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Compositions, kits, and methods for identification, assessment, prevention, and therapy of cancer

A technology of cancer, therapy, applied in the field of compositions, kits and methods for identification, evaluation, prevention and treatment of cancer, which can solve the problem of lack of general understanding

Inactive Publication Date: 2012-10-03
INFINITY PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Despite the identification of cancer biomarkers, there is a lack of overall understanding of the relationship between the presence of such biomarkers and the likelihood of efficacy of cancer therapy, particularly whether a subject with cancer is or is not likely to respond to treatment with an HSP90 inhibitor

Method used

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  • Compositions, kits, and methods for identification, assessment, prevention, and therapy of cancer
  • Compositions, kits, and methods for identification, assessment, prevention, and therapy of cancer
  • Compositions, kits, and methods for identification, assessment, prevention, and therapy of cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0822] [Example 1: Preparation of hydroquinone hydrochloride of 17-AAG]

[0823]

[0824] 17-AAG (0.450 g, 0.768 mmol, 1.0 equiv) was dissolved in dichloromethane (50 mL) and stirred with a 10% aqueous solution of sodium sulfoxylate (50 mL). The solution was stirred for 30 minutes. Collect the organic layer, in Na 2 SO 4 Dry on air, filter and transfer to a round bottom flask. To this solution was added HCl in dioxane (4N, 0.211 mL, 1.1 equiv). The resulting mixture was stirred under nitrogen for 30 minutes. The yellow solid was slowly washed out of solution. The yellow solid was purified by recrystallization from MeOH / EtOAc to yield 0.386 g of hydroquinone HCl salt (2).

[0825] Compound 2 is also referred to herein as IPI-504. IPI-504 (Risspiramycin Hydrochloride) is a water soluble potent inhibitor of Hsp90.

[0826] Additional salts of 17-AAG can be prepared as described herein and / or as known in the art (see, e.g., US 2006 / 0019941, US 7,375,217 and US 7,767,663...

Embodiment 2

[0828] [Example 2: ALK mutation predicts response and clinical benefit of HSP90 inhibitors (including IPI-504) treatment]

[0829] Retrospective molecular characterization was performed on tumor samples from patients with relapsed and / or refractory stage IIIb or IV non-small cell lung cancer (NSCLC) who were enrolled in a test, IPI-504 (Infinity Pharm. ) Phase 1 / 2 study of safety, tolerability and activity. Use Vysis TM The developed probes were used to determine ALK status by two-color, fracture-separation fluorescence in situ hybridization (FISH) following the manufacturer's protocol. Assays were scored as negative when the probes overlapped (yellow) or were within 2 probe lengths of each other. The assay was scored positive when the probes were separated or the distance between them was greater than 2 probe lengths in >15% of cells or >8 / 50 nuclei. For example, in ALK FISH from a patient with a partial response, wild-type ALK is represented by co-localization of the two ...

Embodiment 3A

[0831] [Example 3A: The relationship between ALK rearrangement (rALK) and the clinical activity of IPI-504 (rhespiramycin hydrochloride) in patients with non-small cell lung cancer (NSCLC)]

[0832] 【Overview】

[0833] This example describes results from a clinical trial evaluating IPI-504, a potent Hsp90 inhibitor described herein, in patients with advanced, molecularly defined non-small cell lung cancer (NSCLC) on EGFR Efficacy after tyrosine kinase inhibitor (TKI) therapy.

[0834] Patients with advanced NSCLC, previously treated with an EGFR TKI and with tumor tissue available for molecular genotyping were enrolled in this prospective, nonrandomized, multicenter, phase II study of IPI-504 monotherapy. The primary outcome was objective response rate. Secondary objectives included safety, progression-free survival (PFS), and activity by molecular subtype analysis.

[0835]Seventy-six patients from ten US cancer centers enrolled between December 2007 and May 2009. An over...

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Abstract

Described herein are compositions, kits, and methods for determining whether subjects having cancer(s) are likely to respond to treatment with an HSP90 inhibitor, as a single agent or in combination therapy. Further described are methods for prognosing a time course of disease in a subject having such cancer.

Description

[0001] 【CROSS-REFERENCE TO RELATED APPLICATIONS】 [0002] This application claims U.S. Provisional Application No. 61 / 261,064, filed November 13, 2009; U.S. Provisional Application No. 61 / 283,150, filed November 30, 2009; U.S. Provisional Application No. 61 / 283,150, filed March 12, 2010 61 / 313,364; U.S. Provisional Application No. 61 / 313,594, filed March 12, 2010; U.S. Provisional Application No. 61 / 346,873, filed May 20, 2010; U.S. Provisional Application No. 6, filed September 13, 2010 61 / 382,447; U.S. Provisional Application No. 61 / 390,136, filed October 5, 2010; and U.S. Provisional Application No. 61 / 394,735, filed October 19, 2010. The contents of all aforementioned applications are hereby incorporated by reference in their entirety. [0003] 【Sequence Listing】 [0004] This application contains a Sequence Listing that has been submitted via EFS-Web in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on November 12, 2010, is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/48G01N33/53
CPCG01N2333/485G01N2333/9121G01N33/57492G01N2800/52G01N2333/82G01N2333/71A61P35/00A61P35/02A61P43/00
Inventor C·福里茨E·Y·诺曼特J·G·派兹K·A·维斯特
Owner INFINITY PHARMA
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