantially characterized by the DVS profile as shown in FIG.1D. Crystalline Form B1

[0086] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form B1. Crystalline Form B1 is an ethyl acetate (EA) solvate crystalline form of the compound of formula (I).

[0087] Form B1 can obtained from THF / EA solvent mixtures by anti-solvent addition. Form B1 is of high crystallinity. DSC (FIG.2C) shows a desolvation peak from 110.7°C, an exothermic peak at Tonset of 142.0°C and a melting peak at Tonset of 203.4°C with an enthalpy of about 75J / g, which corresponds to melting of Form F. TGA (FIG.2B) shows about 0.6% weight loss at about 100°C and about 5.5% weight loss from about 100°C to 150°C.1H-NMR (FIG. 2D) shows 4.4% EA residue by weight.

[0088] In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 15.3±0.2,15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 11.1±0.2, 11.8±0.2,12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction patterncomprising at least two characteristic peaks at values of 2 in degrees selected from 5.1±0.2,5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2,Attorney Docket No. TGO-025WO 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least three characteristic peaks at values of 2 indegrees selected from 5.1±0.2, 5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least fourcharacteristic peaks at values of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 11.1±0.2,11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5.1±0.2, 5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least six characteristic peaks at values of2 in degrees selected from 5.1±0.2, 5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2,17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least sevencharacteristic peaks at values of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 11.1±0.2,11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powderdiffraction pattern comprising at least eight characteristic peaks at values of 2 in degreesselected from 5.1±0.2, 5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least nine characteristic peaks atvalues of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 15.3±0.2,15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least tencharacteristic peaks at values of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 11.1±0.2,11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2.

[0089] In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5.1±0.2, 5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.2.Attorney Docket No. TGO-025WO

[0090] In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1(e.g., 5.9±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least one characteristic peak between and including thefollowing values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10.9 to11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least two characteristic peaks between and including the following values of 2 in degrees: 4.9to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least three characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1(e.g., 5.9±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least four characteristic peaks between and including thefollowing values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10.9 to11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g.,Attorney Docket No. TGO-025WO 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least five characteristic peaks between and including the following values of 2 in degrees: 4.9to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least six characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1(e.g., 5.9±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least seven characteristic peaks between and including thefollowing values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10.9 to11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least eight characteristic peaks between and including the following values of 2 in degrees:4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least nine characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1(e.g., 5.9±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2). In certain embodiments, Form B1 has an X-ray powderAttorney Docket No. TGO-025WO diffraction pattern comprising at least ten characteristic peaks between and including thefollowing values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10.9 to11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2).

[0091] In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 4.9 to 5.3 (e.g.,5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2) and 25.8 to 26.2 (e.g., 26±0.2).

[0092] In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least one characteristic peak at valuesof 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least two characteristic peaks at valuesof 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least three characteristic peaks atvalues of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2,Attorney Docket No. TGO-025WO 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least four characteristic peaks at valuesof 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least five characteristic peaks at valuesof 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least six characteristic peaks at valuesof 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least seven characteristic peaks atvalues of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least eight characteristic peaks atvalues of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least nine characteristic peaks atvalues of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2. In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least ten characteristic peaks at valuesof 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2,Attorney Docket No. TGO-025WO 14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2.

[0093] In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2,12.6±0.2, 14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.2.

[0094] In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1(e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least one characteristic peak between and including the following values of 2 in degrees: 4.9to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least two characteristic peaks between and including the following values of 2 in degrees: 4.9Attorney Docket No. TGO-025WO to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least three characteristic peaks between and including the following values of 2 in degrees:4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least four characteristic peaks between and including the following values of 2 in degrees:4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least five characteristic peaks between and including the following values of 2 in degrees: 4.9to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g.,Attorney Docket No. TGO-025WO 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least six characteristic peaks between and including the following values of 2 in degrees: 4.9to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least seven characteristic peaks between and including the following values of 2 in degrees:4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least eight characteristic peaks between and including the following values of 2 in degrees:4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2),Attorney Docket No. TGO-025WO 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least nine characteristic peaks between and including the following values of 2 in degrees:4.9 to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2). In certain embodiments, Form B1 has an X-ray powder diffraction pattern comprisingat least ten characteristic peaks between and including the following values of 2 in degrees: 4.9to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g., 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2).

[0095] In certain embodiments, Form B1 has an X-ray powder diffraction patterncomprising characteristic peaks between and including the following values of 2 in degrees: 4.9to 5.3 (e.g., 5.1±0.2), 5.7 to 6.1 (e.g., 5.9±0.2), 10 to 10.4 (e.g., 10.2±0.2), 10.9 to 11.3 (e.g.,Attorney Docket No. TGO-025WO 11.1±0.2), 11.6 to 12 (e.g., 11.8±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 14.1 to 14.5 (e.g., 14.3±0.2), 15.1 to 15.5 (e.g., 15.3±0.2), 15.5 to 15.9 (e.g., 15.7±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.9 to 20.3 (e.g., 20.1±0.2), 21.2 to 21.6 (e.g., 21.4±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.3 to 22.7 (e.g., 22.5±0.2), 23.2 to 23.6 (e.g., 23.4±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 25.3 to 25.7 (e.g., 25.5±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.4 to 26.8 (e.g., 26.6±0.2), 27.1 to 27.5 (e.g., 27.3±0.2), 28.1 to 28.5 (e.g., 28.3±0.2), 29.4 to 29.8 (e.g., 29.6±0.2), 31.4 to 31.8 (e.g., 31.6±0.2) and 31.9 to 32.3 (e.g., 32.1±0.2).

[0096] In some embodiments, Form B1 has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG.2A.

[0097] In some embodiments, Form B1 has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine,or ten characteristic peaks, in terms of 2 values in degrees shown in Table 3 (±0.2 degrees).

[0098] In some embodiments, Form B1 has an XRPD pattern (obtained using CuKaradiation) comprising at least 50% of the peaks at 2 values in degrees and with relativeintensities shown in Table 3 allowing for variation due to experimental conditions. Table 3 – XRPD peaks for Form B1 of a compound of Formula (I)Attorney Docket No. TGO-025WO

[0099] In certain embodiments, Form B1 is substantially characterized by the thermal gravimetric analysis (TGA) as shown in FIG.2B.

[0100] In certain embodiments, Form B1 is substantially characterized by the differential scanning calorimetry profile (DSC) shown in FIG.2C. In some embodiments, Form B1 can be characterized by the differential scanning calorimetry profile (DSC) shown in FIG.2C, showing a desolvation peak from 110.7°C, an exothermic peak at Tonset of 142.0°C and a melting peak at Tonset of 203.4°C with an enthalpy of about 75J / g.Attorney Docket No. TGO-025WO Crystalline Form B2

[0101] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form B2. Crystalline Form B2 is an acetonitrile (ACN) solvate crystalline form of the compound of formula (I).

[0102] Form B2 can be obtained from ACN by competitive equilibration experiments.

[0103] Form B2 is of high crystallinity. DSC (FIG.3C) shows a desolvation peak from 111.1°C, an exothermic peak at Tonset of 138.1°C and a melting peak at Tonset of 201.0°C with an enthalpy of about 79J / g. TGA (FIG.3B) shows about 1.1% weight loss at about 100°C and about 3.4% weight loss from about 100°C to 150°C.1H-NMR (FIG.3D) shows 3.1% ACN residue by weight. Form B2 shows similar XRPD pattern to that of Form B1, suggesting they are isostructural solvates.

[0104] In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2,18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2,15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-ray powder diffraction patterncomprising at least two characteristic peaks at values of 2 in degrees selected from 6±0.2,11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-raypowder diffraction pattern comprising at least three characteristic peaks at values of 2 indegrees selected from 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least fourcharacteristic peaks at values of 2 in degrees selected from 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2,15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-ray powder diffraction patterncomprising at least five characteristic peaks at values of 2 in degrees selected from 6±0.2,11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-rayAttorney Docket No. TGO-025WOpowder diffraction pattern comprising at least six characteristic peaks at values of 2 in degreesselected from 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least seven characteristic peaks atvalues of 2 in degrees selected from 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2,18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks at values of 2 in degrees selected from 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2,15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-ray powder diffraction patterncomprising at least nine characteristic peaks at values of 2 in degrees selected from 6±0.2,11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2. In certain embodiments, Form B2 has an X-raypowder diffraction pattern comprising at least ten characteristic peaks at values of 2 in degreesselected from 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2.

[0105] In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 6±0.2, 11.2±0.2, 12±0.2, 15.2±0.2, 15.6±0.2,17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2.

[0106] In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 5.8 to 6.2 (e.g., 6±0.2), 11 to 11.4(e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprisingat least one characteristic peak between and including the following values of 2 in degrees: 5.8to 6.2 (e.g., 6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g.,Attorney Docket No. TGO-025WO 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least two characteristic peaks between and includingthe following values of 2 in degrees: 5.8 to 6.2 (e.g., 6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least threecharacteristic peaks between and including the following values of 2 in degrees: 5.8 to 6.2 (e.g.,6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction patterncomprising at least four characteristic peaks between and including the following values of 2 indegrees: 5.8 to 6.2 (e.g., 6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least five characteristic peaks between and includingthe following values of 2 in degrees: 5.8 to 6.2 (e.g., 6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least sixcharacteristic peaks between and including the following values of 2 in degrees: 5.8 to 6.2 (e.g.,6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction patterncomprising at least seven characteristic peaks between and including the following values of 2Attorney Docket No. TGO-025WO in degrees: 5.8 to 6.2 (e.g., 6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least eight characteristic peaks between and includingthe following values of 2 in degrees: 5.8 to 6.2 (e.g., 6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks between and including the following values of 2 in degrees: 5.8 to 6.2 (e.g.,6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction patterncomprising at least ten characteristic peaks between and including the following values of 2 indegrees: 5.8 to 6.2 (e.g., 6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2).

[0107] In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 5.8 to 6.2 (e.g.,6±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.3 to 26.7 (e.g., 26.5±0.2) and 27.5 to 27.9 (e.g., 27.7±0.2).Attorney Docket No. TGO-025WO

[0108] In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2,12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least one characteristic peak at valuesof 2 in degrees selected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2,15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has anX-ray powder diffraction pattern comprising at least two characteristic peaks at values of 2 indegrees selected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-raypowder diffraction pattern comprising at least three characteristic peaks at values of 2 indegrees selected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-raypowder diffraction pattern comprising at least four characteristic peaks at values of 2 in degreesselected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-ray powderdiffraction pattern comprising at least six characteristic peaks at values of 2 in degrees selectedfrom 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2,Attorney Docket No. TGO-025WO 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-ray powderdiffraction pattern comprising at least seven characteristic peaks at values of 2 in degreesselected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-ray powderdiffraction pattern comprising at least eight characteristic peaks at values of 2 in degreesselected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-ray powderdiffraction pattern comprising at least nine characteristic peaks at values of 2 in degreesselected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2. In certain embodiments, Form B2 has an X-ray powderdiffraction pattern comprising at least ten characteristic peaks at values of 2 in degrees selectedfrom 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2.

[0109] In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2,12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.2.

[0110] In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2),Attorney Docket No. TGO-025WO 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least one characteristic peakbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least two characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least three characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 toAttorney Docket No. TGO-025WO 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least four characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least five characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least six characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g.,Attorney Docket No. TGO-025WO 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least seven characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least eight characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least nine characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 , 23.3 to 23.7 (e.g., 23.5±0.2),Attorney Docket No. TGO-025WO 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2). In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprising at least ten characteristic peaksbetween and including the following values of 2 in degrees: 4.9 to 5.3 (e.g., 5.1±0.2), 5.8 to 6.2(e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2).

[0111] In certain embodiments, Form B2 has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 4.9 to 5.3 (e.g.,5.1±0.2), 5.8 to 6.2 (e.g., 6±0.2), 9 to 9.4 (e.g., 9.2±0.2), 9.9 to 10.3 (e.g., 10.1±0.2), 11 to 11.4 (e.g., 11.2±0.2), 11.8 to 12.2 (e.g., 12±0.2), 12.4 to 12.8 (e.g., 12.6±0.2), 15 to 15.4 (e.g., 15.2±0.2), 15.4 to 15.8 (e.g., 15.6±0.2), 16.8 to 17.2 (e.g., 17±0.2), 17 to 17.4 (e.g., 17.2±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 21.6 to 22 (e.g., 21.8±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.3 to 23.7 (e.g., 23.5±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24 to 24.4 (e.g., 24.2±0.2), 24.7 to 25.1 (e.g., 24.9±0.2), 25.5 to 25.9 (e.g., 25.7±0.2), 26.3 to 26.7 (e.g., 26.5±0.2), 26.6 to 27 (e.g., 26.8±0.2), 27.5 to 27.9 (e.g., 27.7±0.2), 31.3 to 31.7 (e.g., 31.5±0.2) and 32.4 to 32.8 (e.g., 32.6±0.2).

[0112] In some embodiments, Form B2 has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG.3A.

[0113] In some embodiments, Form B2 has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine,or ten characteristic peaks, in terms of 2 values in degrees shown in Table 4 (±0.2 degrees).Attorney Docket No. TGO-025WO

[0114] In some embodiments, Form B2 has an XRPD pattern (obtained using CuKaradiation) comprising at least 50% of the peaks at 2 values in degrees and with relativeintensities shown in Table 4 allowing for variation due to experimental conditions. Table 4 – XRPD peaks for Form B2 of a compound of Formula (I)Attorney Docket No. TGO-025WO

[0115] In certain embodiments, Form B2 is substantially characterized by the thermal gravimetric analysis (TGA) as shown in FIG.3B.

[0116] In certain embodiments, Form B2 is substantially characterized by the differential scanning calorimetry profile (DSC) shown in FIG.3C. In some embodiments, Form B2 can be characterized by the differential scanning calorimetry profile (DSC) shown in FIG.3C, showing a desolvation peak from 111.1°C, an exothermic peak at Tonset of 138.1°C and a melting peak at Tonset of 201.0°C with an enthalpy of about 79J / g. TGA. Crystalline Form C

[0117] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form C. Crystalline Form C is an 1,4-dioxane solvate crystalline form of the compound of formula (I).

[0118] Form C can be obtained from 1,4-dioxane by fast cooling.

[0119] Crystalline Form C is of medium crystallinity. Form C is unstable and converts to anhydrate Form D after exposure to about 25°C / 40% RH for about 1 day.

[0120] In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 10.5±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 18.4±0.2,18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least oneAttorney Docket No. TGO-025WOcharacteristic peak at values of 2 in degrees selected from 10.5±0.2, 15.9±0.2, 16±0.2,16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powderdiffraction pattern comprising at least two characteristic peaks at values of 2 in degrees selectedfrom 10.5±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least three characteristic peaks at values of2 in degrees selected from 10.5±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2,19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least fourcharacteristic peaks at values of 2 in degrees selected from 10.5±0.2, 15.9±0.2, 16±0.2,16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 10.5±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least six characteristic peaks at values of2 in degrees selected from 10.5±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2,19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least sevencharacteristic peaks at values of 2 in degrees selected from 10.5±0.2, 15.9±0.2, 16±0.2,16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powderdiffraction pattern comprising at least eight characteristic peaks at values of 2 in degreesselected from 10.5±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks at values of 2 in degrees selected from 10.5±0.2, 15.9±0.2, 16±0.2,16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2. In certain embodiments, Form C has an X-ray powderdiffraction pattern comprising at least ten characteristic peaks at values of 2 in degrees selectedfrom 10.5±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2.Attorney Docket No. TGO-025WO

[0121] In certain embodiments, Form C has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 10.5±0.2, 15.9±0.2, 16±0.2, 16.5±0.2,17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2.

[0122] In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction patterncomprising at least one characteristic peak between and including the following values of 2 indegrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least two characteristic peaks between andincluding the following values of 2 in degrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1 (e.g.,15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprisingat least three characteristic peaks between and including the following values of 2 in degrees:10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least four characteristic peaks betweenand including the following values of 2 in degrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1Attorney Docket No. TGO-025WO (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction patterncomprising at least five characteristic peaks between and including the following values of 2 indegrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least six characteristic peaks between andincluding the following values of 2 in degrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1 (e.g.,15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprisingat least seven characteristic peaks between and including the following values of 2 in degrees:10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least eight characteristic peaks betweenand including the following values of 2 in degrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1(e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction patterncomprising at least nine characteristic peaks between and including the following values of 2 indegrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 toAttorney Docket No. TGO-025WO 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least ten characteristic peaks between andincluding the following values of 2 in degrees: 10.3 to 10.7 (e.g., 10.5±0.2), 15.7 to 16.1 (e.g.,15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2).

[0123] In certain embodiments, Form C has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 10.3 to 10.7(e.g., 10.5±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.1 to 26.5 (e.g., 26.3±0.2).

[0124] In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2, 16±0.2,16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2,15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising atleast two characteristic peaks at values of 2 in degrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2,11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-ray powder diffraction patterncomprising at least three characteristic peaks at values of 2 in degrees selected from 5.2±0.2,7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2,Attorney Docket No. TGO-025WO 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-raypowder diffraction pattern comprising at least four characteristic peaks at values of 2 in degreesselected from 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least five characteristic peaks at values of2 in degrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2,17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least sixcharacteristic peaks at values of 2 in degrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2,11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-ray powder diffraction patterncomprising at least seven characteristic peaks at values of 2 in degrees selected from 5.2±0.2,7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-raypowder diffraction pattern comprising at least eight characteristic peaks at values of 2 indegrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks at values of 2 in degrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2,11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2. In certain embodiments, Form C has an X-ray powder diffraction patterncomprising at least ten characteristic peaks at values of 2 in degrees selected from 5.2±0.2,7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2.Attorney Docket No. TGO-025WO

[0125] In certain embodiments, Form C has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2,16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.2.

[0126] In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 5 to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1(e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X- ray powder diffraction pattern comprising at least one characteristic peak between and includingthe following values of 2 in degrees: 5 to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X-ray powder diffraction patterncomprising at least two characteristic peaks between and including the following values of 2 indegrees: 5 to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprisingat least three characteristic peaks between and including the following values of 2 in degrees: 5Attorney Docket No. TGO-025WO to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least fourcharacteristic peaks between and including the following values of 2 in degrees: 5 to 5.4 (e.g.,5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least five characteristic peaksbetween and including the following values of 2 in degrees: 5 to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1(e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X- ray powder diffraction pattern comprising at least six characteristic peaks between and includingthe following values of 2 in degrees: 5 to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X-ray powder diffraction patternAttorney Docket No. TGO-025WOcomprising at least seven characteristic peaks between and including the following values of 2in degrees: 5 to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprisingat least eight characteristic peaks between and including the following values of 2 in degrees: 5to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks between and including the following values of 2 in degrees: 5 to 5.4 (e.g.,5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2). In certain embodiments, Form C has an X-ray powder diffraction pattern comprising at least ten characteristic peaksbetween and including the following values of 2 in degrees: 5 to 5.4 (e.g., 5.2±0.2), 7.7 to 8.1(e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2),Attorney Docket No. TGO-025WO 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2).

[0127] In certain embodiments, Form C has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 5 to 5.4 (e.g.,5.2±0.2), 7.7 to 8.1 (e.g., 7.9±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.7 to 16.1 (e.g., 15.9±0.2), 15.8 to 16.2 (e.g., 16±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 16.9 to 17.3 (e.g., 17.1±0.2), 17.4 to 17.8 (e.g., 17.6±0.2), 18.2 to 18.6 (e.g., 18.4±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21 to 21.4 (e.g., 21.2±0.2), 23.6 to 24 (e.g., 23.8±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 24.6 to 25 (e.g., 24.8±0.2), 25.6 to 26 (e.g., 25.8±0.2), 25.9 to 26.3 (e.g., 26.1±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 28.2 to 28.6 (e.g., 28.4±0.2), 29 to 29.4 (e.g., 29.2±0.2) and 35.3 to 35.7 (e.g., 35.5±0.2).

[0128] In some embodiments, Form C has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG.4.

[0129] In some embodiments, Form C has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine, or tencharacteristic peaks, in terms of 2 values in degrees shown in Table 5 (±0.2 degrees).

[0130] In some embodiments, Form C has an XRPD pattern (obtained using CuKa radiation)comprising at least 50% of the peaks at 2 values in degrees and with relative intensities shownin Table 5 allowing for variation due to experimental conditions. Table 5 – XRPD peaks for Form C of a compound of Formula (I)Attorney Docket No. TGO-025WOCrystalline Form D

[0131] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form D. Crystalline Form D is an anhydrous crystalline form of the compound of formula (I).

[0132] Form D can be obtained after exposing Form C to about 25°C / 40%RH for 1 day.

[0133] Form D is of medium crystallinity. DSC (FIG.5C) shows a melting peak at Tonsetof 160.2°C, an exothermic peak at Tonsetof 165.5°C and a melting peak at Tonsetof 181.7°C. TGA (FIG.5B) shows about 0.8% weight loss at about 150°C.1H-NMR (FIG.5D) shows 0.5% 1,4- dioxane residue by weight. Form D converts to Form G after heating to 170°C.

[0134] In certain embodiments, Form D has an X-ray powder diffraction pattern comprisingat least one (e.g., one, two, three, four or five) characteristic peaks at values of 2 in degreesselected from 16.1±0.2, 16.9±0.2, 19.4±0.2, 20.7±0.2 and 24.3±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least one characteristic peak atvalues of 2 in degrees selected from 16.1±0.2, 16.9±0.2, 19.4±0.2, 20.7±0.2 and 24.3±0.2. Incertain embodiments, Form D has an X-ray powder diffraction pattern comprising at least twocharacteristic peaks at values of 2 in degrees selected from 16.1±0.2, 16.9±0.2, 19.4±0.2,20.7±0.2 and 24.3±0.2. In certain embodiments, Form D has an X-ray powder diffraction patterncomprising at least three characteristic peaks at values of 2 in degrees selected from 16.1±0.2,Attorney Docket No. TGO-025WO 16.9±0.2, 19.4±0.2, 20.7±0.2 and 24.3±0.2. In certain embodiments, Form D has an X-raypowder diffraction pattern comprising at least four characteristic peaks at values of 2 in degreesselected from 16.1±0.2, 16.9±0.2, 19.4±0.2, 20.7±0.2 and 24.3±0.2.

[0135] In certain embodiments, Form D has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 16.1±0.2, 16.9±0.2, 19.4±0.2, 20.7±0.2 and24.3±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four or five) characteristic peaks between and including thefollowing values of 2 in degrees: 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2),19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2) and 24.1 to 24.5 (e.g., 24.3±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least onecharacteristic peak between and including the following values of 2 in degrees: 15.9 to 16.3(e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2) and 24.1 to 24.5 (e.g., 24.3±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least two characteristic peaks between and includingthe following values of 2 in degrees: 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2),19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2) and 24.1 to 24.5 (e.g., 24.3±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least threecharacteristic peaks between and including the following values of 2 in degrees: 15.9 to 16.3(e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2) and 24.1 to 24.5 (e.g., 24.3±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least four characteristic peaks between and includingthe following values of 2 in degrees: 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2),19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2) and 24.1 to 24.5 (e.g., 24.3±0.2).

[0136] In certain embodiments, Form D has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 15.9 to 16.3(e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2) and 24.1 to 24.5 (e.g., 24.3±0.2).

[0137] In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least one characteristic peak atAttorney Docket No. TGO-025WOvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least two characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least three characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least four characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least five characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least six characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least seven characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least eight characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least nine characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2,Attorney Docket No. TGO-025WO 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2. In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least ten characteristic peaks atvalues of 2 in degrees selected from 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2,18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2.

[0138] In certain embodiments, Form D has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2,16.9±0.2, 17.3±0.2, 18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.2.

[0139] In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 10.6 to 11 (e.g., 10.8±0.2), 13.3 to13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least one characteristic peak between and including thefollowing values of 2 in degrees: 10.6 to 11 (e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction patterncomprising at least two characteristic peaks between and including the following values of 2 indegrees: 10.6 to 11 (e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g.,Attorney Docket No. TGO-025WO 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least threecharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11(e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least fourcharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11(e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least fivecharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11(e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least sixcharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11(e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g.,Attorney Docket No. TGO-025WO 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least sevencharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11(e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11(e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11(e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2). In certain embodiments, Form D has an X-ray powder diffraction pattern comprising at least tencharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11Attorney Docket No. TGO-025WO (e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2).

[0140] In certain embodiments, Form D has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 10.6 to 11(e.g., 10.8±0.2), 13.3 to 13.7 (e.g., 13.5±0.2), 13.8 to 14.2 (e.g., 14±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.7 to 17.1 (e.g., 16.9±0.2), 17.1 to 17.5 (e.g., 17.3±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.4 to 21.8 (e.g., 21.6±0.2), 23.1 to 23.5 (e.g., 23.3±0.2), 24.1 to 24.5 (e.g., 24.3±0.2), 25 to 25.4 (e.g., 25.2±0.2), 25.8 to 26.2 (e.g., 26±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.8 to 27.2 (e.g., 27±0.2), 28.3 to 28.7 (e.g., 28.5±0.2), 33.1 to 33.5 (e.g., 33.3±0.2), 35.3 to 35.7 (e.g., 35.5±0.2), 35.6 to 36 (e.g., 35.8±0.2) and 37.7 to 38.1 (e.g., 37.9±0.2).

[0141] In some embodiments, Form D has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG. 5A.

[0142] In some embodiments, Form D has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine, or tencharacteristic peaks, in terms of 2 values in degrees shown in Table 6 (±0.2 degrees).

[0143] In some embodiments, Form D has an XRPD pattern (obtained using CuKa radiation)comprising at least 50% of the peaks at 2 values in degrees and with relative intensities shownin Table 6 allowing for variation due to experimental conditions. Table 6 – XRPD peaks for Form D of a compound of Formula (I)Attorney Docket No. TGO-025WO

[0144] In certain embodiments, Form D is substantially characterized by the thermal gravimetric analysis (TGA) as shown in FIG.5B.

[0145] In certain embodiments, Form D is substantially characterized by the differential scanning calorimetry profile (DSC) shown in FIG.5C. In some embodiments, Form D can be characterized by the differential scanning calorimetry profile (DSC) shown in FIG.5C, showing a melting peak at Tonset of 160.2°C, an exothermic peak at Tonset of 165.5°C and a melting peak at Tonsetof 181.7°C. Crystalline Form E

[0146] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form E. Crystalline Form E is an 1,4-dioxane solvate crystalline form of the compound of formula (I).

[0147] Form E can be obtained from 1,4-dioxane by slow evaporation.

[0148] Form E is of high crystallinity. DSC (FIG.6C) shows a desolvation peak from 89.7°C and 2 combined endothermic peaks at Tonsetof 155.0°C and 167.5°C, respectively. TGA (FIG.6B) shows about 1.5% weight loss at about 100°C and about 6.6% weight loss from aboutAttorney Docket No. TGO-025WO 100°C to 150°C.1H-NMR (FIG.6D) shows 7.4% 1,4-dioxane residue by weight. After heating to 145°C, a physical mixture of Form A and Form D was obtained.

[0149] In certain embodiments, Form E has an X-ray powder diffraction pattern comprisingat least one (e.g., one, two, three or four) characteristic peaks at values of 2 in degrees selectedfrom 11.8±0.2, 16.5±0.2, 21.3±0.2 and 26.1±0.2. In certain embodiments, Form E has an X-raypowder diffraction pattern comprising at least one characteristic peak at values of 2 in degreesselected from 11.8±0.2, 16.5±0.2, 21.3±0.2 and 26.1±0.2. In certain embodiments, Form E hasan X-ray powder diffraction pattern comprising at least two characteristic peaks at values of 2in degrees selected from 11.8±0.2, 16.5±0.2, 21.3±0.2 and 26.1±0.2. In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least three characteristic peaks atvalues of 2 in degrees selected from 11.8±0.2, 16.5±0.2, 21.3±0.2 and 26.1±0.2.

[0150] In certain embodiments, Form E has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 11.8±0.2, 16.5±0.2, 21.3±0.2 and 26.1±0.2.

[0151] In certain embodiments, Form E has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 11.8±0.2, 16.5±0.2, 21.3±0.2 and 26.1±0.2 andat least one (e.g., one, two, three, four, five or six) additional characteristic peaks at values of 2in degrees selected from: 7.1±0.2, 10.7±0.2, 16.1±0.2, 18.9±0.2, 20.7±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2 and 33.3±0.2.

[0152] In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three or four) characteristic peaks between and including thefollowing values of 2 in degrees: 11.6 to 12 (e.g., 11.8±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 21.1to 21.5 (e.g., 21.3±0.2) and 25.9 to 26.3 (e.g., 26.1±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least one characteristic peak between andincluding the following values of 2 in degrees: 11.6 to 12 (e.g., 11.8±0.2), 16.3 to 16.7 (e.g.,16.5±0.2), 21.1 to 21.5 (e.g., 21.3±0.2) and 25.9 to 26.3 (e.g., 26.1±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least two characteristic peaksbetween and including the following values of 2 in degrees: 11.6 to 12 (e.g., 11.8±0.2), 16.3 to16.7 (e.g., 16.5±0.2), 21.1 to 21.5 (e.g., 21.3±0.2) and 25.9 to 26.3 (e.g., 26.1±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least threecharacteristic peaks between and including the following values of 2 in degrees: 11.6 to 12(e.g., 11.8±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 21.1 to 21.5 (e.g., 21.3±0.2) and 25.9 to 26.3 (e.g., 26.1±0.2).Attorney Docket No. TGO-025WO

[0153] In certain embodiments, Form E has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 11.6 to 12(e.g., 11.8±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 21.1 to 21.5 (e.g., 21.3±0.2) and 25.9 to 26.3 (e.g., 26.1±0.2).

[0154] In certain embodiments, Form E has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 11.6 to 12(e.g., 11.8±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 21.1 to 21.5 (e.g., 21.3±0.2) and 25.9 to 26.3 (e.g., 26.1±0.2) and at least at least one (e.g., one, two, three, four, five or six) additional characteristicpeaks between and including values of 2 in degrees selected from: 6.9 to 7.3 (e.g., 7.1±0.2),10.5 to 10.9 (e.g., 10.7±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2).

[0155] In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 7.1±0.2, 10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2,20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 7.1±0.2, 10.7±0.2, 11.8±0.2,16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction pattern comprising atleast two characteristic peaks at values of 2 in degrees selected from 7.1±0.2, 10.7±0.2,11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction patterncomprising at least three characteristic peaks at values of 2 in degrees selected from 7.1±0.2,10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powderdiffraction pattern comprising at least four characteristic peaks at values of 2 in degreesselected from 7.1±0.2, 10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least five characteristic peaks at values of 2 indegrees selected from 7.1±0.2, 10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least six characteristic peaks at values ofAttorney Docket No. TGO-025WO2 in degrees selected from 7.1±0.2, 10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2,21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least seven characteristic peaks at valuesof 2 in degrees selected from 7.1±0.2, 10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2,20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks at values of 2 in degrees selected from 7.1±0.2, 10.7±0.2, 11.8±0.2,16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction pattern comprising atleast nine characteristic peaks at values of 2 in degrees selected from 7.1±0.2, 10.7±0.2,11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2. In certain embodiments, Form E has an X-ray powder diffraction patterncomprising at least ten characteristic peaks at values of 2 in degrees selected from 7.1±0.2,10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2.

[0156] In certain embodiments, Form E has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 7.1±0.2, 10.7±0.2, 11.8±0.2, 16.1±0.2,16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.2.

[0157] In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to10.9 (e.g., 10.7±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least one characteristic peak between andincluding the following values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g.,10.7±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least two characteristic peaks between and includingthe following values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2),Attorney Docket No. TGO-025WO 11.6 to 12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least three characteristic peaks between and includingthe following values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2),11.6 to 12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least four characteristic peaks between and includingthe following values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2),11.6 to 12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least five characteristic peaks between and includingthe following values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2),11.6 to 12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least six characteristic peaks between and including thefollowing values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2), 11.6 to12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least seven characteristic peaks between and including thefollowing values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2), 11.6 to12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powderAttorney Docket No. TGO-025WO diffraction pattern comprising at least eight characteristic peaks between and including thefollowing values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2), 11.6 to12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least nine characteristic peaks between and including thefollowing values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2), 11.6 to12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2). In certain embodiments, Form E has an X-ray powder diffraction pattern comprising at least ten characteristic peaks between and including thefollowing values of 2 in degrees: 6.9 to 7.3 (e.g., 7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2), 11.6 to12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2).

[0158] In certain embodiments, Form E has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 6.9 to 7.3 (e.g.,7.1±0.2), 10.5 to 10.9 (e.g., 10.7±0.2), 11.6 to 12 (e.g., 11.8±0.2), 15.9 to 16.3 (e.g., 16.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 20.5 to 20.9 (e.g., 20.7±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 21.3 to 21.7 (e.g., 21.5±0.2), 23.5 to 23.9 (e.g., 23.7±0.2), 24 to 24.4 (e.g., 24.2±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 33.1 to 33.5 (e.g., 33.3±0.2).

[0159] In some embodiments, Form E has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG. 6A.

[0160] In some embodiments, Form E has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine, or tencharacteristic peaks, in terms of 2 values in degrees shown in Table 7 (±0.2 degrees).

[0161] In some embodiments, Form E has an XRPD pattern (obtained using CuKa radiation)comprising at least 50% of the peaks at 2 values in degrees and with relative intensities shownin Table 7 allowing for variation due to experimental conditions.Attorney Docket No. TGO-025WO Table 7 – XRPD peaks for Form E of a compound of Formula (I)Attorney Docket No. TGO-025WO

[0162] In certain embodiments, Form E is substantially characterized by the thermal gravimetric analysis (TGA) as shown in FIG.6B.

[0163] In certain embodiments, Form E is substantially characterized by the differential scanning calorimetry profile (DSC) shown in FIG.6C. In some embodiments, Form E can be characterized by the differential scanning calorimetry profile (DSC) shown in FIG.6C, showing a desolvation peak from 89.7°C and 2 combined endothermic peaks at Tonset of 155.0°C and 167.5°C, respectively. Crystalline Form F

[0164] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form F. Crystalline Form F is an anhydrous crystalline form of the compound of formula (I).

[0165] Form F can be obtained from desolvation of EA solvate Form B1. Form F is of highcrystallinity. DSC (FIG. 7C) shows a melting peak at Tonsetof 203.9°C with an enthalpy of about87J / g. TGA (FIG.7B) shows about 0.8% weight loss at about 150°C.1H-NMR (FIG.7D) shows no detectable residual solvent.

[0166] In certain embodiments, Form F has an X-ray powder diffraction pattern comprisingat least one (e.g., one, two, three, four, five, six or seven) characteristic peaks at values of 2 indegrees selected from 5±0.2, 8±0.2, 10±0.2, 18.1±0.2, 23.8±0.2, 24±0.2 and 24.6±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5±0.2, 8±0.2, 10±0.2, 18.1±0.2,23.8±0.2, 24±0.2 and 24.6±0.2. In certain embodiments, Form F has an X-ray powder diffractionpattern comprising at least two characteristic peaks at values of 2 in degrees selected from5±0.2, 8±0.2, 10±0.2, 18.1±0.2, 23.8±0.2, 24±0.2 and 24.6±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least three characteristic peaks at values of2 in degrees selected from 5±0.2, 8±0.2, 10±0.2, 18.1±0.2, 23.8±0.2, 24±0.2 and 24.6±0.2. Incertain embodiments, Form F has an X-ray powder diffraction pattern comprising at least fourAttorney Docket No. TGO-025WOcharacteristic peaks at values of 2 in degrees selected from 5±0.2, 8±0.2, 10±0.2, 18.1±0.2,23.8±0.2, 24±0.2 and 24.6±0.2. In certain embodiments, Form F has an X-ray powder diffractionpattern comprising at least five characteristic peaks at values of 2 in degrees selected from5±0.2, 8±0.2, 10±0.2, 18.1±0.2, 23.8±0.2, 24±0.2 and 24.6±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least six characteristic peaks at values of2 in degrees selected from 5±0.2, 8±0.2, 10±0.2, 18.1±0.2, 23.8±0.2, 24±0.2 and 24.6±0.2.

[0167] In certain embodiments, Form F has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5±0.2, 8±0.2, 10±0.2, 18.1±0.2, 23.8±0.2,24±0.2 and 24.6±0.2.

[0168] In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six or seven) characteristic peaks between andincluding the following values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.8 to 8.2 (e.g., 8±0.2),9.8 to 10.2 (e.g., 10±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2) and 24.4 to 24.8 (e.g., 24.6±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least one characteristic peak between and including thefollowing values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2(e.g., 10±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2) and 24.4 to 24.8 (e.g., 24.6±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least two characteristic peaks between and including thefollowing values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2(e.g., 10±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2) and 24.4 to 24.8 (e.g., 24.6±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least three characteristic peaks between and including thefollowing values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2(e.g., 10±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2) and 24.4 to 24.8 (e.g., 24.6±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least four characteristic peaks between and including thefollowing values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2(e.g., 10±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2) and 24.4 to 24.8 (e.g., 24.6±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least five characteristic peaks between and including thefollowing values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2(e.g., 10±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g.,Attorney Docket No. TGO-025WO 24±0.2) and 24.4 to 24.8 (e.g., 24.6±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least six characteristic peaks between and including thefollowing values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2(e.g., 10±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2) and 24.4 to 24.8 (e.g., 24.6±0.2).

[0169] In certain embodiments, Form F has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 4.8 to 5.2 (e.g.,5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2) and 24.4 to 24.8 (e.g., 24.6±0.2).

[0170] In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, eight, nine or ten) characteristic peaks at valuesof 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2, 12.5±0.2, 15.1±0.2, 16.5±0.2,17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-raypowder diffraction pattern comprising at least one characteristic peak at values of 2 in degreesselected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2, 12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-ray powder diffraction patterncomprising at least two characteristic peaks at values of 2 in degrees selected from 5±0.2,7.5±0.2, 8±0.2, 10±0.2, 12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising atleast three characteristic peaks at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2,10±0.2, 12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least fourcharacteristic peaks at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least fivecharacteristic peaks at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certainAttorney Docket No. TGO-025WO embodiments, Form F has an X-ray powder diffraction pattern comprising at least sixcharacteristic peaks at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least sevencharacteristic peaks at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2. In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least tencharacteristic peaks at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2.

[0171] In certain embodiments, Form F has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5±0.2, 7.5±0.2, 8±0.2, 10±0.2, 12.5±0.2,15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.2.

[0172] In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.3 to 7.7(e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). InAttorney Docket No. TGO-025WO certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least onecharacteristic peak between and including the following values of 2 in degrees: 4.8 to 5.2 (e.g.,5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprisingat least two characteristic peaks between and including the following values of 2 in degrees: 4.8to 5.2 (e.g., 5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprisingat least three characteristic peaks between and including the following values of 2 in degrees:4.8 to 5.2 (e.g., 5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction patterncomprising at least four characteristic peaks between and including the following values of 2 indegrees: 4.8 to 5.2 (e.g., 5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least five characteristic peaks between and including theAttorney Docket No. TGO-025WOfollowing values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2(e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least six characteristic peaks between andincluding the following values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2),7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least seven characteristic peaks betweenand including the following values of 2 in degrees: 4.8 to 5.2 (e.g., 5±0.2), 7.3 to 7.7 (e.g.,7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks between and including the following values of 2 in degrees: 4.8 to 5.2 (e.g.,5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction pattern comprisingat least nine characteristic peaks between and including the following values of 2 in degrees:4.8 to 5.2 (e.g., 5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g.,Attorney Docket No. TGO-025WO 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2). In certain embodiments, Form F has an X-ray powder diffraction patterncomprising at least ten characteristic peaks between and including the following values of 2 indegrees: 4.8 to 5.2 (e.g., 5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2).

[0173] In certain embodiments, Form F has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 4.8 to 5.2 (e.g.,5±0.2), 7.3 to 7.7 (e.g., 7.5±0.2), 7.8 to 8.2 (e.g., 8±0.2), 9.8 to 10.2 (e.g., 10±0.2), 12.3 to 12.7 (e.g., 12.5±0.2), 14.9 to 15.3 (e.g., 15.1±0.2), 16.3 to 16.7 (e.g., 16.5±0.2), 17.6 to 18 (e.g., 17.8±0.2), 17.9 to 18.3 (e.g., 18.1±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.9 to 19.3 (e.g., 19.1±0.2), 20.4 to 20.8 (e.g., 20.6±0.2), 20.8 to 21.2 (e.g., 21±0.2), 21.1 to 21.5 (e.g., 21.3±0.2), 22.6 to 23 (e.g., 22.8±0.2), 23.6 to 24 (e.g., 23.8±0.2), 23.8 to 24.2 (e.g., 24±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 25.1 to 25.5 (e.g., 25.3±0.2), 25.9 to 26.3 (e.g., 26.1±0.2) and 26.2 to 26.6 (e.g., 26.4±0.2).

[0174] In some embodiments, Form F has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG.7A.

[0175] In some embodiments, Form F has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine, or tencharacteristic peaks, in terms of 2 values in degrees shown in Table 8 (±0.2 degrees).

[0176] In some embodiments, Form F has an XRPD pattern (obtained using CuKa radiation)comprising at least 50% of the peaks at 2 values in degrees and with relative intensities shownin Table 8 allowing for variation due to experimental conditions.Attorney Docket No. TGO-025WO Table 8 – XRPD peaks for Form F of a compound of Formula (I)

[0177] In certain embodiments, Form F is substantially characterized by the thermal gravimetric analysis (TGA) as shown in FIG.7B.

[0178] In certain embodiments, Form F is substantially characterized by the differential scanning calorimetry profile (DSC) shown in FIG.7C. In some embodiments, Form F can be characterized by the differential scanning calorimetry profile (DSC) shown in FIG.7C, showing a melting peak at Tonset of 203.9°C with an enthalpy of about 87J / g.Attorney Docket No. TGO-025WO Crystalline Form G

[0179] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form G. Crystalline Form G is an anhydrous crystalline form of the compound of formula (I).

[0180] Form G can be obtained by heating Form D to 170°C.

[0181] Form G is of high crystallinity. DSC (FIG.8C) shows a small melting peak at Tonset of 165.3°C and a melting peak at Tonset of 180.1°C with an enthalpy of about 78J / g. TGA (FIG.8B) shows about 0.4% weight loss at about 150°C. 1H-NMR (FIG. 8D) shows no detectableresidual solvent.

[0182] In certain embodiments, Form G has an X-ray powder diffraction pattern comprisingat least one (e.g., one, two, three, four or five) characteristic peaks at values of 2 in degreesselected from 16.7±0.2, 19.3±0.2, 21.2±0.2, 24.4±0.2 and 26.7±0.2. In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least one characteristic peak atvalues of 2 in degrees selected from 16.7±0.2, 19.3±0.2, 21.2±0.2, 24.4±0.2 and 26.7±0.2. Incertain embodiments, Form G has an X-ray powder diffraction pattern comprising at least twocharacteristic peaks at values of 2 in degrees selected from 16.7±0.2, 19.3±0.2, 21.2±0.2,24.4±0.2 and 26.7±0.2. In certain embodiments, Form G has an X-ray powder diffraction patterncomprising at least three characteristic peaks at values of 2 in degrees selected from 16.7±0.2,19.3±0.2, 21.2±0.2, 24.4±0.2 and 26.7±0.2. In certain embodiments, Form G has an X-raypowder diffraction pattern comprising at least four characteristic peaks at values of 2 in degreesselected from 16.7±0.2, 19.3±0.2, 21.2±0.2, 24.4±0.2 and 26.7±0.2.

[0183] In certain embodiments, Form G has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 16.7±0.2, 19.3±0.2, 21.2±0.2, 24.4±0.2 and26.7±0.2. In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four or five) characteristic peaks between and including thefollowing values of 2 in degrees: 16.5 to 16.9 (e.g., 16.7±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 21to 21.4 (e.g., 21.2±0.2), 24.2 to 24.6 (e.g., 24.4±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least onecharacteristic peak between and including the following values of 2 in degrees: 16.5 to 16.9(e.g., 16.7±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 21 to 21.4 (e.g., 21.2±0.2), 24.2 to 24.6 (e.g., 24.4±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least two characteristic peaks between and includingAttorney Docket No. TGO-025WOthe following values of 2 in degrees: 16.5 to 16.9 (e.g., 16.7±0.2), 19.1 to 19.5 (e.g., 19.3±0.2),21 to 21.4 (e.g., 21.2±0.2), 24.2 to 24.6 (e.g., 24.4±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least threecharacteristic peaks between and including the following values of 2 in degrees: 16.5 to 16.9(e.g., 16.7±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 21 to 21.4 (e.g., 21.2±0.2), 24.2 to 24.6 (e.g., 24.4±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least four characteristic peaks between and includingthe following values of 2 in degrees: 16.5 to 16.9 (e.g., 16.7±0.2), 19.1 to 19.5 (e.g., 19.3±0.2),21 to 21.4 (e.g., 21.2±0.2), 24.2 to 24.6 (e.g., 24.4±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2).

[0184] In certain embodiments, Form G has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 16.5 to 16.9(e.g., 16.7±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 21 to 21.4 (e.g., 21.2±0.2), 24.2 to 24.6 (e.g., 24.4±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2).

[0185] In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2,18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G has an X-ray powderdiffraction pattern comprising at least one characteristic peak at values of 2 in degrees selectedfrom 5.6±0.2, 10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least twocharacteristic peaks at values of 2 in degrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2,15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G hasan X-ray powder diffraction pattern comprising at least three characteristic peaks at values of 2in degrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G has an X-ray powder diffraction patternAttorney Docket No. TGO-025WOcomprising at least four characteristic peaks at values of 2 in degrees selected from 5.6±0.2,10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least fivecharacteristic peaks at values of 2 in degrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2,15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G hasan X-ray powder diffraction pattern comprising at least six characteristic peaks at values of 2 indegrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G has an X-ray powder diffraction patterncomprising at least seven characteristic peaks at values of 2 in degrees selected from 5.6±0.2,10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks at values of 2 in degrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2,15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G hasan X-ray powder diffraction pattern comprising at least nine characteristic peaks at values of 2in degrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2. In certain embodiments, Form G has an X-ray powder diffraction patterncomprising at least ten characteristic peaks at values of 2 in degrees selected from 5.6±0.2,10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2.Attorney Docket No. TGO-025WO

[0186] In certain embodiments, Form G has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 5.6±0.2, 10.5±0.2, 13.9±0.2, 15.8±0.2,16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.2.

[0187] In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 5.4 to 5.8 (e.g., 5.6±0.2), 10.3 to10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least onecharacteristic peak between and including the following values of 2 in degrees: 5.4 to 5.8 (e.g.,5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction patterncomprising at least two characteristic peaks between and including the following values of 2 indegrees: 5.4 to 5.8 (e.g., 5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2),Attorney Docket No. TGO-025WO 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least three characteristic peaks between and including thefollowing values of 2 in degrees: 5.4 to 5.8 (e.g., 5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least four characteristic peaksbetween and including the following values of 2 in degrees: 5.4 to 5.8 (e.g., 5.6±0.2), 10.3 to10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least fivecharacteristic peaks between and including the following values of 2 in degrees: 5.4 to 5.8 (e.g.,5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2Attorney Docket No. TGO-025WO (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction patterncomprising at least six characteristic peaks between and including the following values of 2 indegrees: 5.4 to 5.8 (e.g., 5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least seven characteristic peaks between and including thefollowing values of 2 in degrees: 5.4 to 5.8 (e.g., 5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least eight characteristic peaksbetween and including the following values of 2 in degrees: 5.4 to 5.8 (e.g., 5.6±0.2), 10.3 to10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks between and including the following values of 2 in degrees: 5.4 to 5.8 (e.g.,5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2),Attorney Docket No. TGO-025WO 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2). In certain embodiments, Form G has an X-ray powder diffraction patterncomprising at least ten characteristic peaks between and including the following values of 2 indegrees: 5.4 to 5.8 (e.g., 5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2).

[0188] In certain embodiments, Form G has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 5.4 to 5.8 (e.g.,5.6±0.2), 10.3 to 10.7 (e.g., 10.5±0.2), 13.7 to 14.1 (e.g., 13.9±0.2), 15.6 to 16 (e.g., 15.8±0.2), 16.5 to 16.9 (e.g., 16.7±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.1 to 18.5 (e.g., 18.3±0.2), 18.3 to 18.7 (e.g., 18.5±0.2), 18.7 to 19.1 (e.g., 18.9±0.2), 19.1 to 19.5 (e.g., 19.3±0.2), 19.3 to 19.7 (e.g., 19.5±0.2), 19.7 to 20.1 (e.g., 19.9±0.2), 20.7 to 21.1 (e.g., 20.9±0.2), 21 to 21.4 (e.g., 21.2±0.2), 22.4 to 22.8 (e.g., 22.6±0.2), 23.7 to 24.1 (e.g., 23.9±0.2), 24.2 to 24.6 (e.g., 24.4±0.2), 24.5 to 24.9 (e.g., 24.7±0.2), 25 to 25.4 (e.g., 25.2±0.2), 26.1 to 26.5 (e.g., 26.3±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.4 to 27.8 (e.g., 27.6±0.2), 27.8 to 28.2 (e.g., 28±0.2), 28.7 to 29.1 (e.g., 28.9±0.2), 31.5 to 31.9 (e.g., 31.7±0.2), 34 to 34.4 (e.g., 34.2±0.2) and 35.8 to 36.2 (e.g., 36±0.2).

[0189] In some embodiments, Form G has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG. 8A.Attorney Docket No. TGO-025WO

[0190] In some embodiments, Form G has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine, or tencharacteristic peaks, in terms of 2 values in degrees shown in Table 9 (±0.2 degrees).

[0191] In some embodiments, Form G has an XRPD pattern (obtained using CuKa radiation)comprising at least 50% of the peaks at 2 values in degrees and with relative intensities shownin Table 9 allowing for variation due to experimental conditions. Table 9 – XRPD peaks for Form G of a compound of Formula (I)Attorney Docket No. TGO-025WO

[0192] In certain embodiments, Form G is substantially characterized by the thermal gravimetric analysis (TGA) as shown in FIG.8B.

[0193] In certain embodiments, Form G is substantially characterized by the differential scanning calorimetry profile (DSC) shown in FIG.8C. In some embodiments, Form G can be characterized by the differential scanning calorimetry profile (DSC) shown in FIG.8C, showing a small melting peak at Tonsetof 165.3°C and a melting peak at Tonsetof 180.1°C with an enthalpy of about 78J / g. Crystalline Form H

[0194] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form H. Crystalline Form H is a hydrate crystalline form of the compound of formula (I).

[0195] Form H can be obtained from water by competitive equilibration.

[0196] Form H is of high crystallinity. DSC (FIG.9C) shows a dehydration from 20.5°C, an exothermic peak at 88.2°C, an endothermic peak at 133.4°C and a melting peak at Tonsetof 197.2°C with an enthalpy of about 9J / g. TGA (FIG.9B) shows about 1.8% weight loss at about 100°C.1H-NMR (FIG.9D) shows no detectable residual solvent.

[0197] After being dried at 50°C under vacuum for 2h, Form H showed no form change. After heating to 100°C by VT-XRPD, the dehydrated sample was still Form H. After heating to 180°C by VT-XRPD, Form F was obtained FIG.9E.

[0198] In certain embodiments, Form H has an X-ray powder diffraction pattern comprisingat least one (e.g., one, two, three or four) characteristic peaks at values of 2 in degrees selectedfrom 18.7±0.2, 19±0.2, 20.5±0.2 and 20.8±0.2. In certain embodiments, Form H has an X-raypowder diffraction pattern comprising at least one characteristic peak at values of 2 in degreesselected from 18.7±0.2, 19±0.2, 20.5±0.2 and 20.8±0.2. In certain embodiments, Form H has anX-ray powder diffraction pattern comprising at least two characteristic peaks at values of 2 inAttorney Docket No. TGO-025WO degrees selected from 18.7±0.2, 19±0.2, 20.5±0.2 and 20.8±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least three characteristic peaks at valuesof 2 in degrees selected from 18.7±0.2, 19±0.2, 20.5±0.2 and 20.8±0.2.

[0199] In certain embodiments, Form H has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 18.7±0.2, 19±0.2, 20.5±0.2 and 20.8±0.2.

[0200] In certain embodiments, Form H has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 18.7±0.2, 19±0.2, 20.5±0.2 and 20.8±0.2 andat least one (e.g., one, two, three, four, five or six) additional characteristic peaks at values of 2in degrees selected from: 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 19.7±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2.

[0201] In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three or four) characteristic peaks between and including thefollowing values of 2 in degrees: 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 20.3to 20.7 (e.g., 20.5±0.2) and 20.6 to 21 (e.g., 20.8±0.2). In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least one characteristic peak between andincluding the following values of 2 in degrees: 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g.,19±0.2), 20.3 to 20.7 (e.g., 20.5±0.2) and 20.6 to 21 (e.g., 20.8±0.2). In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least two characteristic peaksbetween and including the following values of 2 in degrees: 18.5 to 18.9 (e.g., 18.7±0.2), 18.8to 19.2 (e.g., 19±0.2), 20.3 to 20.7 (e.g., 20.5±0.2) and 20.6 to 21 (e.g., 20.8±0.2). In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least threecharacteristic peaks between and including the following values of 2 in degrees: 18.5 to 18.9(e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 20.3 to 20.7 (e.g., 20.5±0.2) and 20.6 to 21 (e.g., 20.8±0.2).

[0202] In certain embodiments, Form H has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 18.5 to 18.9(e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 20.3 to 20.7 (e.g., 20.5±0.2) and 20.6 to 21 (e.g., 20.8±0.2).

[0203] In certain embodiments, Form H has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 18.5 to 18.9(e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 20.3 to 20.7 (e.g., 20.5±0.2) and 20.6 to 21 (e.g., 20.8±0.2) and at least one (e.g., one, two, three, four, five or six) additional characteristic peaksAttorney Docket No. TGO-025WObetween and including values of 2 in degrees selected from: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7to 15.1 (e.g., 14.9±0.2), 16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) or 25.5 to 25.9 (e.g., 25.7±0.2).

[0204] In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least one characteristic peak atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least two characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least three characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least four characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least five characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least six characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least seven characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least eight characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least nine characteristic peaks atAttorney Docket No. TGO-025WOvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2. In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least ten characteristic peaks atvalues of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2,19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2.

[0205] In certain embodiments, Form H has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2,18.7±0.2, 19±0.2, 19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.2.

[0206] In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaksbetween and including the following values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7to 15.1 (e.g., 14.9±0.2), 16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least one characteristic peak between andincluding the following values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g.,14.9±0.2), 16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X- ray powder diffraction pattern comprising at least two characteristic peaks between andincluding the following values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g.,14.9±0.2), 16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X- ray powder diffraction pattern comprising at least three characteristic peaks between andincluding the following values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g.,14.9±0.2), 16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X-Attorney Docket No. TGO-025WO ray powder diffraction pattern comprising at least four characteristic peaks between andincluding the following values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g.,14.9±0.2), 16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X- ray powder diffraction pattern comprising at least five characteristic peaks between andincluding the following values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g.,14.9±0.2), 16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X- ray powder diffraction pattern comprising at least six characteristic peaks between and includingthe following values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g., 14.9±0.2),16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least seven characteristic peaks between and including thefollowing values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g., 14.9±0.2),16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least eight characteristic peaks between and including thefollowing values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g., 14.9±0.2),16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least nine characteristic peaks between and including thefollowing values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g., 14.9±0.2),16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g.,Attorney Docket No. TGO-025WO 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2). In certain embodiments, Form H has an X-ray powder diffraction pattern comprising at least ten characteristic peaks between and including thefollowing values of 2 in degrees: 12.1 to 12.5 (e.g., 12.3±0.2), 14.7 to 15.1 (e.g., 14.9±0.2),16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2).

[0207] In certain embodiments, Form H has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 12.1 to 12.5(e.g., 12.3±0.2), 14.7 to 15.1 (e.g., 14.9±0.2), 16.2 to 16.6 (e.g., 16.4±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18.5 to 18.9 (e.g., 18.7±0.2), 18.8 to 19.2 (e.g., 19±0.2), 19.5 to 19.9 (e.g., 19.7±0.2), 20.3 to 20.7 (e.g., 20.5±0.2), 20.6 to 21 (e.g., 20.8±0.2), 21.5 to 21.9 (e.g., 21.7±0.2), 24.4 to 24.8 (e.g., 24.6±0.2), 24.8 to 25.2 (e.g., 25±0.2) and 25.5 to 25.9 (e.g., 25.7±0.2).

[0208] In some embodiments, Form H has an XRPD pattern (obtained using CuKa radiation) substantially corresponding to the XRPD diffraction pattern shown in FIG. 9A.

[0209] In some embodiments, Form H has an XRPD pattern (obtained using CuKa radiation) with characteristic peaks comprising one, two, three, four, five, six, seven, eight, nine, or tencharacteristic peaks, in terms of 2 values in degrees shown in Table 10 (±0.2 degrees).

[0210] In some embodiments, Form H has an XRPD pattern (obtained using CuKa radiation)comprising at least 50% of the peaks at 2 values in degrees and with relative intensities shownin Table 10 allowing for variation due to experimental conditions. Table 10 – XRPD peaks for Form H of a compound of Formula (I)Attorney Docket No. TGO-025WO

[0211] In certain embodiments, Form H is substantially characterized by the thermal gravimetric analysis (TGA) as shown in FIG.9B.

[0212] In certain embodiments, Form H is substantially characterized by the differential scanning calorimetry profile (DSC) shown in FIG.9C. In some embodiments, Form H can be characterized by the differential scanning calorimetry profile (DSC) shown in FIG.9C, showing a dehydration from 20.5°C, an exothermic peak at 88.2°C, an endothermic peak at 133.4°C and a melting peak at Tonsetof 197.2°C with an enthalpy of about 9J / g. Crystalline Form I

[0213] In certain embodiments, the crystalline form of the free base of the compound of formula (I) is crystalline Form I. Crystalline Form I is likely a hydrate crystalline form of the compound of formula (I).

[0214] Form I can be obtained after heating Form A to 180°C.

[0215] Form I is of high crystallinity.Attorney Docket No. TGO-025WO

[0216] Form I DSC (FIG.10B) shows a dehydration endothermic peak from about 52°C and a melting peak at Tonset of 192.4°C with an enthalpy of about 55J / g.1H-NMR (FIG.10C) shows no detectable residual solvent.

[0217] In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven or eight) characteristic peaks at values of2 in degrees selected from 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 21.1±0.2,22.2±0.2 and 26.7±0.2. In certain embodiments, Form I has an X-ray powder diffraction patterncomprising at least one characteristic peak at values of 2 in degrees selected from 17.9±0.2,18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 21.1±0.2, 22.2±0.2 and 26.7±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least twocharacteristic peaks at values of 2 in degrees selected from 17.9±0.2, 18.2±0.2, 18.6±0.2,19.4±0.2, 19.8±0.2, 21.1±0.2, 22.2±0.2 and 26.7±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least three characteristic peaks at values of 2 indegrees selected from 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 21.1±0.2, 22.2±0.2 and 26.7±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising atleast four characteristic peaks at values of 2 in degrees selected from 17.9±0.2, 18.2±0.2,18.6±0.2, 19.4±0.2, 19.8±0.2, 21.1±0.2, 22.2±0.2 and 26.7±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least five characteristic peaks at values of2 in degrees selected from 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 21.1±0.2,22.2±0.2 and 26.7±0.2. In certain embodiments, Form I has an X-ray powder diffraction patterncomprising at least six characteristic peaks at values of 2 in degrees selected from 17.9±0.2,18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 21.1±0.2, 22.2±0.2 and 26.7±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least sevencharacteristic peaks at values of 2 in degrees selected from 17.9±0.2, 18.2±0.2, 18.6±0.2,19.4±0.2, 19.8±0.2, 21.1±0.2, 22.2±0.2 and 26.7±0.2.

[0218] In certain embodiments, Form I has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2,19.8±0.2, 21.1±0.2, 22.2±0.2 and 26.7±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven,eight, nine or ten) characteristic peaks between and including the following values of 2 indegrees: 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4 to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form I has an X-rayAttorney Docket No. TGO-025WO powder diffraction pattern comprising at least one characteristic peak between and including thefollowing values of 2 in degrees: 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least twocharacteristic peaks between and including the following values of 2 in degrees: 17.7 to 18.1(e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4 to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least three characteristic peaks between and including thefollowing values of 2 in degrees: 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least fourcharacteristic peaks between and including the following values of 2 in degrees: 17.7 to 18.1(e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4 to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least five characteristic peaks between and including thefollowing values of 2 in degrees: 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least sixcharacteristic peaks between and including the following values of 2 in degrees: 17.7 to 18.1(e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4 to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2). In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least seven characteristic peaks between and including thefollowing values of 2 in degrees: 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2).

[0219] In certain embodiments, Form I has an X-ray powder diffraction pattern comprisingcharacteristic peaks between and including the following values of 2 in degrees: 17.7 to 18.1Attorney Docket No. TGO-025WO (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4 to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2) and 26.5 to 26.9 (e.g., 26.7±0.2).

[0220] In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks atvalues of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2, 15.5±0.2, 16±0.2, 17.2±0.2,17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least one characteristic peak at values of 2 indegrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2, 15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powderdiffraction pattern comprising at least two characteristic peaks at values of 2 in degrees selectedfrom 8.9±0.2, 12.3±0.2, 14.6±0.2, 15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction patterncomprising at least three characteristic peaks at values of 2 in degrees selected from 8.9±0.2,12.3±0.2, 14.6±0.2, 15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising atleast four characteristic peaks at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2,14.6±0.2, 15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least fivecharacteristic peaks at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2,15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least sixcharacteristic peaks at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2,15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least sevencharacteristic peaks at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2,Attorney Docket No. TGO-025WO 15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least eightcharacteristic peaks at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2,15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least ninecharacteristic peaks at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2,15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least tencharacteristic peaks at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2,15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2.

[0221] In certain embodiments, Form I has an X-ray powder diffraction pattern comprisingcharacteristic peaks at a value of 2 in degrees of 8.9±0.2, 12.3±0.2, 14.6±0.2, 15.5±0.2, 16±0.2,17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.2. In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least one (e.g., one, two, three, four, five, six, seven, eight, nine or ten) characteristic peaks between and including the following values of2 in degrees: 8.7 to 9.1 (e.g., 8.9±0.2), 12.1 to 12.5 (e.g., 12.3±0.2), 14.4 to 14.8 (e.g.,14.6±0.2), 15.3 to 15.7 (e.g., 15.5±0.2), 15.8 to 16.2 (e.g., 16±0.2), 17 to 17.4 (e.g., 17.2±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4 to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2), 22.7 to 23.1 (e.g., 22.9±0.2), 24.3 to 24.7 (e.g., 24.5±0.2), 24.6 to 25 (e.g., 24.8±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.2 to 27.6 (e.g., 27.4±0.2) and 29.8 to 30.2 (e.g., 30±0.2). In certain embodiments, Form I has an X-ray powder diffraction patterncomprising at least one characteristic peak between and including the following values of 2 indegrees: 8.7 to 9.1 (e.g., 8.9±0.2), 12.1 to 12.5 (e.g., 12.3±0.2), 14.4 to 14.8 (e.g., 14.6±0.2), 15.3 to 15.7 (e.g., 15.5±0.2), 15.8 to 16.2 (e.g., 16±0.2), 17 to 17.4 (e.g., 17.2±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4 to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2), 22.7 to 23.1 (e.g., 22.9±0.2), 24.3 to 24.7 (e.g., 24.5±0.2), 24.6 to 25 (e.g.,Attorney Docket No. TGO-025WO 24.8±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.2 to 27.6 (e.g., 27.4±0.2) and 29.8 to 30.2 (e.g., 30±0.2). In certain embodiments, Form I has an X-ray powder diffraction pattern comprising atleast two characteristic peaks between and including the following values of 2 in degrees: 8.7 to9.1 (e.g., 8.9±0.2), 12.1 to 12.5 (e.g., 12.3±0.2), 14.4 to 14.8 (e.g., 14.6±0.2), 15.3 to 15.7 (e.g., 15.5±0.2), 15.8 to 16.2 (e.g., 16±0.2), 17 to 17.4 (e.g., 17.2±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18.4 (e.g., 18.2±0.2), 18.4 to 18.8 (e.g., 18.6±0.2), 19.2 to 19.6 (e.g., 19.4±0.2), 19.6 to 20 (e.g., 19.8±0.2), 20 to 20.4 (e.g., 20.2±0.2), 20.9 to 21.3 (e.g., 21.1±0.2), 22 to 22.4 (e.g., 22.2±0.2), 22.7 to 23.1 (e.g., 22.9±0.2), 24.3 to 24.7 (e.g., 24.5±0.2), 24.6 to 25 (e.g., 24.8±0.2), 26.5 to 26.9 (e.g., 26.7±0.2), 27.2 to 27.6 (e.g., 27.4±0.2) and 29.8 to 30.2 (e.g., 30±0.2). In certain embodiments, Form I has an X-ray powder diffraction pattern comprising at least threecharacteristic peaks between and including the following values of 2 in degrees: 8.7 to 9.1 (e.g.,8.9±0.2), 12.1 to 12.5 (e.g., 12.3±0.2), 14.4 to 14.8 (e.g., 14.6±0.2), 15.3 to 15.7 (e.g., 15.5±0.2), 15.8 to 16.2 (e.g., 16±0.2), 17 to 17.4 (e.g., 17.2±0.2), 17.7 to 18.1 (e.g., 17.9±0.2), 18 to 18....

Claims

Attorney Docket No. TGO-025WO CLAIMS 1. An anhydrous crystalline form, Form A, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3- yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2,15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.

2.

2. The crystalline form of claim 1, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5.3±0.2, 10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 24.4±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2, 28.5±0.2, 29.3±0.2, 31.9±0.2, 37.3±0.2, 37.5±0.2, 37.3±0.2 and 37.5±0.

2.

3. The crystalline form of claim 1, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 5.3±0.2,10.6±0.2, 13.1±0.2, 15±0.2, 15.8±0.2, 17.2±0.2, 18.4±0.2, 19.3±0.2, 19.6±0.2, 20.9±0.2, 21.1±0.2, 22.3±0.2, 22.7±0.2, 22.8±0.2, 24±0.2, 25.8±0.2, 26.3±0.2, 26.5±0.2, 28.3±0.2 and 28.5±0.

2.

4. The crystalline form of claim 1, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.1A.

5. The crystalline form of any one of claims 1-4, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.1C.Attorney Docket No. TGO-025WO 6. The crystalline form of any one of claims 1-5, wherein the crystalline form has a thermogravimetric analysis (TGA) pattern substantially corresponding to FIG.1B.

7. An ethyl acetate solvate crystalline form, Form B1, of (R)-N-(4-amino-4'-fluoro-[1,1'- biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2,11.8±0.2, 12.6±0.2, 14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.

2.

8. The crystalline form of claim 7, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5.1±0.2, 5.9±0.2, 10.2±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 14.3±0.2, 15.3±0.2, 15.7±0.2, 16.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 20.1±0.2, 21.4±0.2, 21.8±0.2, 22.5±0.2, 23.4±0.2, 23.5±0.2, 23.8±0.2, 25.5±0.2, 26±0.2, 26.6±0.2, 27.3±0.2, 28.3±0.2, 29.6±0.2, 31.6±0.2 and 32.1±0.

2.

9. The crystalline form of claim 7, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 5.1±0.2,5.9±0.2, 11.1±0.2, 11.8±0.2, 12.6±0.2, 15.3±0.2, 15.7±0.2, 17.1±0.2, 18.1±0.2, 18.9±0.2, 19.1±0.2, 19.4±0.2, 23.4±0.2, 23.5±0.2 and 26±0.

2.

10. The crystalline form of claim 7, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.2A.Attorney Docket No. TGO-025WO 11. The crystalline form of any one of claims 7-10, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.2C.

12. The crystalline form of any one of claims 7-11, wherein the crystalline form has a thermogravimetric analysis (TGA) pattern substantially corresponding to FIG.2B.

13. An acetonitrile solvate crystalline form, Form B2, of (R)-N-(4-amino-4'-fluoro-[1,1'- biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2,11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.

2.

14. The crystalline form of claim 13, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5.1±0.2, 6±0.2, 9.2±0.2, 10.1±0.2, 11.2±0.2, 12±0.2, 12.6±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 17.2±0.2, 18.4±0.2, 18.7±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 20.5±0.2, 21.5±0.2, 21.8±0.2, 22.8±0.2, 23.5±0.2, 23.8±0.2, 24.2±0.2, 24.9±0.2, 25.7±0.2, 26.5±0.2, 26.8±0.2, 27.7±0.2, 31.5±0.2 and 32.6±0.

2.

15. The crystalline form of claim 13, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 6±0.2, 11.2±0.2,12±0.2, 15.2±0.2, 15.6±0.2, 17±0.2, 18.4±0.2, 19±0.2, 19.3±0.2, 19.5±0.2, 20.2±0.2, 23.8±0.2, 26.5±0.2, 26.5±0.2 and 27.7±0.2.Attorney Docket No. TGO-025WO 16. The crystalline form of claim 13, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.3A.

17. The crystalline form of any one of claims 13-16, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.3C.

18. The crystalline form of any one of claims 13-17, wherein the crystalline form has a thermogravimetric analysis (TGA) pattern substantially corresponding to FIG.3B.

19. An 1,3-dioxane solvate crystalline form, Form C, of (R)-N-(4-amino-4'-fluoro-[1,1'- biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2,15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.

2.

20. The crystalline form of claim 19, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5.2±0.2, 7.9±0.2, 10.5±0.2, 11.8±0.2, 15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 17.6±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 24.8±0.2, 25.8±0.2, 26.1±0.2, 26.3±0.2, 28.4±0.2, 29.2±0.2 and 35.5±0.

2.

21. The crystalline form of claim 19, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 10.5±0.2,15.9±0.2, 16±0.2, 16.5±0.2, 17.1±0.2, 18.4±0.2, 18.7±0.2, 19.4±0.2, 20.7±0.2, 21.2±0.2, 23.8±0.2, 24.3±0.2, 25.8±0.2, 26.1±0.2 and 26.3±0.2.Attorney Docket No. TGO-025WO 22. The crystalline form of claim 19, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.

4.

23. An anhydrous crystalline form, Form D, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3- yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2,16.9±0.2, 17.3±0.2, 18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.

2.

24. The crystalline form of claim 23 wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 10.8±0.2, 13.5±0.2, 14±0.2, 16.1±0.2, 16.9±0.2, 17.3±0.2, 18.1±0.2, 18.9±0.2, 19.4±0.2, 20.7±0.2, 21.6±0.2, 23.3±0.2, 24.3±0.2, 25.2±0.2, 26±0.2, 26.3±0.2, 27±0.2, 28.5±0.2, 33.3±0.2, 35.5±0.2, 35.8±0.2 and 37.9±0.

2.

25. The crystalline form of claim 23, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 16.1±0.2,16.9±0.2, 19.4±0.2, 20.7±0.2 and 24.3±0.

2.

26. The crystalline form of claim 23, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.5A.

27. The crystalline form of any one of claims 23-26, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.5C.

28. The crystalline form of any one of claims 23-27, wherein the crystalline form has a thermogravimetric analysis (TGA) pattern substantially corresponding to FIG.5B.Attorney Docket No. TGO-025WO 29. A 1,3-dioxane solvate crystalline form, Form E, of (R)-N-(4-amino-4'-fluoro-[1,1'- biphenyl]-3-yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 7.1±0.2, 10.7±0.2, 11.8±0.2,16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.

2.

30. The crystalline form of claim 29, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 7.1±0.2, 10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.

2.

31. The crystalline form of claim 29, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at values of 2 in degrees selected from11.8±0.2, 16.5±0.2, 21.3±0.2 and 26.1±0.

2.

32. The crystalline form of claim 29, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 7.1±0.2,10.7±0.2, 11.8±0.2, 16.1±0.2, 16.5±0.2, 18.9±0.2, 20.7±0.2, 21.3±0.2, 21.5±0.2, 23.7±0.2, 24.2±0.2, 26.1±0.2 and 33.3±0.

2.

33. The crystalline form of claim 29, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.6A.

34. The crystalline form of any one of claims 29-33, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.6C.Attorney Docket No. TGO-025WO 35. The crystalline form of any one of claims 29-34, wherein the crystalline form has a thermogravimetric analysis (TGA) pattern substantially corresponding to FIG.6B.

36. An anhydrous crystalline form, Form F, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3- yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5±0.2, 7.5±0.2, 8±0.2, 10±0.2,12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.

2.

37. The crystalline form of claim 36, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5±0.2, 7.5±0.2, 8±0.2, 10±0.2, 12.5±0.2, 15.1±0.2, 16.5±0.2, 17.8±0.2, 18.1±0.2, 18.7±0.2, 19.1±0.2, 20.6±0.2, 21±0.2, 21.3±0.2, 22.8±0.2, 23.8±0.2, 24±0.2, 24.6±0.2, 25.3±0.2, 26.1±0.2 and 26.4±0.

2.

38. The crystalline form of claim 36, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 5±0.2, 8±0.2,10±0.2, 18.1±0.2, 23.8±0.2, 24±0.2 and 24.6±0.

2.

39. The crystalline form of claim 36, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.7A.

40. The crystalline form of any one of claims 36-39, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.7C.

41. The crystalline form of any one of claims 36-40, wherein the crystalline form has a thermogravimetric analysis (TGA) pattern substantially corresponding to FIG.7B.Attorney Docket No. TGO-025WO 42. An anhydrous crystalline form, Form G, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3- yl)-4-(S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 5.6±0.2, 10.5±0.2, 13.9±0.2,15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.

2.

43. The crystalline form of claim 42, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 5.6±0.2, 10.5±0.2, 13.9±0.2, 15.8±0.2, 16.7±0.2, 17.9±0.2, 18.3±0.2, 18.5±0.2, 18.9±0.2, 19.3±0.2, 19.5±0.2, 19.9±0.2, 20.9±0.2, 21.2±0.2, 22.6±0.2, 23.9±0.2, 24.4±0.2, 24.7±0.2, 25.2±0.2, 26.3±0.2, 26.7±0.2, 27.6±0.2, 28±0.2, 28.9±0.2, 31.7±0.2, 34.2±0.2 and 36±0.

2.

44. The crystalline form of claim 42, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 16.7±0.2,19.3±0.2, 21.2±0.2, 24.4±0.2 and 26.7±0.

2.

45. The crystalline form of claim 42, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.8A.

46. The crystalline form of any one of claims 42-45, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.8C.

47. The crystalline form of any one of claims 42-46, wherein the crystalline form has a thermogravimetric analysis (TGA) pattern substantially corresponding to FIG.8B.Attorney Docket No. TGO-025WO 48. A hydrate crystalline form, Form H, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4- (S-methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 12.3±0.2, 14.9±0.2, 16.4±0.2,17.9±0.2, 18.7±0.2, 19±0.2, 19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.

2.

49. The crystalline form of claim 48, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 12.3±0.2, 14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2, 19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.

2.

50. The crystalline form of claim 48, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at values of 2 in degrees selected from18.7±0.2, 19±0.2, 20.5±0.2 and 20.8±0.

2.

51. The crystalline form of claim 48, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 12.3±0.2,14.9±0.2, 16.4±0.2, 17.9±0.2, 18.7±0.2, 19±0.2, 19.7±0.2, 20.5±0.2, 20.8±0.2, 21.7±0.2, 24.6±0.2, 25±0.2 and 25.7±0.

2.

52. The crystalline form of claim 48, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.9A.

53. The crystalline form of any one of claims 48-52, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.9C.Attorney Docket No. TGO-025WO 54. The crystalline form of any one of claims 48-53, wherein the crystalline form has a thermogravimetric analysis (TGA) pattern substantially corresponding to FIG.9B.

55. A crystalline form, Form I, of (R)-N-(4-amino-4'-fluoro-[1,1'-biphenyl]-3-yl)-4-(S- methylsulfonimidoyl)benzamide, having Formula (I):Formula (I), wherein the crystalline form has an X-ray powder diffraction pattern comprising at least onecharacteristic peak at values of 2 in degrees selected from 8.9±0.2, 12.3±0.2, 14.6±0.2,15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.

2.

56. The crystalline form of claim 55, wherein the crystalline form has an X-ray powderdiffraction pattern comprising at least five characteristic peaks at values of 2 in degrees selectedfrom 8.9±0.2, 12.3±0.2, 14.6±0.2, 15.5±0.2, 16±0.2, 17.2±0.2, 17.9±0.2, 18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 20.2±0.2, 21.1±0.2, 22.2±0.2, 22.9±0.2, 24.5±0.2, 24.8±0.2, 26.7±0.2, 27.4±0.2 and 30±0.

2.

57. The crystalline form of claim 55, wherein the crystalline form has an X-ray powderdiffraction pattern comprising characteristic peaks at a value of 2 in degrees of 17.9±0.2,18.2±0.2, 18.6±0.2, 19.4±0.2, 19.8±0.2, 21.1±0.2, 22.2±0.2 and 26.7±0.

2.

58. The crystalline form of claim 55, wherein the crystalline form has an X-ray powder diffraction pattern substantially corresponding to FIG.10A.

59. The crystalline form of any one of claims 55-58, wherein the crystalline form has an differential scanning calorimetry (DSC) pattern substantially corresponding to FIG.10B.

60. The crystalline form of any one of claims 55-59, wherein the crystalline form is a hydrate.Attorney Docket No. TGO-025WO 61. A pharmaceutical composition comprising a crystalline form of any one of claims 1-60.

62. A method for ascertaining susceptibility of a subject having or having been diagnosed with cancer to treatment with a crystalline form of any one of claims 1-60 or a composition of claim 61, the method comprising: determining: i) the presence or absence of a STK11 mutation; and / or ii) the level of STK11 activity or expression in the subject or a sample derived from the subject; wherein the presence of a STK11 mutation and / or a modified level of STK11 activity or expression is indicative of susceptibility to treatment with the crystalline form or composition.

63. A method for ascertaining susceptibility of a subject having or having been diagnosed with cancer to treatment with a combination of a crystalline form of any one of claims 1-60 or a composition of claim 61 and an immune checkpoint modulator, the method comprising: determining: i) the presence or absence of a STK11 mutation; and / or ii) the level of STK11 activity or expression in the subject or a sample derived from the subject; wherein the presence of a STK11 mutation and / or a modified level of STK11 activity or expression is indicative of susceptibility to treatment with a combination of an HDAC inhibitor and an immune checkpoint modulator.

64. A crystalline form of any one of claims 1-60, or a composition of claim 61 comprising an effective amount of compound of Formula (I) for use in a method of treating a subject having, or at risk of developing, a cancer, the method comprising administering to the subject an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I) wherein the cancer is identified as having modified STK11 activity or expression.

65. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a subject having, or at risk of developing, a cancer,Attorney Docket No. TGO-025WO the method comprising administering to the subject an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I), wherein the cancer is identified as having modified STK11 activity or expression.

66. The crystalline form, compound or pharmaceutical composition for use of claim 64 or 65, wherein the compound or composition is administered in combination with one or more additional therapeutic agents.

67. The crystalline form, compound or pharmaceutical composition for use of claim 66, wherein at least one of the additional therapeutic agents is an immune checkpoint modulator.

68. A crystalline form of any one of claims 1-60, or a composition of claim 61 for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator and an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I) wherein the treatment modulates and / or improves the Teff cell to Treg cell ratio in the tumor or tumor microenvironment, wherein the cancer is identified as having modified STK11 activity or expression.

69. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator and (a) an effective amount of a compound of Formula (I) or (b) a pharmaceutical composition comprising an effective amount of a compound of Formula (I),Attorney Docket No. TGO-025WO wherein the treatment modulates and / or improves the Teff cell to Treg cell ratio in the tumor or tumor microenvironment, wherein the cancer is identified as having modified STK11 activity or expression.

70. A crystalline form of any one of claims 1-60, or a composition of claim 61 for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator and an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I) wherein the treatment reduces or depletes Treg cells in the tumor or tumor microenvironment, wherein the cancer is identified as having modified STK11 activity or expression.

71. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator and (a) an effective amount of a compound of Formula (I) or (b) a pharmaceutical composition comprising an effective amount of a compound of Formula (I),Formula (I) wherein the treatment reduces or depletes Treg cells in the tumor or tumor microenvironment, wherein the cancer is identified as having modified STK11 activity or expression.

72. A crystalline form of any one of claims 1-60, or a composition of claim 61 for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator and an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I) wherein the treatment induces or increases the expression of cytokines that promoteAttorney Docket No. TGO-025WO anti-tumor activity, wherein the cancer is identified as having modified STK11 activity or expression.

73. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator and (a) an effective amount of a compound of Formula (I) or (b) a pharmaceutical composition comprising an effective amount of a compound of Formula (I),Formula (I) wherein the treatment induces or increases the expression of cytokines that promote anti-tumor activity, wherein the cancer is identified as having modified STK11 activity or expression.

74. A crystalline form of any one of claims 1-60, or a composition of claim 61 for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator and an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I) wherein the treatment reduces the expression of cytokines that promote Treg cell recruitment, wherein the cancer is identified as having modified STK11 activity or expression.

75. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator and (a) an effective amount of a compound of Formula (I) or (b) a pharmaceutical composition comprising an effective amount of a compound of Formula (I),Attorney Docket No. TGO-025WOFormula (I) wherein the treatment reduces the expression of cytokines that promote Treg cell recruitment, wherein the cancer is identified as having modified STK11 activity or expression.

76. A crystalline form of any one of claims 1-60, or a composition of claim 61 for use in a method of treating a cancer in a subject, the method comprising administering to the subject an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I) wherein the administering of the crystalline form or the composition does not reduce erythroid or myeloid cell viability, wherein the cancer is identified as having modified STK11 activity or expression.

77. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a cancer in a subject, the method comprising administering to the subject (a) an effective amount of a compound of Formula (I) or (b) a pharmaceutical composition comprising an effective amount of a compound of Formula (I),Formula (I) wherein the treatment does not reduce erythroid or myeloid cell viability, wherein the cancer is identified as having modified STK11 activity or expression.Attorney Docket No. TGO-025WO 78. A crystalline form of any one of claims 1-60, or a composition of claim 61 for use in a method of treating a cancer in a subject, wherein the cancer presents an immune evasion phenotype characterized by STK11 mutant expression, the method comprising: administering an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I) wherein the crystalline form, or the composition is capable of attenuating or reversing the immune evasion phenotype.

79. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a cancer in a subject, wherein the cancer presents an immune evasion phenotype characterized by STK11 mutant expression, the method comprising: administering (a) an effective amount of a compound of Formula (I) or (b) a pharmaceutical composition comprising an effective amount of a compound of Formula (I),Formula (I) wherein the compound, or the composition is capable of attenuating or reversing the immune evasion phenotype.

80. The crystalline form, compound or pharmaceutical composition for use of any one of claims 76-79, further comprising administering an immune checkpoint modulator.

81. A crystalline form of any one of claims 1-60, or a composition of claim 61 for use in a method of treating a cancer in a subject, the method comprising administering to the subject an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I) wherein an immune checkpoint modulator has been, is, or will be administered to the subject, wherein the cancer is identified as having modified STK11 activity or expression.Attorney Docket No. TGO-025WO 82. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a cancer in a subject, the method comprising administering to the subject (a) an effective amount of a compound of Formula (I) or (b) a pharmaceutical composition comprising an effective amount of a compound of Formula (I),Formula (I) wherein an immune checkpoint modulator has been, is, or will be administered to the subject, wherein the cancer is identified as having modified STK11 activity or expression.

83. A crystalline form of any one of claims 1-60, or a composition of claim 61 for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator, wherein an effective amount of a crystalline form of any one of claims 1-60, or the composition of claim 61 comprising an effective amount of compound of Formula (I), is, or will be administered to the subject, wherein the cancer is identified as having modified STK11 activity or expression.

84. A compound of Formula (I) or a pharmaceutical composition comprising a compound of Formula (I) for use in a method of treating a cancer in a subject, the method comprising administering to the subject an immune checkpoint modulator, wherein (a) an effective amount of a compound of Formula (I) or (b) a pharmaceutical composition comprising an effective amount of a compound of Formula (I),Attorney Docket No. TGO-025WOFormula (I) is, or will be administered to the subject, wherein the cancer is identified as having modified STK11 activity or expression.

85. The crystalline form, compound or pharmaceutical composition for use of claim 64, wherein the crystalline form or the composition is administered in combination with two or more additional therapeutic agents, wherein at least two of the additional therapeutic agents are immune checkpoint modulators.

86. The crystalline form, compound or pharmaceutical composition for use of any one of claims 67-75 and 80-85, wherein at least one immune checkpoint modulator is a checkpoint inhibitor.

87. The crystalline form, compound or pharmaceutical composition for use of claim 86, wherein each checkpoint inhibitor is independently selected from an anti-CTLA-4 agent, an anti- PD-1 agent, an anti-PD-L1 agent, an anti-4-1 BB agent, an anti-OX-40 agent, an anti-GITR agent, an anti- CD27 agent, an anti-CD28 agent, an anti-CD40 agent, an anti-LAG3 agent, an anti-ICOS agent, an anti-TWEAKR agent, an anti-HVEM agent, an anti-TIM-1 agent, an anti- TIM-3 agent, an anti-VISTA agent, and an anti-TIGIT agent.

88. The crystalline form, compound or pharmaceutical composition for use of claim 64, wherein the crystalline form or the composition is administered in combination with an anti- CTLA-4 agent and an anti PD-1 or anti PD-L1 agent.

89. The crystalline form, compound or pharmaceutical composition for use of any one of claims 86 or 87, wherein each immune checkpoint inhibitor is independently an antibody.Attorney Docket No. TGO-025WO 90. The crystalline form, compound or pharmaceutical composition for use of claim 89, wherein the each checkpoint inhibitor is independently selected from an anti-CTLA-4 antibody, an anti-PD-1 antibody, an anti-PD-L1 antibody, an anti-4-1 BB antibody, an anti-OX-40 antibody, an anti-GITR antibody, an anti-CD27 antibody, an anti-CD28 antibody, an anti-CD40 antibody, an anti-LAG3 antibody, an anti-ICOS antibody, an anti-TWEAKR antibody, an anti- HVEM antibody, an anti-TIM-1 antibody, an anti-TIM-3 antibody, an anti-VISTA antibody, and an anti-TIGIT antibody.

91. The crystalline form, compound or pharmaceutical composition for use of claim 89, wherein each immune checkpoint inhibitor is independently selected from nivolumab; CT-011; AMP-224; pembrolizumab; pidilizumab; cemiplimab; dostarlimab; prolgolimab; spartalizumab; camrelizumab; sasanlimab, sintilimab; tislelizumab; toripalimab; retifanlimab; MEDI0680; budigalimab and geptanolimab.

92. The crystalline form, compound or pharmaceutical composition for use of claim 89, wherein the checkpoint inhibitor is an anti-PD1 antibody.

93. The crystalline form, compound or pharmaceutical composition for use of any one of claims 90 or 92, wherein the anti-PD-1 antibody is pembrolizumab.

94. The crystalline form, compound or pharmaceutical composition for use of any one of claims 66-93, wherein at the method further comprises administering at least one additional therapeutic agent wherein the additional therapeutic agent is targeted agent.

95. The crystalline form, compound or pharmaceutical composition for use of claim 94, wherein each targeted agent is independently selected from an anti-angiogenesis agent (e.g., an anti-VEGF agent), a KRAS inhibitor, an ALK inhibitor, a ROS1 inhibitor, a BRAF inhibitor, a RET inhibitor, a MEK inhibitor, a MET inhibitor and a TRK inhibitor.

96. The crystalline form, compound or pharmaceutical composition for use of claim 94, wherein each targeted agent is independently selected from bevacizumab, ramucirumab, sotorasib, crizotinib, ceritinib, alectinib, brigatinib, lorlatinib, entrectinib, dabrafenib, trametinib, capmatinib, tepotinib and larotrectinib.Attorney Docket No. TGO-025WO 97. The crystalline form, compound or pharmaceutical composition for use of any one of claims 66-93, wherein the method further comprises administering at least one additional therapeutic agent wherein the additional therapeutic agent is a chemotherapeutic agent.

98. The crystalline form, compound or pharmaceutical composition for use of any one of claims 66-93, wherein the method further comprises administering at least one additional therapeutic agent wherein the additional therapeutic agent is radiation.

99. The crystalline form, compound or pharmaceutical composition for use of any one of claims 64-98, wherein the cancer is resistant to anti-PD1 therapy or anti-PD-L1 therapy.

100. The crystalline form, compound or pharmaceutical composition for use of any one of claims 64-99, wherein the cancer is resistant to chemotherapy (e.g., platinum-containing chemotherapy).

101. The crystalline form, compound or pharmaceutical composition for use of any one of claims 64-100, wherein the cancer does not respond to or benefit from treatment with an immune checkpoint modulator when administered alone or as part of a treatment regimen that does not include an HDAC inhibitor.

102. The crystalline form, compound or pharmaceutical composition for use of any one of claims 64-101, wherein the cancer is selected from the group consisting of: lung cancer (e.g., lung adenocarcinoma, non-small cell lung cancer (NSCLC), squamous cell lung carcinoma), colorectal cancer (e.g., colon adenocarcinoma, rectal adenocarcinoma), breast cancer (e.g., invasive ductal carcinoma), pancreatic cancer (e.g., pancreatic adenocarcinoma), endometrial cancer (e.g., endometrioid carcinoma), neuroendocrine cancer (e.g., large cell neuroendocrine carcinoma), melanoma, non-melanoma skin cancer (e.g., skin squamous cell carcinoma), cholangiocarcinoma, gallbladder cancer, ovarian cancer (e.g., ovarian serous adenocarcinoma), bladder cancer (e.g., bladder urothelial carcinoma), prostate cancer (e.g., prostate adenocarcinoma), cervical cancer, endocervical cancer or cancer of unknown primary (e.g., adenocarcinoma of unknown primary).

103. The crystalline form, compound or pharmaceutical composition for use of any one of claims 64-102, wherein the cancer is identified as having a STK11 mutation and one or more additional mutations.Attorney Docket No. TGO-025WO 104. The crystalline form, compound or pharmaceutical composition for use of claim 103, wherein the additional mutations are selected from KRAS mutations and KEAP1 mutations.

105. The crystalline form, compound or pharmaceutical composition for use of claim 104 or 270, wherein the KRAS mutations are mutations at position G12, optionally wherein the KRAS mutations are selected from G12D mutations, G12C mutations, G12V mutations or combinations thereof.

106. The crystalline form or compound for use of any one of claims 64-105 wherein the effective amount of compound is 40 mg or 80 mg administered once daily (QD).

107. The pharmaceutical composition for use of any one of claims 64-105 wherein the effective amount of composition is calculated to administer 40 mg or 80 mg of free base equivalent of compound of Formula (I) once daily (QD).

108. The crystalline form or compound for use of any one of claims 64-105 wherein the effective amount of compound is 40 mg or 80 mg administered once daily (QD) 2 weeks on / 1 week off, once daily (QD) 1 week on / 2 weeks off, once daily (QD) 2 days on / 5 days off, once weekly, or twice weekly.

109. The pharmaceutical composition for use of any one of claims 64-105 wherein the effective amount of composition is calculated to administer 40 mg or 80 mg of free base equivalent of compound of Formula (I) once daily (QD) 2 weeks on / 1 week off, once daily (QD) 1 week on / 2 weeks off, once daily (QD) 2 days on / 5 days off, once weekly, or twice weekly.

Citation Information

Patent Citations

  • Tgonovel HDAC inhibitors and therapeutic use thereof

    WO2023102162A1