Resiquimod in combination with a PD-1 or PD-l1 antagonist for treating cancer

Abstract

The present disclosure relates to compositions and methods for treating cancer comprising the administration of TLR7 / 8 agonist-containing compositions at dosages effective to elicit anti-tumor activity yet maintaining advantageous safety and tolerability profiles.

Description

Attorney Ref: 092295.0162 EIK-1019-WO METHODS OF TREATING CANCER 1. CROSS-REFERENCE TO RELATED APPLICATIONSThis application claims priority to U.S. Provisional Application No.63 / 653,632, filed May 30, 2024, the content of which is incorporated herein by reference herein in its entirety. 2. FIELD OF THE INVENTIONThe present disclosure relates to compositions and methods for treating cancer comprising the administration of Toll-like Receptor (TLR) 7 / 8 agonist-containing compositions at dosages effective to elicit anti-tumor activity yet maintaining advantageous safety and tolerability profiles. 3. BACKGROUND OF THE INVENTIONEIK1001 (also known as BDB001, resiquimod, and 1-(4-amino-2-(ethoxymethyl)- 1H-imidazo[4,5-c]quinoline-1-yl)-2-methylpropan-2-ol) is a TLR7 / 8 agonist having a Chemical Abstracts Service (CAS) registry number 144875-48-9. EIK1001 has been demonstrated to stimulate myeloid and plasmacytoid dendritic cells, thereby activating immune and inflammatory responses. This dual activity provides a pathway distinct from effects on checkpoint proteins, and thus EIK1001 can enhance antitumor T-cell activity alone or in combination with immune checkpoint inhibitors. EIK1001’s antitumor efficacy against a variety of solid tumors has been demonstrated in a series of nonclinical studies. 4. SUMMARY OF THE INVENTIONIn certain embodiments, the present disclosure is directed a method of treating cancer in a human subject, the method comprising administering to the subject 4-amino-2- (ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof where the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2. In certain embodiments, the present disclosure is directed to a method of treating cancer in a human subject, the method comprising administering to the subject 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5- c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof; and a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) antagonist, where the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75Attorney Ref: 092295.0162 EIK-1019-WO mg / m2. In certain embodiments, the EIK1001 is administered as a weekly dose over 20 to 30 weeks. In certain embodiments, the EIK1001 is administered as a weekly dose over 27 weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 20-30 weeks, administered once every three weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 20-30 weeks, administered as a weekly dose if the subject experiences progressive disease. In certain embodiments, the EIK1001 is administered as a weekly dose over 24 weeks. In certain embodiments, the EIK1001 is thereafter administered once every three weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 24 weeks, administered as a weekly dose if the subject experiences progressive disease. In certain embodiments, the PD-1 antagonist is selected from the group consisting of pembrolizumab, cemiplimab, dostarlimab, tislelizumab, nivolumab, retifanlimab, and toripalimab. In certain embodiments, the PD-L1 antagonist is selected from the group consisting of atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab. In certain embodiments, the present disclosure is directed a method of treating cancer in a human subject, the method comprising administering to the subject 4-amino-2- (ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof and pembrolizumab. In certain embodiments, the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks. In certain embodiments of the above methods, the cancer is selected from the group consisting of lung cancer, melanoma, breast cancer, colorectal cancer, endometrial cancer, gastric cancer, glioblastoma, head and neck cancer, hepatocellular cancer, ovarian cancer, pancreatic cancer, prostate cancer, renal cell carcinoma, esophageal cancer, non-melanoma skin cancers, and gallbladder cancer. In certain embodiments of the above methods, the cancer is melanoma. In certain embodiments of the above methods, the cancer is squamous non-small cell lung cancer or nonsquamous non-small cell lung cancer. In certain embodiments of the above methods, the cancer is squamous non-small cell lung cancer or nonsquamous non-small cell lung cancer and the method further comprises administering to the subject a chemotherapeutic agent, such as carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments of the above methods, the cancer is squamous non-small cell lung cancer and the chemotherapeutic is a) carboplatin and paclitaxel, or b) carboplatin and nab-paclitaxel. In certain embodiments of theAttorney Ref: 092295.0162 EIK-1019-WO above methods, the cancer is nonsquamous non-small cell lung cancer is a) carboplatin and pemetrexed, or b) cisplatin and pemetrexed. In certain embodiments of the above methods, administration of EIK1001 results in an increase in the level of a TLR7 or TLR8 activation biomarker, such as IL-6, IL-8, IFN^, or IP-10. In certain embodiments, the biomarker is increased at least 1.5-fold, 2-fold, 4-fold or more over baseline. In certain embodiments, the biomarker is increased at least 2-fold over baseline. In certain embodiments of the above methods, administration of EIK1001 results in an objective disease response as measured by RECIST 1.1. In certain embodiments of the above methods, the administration of EIK1001 results in a partial response, a complete response, or a stable disease. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with hematological toxicity. In certain embodiments, the method further comprises administering the EIK1001 at the prior administered weekly dose when the Grade 3 event or the Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 7 days. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when the Grade 3 event or Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from0.60 mg / m2 and 0.45 mg / m2, and when the previously administered dose is 0.60 mg / m2 the dosebelow is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event or a Grade 4 event associated with hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 7 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with non- hematological toxicity. In certain embodiments, the method further comprises administering the EIK1001 at the prior administered weekly dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days. In certainAttorney Ref: 092295.0162 EIK-1019-WO embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2and 0.45 mg / m2, and when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 21 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2. In certain embodiments, the method further comprises administering EIK1001 at a weekly dose below the previously administered dose when a Grade 4 event associated with non-hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction. In certain embodiments, the method further comprises administering the EIK1001 at a reduced infusion rate when the infusion reaction resolves. In certain embodiments, the method further comprises administering the EIK1001 at half infusion rate when the infusion reaction resolves within 24 hours. In certain embodiments, the method further comprises withholding administration of the PD-1 or PD-L1 antagonist when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction. In certain embodiments, the method further comprises administering the PD- 1 or PD-L1 antagonist at a reduced infusion rate when the Grade 2 infusion reaction resolves within 1 hour. In certain embodiments, the method further comprises administering the PD-1 or PD-L1 antagonist at half infusion rate when the Grade 2 infusion reaction resolves within 1 hour.Attorney Ref: 092295.0162 EIK-1019-WO In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with cytokine release syndrome. In certain embodiments, the method further comprises administering the EIK1001 when the event associated with cytokine release syndrome resolves. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a persistent Grade 2 event associated with cytokine release syndrome. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 immune-related adverse reaction (iAE), a Grade 3 iAE, or a Grade 4 iAE. In certain embodiments, the method further comprises administering the EIK1001 when the event associated with immune-related adverse reaction resolves. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a persistent Grade 2 immune-related adverse reaction. In certain embodiments, the present disclosure is directed to a method of inducing an immune response in a human subject, the method comprising administering to the subject 4- amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof, where the EIK1001 is administered intravenously ata weekly dose of 0.60 mg / m2 or 0.75 mg / m2. In certain embodiments, the present disclosure isdirected to a method of inducing an immune response in a human subject, the method comprising administering to the subject 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H- imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof, where the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2and a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) antagonist. In certain embodiments, the PD-1 antagonist is selected from the group consisting of pembrolizumab, cemiplimab, dostarlimab, tislelizumab, nivolumab, retifanlimab, and toripalimab. In certain embodiments, the PD-L1 antagonist is selected from the group consisting of atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab. In certain embodiments, the PD-1 antagonist is pembrolizumab administered intravenously at a dose of 200 mg once every 3 weeks. In certain embodiments, the method further comprises administering to the subject a chemotherapeutic agent. In certain embodiments, the chemotherapeutic agent is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. InAttorney Ref: 092295.0162 EIK-1019-WO certain embodiments, the chemotherapeutic is a) carboplatin and paclitaxel, or b) carboplatin and nab-paclitaxel. In certain embodiments, the chemotherapeutic is a) carboplatin and pemetrexed, or b) cisplatin and pemetrexed. In certain embodiments, the EIK1001 is administered as a weekly dose over 20 to 30 weeks. In certain embodiments, the EIK1001 is administered as a weekly dose over 27 weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 20-30 weeks, administered once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose if the subject experiences progressive disease after beginning administration once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose over 24 weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 24 weeks, administered once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose if the subject experiences progressive disease after beginning administration once every three weeks. In certain embodiments, inducing the immune response is indicated by an increase in a biomarker associated with TLR7 and or TLR8 activation, such as IL-6, IL-8, IFN^, or IP-10. In certain embodiments, the biomarker is increased at least 1.5-fold, 2-fold, 4-fold or more over baseline. In certain embodiments, the biomarker is increased at least 2-fold over baseline. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with hematological toxicity. In certain embodiments, the method further comprises administering the EIK1001 at the prior administered weekly dose when the Grade 3 event or the Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 7 days. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when the Grade 3 event or Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from0.60 mg / m2 and 0.45 mg / m2, and when the previously administered dose is 0.60 mg / m2 the dosebelow is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event or a Grande 4 event associated with hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 7 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45Attorney Ref: 092295.0162 EIK-1019-WO mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with non- hematological toxicity. In certain embodiments, the method further comprises administering the EIK1001 at the prior administered weekly dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2and 0.45 mg / m2, and when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 21 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2. In certain embodiments, the method further comprises administering EIK1001 at a weekly dose below the previously administered dose when a Grade 4 event associated with non-hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction. In certain embodiments, the method further comprises administering the EIK1001 at a reduced infusion rate when the infusion reaction resolves. In certain embodiments, the method further comprises administering the EIK1001 at half infusion rate when the infusion reaction resolves within 24 hours. In certain embodiments, the methodAttorney Ref: 092295.0162 EIK-1019-WO further comprises withholding administration of the PD-1 or PD-L1 antagonist when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction. In certain embodiments, the method further comprises administering the PD- 1 or PD-L1 antagonist at a reduced infusion rate when the Grade 2 infusion reaction resolves within 1 hour. In certain embodiments, the method further comprises administering the PD-1 or PD-L1 antagonist at half infusion rate when the Grade 2 infusion reaction resolves within 1 hour. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with cytokine release syndrome. In certain embodiments, the method further comprises administering the EIK1001 when the event associated with cytokine release syndrome resolves. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a persistent Grade 2 event associated with cytokine release syndrome. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 immune-related adverse reaction (iAE), a Grade 3 iAE, or a Grade 4 iAE. In certain embodiments, the method further comprises administering the EIK1001 when the event associated with immune-related adverse reaction resolves. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a persistent Grade 2 immune-related adverse reaction. In certain embodiments, the present disclosure is directed to a method of inducing an increase in expression of a biomarker associated with TLR7 and or TLR8 activation in a human subject, the method comprising administering to the subject 4-amino-2-(ethoxymethyl)-a,a-di- methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof, where the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2. In certain embodiments, the present disclosure is directed to a method ofinducing an increase in expression of a biomarker associated with TLR7 and or TLR8 activation in a human subject, the method comprising administering to the subject 4-amino-2- (ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof, where the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2and a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) antagonist.Attorney Ref: 092295.0162 EIK-1019-WO In certain embodiments, the PD-1 antagonist is selected from the group consisting of pembrolizumab, cemiplimab, dostarlimab, tislelizumab, nivolumab, retifanlimab, and toripalimab. In certain embodiments, the PD-L1 antagonist is selected from the group consisting of atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab. In certain embodiments, the PD-1 antagonist is pembrolizumab administered intravenously at a dose of 200 mg once every 3 weeks. In certain embodiments, the method further comprises administering to the subject a chemotherapeutic agent. In certain embodiments, the chemotherapeutic agent is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments, the chemotherapeutic is a) carboplatin and paclitaxel, or b) carboplatin and nab-paclitaxel. In certain embodiments, the chemotherapeutic is a) carboplatin and pemetrexed, or b) cisplatin and pemetrexed. In certain embodiments, the EIK1001 is administered as a weekly dose over 20 to 30 weeks. In certain embodiments, the EIK1001 is administered as a weekly dose over 27 weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 27 weeks, administered once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose if the subject experiences progressive disease after beginning administration once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose over 24 weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 24 weeks, administered once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose if the subject experiences progressive disease after beginning administration once every three weeks. In certain embodiments, inducing the immune response is indicated by an increase in a biomarker associated with TLR7 and or TLR8 activation, such is IL-6, IL-8, IFN^, or IP-10. In certain embodiments the biomarker is increased at least 1.5-fold, 2-fold, 4-fold or more over baseline. In certain embodiments the biomarker is increased at least 2-fold over baseline. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with hematological toxicity. In certain embodiments, the method further comprises administering the EIK1001 at the prior administered weekly dose when the Grade 3 event or the Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 7 days. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when the Grade 3 event or Grade 4 eventAttorney Ref: 092295.0162 EIK-1019-WO associated with hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from0.60 mg / m2 and 0.45 mg / m2, and when the previously administered dose is 0.60 mg / m2 the dosebelow is selected from 0.45 mg / m2and 0.30 mg / m2, . In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event or a Grande 4 event associated with hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 7 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with non- hematological toxicity. In certain embodiments, the method further comprises administering the EIK1001 at the prior administered weekly dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2and 0.45 mg / m2, and when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 21 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises administering the EIK1001 at a weekly dose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2. In certain embodiments, the method further comprises administering EIK1001 at a weekly dose below the previously administered dose when a Grade 4 event associated with non-hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, whereinAttorney Ref: 092295.0162 EIK-1019-WO when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction. In certain embodiments, the method further comprises administering the EIK1001 at a reduced infusion rate when the infusion reaction resolves. In certain embodiments, the method further comprises administering the EIK1001 at half infusion rate when the infusion reaction resolves within 24 hours. In certain embodiments, the method further comprises withholding administration of the PD-1 or PD-L1 antagonist when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction. In certain embodiments, the method further comprises administering the PD- 1 or PD-L1 antagonist at a reduced infusion rate when the Grade 2 infusion reaction resolves within 1 hour. In certain embodiments, the method further comprises administering the PD-1 or PD-L1 antagonist at half infusion rate when the Grade infusion reaction resolves within 1 hour. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with cytokine release syndrome. In certain embodiments, the method further comprises administering the EIK1001 when the event associated with cytokine release syndrome resolves. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a persistent Grade 2 event associated with cytokine release syndrome. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a Grade 2 immune-related adverse reaction (iAE), a Grade 3 iAE, or a Grade 4 iAE. In certain embodiments, the method further comprises administering the EIK1001 when the event associated with immune-related adverse reaction resolves. In certain embodiments, the method further comprises withholding administration of EIK1001 when the subject experiences a persistent Grade 2 immune-related adverse reaction. In certain embodiments, the present disclosure is directed to a pharmaceutical composition comprising 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5- c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof for use in the treatment of cancer, wherein the pharmaceutical composition is formulated for administration to a human subject in a dosage of 0.60 mg / m2or 0.75 mg / m2to be administered intravenouslyAttorney Ref: 092295.0162 EIK-1019-WO once a week. In certain embodiments, the EIK1001 is administered as a weekly dose over 20 to 30 weeks. In certain embodiments, the EIK1001 is administered as a weekly dose over 27 weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 27 weeks, administered once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose if the subject experiences progressive disease after beginning administration once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose over 24 weeks. In certain embodiments, the EIK1001 is thereafter, i.e., after initial administration period, e.g., of 24 weeks, administered once every three weeks. In certain embodiments, the EIK1001 is administered as a weekly dose if the subject experiences progressive disease after beginning administration once every three weeks. In certain embodiments, the composition further comprises a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) antagonist and optionally a chemotherapeutic agent. In certain embodiments, the PD-1 antagonist is pembrolizumab, cemiplimab, dostarlimab, tislelizumab, nivolumab, retifanlimab, or toripalimab. In certain embodiments the PD-L1 antagonist atezolizumab, avelumab, durvalumab, sugemalimab, or cosibelimab. In certain embodiments, the PD-1 antagonist is pembrolizumab to be administered intravenously at a dose of 200 mg once every 3 weeks. In certain embodiments, the pharmaceutical composition further comprises the chemotherapeutic agent selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments, the present disclosure is directed to a method of treating melanoma in a human subject, the method comprising administering to the subject (a) 4-amino- 2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof; and (b) pembrolizumab; wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2over 27 weeks and is thereafter administered once every three weeks at a dose of 0.60 mg / m2; and wherein the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks. In certain embodiments, the present disclosure is directed to a method of treating melanoma in a human subject, the method comprising administering to the subject (a) 4-amino- 2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof; and (b) pembrolizumab; wherein the EIK1001 is administered intravenously at a weekly dose of 0.75 mg / m2over 27 weeks and is thereafter administered once every three weeks at a dose of 0.75 mg / m2; and wherein the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks.Attorney Ref: 092295.0162 EIK-1019-WO In certain embodiments, the present disclosure is directed to a method of treating nonsquamous NSCLC in a human subject, the method comprising administering to the subject (a) 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof; and (b) pembrolizumab; wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2over 24 weeks and is thereafter administered once every three weeks at a dose of 0.60 mg / m2; and wherein the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks. In certain embodiments, the method further comprises administering to the subject a) carboplatin and pemetrexed, or b) cisplatin and pemetrexed. In certain embodiments, the present disclosure is directed to a method of treating squamous NSCLC in a human subject, the method comprising administering to the subject (a) 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof; and (b) pembrolizumab; wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2over 24 weeks and is thereafter administered once every three weeks at a dose of 0.60 mg / m2; and wherein the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks. In certain embodiments, the method further comprises administering to the subject a) carboplatin and paclitaxel, or b) carboplatin and nab-paclitaxel. 5. DESCRIPTION OF THE FIGURESFIG.1 provides a swimmer plot of the time on study treatment in months and response evaluation by irRECIST in monotherapy phase (BDB001-101; Safety Population). FIG. 2 provides a spider plot of percentage change from the baseline of the target lesions (based on site assessment per irRECIST) in monotherapy phase (BDB001-101; Efficacy Population). FIG.3 provides a swimmer plot of time on study treatment in months and response evaluation by irRECIST by dose levels (BDB001-102; Safety Population). FIG. 4 provides a spider plot of percentage change from baseline of target lesions based on site assessment per irRECIST by dose levels (BDB001-102; Efficacy Population). FIG. 5 illustrates the time profiles of IFN^ and IP-10 on C1D1 based on data from combined BDB001-101 and BDB001-102 studies. FIG.6 illustrates the fold change from baseline at peak on C1D1 for IL-6, IL-8, IFN^ and IP-10 based on data from combined BDB001-101 and BDB001-102 studies.Attorney Ref: 092295.0162 EIK-1019-WO FIG.7 demonstrates the logistic regression analysis of efficacy versus Cmax,ss based on data from combined BDB001-101 and BDB001-102 studies. FIG.8 demonstrates the logistic regression analysis of efficacy versus AUC^,ss based on data from combined BDB001-101 and BDB001-102 studies. FIG. 9 is a graphical display of logistic regression analysis for the composite AE versus Cmax,ss based on data from combined BDB001-101 and BDB001-102 studies. 6. DETAILED DESCRIPTION OF THE INVENTIONAs described herein and in the Examples and associated Figures, presented below, the instant disclosure relates, in certain embodiments, to compositions and methods for treating cancer comprising the administration of a TLR7 / 8 agonist-containing composition, where the TLR7 / 8 agonist-containing composition is administered at a dosage effective to elicit anti- tumor activity while maintaining an advantageous safety profile. For example, but not by way of limitation, the present disclosure is directed to compositions comprising EIK1001, alone or in combination with one or more additional therapeutics (e.g., a PD-1 antagonist, a PD-L1 antagonist, and / or one or more chemotherapeutics), administered at a dosage effective to elicit anti-tumor activity against solid tumors, e.g., lung cancer, melanoma, breast cancer, colorectal cancer, endometrial cancer, gastric cancer, glioblastoma, head and neck cancer, hepatocellular cancer, ovarian cancer, pancreatic cancer, prostate cancer, renal cell carcinoma, esophageal cancer, non-melanoma skin cancers, and gallbladder cancer, while maintaining an advantageous safety profile. In certain of the embodiments disclosed herein, the solid tumor is melanoma. In certain of the embodiments disclosed herein, the solid tumor is nonsquamous or squamous non-small cell lung cancer (NSCLC). In certain embodiments, the dosage of the EIK1001-containing composition effective to elicit anti-tumor activity against melanoma, while maintaining an advantageous safety profile, is 0.60 mg / m2EIK1001 or 0.75 mg / m2EIK1001. In certain embodiments, the dosage of the EIK1001-containing composition effective to elicit anti-tumor activity against metastatic nonsquamous or squamous NSCLC, while maintaining an advantageous safety profile, is 0.60 mg / m2EIK1001 or 0.75 mg / m2EIK1001. The instant disclosure also relates, in certain embodiments, to compositions and methods for eliciting an immune response in a subject comprising the administration of a TLR7 / 8 agonist-containing composition, alone or in combination with one or more additional therapeutics, where the TLR7 / 8 agonist-containing composition is administered at a dosageAttorney Ref: 092295.0162 EIK-1019-WOeffective to elicit the immune response while maintaining an advantageous safety profile. Incertain embodiments, the present disclosure is directed to compositions comprising EIK1001, alone or in combination with one or more additional therapeutics (e.g., a PD-1 antagonist, a PD-L1 antagonist, and / or one or more chemotherapeutics), administered at a dosage effective to elicit an immune response, while maintaining an advantageous safety profile. In certain embodiments, the dosage of the EIK1001-containing composition effective to elicit an immune response, while maintaining an advantageous safety profile, is 0.60 mg / m2EIK1001 or 0.75 mg / m2EIK1001. The instant disclosure also relates, in certain embodiments, to compositions and methods for eliciting an increase in expression of a biomarker associated with TLR7 and or TLR8 activation comprising the administration of a TLR7 / 8 agonist-containing composition, alone or in combination with one or more additional therapeutics, where the TLR7 / 8 agonist- containing composition is administered at a dosage effective to elicit an increase in expression of a biomarker associated with TLR7 and or TLR8 activation while maintaining anadvantageous safety profile. In certain embodiments, the present disclosure is directed tocompositions comprising EIK1001, alone or in combination with one or more additional therapeutics (e.g., a PD-1 antagonist, a PD-L1 antagonist, and / or one or more chemotherapeutics), administered at a dosage effective to elicit an increase in expression of a biomarker associated with TLR7 and or TLR8 activation, while maintaining an advantageous safety profile. In certain embodiments, the dosage of the EIK1001-containing composition effective to elicit an increase in expression of a biomarker associated with TLR7 and or TLR8 activation, while maintaining an advantageous safety profile, is 0.60 mg / m2EIK1001 or 0.75 mg / m2EIK1001. 6.1 Definitions The definitions used herein are for the purpose for describing particular embodiments and is not intended to be limiting of the various embodiments of the invention disclosed herein. In addition, unless defined otherwise, all technical and scientific terms used herein are to be understood in accordance with their generally accepted meanings as would be appreciated by one of ordinary skill in the relevant art. As used herein, the term “pharmaceutically acceptable salts” refers to salts that retain the biological effectiveness and properties of the compounds of this invention and, which are not biologically or otherwise undesirable. Pharmaceutically acceptable salts include both acidAttorney Ref: 092295.0162 EIK-1019-WO and base addition salts. For example, but not by way of limitation, EIK1001 can be prepared as a sulfate salt, e.g., as 1-(4-amino-2-(ethoxymethyl)-1H-imidazo[4,5-c]quinoline-1-yl)-2- methylpropan-2-ol sulfate (CAS Registry No.2762439-40-5). A “pharmaceutically acceptable carrier” is an ingredient in a pharmaceutical formulation, other than an active ingredient, which is nontoxic to a subject. A pharmaceutically acceptable carrier includes, for example, an excipient, a buffer, a stabilizer, or a preservative. As used herein, the term “subject” is a mammal including, but not limited to, primates (e.g., humans and non-human primates such as monkeys), rodents (e.g., mice and rat), rabbits, cows, sheep, cats, dogs and horses. In certain embodiments, the subject is a human. As used herein, the term “combination therapy” refers to a combination of two or more active therapeutics. In certain embodiments, the combination therapies provided here include combined administration (where two or more therapeutic agents are included in the same or separate formulations), and separate administration, in which case, administration of the composition of the invention can occur prior to, simultaneously, and / or following, administration of the additional therapeutic agent or agents. “Dose”, “Dosing”, and grammatical equivalents thereof as used herein refers to the administration of an amount of one or more therapeutic and can be by any suitable route, for example, by injections, such as intravenous or subcutaneous injections. Various dosing schedules including but not limited to single or multiple administrations over various time- points, bolus administration, and pulse infusion are contemplated herein. As used herein, “treating” or “treatment” refers to a reduction in one or more symptom associated with the condition to be treated. By way of example, but not limitation, following administering of a composition of the present disclosure, a subject with a solid tumor can experience a reduction in tumor size. For example, but without any limitation, such reduction in tumor size can be complete resolution of non-nodal lesions and < 10 mm short- axis for lymph nodes, as well as no new lesions (i.e., a complete response as defined below). Additionally, for example and without limitation, following administering of a composition of the present disclosure, a subject with a solid tumor can experience a ≥30% decrease in tumor burden (i.e., a partial response as defined below). In a further non-limiting example, following administering of a composition of the present disclosure, a subject with a solid tumor can experience neither sufficient shrinkage (compared to baseline) to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). In certain embodiments, “treating” or “treatment” refers to a response determined using immune-related Response EvaluationAttorney Ref: 092295.0162 EIK-1019-WO Criteria in Solid Tumors (irRECIST) 1.1 criteria or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. These criteria include, among other criteria : Complete Response (CR): defined as a complete resolution of non-nodal lesions and < 10 mm short-axis for lymph nodes, as well as no new lesions. Partial Response (PR): defined as a ≥30% decrease in tumor burden. Stable Disease (SD): Neither sufficient shrinkage (compared to baseline) to qualify for PR nor sufficient increase (taking as reference the smallest sum diameters while on study) to qualify for Progressive Disease (PD). Progressive Disease (PD): defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Objective Response (OR): defined as a confirmed complete response (CR) or partial response (PR). Objective Response Rate (ORR): defined as participants who have a confirmed CR or PR. In certain embodiments, “treating” or “treatment” refers to a response determined by using the following criteria: Overall Survival (OS): defined as the time from subject randomization to the time of death from any cause. Duration of Response (DOR): defined as the time from randomization to disease progression or death for patients who achieve complete or partial response. Progression-Free Survival (PFS): defined as the time from randomization until objective tumor progression or death. As used herein, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 are standardized guidelines used to measure the response of solid tumors to treatment. These criteria help in assessing whether tumors are shrinking, staying the same, or growing. Additional information on RECIST can be found in Eisenhauer et al., European journal of cancer 45.2 (2009): 228-247, which is incorporated by reference in its entirety. As used herein, the phrase “advantageous safety profile” refers to safety profiles indicating the probability that a patient will experience a drug-related adverse event, e.g., a Grade 3 adverse event, is of a magnitude that is nevertheless justified in view of the efficacyAttorney Ref: 092295.0162 EIK-1019-WO associated with the underlying treatment. In certain embodiments, the magnitude of the probability that a patient will experience a drug-related adverse event is presented as a specific value, e.g., an average or median of probabilities. In certain embodiments, the magnitude of the probability that a patient will experience a drug-related adverse event is presented as a range, e.g., a range representing a 95% confidence interval associated with a number of probabilities. Similarly, the efficacy of the underlying treatment can also be presented as a specific value, e.g., an average or median of probabilities of achieving an outcome or as a range, e.g., a range representing a 95% confidence interval associated with a number of probabilities of achieving an outcome, e.g., the outcome can be defined by ORR, OS, or by any other efficacy measure such as, but not limited to, the maximal change from baseline for a target lesion being ≤ 10%. For example, but not by way of limitation, the data provided in Figures 7-9 of the instant application indicate that certain EIK1001 dosages described herein are associated with both efficacious treatment and advantageous safety profiles. In certain embodiments, an advantageous safety profile is associated with the probability of a patient experiencing a drug related adverse event of > Grade 3, as defined herein, of 49.6% (with a 95% CI level within the range of 38.6% – 60.6%) or less, or a probability of a patient experiencing a composite adverse event, as that term is used in Examples 6 and 7, below, of 54.4% (with a 95% CI level within the range of 42.2% - 65.5%) or less. In certain embodiments, an advantageous safety profile refers to a probability of a patient experiencing a drug-related adverse event of > Grade 3 of 45.4% (with a 95% CI level within the range of 35.2% – 56.0%) or less, or a probability of a patient experiencing a composite adverse event, as that term is used in Examples 6 and 7, below, of 46.2% (with a 95% CI level within the range of 36.0%-56.7%) or less. In certain embodiments, efficacious treatment is associated with a probability of a patient experiencing maximal change from baseline for a target lesion being ≤ 10% of 19.6% (with a 95% CI level within the range of 12.0% – 30.4%). In certain embodiments, efficacious treatment is associated with a probability of a patient experiencing maximal change from baseline for a target lesion being ≤ 10% of 17.6% (with a 95% CI level within the range of 10.5% – 27.9%). As used herein, the term “adverse event” refers to an abnormal clinical finding temporally associated with the use of a therapy (e.g., a cancer therapy). Non-limiting examples of adverse events include hematologic toxicity, non-hematologic toxicity, infusion reaction, cytokine release syndrome, immune-related adverse reactions, and the like. Additional detailsAttorney Ref: 092295.0162 EIK-1019-WO regarding grades and categories of adverse events can be found in Brahmer et al., Journal forImmunoTherapy of Cancer 9(6): e002435.A “Grade 1 adverse event,” as used herein, refers to one that is asymptomatic or with mild symptoms for which intervention is not indicated. As used herein, “Grade 2 adverse event” is one that is moderate for which a minimal, local, or noninvasive intervention is indicated. As used herein, “Grade 3 adverse event” is one that is severe but not immediately life-threatening. As used herein, “Grade 4 adverse event” is one that is severe and can have life- threatening consequences. For Grade 4 adverse events, urgent intervention is indicated. As used herein, “composite adverse event” refers, in certain embodiments, to a group of pooled adverse events (including, e.g., CRS, chills, pyrexia and infusion-related reactions) for all adverse event Grades. As used herein, the term “hematologic toxicity” refers to the adverse effects on the blood-forming tissues, which can be caused by various factors such as chemotherapy, radiation therapy, certain medications, environmental toxins, and underlying medical conditions. For example, but without limitation, hematologic toxicity includes neutropenia and thrombocytopenia (low platelet count). In certain embodiments, hematologic toxicity excludes anemia and lymphopenia. As used herein, the term “non-hematologic toxicity” refers to adverse effects on organs and tissues outside of the blood-forming system. These toxicities can result from treatments like chemotherapy, radiation, or other medications, and can affect various parts of the body such as the liver, kidneys, gastrointestinal tract, skin, and nervous system. Non- limiting examples of non-hematologic toxicity include nausea, vomiting, diarrhea, liver enzyme abnormalities, kidney dysfunction, and neuropathy. In certain embodiments, non- hematologic toxicity excludes infusion reactions and immune-related adverse events. As used herein, the term “infusion reaction” is an adverse response that occurs during or shortly after the administration of medication intravenously (IV). Signs and symptoms of infusion reactions include, for example but without limitation, rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. As used herein, the phrase “cytokine release syndrome” (CRS) is a condition where the immune system responds excessively to infection or certain treatments, such as immunotherapy. Details on CRS and its grading can be found in Lee et al. Biology of bloodAttorney Ref: 092295.0162 EIK-1019-WO and marrow transplantation 25.4 (2019): 625-638, the content of which is incorporated in its entirety. As used herein, an “immune-related adverse reaction” (irAR) is a side effect that occurs when the immune system becomes overactive in response to certain treatments, such as immunotherapies like immune checkpoint inhibitors. These reactions can affect various organs and tissues, leading to conditions such as inflammation, autoimmune disorders, and damage to healthy tissues. Non-limiting examples of affected tissues and organs include the skin, gastrointestinal tract, liver, and endocrine system. As used herein, the term “PD-1 antagonist” refers to a molecule that interferes with signal transduction resulting from the interaction of PD-1 with one or more of its binding partners, such as PD-L1 and / or PD L2. In certain embodiments, the PD-1 antagonist is a molecule that inhibits the binding of PD-1 to its binding partners. For example, PD-1 antagonists include anti-PD-1 antibodies, antigen binding fragments thereof, immunoadhesins, fusion proteins, oligopeptides and other molecules that interfere with signal transduction resulting from the interaction of PD-1 with PD-L1 and / or PD L2. Non-limiting examples of PD-1 antagonists include: cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab. As used herein, the term “PD-L1 antagonist” refers to a molecule that interferes with signal transduction resulting from the interaction of PD-L1 with one or more of its binding partners, such as PD-1. In certain embodiments, the PD-L1 antagonist is a molecule that inhibits the binding of PD-L11 to its binding partners. For example, PD-L1 antagonists include anti-PD-L1 antibodies, antigen binding fragments thereof, immunoadhesins, fusion proteins, oligopeptides and other molecules that interfere with signal transduction resulting from the interaction of PD-L1 with PD-1. Non-limiting examples of PD-L1 antagonists include: atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab. The term “antibody” herein is used in the broadest sense and encompasses various antibody structures, including but not limited to monoclonal antibodies, polyclonal antibodies, multi-specific antibodies (e.g. bispecific antibodies), and antibody fragments so long as they exhibit the desired antigen-binding activity and comprise an Fc region or a region equivalent to the Fc region of an immunoglobulin The terms “full-length antibody”, “intact antibody”, “and “whole antibody” are used herein interchangeably to refer to an antibody having a structure substantially similar to a native antibody structure or having heavy chains that contain an Fc region as defined herein.Attorney Ref: 092295.0162 EIK-1019-WO A “chemotherapeutic agent” is a compound useful in the treatment of cancer. In certain embodiments, the chemotherapeutic agent is one that is an FDA approved therapeutic that is part of a standard of care treatment. In certain examples, the chemotherapeutic agent is approved for the treatment of non-small cell lung cancer, including squamous and nonsquamous non-small cell lung cancer. Examples of such chemotherapeutic agents include, but are not limited to, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and cisplatin. In certain embodiments, the chemotherapeutic agents approved for treatment of nonsquamous non-small cell lung cancer include, for example, a combination of carboplatin and pemetrexed or a combination of cisplatin and pemetrexed. In certain embodiments, the chemotherapeutic agents approved for treatment of squamous non-small cell lung cancer include, for example, a combination of carboplatin and paclitaxel, or a combination of carboplatin and nab-paclitaxel. The term “package insert” is used to refer to instructions customarily included in packages of therapeutic products, containing information such as therapeutic indications, usage, dosage, administration, combination therapy concerning the use of such therapeutic products. 6.2 Pharmaceutical Compositions & Dosages While the antitumor efficacy of EIK1001 in combination with anti-PD-1 or anti-PD- L1 therapeutics has been established against a variety of solid tumors in preclinical studies, there has remained a need in the art to determine dosages of TLR7 / 8 agonist-containing compositions, e.g., EIK1001-containing compositions, alone or in combination with one or more additional therapeutics, capable of eliciting: (1) effective anti-tumor activity; (2) an immune response; and / or (3) an increase in expression of one or more biomarkers associated with TLR7 and or TLR8 activation, while maintaining an advantageous safety profile. For the first time, the clinical studies disclosed herein evaluating EIK1001 (as a monotherapy, as well as in combination with additional therapeutics such as anti-PD-1 or anti- PD-L1 antagonists), have demonstrated the efficacy of specific dosages of this TLR7 / 8 agonist, while maintaining an advantageous safety profile. For example, but not by way of limitation, the results of two of these studies, a Phase 1, open-label, dose escalation study evaluating EIK1001 as a monotherapy and in combination with pembrolizumab (BDB001-101) and a Phase 1, open-label, dose-escalation study evaluating EIK1001 in combination with atezolizumab (BDB001-102), provide pharmacokinetic and pharmacodynamic (PK / PD) analyses, that allow for the determination doses of EIK1001 capable of eliciting: (1) effectiveAttorney Ref: 092295.0162 EIK-1019-WO anti-tumor activity; (2) an immune response; and / or (3) an increase in expression of one or more biomarkers associated with TLR7 and or TLR8 activation, which also exhibit an advantageous safety profile. Of note, the doses of TLR7 / 8 agonist-containing compositions described herein as capable of eliciting: (1) effective anti-tumor activity; (2) an immune response; and / or (3) an increase in expression of one or more biomarkers associated with TLR7 and or TLR8 activation, which also exhibit an advantageous safety profile, are based on a body surface area (BSA) mg / m2basis, rather than the mg / kg basis used in earlier trials. For example, after observing dose limiting toxicity (DLT) in two patients in the BDB001-101 Monotherapy Dose Escalation Trial (one patient in cohort 3 receiving 0.18 mg / kg and one patient in cohort 4 receiving 0.024 mg / kg), the dosing was revised to be based on BSA (mg / m2). The mg / m2dosage accounts for both the weight and the height of the subject, as opposed to the weight- based only method used to determine dosage when using a mg / kg approach. Moreover, the BSA approach also correlates with blood volume and renal and hepatic function. The doses administered to the participants who experienced Grade 3 cytokine release syndrome (CRS) corresponded to 0.82 mg / m2and 0.93 mg / m2when recalculated as a BSA-based dose. Among participants dosed based on BSA in the dose escalation trial (Cohorts 5 to 8), there were no DLTs among the 25 DLT evaluable participants. In fact, a maximum tolerated dose (MTD) for EIK1001 monotherapy was not reached. Efficacy including complete response (CR), partial response (PR), and stable disease (SD) was observed at doses of 0.60 mg / m2and 0.75 mg / m2, in contrast to only one response observed at a dose of 0.30 mg / m2when EIK1001 was combined with pembrolizumab. The observed efficacy was supported by a corresponding rise in serum cytokines IFN-γ and IP-10 in the 0.60 mg / m2and 0.75 mg / m2dose groups, which is understood to be representative of target engagement. In contrast, cytokine response was substantially lower in the 0.30 and 0.45 mg / m2dose groups, suggesting limited pharmacodynamic response at doses of ≤ 0.45 mg / m2. 6.2.1. Compositions Comprising TLR7 / 8 Agonist In view of the clinical results described herein, the present disclosure is directed, in certain embodiments, to compositions capable of eliciting: (1) effective anti-tumor activity; (2) an immune response; and / or (3) an increase in expression of one or more biomarkers associated with TLR7 and or TLR8 activation, which also exhibit advantageous safety profiles, comprising a TLR7 / 8 agonist at 0.60 mg / m2or 0.75 mg / m2. In certain embodiments, theAttorney Ref: 092295.0162 EIK-1019-WO TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2. In certain embodiments, the composition is a TLR7 / 8 agonist monotherapy composition. In certain embodiments, the composition is a TLR7 / 8 agonist combination therapy. 6.2.2. Compositions Comprising TLR7 / 8 Agonist & PD-1 / PD-L1 Antagonist In certain embodiments, the present disclosure is directed to combination therapy compositions capable of eliciting: (1) effective anti-tumor activity; (2) an immune response; and / or (3) an increase in expression of one or more biomarkers associated with TLR7 and or TLR8 activation, which also exhibit advantageous safety profiles, comprising: (a) a TLR7 / 8 agonist at 0.60 mg / m2or 0.75 mg / m2; and (b) a PD-1 or PD-L1 antagonist. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2in combination with a PD-1 or PD-L1 antagonist. In certain embodiment, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2in combination with a PD-1 antagonist, where the PD-1 antagonist is pembrolizumab. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selectedfrom atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab. In certainembodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab. 6.2.3. Compositions Comprising TLR7 / 8 Agonist, PD-1 / PD-L1 Antagonist, & One or More Chemotherapeutic In certain embodiments, the present disclosure is directed to combination therapy compositions capable of eliciting: (1) effective anti-tumor activity; (2) an immune response; and / or (3) an increase in expression of one or more biomarkers associated with TLR7 and or TLR8 activation, which also exhibit advantageous safety profiles, comprising: (a) a TLR7 / 8 agonist at 0.60 mg / m2or 0.75 mg / m2; (b) a PD-1 or PD-L1 antagonist; and (c) one or more chemotherapeutic. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 or PD-L1 antagonist, and one or more chemotherapeutic. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, andAttorney Ref: 092295.0162 EIK-1019-WO toripalimab, and one or more chemotherapeutic. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, a PD-1 antagonist, where the PD-1 antagonist is pembrolizumab, and one or more chemotherapeutic. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selected from atezolizumab, avelumab, durvalumab,sugemalimab, and cosibelimab, and one or more chemotherapeutic. In certain embodiments,the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab, and one or more chemotherapeutic. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 or PD-L1 antagonist, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain of such embodiments, the chemotherapeutic is carboplatin. In certain of such embodiments, the chemotherapeutic is carboplatin and pemetrexed. In certain of such embodiments, the chemotherapeutic is carboplatin and paclitaxel. In certain of such embodiments, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain of such embodiments, the chemotherapeutic is cisplatin. In certain of such embodiments, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain of such embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin. In certain embodiments, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeuticAttorney Ref: 092295.0162 EIK-1019-WO is carboplatin and nab-paclitaxel. In certain embodiments, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is cisplatin. In certain embodiments, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is pembrolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selectedfrom atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab, and one or morechemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab,durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is carboplatin. In certainembodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab,durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is carboplatin andpemetrexed. In certain embodiments where the PD-L1 antagonist is selected fromatezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic iscarboplatin and paclitaxel. In certain embodiments where the PD-L1 antagonist is selectedfrom atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab, thechemotherapeutic is carboplatin and nab-paclitaxel. In certain embodiments where the PD-L1antagonist is selected from atezolizumab, avelumab, durvalumab, sugemalimab, andAttorney Ref: 092295.0162 EIK-1019-WO cosibelimab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-L1antagonist is selected from atezolizumab, avelumab, durvalumab, sugemalimab, andcosibelimab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the TLR7 / 8 agonist is EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is cisplatin and pemetrexed. 6.2.4. Dosing Schedules In certain embodiments, a composition of the present disclosure comprising EIK1001 is administered as a weekly intravenous dose. In certain embodiments, a composition of the present disclosure comprising EIK1001 is administered as a weekly intravenous dose over a specified dosing cycle. In certain embodiments, a composition of the present disclosure comprising EIK1001 is administered as a weekly intravenous dose over a specified dosing cycle and subsequently reduced to a less frequent dosing. For example, but not by way of limitation, a weekly dosing schedule can be reduced to a Q3W dosing schedule after 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, or more weeks. In certain embodiments, a composition of the present disclosure comprising EIK1001 is administered as a weekly intravenous dose over 20 weeks to 30 weeks, and thereafter is reduced to a Q3W dosing schedule. In certain embodiments, a composition of the present disclosure comprising EIK1001 is administered as a weekly intravenous dose over 27 weeks and thereafter is reduced to a Q3W dosing schedule. In certain embodiments, a composition of the present disclosure comprising EIK1001 is administered as a weekly intravenous dose over 24 weeks and thereafter is reduced to a Q3W dosing schedule. In certain embodiments, a composition of the present disclosure comprising EIK1001 is administered as a weekly intravenous dose over 6 weeks to 10 weeks, and thereafter is reduced to a Q3W dosingAttorney Ref: 092295.0162 EIK-1019-WO schedule. In certain embodiments, a composition of the present disclosure comprising EIK1001 is administered as a weekly intravenous dose over 9 weeks and thereafter is reduced to a Q3W dosing schedule. In certain embodiments, EIK1001 is administered in combination with pembrolizumab. In certain embodiments, such combined administration occurs via separate intravenous administrations. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, pembrolizumab is administered at a fixed dose of 400 mg once every 6 weeks (Q6W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (400 mg) once every 6 weeks (Q6W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and cisplatin 75 mg / m2Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination withAttorney Ref: 092295.0162 EIK-1019-WO pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with nab- paclitaxel 100 mg / m2QW for 4 cycles and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, EIK1001 is administered in combination with pembrolizumab where EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, pembrolizumab is administered at a fixed dose of 400 mg once every 6 weeks (Q6W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (400 mg) once every 6 weeks (Q6W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and cisplatin 75 mg / m2Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2) In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with nab- paclitaxel 100 mg / m2QW for 4 cycles and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, for example for those subjects with melanoma, EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certainAttorney Ref: 092295.0162 EIK-1019-WO embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 25-30 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 27 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, for example for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2(QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 20-25 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 24 weeks. In certain embodiments, for example for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2(QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination withAttorney Ref: 092295.0162 EIK-1019-WO pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 20-25 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 24 weeks. In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and cisplatin 75 mg / m2Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination withAttorney Ref: 092295.0162 EIK-1019-WO pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with nab- paclitaxel 100 mg / m2QW for 4 cycles and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, EIK1001 is administered in combination with atezolizumab. In certain embodiments, such combined administration occurs via separate intravenous administrations. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, atezolizumab is administered at a fixed dose of 1200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for 3 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once every 3 weeks (Q3W) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, atezolizumab is administered at a fixed dose of 1200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.75 mg / m2at a reduced frequency.Attorney Ref: 092295.0162 EIK-1019-WO In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.75 mg / m2once every 3 weeks (Q3W) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 6-10 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 9 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, atezolizumab is administered at a fixed dose of 1200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) and with radiotherapy. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.75 mg / m2at a reduced frequency. In certain embodiments, radiotherapy is administered at a total dose between 27 Gy and 60 Gy. In certain embodiments, radiotherapy is administered at least one week after the first administration of atezolizumab and at the latest before the 2ndadministration. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.75 mg / m2once every 3 weeks (Q3W) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 6-10 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 9 weeks. In certain embodiments, radiotherapy is administered at a total dose between 27 Gy and 60 Gy. In certain embodiments, radiotherapy is administered at least one week after the first administration of atezolizumab and at the latest before the 2ndadministration. In certain embodiments, the EIK1001 dose frequency is adjusted in response to progressive disease. For example, but not by way of limitation, for subjects who have transitioned from QW dosing of EIK1001 (e.g., administered IV weekly at a dose of 0.60 mg / m2or 0.75 mg / m2) to Q3W dosing of EIK1001 (e.g., after 24 weeks of QW EIK1001 dosing, after 27 weeks of QW EIK1001 dosing), but who experience progressive disease, can transition back to QW dosing of EIK1001. In certain embodiments, such transition back to QWAttorney Ref: 092295.0162 EIK-1019-WO dosing of EIK1001 does not involve a change in dosing of any other therapeutic, e.g., a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) antagonist. In certain embodiments, e.g., for those subjects with melanoma, an EIK1001 dose adjustment is made if the subject experiences an adverse reaction. For example, but not by way of limitation, if a subject with melanoma experiences a Grade 3 event associated with hematological toxicity (excluding anemia and lymphopenia, but including neutropenia and thrombocytopenia), then EIK1001 is held. In certain embodiments, e.g., if the hematologic toxicity resolves to ≤ Grade 1 within seven days, then EIK1001 treatment can resume at the prior administered dose. In certain embodiments, e.g., if toxicity is reduced to ≤ Grade 1 within 14 days , then EIK1001 treatment can resume at a dose below the previously administered dose. In certain embodiments when the previously administered dose is 0.75 mg / m2, the dose belowis selected from 0.60 mg / m2 and 0.45 mg / m2. In certain embodiments when the previouslyadministered dose is 0.60 mg / m2, the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, e.g., if a Grade 3 hematological reaction recurs a second time and resolves to ≤ Grade 1 within seven days, then EIK1001 treatment can resume at a dose below the previously administered dose. In certain embodiments when the previously administered dose is 0.60 mg / m2, the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments when the previously administered dose is 0.45 mg / m2, the dose below is 0.30 mg / m2. In certain embodiments, e.g., if a subject with melanoma experiences a Grade 4 event associated with hematological toxicity including anemia and lymphopenia, EIK1001 is held. In certain embodiments, e.g., if the toxicity resolves to ≤ Grade 1 within seven days, then EIK1001 treatment can resume at the prior administered dose. In certain embodiments, e.g., if toxicity is reduced to ≤ Grade 1 within 14 days, then EIK1001 treatment can resume at a dose below the previously administered dose. In certain embodiments when the previously administered dose is 0.75 mg / m2, the dose below is selected from 0.60 mg / m2and 0.45 mg / m2. In certain embodiments when the previously administered dose is 0.60 mg / m2, the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, e.g., if a Grade 4 hematological reaction recurs a second time and resolves to ≤ Grade 1 within seven days, then EIK1001 treatment can resume at a dose below the previously administered dose. In certain embodiments when the previously administered dose is 0.60 mg / m2, the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments when the previously administered dose is 0.45 mg / m2, the dose below is 0.30 mg / m2.Attorney Ref: 092295.0162 EIK-1019-WO In certain embodiments, e.g., if a subject with melanoma experiences a Grade 3 event associated with non-hematological toxicity (excluding infusion reactions, immune-related adverse events, and alopecia), then EIK1001 is held. In certain embodiments, e.g., if the non- hematologic toxicity is reduced to ≤ Grade 1 within 14 days, then EIK1001 treatment can resume at a dose below the previously administered dose. In certain embodiments when the previously administered dose is 0.75 mg / m2, the dose below is selected from 0.60 mg / m2and0.45 mg / m2. In certain embodiments when the previously administered dose is 0.60 mg / m2, thedose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, if a Grade 3 non-hematologic reaction recurs a second time and resolves to ≤ Grade 1 within 14 days, then EIK1001 treatment can resume at a dose below the previously administered dose. In certain embodiments when the previously administered dose is 0.60 mg / m2, the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments when the previously administered dose is 0.45 mg / m2, the dose below is 0.30 mg / m2. In certain embodiments, e.g., for those subjects with squamous NSCLC or nonsquamous NSCLC, an EIK1001 dose adjustment is made if the subject experiences an adverse reaction. For example, but not by way of limitation, if a subject with squamous NSCLC or nonsquamous NSCLC experiences a Grade 3 event associated with hematological toxicity (excluding anemia and lymphopenia, but including neutropenia and thrombocytopenia), then EIK1001 is held. In certain embodiments, e.g., if the hematologic toxicity resolves to ≤ Grade 1 within seven days, then EIK1001 treatment can resume at the prior administered dose. In certain embodiments, e.g., if toxicity is reduced to ≤ Grade 1 within 14 days , then EIK1001 treatment can resume at a dose level below the previously administered dose. In certain embodiments when the previously administered dose is 0.60 mg / m2, the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, e.g., if a Grade 3 hematological reaction recurs a second time and resolves to ≤ Grade 1 within seven days, then EIK1001 treatment can resume at a dose level below the previously administered dose. In certain embodiments when the previously administered dose is 0.45 mg / m2, the dose below is 0.30 mg / m2. In certain embodiments, e.g., if a subject with squamous NSCLC or nonsquamous NSCLC experiences a Grade 4 event associated with hematological toxicity, EIK1001 is held. In certain embodiments, e.g., if the toxicity resolves to ≤ Grade 1 within seven days, then EIK1001 treatment can resume at the prior administered dose. In certain embodiments, e.g., if toxicity is reduced to ≤ Grade 1 within 14 days, then EIK1001 treatment can resume at a doseAttorney Ref: 092295.0162 EIK-1019-WO level below the previously administered dose. In certain embodiments when the previously administered dose is 0.60 mg / m2, the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, e.g., if a subject with squamous NSCLC or nonsquamous NSCLC experiences a Grade 3 event associated with non-hematological toxicity (excluding infusion reactions, immune-related adverse events), then EIK1001 is held. In certain embodiments, e.g., if the non-hematologic toxicity is reduced to ≤ Grade 1 within 14 days, then EIK1001 treatment can resume at the prior administered dose. In certain embodiments, e.g., for those subjects with squamous NSCLC or nonsquamous NSCLC, if the non-hematologic toxicity is reduced to ≤ Grade 1 within 21 days then EIK1001 treatment can resume at a dose below the previously administered dose. In certain embodiments when the previously administered dose is 0.60 mg / m2, the dose below is selected from 0.45 mg / m2and 0.30 mg / m2. In certain embodiments, an EIK1001 dose adjustment is made if the subject experiences an infusion reaction. For example, but not by way of limitation, if a subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with infusion of EIK1001, then EIK1001 is held. In certain embodiments, e.g., if a subject experiences a Grade 2 event associated with infusion of EIK1001, EIK1001 is held. In certain embodiments, e.g., if the infusion reaction resolves to ≤ Grade 1, then EIK1001 treatment can resume at a reduced infusion rate. In certain embodiments, e.g., if the infusion reaction resolves to ≤ Grade 1 within 24 hours, then EIK1001 treatment can resume at half of the infusion rate. In certain embodiments, a pembrolizumab dose adjustment is made if the subject experiences an infusion reaction. For example, but not by way of limitation, if a subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with infusion of pembrolizumab, then pembrolizumab is held. In certain embodiments, e.g., if a subject experiences a Grade 2 event associated with infusion of pembrolizumab, pembrolizumab is held. In certain embodiments, e.g., if the infusion reaction resolves to ≤ Grade 1, then pembrolizumab treatment can resume at a reduced infusion rate. In certain embodiments, e.g., if the infusion reaction resolves to ≤ Grade 1 within 1 hour, then pembrolizumab treatment can resume at half of the infusion rate. In certain embodiments, an EIK1001 dose adjustment is made if the subject experiences cytokine release syndrome (CRS). Details on CRS and its grading can be found in Lee et al. Biology of blood and marrow transplantation 25.4 (2019): 625-638, the content of which is incorporated in its entirety. For example, but not by way of limitation, if a subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with CRS, thenAttorney Ref: 092295.0162 EIK-1019-WO EIK1001 is held. In certain embodiments, e.g., if a subject experiences a Grade 2 event associated with CRS, EIK1001 is held. In certain embodiments, e.g., if the CRS resolves to ≤ Grade 1, then EIK1001 treatment can resume at the original dose. In certain embodiments, e.g., if a subject experiences recurrent Grade 2 events associated with CRS, EIK1001 is held. In certain embodiments, an EIK1001 dose adjustment is made if the subject experiences an immune-related adverse reaction (iAE). For example, but not by way of limitation, if a subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with an immune-related adverse reaction, then EIK1001 is held. In certain embodiments, e.g., if a subject experiences a Grade 2 event associated with an immune-related adverse reaction, EIK1001 is held. In certain embodiments, e.g., if the immune-related adverse reaction resolves to ≤ Grade 1, then EIK1001 treatment can resume at the original dose. In certain embodiments, e.g., if a subject experiences persistent Grade 2 events associated with an immune-related adverse reaction, EIK1001 is held. In certain embodiments, a pembrolizumab dose adjustment is made if the subject experiences an immune-related adverse reaction (iAE). For example, but not by way of limitation, if a subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with an immune-related adverse reaction, then EIK1001 is held. In certain embodiments, e.g., if a subject experiences a Grade 2 event associated with an immune-related adverse reaction, pembrolizumab is held. In certain embodiments, e.g., if the immune-related adverse reaction resolves to ≤ Grade 1, then pembrolizumab treatment can resume at the original dose. In certain embodiments, e.g., if a subject experiences persistent Grade 2 events associated with an immune-related adverse reaction, pembrolizumab is held. 6.2.5. Formulations Pharmaceutical compositions for use in accordance with the present invention are typically formulated in a conventional manner using one or more physiologically acceptable carriers comprising excipients and auxiliaries, which facilitate processing of the therapeutics into compositions that can be used pharmaceutically. Proper formulation is dependent upon theroute of administration chosen. For example, but not by way of limitation, compositions of thepresent disclosure can be formulated for parenteral administration by injection, e.g., by bolus injection or continuous infusion. Formulations for injection can be presented in unit dosage form, e.g., in ampoules or in multi-dose containers, and in certain embodiments, with an added preservative.Attorney Ref: 092295.0162 EIK-1019-WO Pharmaceutical formulations for parenteral administration include aqueous solutions of the therapeutic compositions in water-soluble form. Additionally, suspensions of the therapeutic compositions of the present disclosure can be prepared as appropriate oily injection suspensions. Suitable lipophilic solvents or vehicles include fatty oils such as sesame oil, or synthetic fatty acid esters, such as ethyl oleate or triglycerides, or liposomes. Aqueous injection suspensions can comprise substances that increase the viscosity of the suspension, such as sodium carboxymethyl cellulose, sorbitol, or dextran. For injection, the therapeutic compositions of the instant disclosure can be formulated in aqueous solutions, preferably in physiologically compatible buffers such as Hanks's solution, Ringer's solution, or physiological saline buffer. 6.3 Methods of Treating Cancer Provided herein are methods of treating cancer comprising administering to a subject, e.g., a human subject a TLR7 / 8 agonist, e.g., EIK1001 or a pharmaceutically acceptable salt thereof. In certain embodiments, the TLR7 / 8 agonist, e.g., EIK1001 or a pharmaceutically acceptable salt thereof, is administered intravenously at a dose of 0.60 mg / m2. In certain embodiments, EIK1001 is administered intravenously at a dose of 0.75 mg / m2. In certain embodiments, EIK1001 is administered intravenously at a dose of 0.45 mg / m2. In certain embodiments, the method of treating cancer further comprises administering to the subject a PD-1 or PD-L1 antagonist. In certain embodiments, the method of treating cancer further comprises administering to the subject one or more chemotherapeutic, e.g., carboplatin, paclitaxel and / or pemetrexed. The utility of EIK1001, as a monotherapy or in a combination therapy as described herein, has been determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, amongst other criteria. For example, but not by way of limitation, the effect of EIK1001 has been determined by an observed increase in CR, PR, SD, ORR, OS, DOR, and / or PFS of human subjects when administered EIK1001. In certain embodiments, the cancer to be treated is a solid tumor cancer. Examples of solid tumor cancers include, but are not limited to, lung cancer, melanoma, breast cancer, colorectal cancer, endometrial cancer, gastric cancer, glioblastoma, head and neck cancer, hepatocellular cancer, ovarian cancer, pancreatic cancer, prostate cancer, renal cell carcinoma, esophageal cancer, non-melanoma skin cancer, and gallbladder cancer. In certain embodiments, the method of treating cancer comprises administering to a subject, e.g., a human subject,Attorney Ref: 092295.0162 EIK-1019-WO EIK1001 or a pharmaceutically acceptable salt thereof and a PD-1 antagonist, such as pembrolizumab. In certain embodiments, the cancer is melanoma. In certain embodiments, the method of treating cancer comprises administering to a human subject with melanoma a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 or PD-L1 antagonist. In certain embodiments, the method of treating cancer comprises administering to a human subject with melanoma a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab. In certain embodiments, the method of treating cancer comprises administering to a human subject with melanoma a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selectedfrom atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab.In certain embodiments, the method of treating cancer comprises administering to a human subject with melanoma a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is pembrolizumab. In certain embodiments, the method of treating cancer comprises administering to a human subject with melanoma a composition comprising EIK1001 administered in combination with pembrolizumab. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.60 mg / m2or 0.75 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeksAttorney Ref: 092295.0162 EIK-1019-WO (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 25-30 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 27 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, the method of treating cancer comprises administering to a human subject with melanoma a composition comprising EIK1001 administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab is administered at a fixed dose of 200 mg once every 3 weeks (Q3W) for 27 weeks. In certain embodiments, EIK1001 is thereafter administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the method of treating cancer comprises administering to a human subject with melanoma a composition comprising EIK1001 administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab is administered at a fixed dose of 200 mg once every 3 weeks (Q3W) for 27 weeks. In certain embodiments, EIK1001 is thereafter administered IV at a dose of 0.75 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the cancer is NSCLC. In certain embodiments, the cancer is squamous NSCLC. In certain embodiments, the cancer is nonsquamous NSCLC. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC: i) EIK1001 or a pharmaceutically acceptable salt thereof;ii) a PD-1 or PD-L1 antagonist; andiii) a chemotherapeutic agent that has been approved for treatment of NSCLC.Examples of chemotherapeutic agents that have been approved for treatment of NSCLC include, for example, carboplatin, cisplatin, paclitaxel, nab- paclitaxel, pemetrexed, or a combination thereof. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 or PD-L1 antagonist, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab- paclitaxel, pemetrexed, or a combination thereof. In certain of such embodiments, the chemotherapeutic is carboplatin. In certain of such embodiments, the chemotherapeutic isAttorney Ref: 092295.0162 EIK-1019-WO carboplatin and pemetrexed. In certain of such embodiments, the chemotherapeutic is carboplatin and paclitaxel. In certain of such embodiments, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain of such embodiments, the chemotherapeutic is cisplatin. In certain of such embodiments, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain of such embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, and nivolumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and nabpaclitaxel. In certain of such embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, and nivolumab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is pembrolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and paclitaxel. In certainAttorney Ref: 092295.0162 EIK-1019-WO embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selected fromatezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab, and one or morechemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab,durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is carboplatin. In certainembodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab,durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is carboplatin andpemetrexed. In certain embodiments where the PD-L1 antagonist is selected fromatezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic iscarboplatin and paclitaxel. In certain embodiments where the PD-L1 antagonist is selectedfrom atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab, thechemotherapeutic is carboplatin and nab-paclitaxel. In certain embodiments where the PD-L1antagonist is selected from atezolizumab, avelumab, durvalumab, sugemalimab, andcosibelimab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-L1antagonist is selected from atezolizumab, avelumab, durvalumab, sugemalimab, andcosibelimab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatinAttorney Ref: 092295.0162 EIK-1019-WO and nab-paclitaxel. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC a composition comprising EIK1001 administered in combination with pembrolizumab. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and cisplatin 75 mg / m2Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with nab- paclitaxel 100 mg / m2QW for 4 cycles and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC a composition comprising EIK1001 administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at aAttorney Ref: 092295.0162 EIK-1019-WO fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of treating cancer comprises administering to a human subject with NSCLC a composition comprising EIK1001 administered in combination with pembrolizumab. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 20-25 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 24 weeks. In certain embodiments, e.g., for those subjects with nonsquamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination withAttorney Ref: 092295.0162 EIK-1019-WO pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, e.g., for those subjects with squamous NSCLC, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of treating cancer comprises administering to a human subject with nonsquamous NSCLC a composition comprising EIK1001 administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab is administered at a fixed dose of 200 mg once every 3 weeks (Q3W) for 24 weeks. In certain embodiments, EIK1001 is thereafter administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the method further comprises administering to the human subject pemetrexed and carboplatin. In certain embodiments, the method of treating cancer comprises administering to a human subject with squamous NSCLC a composition comprising EIK1001 administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab is administered at a fixed dose of 200 mg once every 3 weeks (Q3W) for 24 weeks. In certain embodiments, EIK1001 is thereafter administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the method further comprises administering to the human subject paclitaxel and carboplatin. In certain embodiments, the method of treating cancer comprises administering to a human subject with squamous NSCLC a composition comprising EIK1001 administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab is administered at a fixed dose of 200 mg once every 3 weeks (Q3W) for 24 weeks. In certain embodiments, EIK1001 is thereafter administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the method further comprises administering to the human subject nab-paclitaxel and carboplatin.Attorney Ref: 092295.0162 EIK-1019-WO 6.4 Methods of Inducing an Immune Response Also provided herein are methods of inducing an immune response by administering to a human subject EIK1001 or a pharmaceutically acceptable salt thereof. In certain embodiments, the immune response induced by administration of EIK1001 is determined by measuring the activation of TLR7 or TLR8 pathways. Activation of the TLR7 or TLR8 can be measured by an increase in the level of one or more TLR7 or TLR8 activation-related biomarkers, relative to a baseline level of such biomarker. As used herein, “baseline” refers to the level of the corresponding biomarker prior to administration (e.g., C1D1 pre-infusion as described paragraphs

[0141] -00142], below). Such TLR7 or TLR8 activation biomarkers include, for example, IL-6, IL-8, IFN^^^and IP-10. In certain embodiments, the TLR7 or TLR8 activation biomarkers are measured on the first day of administration of EIK1001. Single dose administration of EIK1001 was associated with a dose-dependent increase in IFN^^^and IP-10. It was noted that subjects with PR / CR response demonstrate at least a 2-fold increase in IFN^ and IP-10 levels. Accordingly, in certain embodiments, the method comprises administering EIK1001 in an amount that results in at least a 2-fold increase in IFN^^and / or^IP- 10^levels over baseline. As described in Example 5, the median fold changes from baseline at peak for IFN^ were 1.13, 1.37, 3.52 and 7.97 at 0.30, 0.45, 0.60 and 0.75 mg / m2doses, respectively. Similarly, the median fold changes from baseline at peak for IP-10 were 0.63, 0.71, 4.46 and 12.1 at 0.30, 0.45, 0.60 and 0.75 mg / m2doses. Provided herein is a method of inducing an immune response by administering to a human subject EIK1001 or a pharmaceutically acceptable salt thereof, where the EIK1001 or a pharmaceutically acceptable salt thereof is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2. In certain embodiments, the administration intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2results in at least a 2-fold increase in IFN^^and / or^IP-10^levels over baseline. In certain embodiments, the administration intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2results in at least a 4-fold increase in IFN^^and / or^IP-10^levels over baseline. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 or PD-L1 antagonist.Attorney Ref: 092295.0162 EIK-1019-WO In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 or PD-L1 antagonist, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, pemetrexed, and / or paclitaxel. In certain of such embodiments, the chemotherapeutic is carboplatin. In certain of such embodiments, the chemotherapeutic is carboplatin and pemetrexed. In certain of such embodiments, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, pemetrexed, and / or paclitaxel. In certain of such embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is pembrolizumab. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist isAttorney Ref: 092295.0162 EIK-1019-WO pembrolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, pemetrexed, and / or paclitaxel. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selected from atezolizumab, avelumab, durvalumab, and cosibelimab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, pemetrexed, and / or paclitaxel. In certain embodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab, durvalumab, and cosibelimab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab, durvalumab, and cosibelimab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab, durvalumab, and cosibelimab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, pemetrexed, and / or paclitaxel. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 administered inAttorney Ref: 092295.0162 EIK-1019-WO combination with pembrolizumab. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 20-25 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 24 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 administered in combination with pembrolizumab. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW). In certain embodiments, pembrolizumab isAttorney Ref: 092295.0162 EIK-1019-WO administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 25-30 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 27 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of inducing an immune response comprises administering to a human subject a composition comprising EIK1001 administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.75 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.75 mg / m2Attorney Ref: 092295.0162 EIK-1019-WO once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 25-30 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 27 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with nab-paclitaxel !00 mg / m2QW for 4 cycles and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of inducing an immune response comprises administering to a human subject with a cancer a composition comprising EIK1001 administered in combination with atezolizumab. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, atezolizumab is administered at a fixed dose of 1200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.75 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.75 mg / m2once every 3 weeks (Q3W) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 6-10 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 9Attorney Ref: 092295.0162 EIK-1019-WO weeks. In certain embodiments, the method further comprises administering to the human subject radiotherapy. In certain embodiments, radiotherapy is administered at a total dose between 27 Gy and 60 Gy. In certain embodiments, radiotherapy is administered at least one week after the first administration of atezolizumab and at the latest before the 2ndadministration. 6.5 Methods of Increasing Expression of TLR7 and / or TLR8 Activation Biomarkers Provided herein are methods of inducing an increase in expression of a biomarker associated with TLR7 and or TLR8 activation in a subject, the method comprising administering to the subject EIK1001 or a pharmaceutically acceptable salt thereof in amount sufficient to increase the level of the biomarker over baseline. In certain embodiments, the biomarker is IL-6, IL-8, IFN^^or^IP-10. In certain embodiments, the method comprises administering the EIK1001 or a pharmaceutically acceptable salt thereof intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2. In certain embodiments, the administration intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2results in at least a 1.5-fold, 2.0- fold, 4.0-fold or greater increase in IL-6, IL-8, IFN^^and / or IP-10 levels over baseline. In certain embodiments, the administration intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2results in at least a 2-fold increase in IFN^^and / or^IP-10^levels over baseline. In certain embodiments, the administration intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2results in at least a 4-fold increase in IFN^^and / or^IP-10^levels over baseline. In certain embodiments, the method of inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 or PD-L1 antagonist. In certain embodiments, the method of inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 or PD-L1 antagonist, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain of such embodiments, the chemotherapeutic is carboplatin. In certain of such embodiments, the chemotherapeutic is carboplatin and pemetrexed. In certain of such embodiments, theAttorney Ref: 092295.0162 EIK-1019-WO chemotherapeutic is carboplatin and paclitaxel. In certain of such embodiments, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain of such embodiments, the chemotherapeutic is cisplatin. In certain of such embodiments, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the method inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab. In certain embodiments, the method inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain of such embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, and nivolumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain of such embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, and nivolumab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-1 antagonist is selected from cemiplimab, dostarlimab, pembrolizumab, tislelizumab, nivolumab, retifanlimab, and toripalimab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the method of inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2orAttorney Ref: 092295.0162 EIK-1019-WO 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is pembrolizumab. In certain embodiments, the method of inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-1 antagonist, where the PD-1 antagonist is pembrolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is cisplatin. In certain embodiments where the PD-1 antagonist is pembrolizumab, the chemotherapeutic is cisplatin and pemetrexed. In certain embodiments, the method of inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selectedfrom atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab.In certain embodiments, the method of inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selectedfrom atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab, and one or morechemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab,durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is carboplatin. In certainembodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab,durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is carboplatin andpemetrexed.Attorney Ref: 092295.0162 EIK-1019-WO In certain embodiments, the method of inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is selectedfrom atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab, and one or morechemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab,durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is cisplatin. In certainembodiments where the PD-L1 antagonist is selected from atezolizumab, avelumab,durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is cisplatin and pemetrexed.In certain embodiments where the PD-L1 antagonist is selected from atezolizumab,avelumab, durvalumab, sugemalimab, and cosibelimab, the chemotherapeutic is carboplatinand paclitaxel. In certain embodiments, the method of inducing an increase in expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab. In certain embodiments, the method of inducing an increase in expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab. In certain embodiments, the method of inducing an increase in expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab- paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and paclitaxel. In certain embodiments, the method of inducing an increase in expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject aAttorney Ref: 092295.0162 EIK-1019-WO composition comprising EIK1001 at 0.60 mg / m2or 0.75 mg / m2, in combination with a PD-L1 antagonist, where the PD-L1 antagonist is atezolizumab, and one or more chemotherapeutic, where the one or more chemotherapeutic is selected from carboplatin, cisplatin, paclitaxel, nab- paclitaxel, pemetrexed, or a combination thereof. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and pemetrexed. In certain embodiments where the PD-L1 antagonist is atezolizumab, the chemotherapeutic is carboplatin and nab-paclitaxel. In certain embodiments, the method of inducing an increase in expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 administered in combination with pembrolizumab. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 20-25 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 24 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination withAttorney Ref: 092295.0162 EIK-1019-WO pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and cisplatin 75 mg / m2Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 8 cycles and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 27 cycles in combination with nab-paclitaxel 100 mg / m2QW for 4 cycles and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of inducing an increase in expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 administered in combination with pembrolizumab. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weeklyAttorney Ref: 092295.0162 EIK-1019-WO (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.60 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 25-30 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 27 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and cisplatin 75 mg / m2Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.60 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with nab-paclitaxel 100 mg / m2QW for 4 cycles and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of inducing an increase in expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject a composition comprising EIK1001 administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, pembrolizumab is administered at a fixed dose of 200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW)in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certainembodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) inAttorney Ref: 092295.0162 EIK-1019-WO combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.75 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.75 mg / m2once every 3 weeks (Q3W) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 25-30 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 27 weeks. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and carboplatin AUC 5 Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with paclitaxel 200 mg / m2and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with pemetrexed 500 mg / m2(with folate / vitamin B12 supplementation) and cisplatin 75 mg / m2Q3W for 4 cycles, followed by pemetrexed until progression (500 mg / m2). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with pembrolizumab (200 mg) once every 3 weeks (Q3W) for 35 cycles in combination with nab-paclitaxel 100 mg / m2QW for 4 cycles and carboplatin AUC 6 Q3W for 4 cycles. In certain embodiments, the method of inducing an increase in expression of a biomarker expression of one or more TLR7 and / or TLR8 activation biomarker comprises administering to a human subject with a cancer a composition comprising EIK1001 administered in combination with atezolizumab. In certain embodiments, EIK1001 isAttorney Ref: 092295.0162 EIK-1019-WO administered IV at a dose of 0.75 mg / m2once weekly (QW). In certain embodiments, atezolizumab is administered at a fixed dose of 1200 mg Q3W. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for a set number of weeks and then EIK1001 is administered IV at a dose of 0.75 mg / m2at a reduced frequency. In certain embodiments, EIK1001 is administered IV at a dose of 0.75 mg / m2once weekly (QW) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W) for a set number of weeks and then administered IV at a dose of 0.75 mg / m2once every 3 weeks (Q3W) in combination with atezolizumab (1200 mg) once every 3 weeks (Q3W). In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is between 6-10 weeks. In certain embodiments, the number of weeks before the EIK1001 dosing frequency is reduced is 9 weeks. In certain embodiments, the method further comprises administering to the human subject radiotherapy. In certain embodiments, radiotherapy is administered at a total dose between 27 Gy and 60 Gy. In certain embodiments, radiotherapy is administered at least one week after the first administration of atezolizumab and at the latest before the 2ndadministration. 6.6 Articles of Manufacture Provided herein are articles of manufacture, also referred herein as kits, that are useful for the treatment of cancer. The kit comprises a vial comprising EIK1001 at a specific concentration in an aqueous solution that maintains the stability of EIK1001. In certainembodiments, the vial comprises EIK1001 at a concentration of 1.0 mg / mL free baseequivalent. The kit further comprises a packet insert that provides instructions for preparing EIK1001 for intravenous administration at a specified dose. In certain embodiments, the packet insert provides instructions for preparing EIK1001 for intravenous administration at a weekly dose of 0.60 mg / m2or 0.75 mg / m2. 7. EXAMPLESThe following are examples of methods and compositions of the invention. It is understood that various other embodiments may be practiced, given the general description provided above.Attorney Ref: 092295.0162 EIK-1019-WO Example 1 – BDB001-101 & BDB001-102 Studies Participant Disposition and Demographics. The following study populations were evaluated for both BDB001-101 (EIK1001 monotherapy & EIK1001 combination with pembrolizumab) and BDB001-102 (EIK1001 monotherapy & EIK1001 combination with atezolizumab): •Safety Population: participants who received at least one dose of EIK1001(monotherapy) and / or pembrolizumab or atezolizumab (combination). •DLT Population: participants who received at least 3 planned EIK1001 doses aloneor in combination with pembrolizumab / atezolizumab in the first cycle (Days 1 to 21), unless a reduction in doses resulted due to treatment-emergent toxicity. Participants who experienced a DLT within the first treatment cycle and discontinued were still considered evaluable for DLT. •Efficacy Population: participants who received at least one dose of EIK1001(monotherapy) and / or pembrolizumab or atezolizumab (combination) and who met the following criteria: 1) had measurable disease at baseline and had at least one follow-up tumor assessment; 2) experienced early withdrawal due to toxicity or death and didn’t have a follow up tumor assessment; or 3) experienced disease progression without a follow-up tumor assessment. Participants were allocated into each monotherapy and combination dose cohort for pembrolizumab (BDB001-101) or atezolizumab (BDB001-102). Phase 1 Study BDB001-101. A total of 87 participants were enrolled in study BDB001-101: •36 participants in the EIK1001 monotherapy dose-escalation phase across 8 dosecohorts (Cohorts 1 to 4 [0.008, 0.012, 0.018, and 0.024 mg / kg EIK1001] and Cohorts 5 to 8 [0.3, 0.45, 0.60, and 0.75 mg / m2EIK1001]) •23 participants in the EIK1001 + pembrolizumab combination dose-escalation phaseacross 4 dose cohorts (0.3, 0.45, 0.60, or 0.75 mg / m2plus 200 mg pembrolizumab) •28 participants in the 0.60 mg / m2 dose level for the EIK1001 + pembrolizumabefficacy expansion. In all phases of the study, the primary reason for discontinuation was disease progression or death due to disease progression. A total of three participants are ongoing (one in the 0.3 mg / m2+ pembrolizumab group and two in the 0.60 mg / m2EIK1001 +Attorney Ref: 092295.0162 EIK-1019-WO pembrolizumab group) as of 05 May 2023. A summary of the disposition of participants in the monotherapy, combination, and dose expansion phases of BDB001-101 are provided in Table 1. Table 1. Summary of Disposition (BDB001-101) – Safety Population. Monotherapy Dose Combination Dose 0.60 mg / m2Escalation Escalation Combination Dose[c](N=36) (N=23) (N=34) Disposition n (%) n (%) n (%) All successfully screened subjects 36 23 34 Screen Failure 19 19 19 Safety Population 36 (100) 23 (100) 34 (100) DLT Population 34 ( 94.4) 19 ( 82.6) NA Efficacy Population 35 ( 97.2) 23 (100) 33 ( 97.1) Subject Completed the Study 0 0 0 Subject who Discontinued Early from Study 36 (100) 22 ( 95.7) 32 ( 94.1) Ongoing subjects 1 ( 4.3) 2 ( 5.9) Primary Reason for Discontinuation[a]Adverse Event[b]4 ( 11.1) 2 ( 9.1) 1 ( 3.1) Death 1 ( 2.8) 2 ( 9.1) 6 ( 18.8) Lost to Follow-up 0 0 0 Non-Compliance with Study Drug 0 0 0 Physician Decision 3 ( 8.3) 3 ( 13.6) 3 ( 9.4) Pregnancy 0 0 0 Progressive Disease - Clinical 6 ( 16.7) 1 ( 4.5) 5 ( 15.6) Progressive Disease - Radiographic 15 ( 41.7) 10 ( 45.5) 10 ( 31.3) Progressive Disease - Clinical and 3 ( 8.3) 0 0 Radiographic Subject Decision 0 1 ( 4.5) 1 ( 3.1) Withdrawn Consent 1 ( 2.8) 2 ( 9.1) 4 ( 12.5) Others 3 ( 8.3) 1 ( 4.5) 2 ( 6.3) Note: DLT = Dose Limiting Toxicity. n = Number of subjects with non-missing data within the specific category; N = Number of subjects in the Safety Population. The percentage for DLT, Efficacy and Subject who discontinued early from study are based on Safety Population.[a]Percentages for discontinuation reasons are based on the number of subjects who discontinued early from the study.[b]Percentages of adverse events that are both related and unrelated to BDB001.[c]The 34 subjects noted here includes 6 subjects receiving 0.60 mg / m2in the combination dose-escalation phase.Attorney Ref: 092295.0162 EIK-1019-WO Participants were allocated to each cohort, and the demographics were similar among each dose level and dose expansion cohort. The mean age of participants in the monotherapy dose-escalation, combination dose-escalation, and 0.60 mg / m2dose-expansion phases was 64.9, 61.3, and 65.4 years, respectively. A greater proportion of participants were female (> 60%) and the majority of participants were white (> 86%) across all study phases. In each study phase, a positive PD-L1 status was observed in 13.9, 17.4, and 17.6% of participants, respectively. Most participants in each study phase had a prior treatment-related surgical intervention (72.2, 78.3, and 70.6%, respectively), nearly all participants had received prior cytotoxic therapy (100, 100, and 97.1%, respectively), and many participants had received radiotherapy (63.9, 43.5, and 38.2%, respectively). Phase 1 Study BDB001-102. A total of 41 participants were enrolled in study BDB001-102: •21 participants in the EIK1001 + atezolizumab dose escalation phase across four dosecohorts (0.3, 0.45, 0.60, and 0.75 mg / m2EIK1001 + atezolizumab) •20 participants at the 0.75 mg / m2 dose level for EIK1001 + atezolizumab efficacyexpansion. Note that each tabular summary for study BDB001-102 includes a column including all participants from the 0.75 mg / m2dose‑expansion cohort and the 0.75 mg / m2dose‑escalation phase (N = 26 total participants administered 0.75 mg / m2EIK1001 + atezolizumab). In both the dose-escalation phase and the 0.75 mg / m2EIK1001 + atezolizumab combination expansion phase, most discontinuations were due to disease progression. One subject is ongoing in the study as of 05 May 2023. Participants were allocated into each cohort, and the demographics were similar among each dose level and dose expansion cohort. The mean age in the combination dose- escalation phase and the 0.75 mg / m2EIK1001 + atezolizumab was 62.4 and 65.4 years, respectively. In each phase, the majority of participants were white and there was a larger proportion of female participants (57.1 and 61.5%, respectively). The PD-L1 status was positive in approximately 19% of participants across all participants. A summary of the disposition of participants in the dose-escalation and dose-expansion phases of BDB001-102 are provided in Table 2.Attorney Ref: 092295.0162 EIK-1019-WO Table 2. Summary of Disposition (BDB001-102) – Safety Population. Combination Dose 0.75 mg / m2Escalation Combination Dose Overall Overall N = 21 N = 26[a]Disposition n (%) n (%) All successfully screened subjects 21 26 Screen Failure 5 5 Enrolled 21 26 Safety Population 21 (100) 26 (100) DLT Population 20 ( 95.2) NA Efficacy Population 19 ( 90.5) 24 ( 92.3) Subject Completed the Study 0 0 Subject who Discontinued Early from Study 21 (100) 25 ( 96.2) Ongoing subjects 0 1 ( 3.8) Primary Reason Off Study Adverse event 0 1 ( 4.0) Completed 0 0 Death 1 ( 4.8) 1 ( 4.0) Lost to follow-up 0 0 Non-compliance with study drug 0 0 Physician decision 0 5 ( 20.0) Pregnancy 0 0 Progressive Disease - Clinical 2 ( 9.5) 7 ( 28.0) Progressive Disease - Radiographic 14 ( 66.7) 9 ( 36.0) Progressive Disease - Clinical and Radiographic 0 0 Protocol violation 0 0 Screen failure 0 0 Site terminated by sponsor 0 0 Study terminated by sponsor 0 0 Subject Decision 2 ( 9.5) 0 Withdrawn Consent 2 ( 9.5) 1 ( 4.0) Other 0 1 ( 4.0) Note: DLT = Dose Limiting Toxicity; n = Number of subjects with non-missing data within the specific Category. N = Number of subjects in the Safety Population, Percentages are based on N. Percentages for Primary reason off study are based on the number of subjects who did not complete the study. [a] The 26 subjects noted here includes 6 subjects receiving 0.75 mg / m2 in the combination dose-escalation phase. Example 2: SafetyAttorney Ref: 092295.0162 EIK-1019-WO The safety of EIK1001 as monotherapy or in combination with pembrolizumab or atezolizumab was evaluated by tabulation of AEs, TEAEs, TRAEs, and SAEs by grade and relatedness to study drug administration. Phase 1 Study BDB001-101. The safety of EIK1001 as monotherapy or combination with pembrolizumab was evaluated for the Safety Population by tabulation of AEs, TEAEs, SAEs, and DLTs. A total of two participants (5.6%) experienced a DLT during the monotherapy dose escalation, both of which were cytokine release syndrome (CRS). Based on the original, protocol-specified mg / kg dosing (Cohorts 1 to 4), these two DLTs among the nine DLT- evaluable participants occurred in: 1 / 6 participants at the 0.018 mg / kg level and 1 / 1 participants at the 0.024 mg / kg level (Table 3). Following the DLT at 0.024 mg / kg, the Sponsor revised the dosing to be based on BSA (mg / m2). Dosage based on BSA is calculated by using the Analysis Body Surface Area formula: Formula = sqr[height (cm)*weight(kg) / 3600] The mg / m2dosage was used to determine the dosage for the individual patients because it takes into account both the weight and the height of the patient, as opposed to the weight-only method used to determine dosage based on a mg / kg basis. Of note, the two participants experiencing DLTs during the initial dose-escalation phase corresponded to 0.82 and 0.93 mg / m2dose levels when mapped to dosing based on BSA. Among participants dosed based on BSA (Cohorts 5 to 8), there were no DLTs among the 25 DLT evaluable participants. A maximum tolerated dose (MTD) for EIK1001 monotherapy was not reached. Of the 36 treated participants in the monotherapy dose-escalation phase, 25 (69.5%) experienced treatment-related TEAEs (TRAEs), 17 (47.2%) experienced ≥ Grade 3 TEAEs (6 of these ≥ Grade 3 TEAEs were disease progression and were recorded as AEs per protocol), 14 (38.9%) experienced serious TEAEs, and seven (19.4%) experienced TEAEs leading to drug discontinuation. No participants died due to treatment-related TEAEs (Table 3 and Table 4). The most common AEs (experienced by > 10% of participants) were fatigue, pyrexia, chills, anaemia, dyspnoea, disease progression, oedema peripheral, vomiting, diarrhoea, nausea, pruritus, constipation, decreased appetite, and headache. The most common TRAEs (experienced by > 10% of participants) were chills, pyrexia, fatigue, nausea, and pruritus. Table 3. Overall Summary of Adverse Events for the Dose-Escalation Phase Evaluating BDB001 Monotherapy (BDB001101; Cohorts 1 to 4; Safety Population).Attorney Ref: 092295.0162 EIK-1019-WO BDB001 Cohort 1 Cohort 2 Cohort 3 Cohort 4 0.008 0.012 0.018 0.024 Overall mg / kg mg / kg mg / kg mg / kg Cohort 1-4 Overall (N=1) (N=1) (N=6) (N=1) (N=9) (N=36) Category n (%) n (%) n (%) n (%) n (%) n (%) Number of Subjects who had an 1 (100) 1 (100) 6 (100) 1 (100) 9 (100) 35 ( 97.2) AE Number of Subjects who had a 1 (100) 1 (100) 6 (100) 1 (100) 9 (100) 35 ( 97.2) TEAE Number of Subjects who had a 1 (100) 0 5 ( 83.3) 1 (100) 7 ( 77.8) 17 ( 47.2) grade 3+ TEAE Number of Subjects who had a 1 (100) 0 4 ( 66.7) 1 (100) 6 ( 66.7) 25 ( 69.4) Related TEAE Number of Subjects who had a 1 (100) 0 2 ( 33.3) 1 (100) 4 ( 44.4) 14 ( 38.9) Serious TEAE Number of Subjects who had a 0 0 1 ( 16.7) 1 (100) 2 ( 22.2) 4 ( 11.1) Related Serious TEAE Number of Subjects who had a 0 0 2 ( 33.3) 1 (100) 3 ( 33.3) 7 ( 19.4) TEAE Leading to Study Drug Discontinuation Number of Subjects who had a 0 0 1 ( 16.7) 1 (100) 2 ( 22.2) 2 ( 5.6) DLT Number of Subjects Who had a 0 0 1 ( 16.7) 1 (100) 2 ( 22.2) 4 ( 11.1) Treatment Emergent Suspected Unexpected Serious Adverse Reaction Number of Deaths due to Related 0 0 0 0 0 0 TEAE Abbreviations: AE = Adverse Event; DLT = Dose-Limiting Toxicity; TEAE = Treatment Emergent Adverse Event; n = Number of participants with non-missing data within the specific Category; N = Number of participants in Safety Population. Note: Percentages are based on N in each cohort. Table 4. Overall Summary of Adverse Events for the Dose-Escalation Phase Evaluating BDB001 Monotherapy (BDB001101; Cohorts 5 to 8; Safety Population). BDB001 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Overall 0.3 mg / m20.45 mg / m20.60 mg / m20.75 mg / m2 Cohort >=5 Overall (N=7) (N=7) (N=6) (N=7) (N=27) (N=36) Category n (%) n (%) n (%) n (%) n (%) n (%) Number of Subjects who had an 7 (100) 7 (100) 5 ( 83.3) 7 (100) 26 ( 96.3) 35 ( 97.2) AE Number of Subjects who had a 7 (100) 7 (100) 5 ( 83.3) 7 (100) 26 ( 96.3) 35 ( 97.2) TEAEAttorney Ref: 092295.0162 EIK-1019-WO BDB001 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Overall 0.3 mg / m20.45 mg / m20.60 mg / m20.75 mg / m2 Cohort >=5 Overall (N=7) (N=7) (N=6) (N=7) (N=27) (N=36) Category n (%) n (%) n (%) n (%) n (%) n (%) Number of Subjects who had a 2 ( 28.6) 2 ( 28.6) 3 ( 50.0) 3 ( 42.9) 10 ( 37.0) 17 ( 47.2) grade 3+ TEAE Number of Subjects who had a 5 ( 71.4) 6 ( 85.7) 4 ( 66.7) 4 ( 57.1) 19 ( 70.4) 25 ( 69.4) Related TEAE Number of Subjects who had a 2 ( 28.6) 2 ( 28.6) 3 ( 50.0) 3 ( 42.9) 10 ( 37.0) 14 ( 38.9) Serious TEAE Number of Subjects who had a 1 ( 14.3) 0 0 1 ( 14.3) 2 ( 7.4) 4 ( 11.1) Related Serious TEAE Number of Subjects who had a 1 ( 14.3) 1 ( 14.3) 0 2 ( 28.6) 4 ( 14.8) 7 ( 19.4) TEAE Leading to Study Drug Discontinuation Number of Subjects who had a 0 0 0 0 0 2 ( 5.6) DLT Number of Subjects Who had a 1 ( 14.3) 0 0 1 ( 14.3) 2 ( 7.4) 4 ( 11.1) Treatment Emergent Suspected Unexpected Serious Adverse Reaction Number of Deaths due to Related 0 0 0 0 0 0 TEAE Abbreviations: AE = Adverse Event; DLT = Dose Limiting Toxicity; TEAE = Treatment Emergent Adverse Event; n = Number of subjects with non-missing data within the specific Category; N = Number of subjects in Safety Population. Note: Percentages are based on N in each cohort.Attorney Ref: 092295.0162 EIK-1019-WO Of the 23 treated participants in the pembrolizumab dose-escalation phase, 21 (91.3%) experienced TRAEs, 12 (52.2%) experienced ≥ Grade 3 TEAEs (two of these ≥ Grade 3 TEAEs were disease progression and were recorded as AEs per protocol), 10 (43.5%) experienced serious TEAEs, four (17.4%) experienced TEAEs leading to drug discontinuation, and one (4.3%) participant experienced death following a potentially related TEAE (although follow-up information obtained after database lock indicates disease progression as the cause of death in this subject) (Table 5). The most common AEs (experienced by > 10% of participants) were fatigue, pyrexia, chills, vomiting, abdominal distension, hypothyroidism, abdominal pain, anaemia, decreased appetite, nausea, arthralgia, aspartate aminotransferase increased, blood creatinine increased, constipation, dehydration, diarrhoea, dizziness, lymphocyte count decreased, pruritus, and rash maculo-papular. The most common TRAEs (experienced by > 10% of participants) were fatigue, pyrexia, chills, hypothyroidism, abdominal distension, diarrhoea, nausea, and rash maculo-papular. Table 5. Overall Summary of Adverse Events for BDB001 plus Pembrolizumab Combination Therapy for BDB001-101 (Safety Population). BDB001+Pembrolizumab Cohort 21 Cohort 22 Cohort 23 Cohort 24 Overall (N=5) (N=4) (N=6) (N=8) (N=23) Category n (%) n (%) n (%) n (%) n (%) Number of Subjects who had an AE 5 (100) 4 (100) 6 (100) 8 (100) 23 (100)Number of Subjects who had a TEAE 5 (100) 4 (100) 6 (100) 8 (100) 23 (100)Number of Subjects who had a grade 4 ( 80.0) 2 ( 50.0) 1 ( 16.7) 5 ( 62.5) 12 ( 52.2) 3+ TEAE Number of Subjects who had a 4 ( 80.0) 3 ( 75.0) 6 (100) 8 (100) 21 ( 91.3) Related TEAE Number of Subjects who had a 3 ( 60.0) 2 ( 50.0) 1 ( 16.7) 4 ( 50.0) 10 ( 43.5) Serious TEAE Number of Subjects who had a 0 0 1 ( 16.7) 2 ( 25.0) 3 ( 13.0) Related Serious TEAE Number of Subjects who had a TEAE 0 0 1 ( 16.7) 3 ( 37.5) 4 ( 17.4) Leading to Study Drug Discontinuation Number of Subjects who had a DLT 0 0 0 0 0 Number of Subjects Who had a 0 0 0 0 0 Treatment Emergent Suspected Unexpected Serious Adverse ReactionAttorney Ref: 092295.0162 EIK-1019-WO BDB001+Pembrolizumab Cohort 21 Cohort 22 Cohort 23 Cohort 24 Overall (N=5) (N=4) (N=6) (N=8) (N=23) Category n (%) n (%) n (%) n (%) n (%) Number of Deaths due to Related 0 0 0 1 ( 12.5) 1 ( 4.3) TEAE Abbreviations: AE = Adverse Event; DLT = Dose-Limiting Toxicity; TEAE = Treatment Emergent Adverse Event; n = Number of subjects with non-missing data within the specific Category; N = Number of subjects in Safety Population. Notes: Percentages are based on N in each cohort. Cohort 21 = BDB0010.30 mg / m2+ Pembrolizumab, Cohort 22 = BDB0010.45 mg / m2+ Pembrolizumab, Cohort 23 = BDB0010.60 mg / m2+ Pembrolizumab, Cohort 24 = BDB0010.75 mg / m2+ Pembrolizumab. During the EIK1001 + pembrolizumab combination dose-escalation phase, there were no DLTs observed among the 19 DLT evaluable participants, and a MTD for EIK1001 + pembrolizumab was not reached. Of the 34 total participants receiving 0.60 mg / m2in combination with pembrolizumab, which includes the six participants receiving 0.60 mg / m2EIK1001 in the combination dose-escalation phase, 27 (79.4%) experienced TRAEs, 15 (44.1%) experienced ≥ Grade 3 TEAEs (seven of these ≥ Grade 3 TEAEs were disease progression and were recorded as AEs per protocol), 13 (38.2%) experienced serious TEAEs, and five (14.7%) experienced TEAEs leading to drug discontinuation. No participant died due to treatment- related TEAEs (Table 6). The most common AEs (experienced by > 10% of participants) were fatigue, chills, pyrexia, disease progression, infusion related reaction, nausea, abdominal pain, abdominal distension, decreased appetite, dehydration, hypothyroidism, and urinary tract infection. The most common TRAEs (experienced by > 10% of participants) were chills, pyrexia, fatigue, infusion-related reaction, and hypothyroidism. Table 6. Overall Summary of Adverse Events for 0.60 mg / m2 BDB001 plus Pembrolizumab Combination Therapy for BDB001-101 (Safety Population). BDB001+Pembrolizumab Cohort 23 Cohort 31 & Cohort 32 Overall (N=6) (N=28) (N=34)[a]Category n (%) n (%) n (%) Number of Subjects who had an AE 6 (100) 27 ( 96.4) 33 ( 97.1) Number of Subjects who had a TEAE 6 (100) 27 ( 96.4) 33 ( 97.1) Number of Subjects who had a grade 3+ 1 ( 16.7) 14 ( 50.0) 15 ( 44.1) TEAEAttorney Ref: 092295.0162 EIK-1019-WO BDB001+Pembrolizumab Cohort 23 Cohort 31 & Cohort 32 Overall (N=6) (N=28) (N=34)[a]Category n (%) n (%) n (%) Number of Subjects who had a Related 6 (100) 21 ( 75.0) 27 ( 79.4) TEAE Number of Subjects who had a Serious 1 ( 16.7) 12 ( 42.9) 13 ( 38.2) TEAE Number of Subjects who had a Related 1 ( 16.7) 2 ( 7.1) 3 ( 8.8) Serious TEAE Number of Subjects who had a TEAE 1 ( 16.7) 4 ( 14.3) 5 ( 14.7) Leading to Study Drug Discontinuation Number of Subjects Who had a Treatment 0 1 ( 3.6) 1 ( 2.9) Emergent Suspected Unexpected Serious Adverse Reaction Number of Deaths due to Related TEAE 0 0 0 Abbreviations: AE = Adverse Event; TEAE = Treatment Emergent Adverse Event; n = Number of subjects with non-missing data within the specific Category; N = Number of subjects in Safety Population. Note: Percentages are based on N in each cohort.[a]The 34 subjects noted here includes 6 subjects receiving 0.60 mg / m2in the combination dose-escalation phase. Cohort 23 = BDB0010.60 mg / m2+ Pembrolizumab, Cohort 31 = BDB0010.60 mg / m2+ Pembrolizumab, Cohort 32= BDB0010.60 mg / m2+ Pembrolizumab. Phase 1 Study BDB001-102. The safety of EIK1001 in combination with atezolizumab was evaluated for the Safety Population by tabulation of AEs, TEAEs, TRAEs, SAEs, and DLTs. There was no clear dose-dependent trend with respect to the number of AEs during the combination dose-escalation phase of EIK1001 in combination with atezolizumab. Of the 21 treated participants in the EIK1001 + atezolizumab dose-escalation phase, 14 (66.7%) experienced TRAEs, seven (33.3%) experienced ≥ Grade 3 TEAEs (one of these ≥ Grade 3 TEAEs was disease progression and was recorded as an AE per protocol), five (23.8%) experienced serious TEAEs, and two (9.5%) experienced TEAEs leading to drug discontinuation. No participants experienced death due to a treatment-related TEAE (Table 7). The most common AEs (experienced by > 10% of participants) were fatigue, vomiting, constipation, pyrexia, chills, dyspnoea, nausea, abdominal pain, back pain, decreased appetite, and diarrhoea. The most common TRAEs (experienced by > 10% of participants) were fatigue, chills, pyrexia, dyspnoea, nausea, and vomiting.Attorney Ref: 092295.0162 EIK-1019-WO Table 7. Overall Summary of Adverse Events: Dose-Escalation Phase for BDB001-102 (Safety Population). BDB001+Atezolizumab Cohort 1 Cohort 2 Cohort 3 Cohort 4 Overall N = 3 N = 6 N = 6 N = 6 N = 21 Category n (%) n (%) n (%) n (%) n (%) Number of Subjects who had an 3 (100) 6 (100) 6 (100) 6 (100) 21 (100) AE Number of Subjects who had a 3 (100) 6 (100) 6 (100) 6 (100) 21 (100) TEAE Number of Subjects who had a 0 3 ( 50.0) 1 ( 16.7) 3 ( 50.0) 7 ( 33.3) grade 3+ TEAE Number of Subjects who had a 2 ( 66.7) 3 ( 50.0) 4 ( 66.7) 5 ( 83.3) 14 ( 66.7) Related TEAE Number of Subjects who had a 0 3 ( 50.0) 1 ( 16.7) 1 ( 16.7) 5 ( 23.8) Serious TEAE Number of Subjects who had a 0 1 ( 16.7) 0 0 1 ( 4.8) Related Serious TEAE Number of Subjects who had a 0 1 ( 16.7) 0 1 ( 16.7) 2 ( 9.5) TEAE Leading to Study Drug Discontinuation Number of Subjects who had a 0 0 0 0 0 DLT Number of Deaths due to Related 0 0 0 0 0 TEAE Abbreviations: AE = Adverse Event; DLT = Dose-Limiting Toxicity; TEAE = Treatment Emergent Adverse Event; N = Number of Subjects in Safety Population. Note: Percentages are based on N. TEAE is any AE does not present prior to the initiation of study drug administration or any event already present that worsens in either intensity or frequency following exposure to the study drug. Adverse events are coded using Medical Dictionary for Regulatory Activities (MedDRA), Version 26.0. Cohort 1 = BDB0010.30 mg / m2 + Atezolizumab, Cohort 2 = BDB0010.45 mg / m2 + Atezolizumab, Cohort 3 = BDB0010.60 mg / m2 + Atezolizumab, Cohort 4 = BDB0010.75 mg / m2 + Atezolizumab. There were no DLTs among the 20 DLT-evaluable participants, and an MTD for EIK1001 in combination with atezolizumab was not reached. Based on the safety, efficacy, and pharmacodynamic data, EIK1001 administered at a dose of 0.75 mg / m2was selected as the dose to administer in combination with atezolizumab. Of the 26 treated participants at 0.75 mg / m2efficacy expansion dose level, 19 (73.1%) experienced TRAEs, 17 (65.4%) experienced ≥ Grade 3 TEAEs (two of these ≥ Grade 3 TEAEs were disease progression and were recorded as AEs per protocol), seven (26.9%) experienced serious TEAEs, and four (15.4%) experienced TEAEs leading to drug discontinuation. No participants experienced death due to treatment-related TEAEs (Table 8). Most common AEsAttorney Ref: 092295.0162 EIK-1019-WO (experienced by > 10% of participants) were fatigue, chills, nausea, pyrexia, decreased appetite, vomiting, back pain, constipation, cough, dyspnoea, anaemia, diarrhoea, rash maculo-papular, COVID-19, dehydration, hyponatraemia, infusion related reaction, as well as musculoskeletal chest pain. The most common TRAEs (experienced by > 10% of participants) were chills, fatigue, pyrexia, infusion-related reaction, and rash maculo-papular. Table 8. Overall Summary of Adverse Events for 0.75 mg / m2 BDB001 in Combination with Atezolizumab for BDB001-102 (Safety Population). BDB001 Cohort 5 & Cohort 4 Cohort 6 Overall N = 6 N = 20 N = 26[a]Category n (%) n (%) n (%) Number of Subjects who had an AE 6 (100) 19 ( 95.0) 25 ( 96.2) Number of Subjects who had a TEAE 6 (100) 19 ( 95.0) 25 ( 96.2) Number of Subjects who had a grade 3+ TEAE 3 ( 50.0) 14 ( 70.0) 17 ( 65.4) Number of Subjects who had a Related TEAE 5 ( 83.3) 14 ( 70.0) 19 ( 73.1) Number of Subjects who had a Serious TEAE 1 ( 16.7) 6 ( 30.0) 7 ( 26.9) Number of Subjects who had a Related Serious 0 0 0 TEAE Number of Subjects who had a TEAE Leading to 1 ( 16.7) 3 ( 15.0) 4 ( 15.4) Study Drug Discontinuation Number of Deaths due to Related TEAE 0 0 0 Abbreviations: AE = Adverse Event; TEAE = Treatment Emergent Adverse Event; N = Number of Subjects in Safety Population. Note: Percentages are based on N. TEAE is any AE does not present prior to the initiation of study drug administration or any event already present that worsens in either intensity or frequency following exposure to the study drug. Adverse events are coded using Medical Dictionary for Regulatory Activities (MedDRA), Version 26.0. Cohort 4 = BDB0010.75 mg / m2+ Atezolizumab, Cohort 5 = BDB0010.75 mg / m2+ Atezolizumab, Cohort 6 = BDB0010.75 mg / m2+ Atezolizumab.[a]The 26 subjects noted here includes 6 subjects receiving 0.75 mg / m2in the combination dose-escalation phase. Example 3: Efficacy Efficacy was evaluated using the Best Overall Response (BOR), and is based on irRECIST criteria via Investigator assessment. Prior anti-PD-L1 therapy exposure and PD-L1 expression were explored for both BDB001-101 and BDB001-102. Phase 1 Study BDB001-101. In the EIK1001 monotherapy dose-escalation phase: of 35 participants in the efficacy analysis population, two (5.7%) experienced PR, and 14 (40%) experienced DC which included PR / CR and SD. The two partial responders observed in the monotherapy dose-escalation phase had been exposed to prior anti-PD-L1 therapies; one hadAttorney Ref: 092295.0162 EIK-1019-WO positive tumor PD-L1 and the other subject’s tumor PD-L1 status was unknown. The two confirmed responders are at 0.75 mg / m2dose level and the DOR was two and eight months, respectively. Among the 12 participants with BOR as SD, one had duration of SD of 15 months and three had a duration of SD of six months. Efficacy by dose level and PD-L1 status is summarized in Table 9, Table 10, and Table 11, and presented as a swimmer plot and spider plot in Figure 1 and Figure 2, respectively. Table 9. Summary of Best Overall Response based on irRECIST for Monotherapy Phase (BDB001-101; Efficacy Population; mg / kg Dose). BDB001 Cohort 1 Cohort 2 Cohort 3 Cohort 4 Overall 0.008 mg / kg 0.012 mg / kg 0.018 mg / kg 0.024 mg / kg Cohort 1-4 Overall (N=1) (N=1) (N=6) (N=1) (N=9) (N=35) Category n (%) n (%) n (%) n (%) n (%) n (%)Complete Response (irCR) 0 0 0 0 0 0Partial Response (irPR) 0 0 1 ( 16.7) 0 1 ( 11.1) 2 ( 5.7)Objective Response (irOR) 0 0 1 ( 16.7) 0 1 ( 11.1) 2 ( 5.7)Stable Response (irSD) 0 0 1 ( 16.7) 0 1 ( 11.1) 12 ( 34.3) Disease control (irDC) 0 0 2 ( 33.3) 0 2 ( 22.2) 14 ( 40.0) Unconfirmed Progression 0 0 0 0 0 11 ( 31.4) (uirPD) Confirmed Progression 1 (100) 1 (100) 3 ( 50.0) 0 5 ( 55.6) 5 ( 14.3) (cirPD) Not available 0 0 1 ( 16.7) 1 (100) 2 ( 22.2) 5 ( 14.3) Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors. n = Number of subjects categorized in the respective Response category. N = Number of subjects in Efficacy Population. Percentages are based on N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Percentages are based on N.Attorney Ref: 092295.0162 EIK-1019-WO Table 10. Summary of Best Overall Response based on irRECIST for Monotherapy Phase (BDB001-101; Efficacy Population; mg / m2Dose) BDB001 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Overall 0.3 mg / m20.45 mg / m20.60 mg / m20.75 mg / m2Cohort >=5 Overall (N=7) (N=6) (N=6) (N=7) (N=26) (N=35) Category n (%) n (%) n (%) n (%) n (%) n (%)Complete Response (irCR) 0 0 0 0 0 0Partial Response (irPR) 0 0 0 1 ( 14.3) 1 ( 3.8) 2 ( 5.7)Objective Response (irOR) 0 0 0 1 ( 14.3) 1 ( 3.8) 2 ( 5.7)Stable Response (irSD) 3 ( 42.9) 3 ( 50.0) 2 ( 33.3) 3 ( 42.9) 11 ( 42.3) 12 ( 34.3) Disease control (irDC) 3 ( 42.9) 3 ( 50.0) 2 ( 33.3) 4 ( 57.1) 12 ( 46.2) 14 ( 40.0) Unconfirmed Progression 3 ( 42.9) 3 ( 50.0) 3 ( 50.0) 2 ( 28.6) 11 ( 42.3) 11 ( 31.4) (uirPD) Confirmed Progression 0 0 0 0 0 5 ( 14.3) (cirPD) Not available 1 ( 14.3) 0 1 ( 16.7) 1 ( 14.3) 3 ( 11.5) 5 ( 14.3) Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors. n = Number of subjects categorized in the respective Response category. N = Number of subjects in Efficacy Population. Percentages are based on N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Table 11. Summary of Best Overall Response based on irRECIST by Prior anti PD-L1 therapy and PD-L1(+) for Monotherapy Phase (Efficacy Population). No Prior Anti-PD-L1 therapy Prior Anti-PD-L1 therapy exposed exposed (N=22) (N=13) PD-L1+ PD-L1- Unknown PD-L1+ PD-L1- Unknown Total a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) (N=35) Complete Response 0 / 5 0 / 3 0 / 14 0 / 0 0 / 2 0 / 11 0 (irCR) Partial Response1 / 5 ( 20.0) 0 / 3 1 / 14 ( 7.1) 0 / 0 0 / 2 0 / 11 2 ( 5.7)(irPR) Objective Response1 / 5 ( 20.0) 0 / 3 1 / 14 ( 7.1) 0 / 0 0 / 2 0 / 11 2 ( 5.7)(irOR)Stable Disease (irSD) 1 / 5 ( 20.0) 1 / 3 ( 4 / 14 ( 28.6) 0 / 0 1 / 2 ( 5 / 11 ( 45.5) 12 ( 34.3)33.3) 50.0) Disease control2 / 5 ( 40.0) 1 / 3 ( 5 / 14 ( 35.7) 0 / 0 1 / 2 ( 5 / 11 ( 45.5) 14 ( 40.0)(irDC) 33.3) 50.0) Unconfirmed1 / 5 ( 20.0) 1 / 3 ( 8 / 14 ( 57.1) 0 / 0 0 / 2 1 / 11 ( 9.1) 11 ( 31.4)Progression (uirPD) 33.3)Attorney Ref: 092295.0162 EIK-1019-WO Table 11. Summary of Best Overall Response based on irRECIST by Prior anti PD-L1 therapy and PD-L1(+) for Monotherapy Phase (Efficacy Population). No Prior Anti-PD-L1 therapy Prior Anti-PD-L1 therapy exposed exposed (N=22) (N=13) PD-L1+ PD-L1- Unknown PD-L1+ PD-L1- Unknown Total a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) (N=35) Confirmed1 / 5 ( 20.0) 1 / 3 (0 / 14 0 / 0 1 / 2 (2 / 11 ( 18.2) 5 ( 14.3)Progression (cirPD) 33.3) 50.0)Not available 1 / 5 ( 20.0) 0 / 3 1 / 14 ( 7.1) 0 / 0 0 / 2 3 / 11 ( 27.3) 5 ( 14.3)Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors; PD-1 = Programmed Death Protein 1; PD-L1 = Programmed Death-Ligand 1. a = Number of subjects achieving the response. n = Number of subjects categorized in the respective PD-L1 expression. N = Number of subjects in Efficacy Population. Percentage for Total column is calculated using N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Percentage for Total column is calculated using N. In the EIK1001 + pembrolizumab combination dose-escalation phase: of 23 participants in the efficacy analysis population, three (13%) experienced PR / CR, and 13 (56.5%) experienced DC. A total of 33 participants in the efficacy analysis population received 0.60 mg / m2EIK1001 in combination with pembrolizumab, including participants from the 0.60 mg / m2dose-escalation phase and the 0.60 mg / m2dose-expansion phase. Of these, five (15.2%) experienced PR / CR (one PR unconfirmed), and 15 (45.5%) experienced DC. There were six confirmed PR / CR (four at 0.60 mg / m2, one each at 0.30 and 0.75 mg / m2) and one unconfirmed PR (at 0.60 mg / m2). The DOR lasted a median of 10 months (range 4 – 32 months). Among the 17 participants with BOR as SD, six had duration of SD of six months. Efficacy by dose level and PD-L1 status is summarized in Table 12, Table 13, Table 14, and Table 15. In combination with pembrolizumab, only a single response was observed in patients treated below 0.60 mg / m2(in the 0.30 mg / m2treatment group).Attorney Ref: 092295.0162 EIK-1019-WO Table 12. Summary of Best Overall Response based on irRECIST for Combination Therapy Phase – BDB001-101; Efficacy Population. BDB001+Pembrolizumab Cohort 21 Cohort 22 Cohort 23 Cohort 24 Overall (N=5) (N=4) (N=6) (N=8) (N=23) Category n (%) n (%) n (%) n (%) n (%) Complete Response (irCR) 1 ( 20.0) 0 0 0 1 ( 4.3) Partial Response (irPR) 0 0 1 ( 16.7) 1 ( 12.5) 2 ( 8.7) Objective Response (irOR) 1 ( 20.0) 0 1 ( 16.7) 1 ( 12.5) 3 ( 13.0) Stable Disease (irSD) 4 ( 80.0) 1 ( 25.0) 3 ( 50.0) 2 ( 25.0) 10 ( 43.5) Disease control (irDC) 5 (100) 1 ( 25.0) 4 ( 66.7) 3 ( 37.5) 13 ( 56.5) Unconfirmed Progression (uirPD) 0 3 ( 75.0) 2 ( 33.3) 4 ( 50.0) 9 ( 39.1) Confirmed Progression (cirPD) 0 0 0 0 0 Not available 0 0 0 1 ( 12.5) 1 ( 4.3) Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors. n = Number of subjects categorized in the respective Response category. N = Number of subjects in Efficacy Population. Percentages are based on N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Cohort 21= BDB0010.30 mg / m2+ Pembro, Cohort 22= BDB0010.45 mg / m2+ Pembro, Cohort 23= BDB001 0.60 mg / m2+ Pembro, Cohort 24= BDB0010.75 mg / m2+ Pembro. Table 13. Summary of Best Overall Response based on irRECIST by Prior anti PD-L1 therapy and PD-L1(+) for Combination Therapy Phase – BDB001-101; Efficacy Population. Prior Anti-PD-L1 therapy No Prior Anti-PD-L1 therapy exposed exposed (N=10) (N=13) PD-L1+ PD-L1- Unknown PD-L1+ PD-L1- Unknown Total a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) (N=23) Complete Response0 / 2 0 / 2 0 / 6 0 / 2 1 / 3 ( 33.3) 0 / 8 1 ( 4.3)(irCR)Partial Response (irPR) 0 / 2 0 / 2 1 / 6 ( 16.7) 0 / 2 1 / 3 ( 33.3) 0 / 8 2 ( 8.7)Objective Response0 / 2 0 / 2 1 / 6 ( 16.7) 0 / 2 2 / 3 ( 66.7) 0 / 8 3 ( 13.0)(irOR)Stable Disease (irSD) 1 / 2 ( 50.0) 2 / 2 (100) 2 / 6 ( 33.3) 1 / 2 ( 50.0) 0 / 3 4 / 8 ( 50.0) 10 (43.5)Disease control (irDC) 1 / 2 ( 50.0) 2 / 2 (100) 3 / 6 ( 50.0) 1 / 2 ( 50.0) 2 / 3 ( 66.7) 4 / 8 ( 50.0) 13 (56.5) Unconfirmed1 / 2 ( 50.0) 0 / 2 3 / 6 ( 50.0) 1 / 2 ( 50.0) 1 / 3 ( 33.3) 3 / 8 ( 37.5) 9 ( 39.1)Progression (uirPD) Confirmed Progression 0 / 2 0 / 2 0 / 6 0 / 2 0 / 3 0 / 8 0 (cirPD)Attorney Ref: 092295.0162 EIK-1019-WO Prior Anti-PD-L1 therapy No Prior Anti-PD-L1 therapy exposed exposed (N=10) (N=13) PD-L1+ PD-L1- Unknown PD-L1+ PD-L1- Unknown Total a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) (N=23)Not available 0 / 2 0 / 2 0 / 6 0 / 2 0 / 3 1 / 8 ( 12.5) 1 ( 4.3)Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors; PD-1 = Programmed Death Protein 1; PD-L1 = Programmed Death-Ligand 1. a = Number of subjects achieving the response. n = Number of subjects categorized in the respective PD-L1 expression. N = Number of subjects in Efficacy Population. Percentage for Total column is calculated using N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Table 14. Summary of Best Overall Response based on irRECIST for 0.60 mg / m2dose level – BDB001-101; Efficacy Population. BDB001+Pembrolizumab Cohort 23 Cohort 31 & Cohort 32 Overall (N=6) (N=27) (N=33) Category n (%) n (%) n (%)Complete Response (irCR) 0 2 ( 7.4) 2 ( 6.1)Partial Response (irPR) 1 ( 16.7) 2 ( 7.4) 3 ( 9.1)Objective Response (irOR) 1 ( 16.7) 4 ( 14.8) 5 ( 15.2)Stable Disease (irSD) 3 ( 50.0) 7 ( 25.9) 10 ( 30.3) Disease control (irDC) 4 ( 66.7) 11 ( 40.7) 15 ( 45.5) Unconfirmed Progression 2 ( 33.3) 11 ( 40.7) 13 ( 39.4) (uirPD) Confirmed Progression 0 0 0 (cirPD) Not available 0 5 ( 18.5) 5 ( 15.2) Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors. n = Number of subjects categorized in the respective Response category. N = Number of subjects in Efficacy Population. Percentages are based on N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Cohort 23= BDB0010.60 mg / m2+ Pembro, Cohort 31= BDB0010.60 mg / m2+ Pembro, Cohort 32= BDB001 0.60 mg / m2+ Pembro.Attorney Ref: 092295.0162 EIK-1019-WO Table 15. Summary of Best Overall Response based on irRECIST by Prior anti PD-L1 therapy and PD-L1(+) for 0.60 mg / m2dose level – BDB001-101; Efficacy Population. Prior Anti-PD-L1 therapy No Prior Anti-PD-L1 therapy exposed exposed (N=9) (N=24) PD-L1+ PD-L1- Unknown PD-L1+ PD-L1- Unknown Total a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) (N=33) Complete Response0 / 1 0 / 2 0 / 6 1 / 5 ( 20.0) 1 / 9 ( 11.1) 0 / 10 2 ( 6.1)(irCR)Partial Response (irPR) 0 / 1 0 / 2 1 / 6 ( 16.7) 0 / 5 1 / 9 ( 11.1) 1 / 10 ( 10.0) 3 ( 9.1)Objective Response0 / 1 0 / 2 1 / 6 ( 16.7) 1 / 5 ( 20.0) 2 / 9 ( 22.2) 1 / 10 ( 10.0) 5 ( 15.2)(irOR)Stable Disease (irSD) 0 / 1 1 / 2 ( 50.0) 1 / 6 ( 16.7) 0 / 5 2 / 9 ( 22.2) 6 / 10 ( 60.0) 10 (30.3)Disease control (irDC) 0 / 1 1 / 2 ( 50.0) 2 / 6 ( 33.3) 1 / 5 ( 20.0) 4 / 9 ( 44.4) 7 / 10 ( 70.0) 15 (45.5) Unconfirmed1 / 1 (100) 0 / 2 4 / 6 ( 66.7) 3 / 5 ( 60.0) 3 / 9 ( 33.3) 2 / 10 ( 20.0) 13 (Progression (uirPD) 39.4) Confirmed Progression 0 / 1 0 / 2 0 / 6 0 / 5 0 / 9 0 / 10 0 (cirPD)Not available 0 / 1 1 / 2 ( 50.0) 0 / 6 1 / 5 ( 20.0) 2 / 9 ( 22.2) 1 / 10 ( 10.0) 5 ( 15.2)Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors; PD-1 = Programmed Death Protein 1; PD-L1 = Programmed Death-Ligand 1. a = Number of subjects achieving the response. n = Number of subjects categorized in the respective PD-L1 expression. N = Number of subjects in Efficacy Population. Percentage for Total column is calculated using N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Phase 1 Study BDB001-102. In the EIK1001 + atezolizumab combination dose- escalation phase: of 19 participants in the efficacy analysis population, there were no responders, but nine (47.4%) participants experienced DC (Table 16). At the 0.75 mg / m2dose level for the EIK1001 + atezolizumab combination expansion cohorts: of 24 participants in the efficacy analysis population, three (12.5%) experienced PR and 13 (54.2%) experienced DC. Among the total of 41 treated and 37 efficacy-evaluable participants, there were three confirmed PRs at the 0.75 mg / m2dose level. The DOR was a median of 13 months (range 10 – 27 months). Among the 16 participants with BOR as SD, two had a DOSD over one year and four had duration of SD of approximately 6 to 12 months. Efficacy by PD-L1 status isAttorney Ref: 092295.0162 EIK-1019-WO summarized in Table 17 and Table 18, and efficacy data are presented as a swimmer plot and spider plot in Figure 3 and Figure 4, respectively. Table 16. Summary of Best Overall Response based on irRECIST– BDB001-102; Efficacy Population. Combination Dose 0.75 mg / m2Combination Escalation Overall Dose Overall N = 19 N = 24 Category n (%) n (%) Complete Response (irCR) 0 0 Partial Response (irPR) 0 3 ( 12.5) Objective Response (irOR) 0 3 ( 12.5) Stable Disease (irSD) 9 ( 47.4) 10 ( 41.7) Disease control (irDC) 9 ( 47.4) 13 ( 54.2) Unconfirmed Progression (uirPD) 9 ( 47.4) 6 ( 25.0) Confirmed Progression (cirPD) 0 0 Not available 1 ( 5.3) 5 ( 20.8) Note: irRECIST = Immune-related Response Evaluation Criteria in Solid Tumors. n = Number of subjects categorized in the respective Response category. N = Number of subjects in Efficacy Population. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Cohort 4= BDB0010.75 mg / m2+ Atezolizumab, Cohort 5= BDB0010.75 mg / m2+ Atezolizumab, Cohort 6= BDB0010.75 mg / m2+ Atezolizumab. Table 17. Summary of Best Overall Response based on irRECIST by Prior anti PD-L1 therapy and PD-L1(+) for Dose Escalation Phase – BDB001-102; Efficacy Population. Prior Anti-PD-L1 therapy No Prior Anti-PD-L1 therapy exposed exposed (N=7) (N=12) PD-L1+ PD-L1- Unknown PD-L1+ PD-L1- Unknown Total a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) (N=19) Complete Response 0 / 1 0 / 0 0 / 6 0 / 3 0 / 2 0 / 7 0 (irCR)Partial Response (irPR) 0 / 1 0 / 0 0 / 6 0 / 3 0 / 2 0 / 7 0Objective Response 0 / 1 0 / 0 0 / 6 0 / 3 0 / 2 0 / 7 0 (irOR)Stable Disease (irSD) 1 / 1 (100) 0 / 0 3 / 6 ( 50.0) 1 / 3 ( 33.3) 0 / 2 4 / 7 ( 57.1) 9 ( 47.4)Disease control (irDC) 1 / 1 (100) 0 / 0 3 / 6 ( 50.0) 1 / 3 ( 33.3) 0 / 2 4 / 7 ( 57.1) 9 ( 47.4)Unconfirmed0 / 1 0 / 0 2 / 6 ( 33.3) 2 / 3 ( 66.7) 2 / 2 (100) 3 / 7 ( 42.9) 9 ( 47.4)Progression (uirPD)Attorney Ref: 092295.0162 EIK-1019-WO Prior Anti-PD-L1 therapy No Prior Anti-PD-L1 therapy exposed exposed (N=7) (N=12) PD-L1+ PD-L1- Unknown PD-L1+ PD-L1- Unknown Total a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) (N=19) Confirmed Progression 0 / 1 0 / 0 0 / 6 0 / 3 0 / 2 0 / 7 0 (cirPD)Not available 0 / 1 0 / 0 1 / 6 ( 16.7) 0 / 3 0 / 2 0 / 7 1 ( 5.3)Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors; PD-1 = Programmed Death Protein 1; PD-L1 = Programmed Death-Ligand 1. a = Number of subjects achieving the response. n = Number of subjects categorized in the respective PD-L1 expression. N = Number of subjects in Efficacy Population. Percentage for Total column is calculated using N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Table 18. Summary of Best Overall Response based on irRECIST by Prior anti PD-L1 therapy and PD-L1(+) for 0.75 mg / m2dose level – BDB001-102; Efficacy Population. Prior Anti-PD-L1 therapy No Prior Anti-PD-L1 therapy exposed exposed (N=18) (N=6) PD-L1+ PD-L1- Unknown PD-L1+ PD-L1- Unknown Total a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) a / n (%) (N=24) Complete Response 0 / 3 0 / 6 0 / 9 0 / 2 0 / 1 0 / 3 0 (irCR)Partial Response (irPR) 1 / 3 ( 33.3) 0 / 6 0 / 9 1 / 2 ( 50.0) 1 / 1 (100) 0 / 3 3 ( 12.5)Objective Response1 / 3 ( 33.3) 0 / 6 0 / 9 1 / 2 ( 50.0) 1 / 1 (100) 0 / 3 3 ( 12.5)(irOR)Stable Disease (irSD) 1 / 3 ( 33.3) 4 / 6 ( 66.7) 3 / 9 ( 33.3) 1 / 2 ( 50.0) 0 / 1 1 / 3 ( 33.3) 10 ( 41.7)Disease control (irDC) 2 / 3 ( 66.7) 4 / 6 ( 66.7) 3 / 9 ( 33.3) 2 / 2 (100) 1 / 1 (100) 1 / 3 ( 33.3) 13 ( 54.2)Unconfirmed0 / 3 2 / 6 ( 33.3) 2 / 9 ( 22.2) 0 / 2 0 / 1 2 / 3 ( 66.7) 6 ( 25.0)Progression (uirPD) Confirmed Progression 0 / 3 0 / 6 0 / 9 0 / 2 0 / 1 0 / 3 0 (cirPD)Not available 1 / 3 ( 33.3) 0 / 6 4 / 9 ( 44.4) 0 / 2 0 / 1 0 / 3 5 ( 20.8)Note: irRECIST = immune-related Response Evaluation Criteria in Solid Tumors; PD-1 = Programmed Death Protein 1; PD-L1 = Programmed Death-Ligand 1. a = Number of subjects achieving the response. n = Number of subjects categorized in the respective PD-L1 expression. N = Number of subjects in Efficacy Population.Attorney Ref: 092295.0162 EIK-1019-WO Percentage for Total column is calculated using N. Objective Response includes complete response and partial response; Disease control includes complete response, partial response and stable disease. Example 4: Clinical Pharmacokinetics PK characteristics. Single dose PK of EIK1001 was characterized in the monotherapy arm of study BDB001-101 (Table 19). Based on the overall clearance [20.1 L / hr or 0.28 L / hr / kg for a 70 kg subject, ~18% of hepatic blood flow in humans (1.5 L / hr / kg)] and volume of distribution [171 L or 2.44 L / hr / kg for a 70 kg subject, ~4X total body water in humans (0.60 L / kg)], EIK1001 appears to be a low clearance and moderately distributed drug. The median elimination T1 / 2 was variable ranging from 4 to 12 hours. Key PK parameters such Area Under the Curve (AUC), Maximum Serum Concentrations (Cmax), and Clearance (CL) were generally similar after the second IV dose on Day 8 (Table 15). Overall, EIK1001 is unlikely to accumulate upon QW IV dosing. Increasing doses of intravenous EIK1001 resulted in a linear increase in exposure (Table 19 and Table 20). Overall, the median clearance was also similar between doses, Cycle 1 / Day 1 and Cycle 1 / Day 8 indicating that PK of EIK1001 followed linear kinetics. Table 19. Model-Derived Pharmacokinetic Parameters for BDB001 Monotherapy on Cycle 1 Day 1. 0.3 mg / m20.45 mg / m20.60 mg / m20.75 mg / m21 mg / m2Overall Parameter (N=16) (N=18) (N=24) (N=35) (N=1) (N=94) AUClast (ng.h / mL) 55.7 60.60 Mean (CV%)72.4 (88.4%) 111 (85.4%) NA 82.1 (99.2%)(163.1%) (80.0%) Median [Min, 27.5 [12.3, 45.0 [16.9, 58.7 [25.0, 88.1 [32.0, 101 [101, 61.4 [12.3, Max] 386] 198] 341] 426] 101] 426] AUCinf (ng.h / mL) 55.9 73.1 72.8 (85.5 Mean (CV%)90.1%) 114 (91.6%) NA(163.8%) (127.5%) (107.8%) Median [Min, 27.5 [12.3, 45.1 [16.9, 58.7 [25.0, 88.1 [32.0, 101 [101, 61.4 [12.3, Max] 390] 420] 350] 514] 101] 514] Cmax (ng / mL) Mean (CV%) 5.22 (67.1%) 7.82 (35.4%) 9.59 (31.3%) 14.2 (28.0%) NA 10.2 (46.6%)Median [Min, 4.38 [3.04, 7.66 [3.31, 9.20 [5.32, 13.2 [8.36, 12.3 [12.3, 9.73 [3.04, Max] 17.9] 14.2] 16.7] 24.1] 12.3] 24.1] Tmax (h)Attorney Ref: 092295.0162 EIK-1019-WO 0.3 mg / m20.45 mg / m20.60 mg / m20.75 mg / m21 mg / m2Overall Parameter (N=16) (N=18) (N=24) (N=35) (N=1) (N=94) Mean (CV%) 0.58 (12.9%) 0.60 (12.8%) 0.62 (10.3%) 0.60 (13.4%) NA 0.60 (12.3%)Median [Min, 0.60 [0.50, 0.60 [0.50, 0.600 [0.50, 0.600 [0.50, 0.600 [0.60, 0.60 [0.50, Max] 0.70] 0.70] 0.70] 0.80] 0.60] 0.80] T1 / 2 (h) 25.0 12.9 (76.0%) 11.1 (94.0%)14.5 Mean (CV%) 12.6 (47.8%)NA(222.6%) (178.0%) Median [Min, 10.7 [5.26, 9.48 [5.83, 10.0 [4.73, 8.93 [4.40, 12.4 [12.4, 9.59 [4.40, Max] 25.4] 247] 47.0] 68.4] 12.4] 247] CL (L / h) Mean (CV%) 21.1 (55.9%) 21.7 (67.2%) 21.7 (53.0%) 17.8 (55.8%) NA 20.1 (57.3%)Median [Min, 20.8 [2.82, 18.4 [1.81, 18.9 [3.43, 16.0 [2.83, 20.8 [20.8, 18.4 [1.81, Max] 45.4] 55.6] 48.0] 43.7] 20.8] 55.6] Vss (L) Mean (CV%) 178 (23.1%) 198 (57.3%) 179 (44.6%) 145 (31.2%) NA 171 (43.2%)Median [Min, 186 [93.4, 156 [81.8, 161 [83.4, 141 [62.2, 239 [239, 156 [62.2, Max] 237] 546] 446] 269] 239] 546] Abbreviations: AUC = area under the curve; CL = clearance; Cmax = maximum plasma concentration; N = sample size; T1 / 2 = half-life; Tmax = time to Cmax; Vss = volume of distribution at steady state. Table 20. Model-derived Pharmacokinetic Parameters for BDB001 Monotherapy on Cycle 1 Day 8. 0.3 mg / m20.45 mg / m20.60 mg / m20.75 mg / m2Overall Parameter (N=13) (N=16) (N=24) (N=33) (N=86) AUClast (ng.h / mL) Mean (CV%) 23.4 (40.1%) 37.0 (42.6%) 50.9 (49.2%) 71.3 (41.4%) 52.0 (56.6%) Median [Min, 24.2 [11.6, 33.3 [11.4, 44.3 [22.4, 64.8 [28.7, 45.1 [11.4, 166] Max] 44.7] 68.6] 122] 166] AUCinf (ng.h / mL) Mean (CV%) 33.7 (63.7%) 44.7 (47.1%) 80.8 (109.9%) 95.8 (59.5%) 72.7 (88.1%) Median [Min, 30.5 [12.1, 39.9 [12.1, 55.3 [23.6, 81.1 [30.2, 57.0 [12.1, 422] Max] 88.1] 78.6] 422] 304] Cmax (ng / mL) Mean (CV%) 4.37 (21.8%) 7.85 (36.2%) 9.74 (31.9%) 14.0 (28.6%) 10.2 (46.0%)Attorney Ref: 092295.0162 EIK-1019-WO 0.3 mg / m20.45 mg / m20.60 mg / m20.75 mg / m2Overall Parameter (N=13) (N=16) (N=24) (N=33) (N=86) Median [Min, 4.24 [3.06, 7.66 [3.24, 9.42 [5.29, 13.1 [8.47, 9.82 [3.06, 24.2] Max] 5.97] 14.1] 16.9] 24.2] Tmax (h) Mean (CV%) 0.68 (30.3%) 0.62 (25.1%) 0.60 (17.9%) 0.68 (30.7%) 0.65 (27.2%) Median [Min, 0.60 [0.50, 0.60 [0.50, 0.60 [0.50, 0.60 [0.50, 0.60 [0.50, 1.30] Max] 1.10] 1.10] 1.00] 1.30] T1 / 2 (h) Mean (CV%) 6.28 (49.8%) 4.81 (24.3%) 6.51 (89.2%) 5.82 (34.1%) 5.89 (60.2%) Median [Min, 5.49 [3.21, 4.37 [3.19, 4.71 [2.98, 5.43 [3.34, 5.11 [2.98, 30.8] Max] 13.0] 7.67] 30.8] 11.3] CL (L / h) Mean (CV%) 21.7 (51.3%) 24.4 (71.0%) 22.0 (53.9%) 18.0 (49.7%) 20.9 (57.6%) Median [Min, 18.4 [7.15, 20.9 [9.07, 21.1 [2.84, 17.6 [4.81, 18.5 [2.84, 77.8] Max] 46.4] 77.8] 50.9] 44.6] Vss (L) Mean (CV%) 147 (21.8%) 138 (50.3%) 141 (35.4%) 120 (26.6%) 133 (34.9%) Median [Min, 151 [98.6, 210] 125 [53.6, 317] 136 [73.4, 253] 122 [61.9, 196] 126 [53.6, 317]Max] Abbreviations: AUC = area under the curve; CL = clearance; Cmax = maximum plasma concentration; N = sample size; T1 / 2 = half-life; Tmax = time to Cmax; Vss = volume of distribution at steady state. Pharmacokinetics of EIK1001 after intravenous administration is linear and generally dose-proportional between four dose levels (0.30, 0.45, 0.60 and 0.75 mg / m2). The T1 / 2 was variable and ranged from 4 to 12 hours. There was no drug accumulation upon QW IV dosing. Population PK analysis indicated that while body weight metrics (BW, BMI, BSA) can influence clearance, intrinsic factors such as age, gender, tumor type, ECOG status, hepatic impairment, renal impairment (mild / moderate) and combination drug (pembrolizumab and atezolizumab) do not have significant influence on the clearance. These drug attributes support the current BSA-based dosing, Inclusion / Exclusion criteria and combination drug strategy. The 0.60 mg / m2dose and 0.75 mg / m2dose are in the linear PK range of doses examined in Phase 1. Example 5: Exposure-PD assessmentAttorney Ref: 092295.0162 EIK-1019-WO The dataset for exposure-PD assessment consisted of combined BDB001-101 and BDB001-102 studies. For EIK1001 monotherapy, EIK1001 + pembrolizumab, and EIK1001 + atezolizumab, there was a rich assessment of PD biomarkers (IL-6, IL-8, IL-10, INF^, IP-10 and TNFα) on C1D1 and C1D8, and a sparse assessment at C3D1 and C6D1. This allowed determination of inter-occasion baseline levels, time to peak and duration of effect. Fold change from baseline (C1D1 pre-infusion) was calculated [(PD – baseline) / baseline] for C1D1, C1D8, C3D1 and C6D1. Only PD samples collected in the PK population were considered (PKPD population, N = 94). Since the PD data was variable, median fold change from baseline was used to describe the data. It was noted that the PD profiles were generally similar between C1D1 and C1D8. Also, since steroids were administered after C1D1, PKPD analysis was performed using C1D1 data to get an unbiased evaluation of the EIK1001 effect. The baseline levels of all biomarkers examined were similar before and after EIK1001 treatment, indicating that there was no carryover effect. While there was no change in IL-10 and TNFα, there was time-dependent increase in other biomarkers. The rank order for Tmax was IL-8 (3-5 hr) < IL-6 (5-8 hr) < IFN^ / IP-10 (7-8 hr). The earlier peak effect on IL-8 is consistent with a direct effect of TLR8 activation on neutrophils, whereas the delayed peak effect on IFN^ / IP-10 (Figure 5) is indicative of an indirect and downstream effect of TLR7 / 8 activation. The effect was also reversible after single dose of EIK1001 for all biomarkers (Figure 5). The overall effect of EIK1001 on key PD markers showing change was quantified by examining fold change from baseline at peak on C1D1 (Figure 6). The median fold changes in IL-6 (2.41 and 2.67) and IL-8 (1.72 and 1.59) were generally similar between the 0.60 mg / m2and 0.75 mg / m2doses. Single dose administration of EIK1001 was associated with a dose- dependent increase in IFN^ and IP-10 levels. The median fold changes from baseline at peak for IFN^ were 1.13, 1.37, 3.52 and 7.97 at 0.30, 0.45, 0.60 and 0.75 mg / m2doses, respectively. Similarly, the median fold changes from baseline at peak for IP-10 were 0.63, 0.71, 4.46 and 12.1 at 0.30, 0.45, 0.60 and 0.75 mg / m2doses, respectively. It was noted that subjects with PR / CR response tended to demonstrate at least a 2-fold increase in IFN^ and IP-10 levels. Overall, both the 0.60 mg / m2and 0.75 mg / m2doses of EIK1001 provide evidence of target engagement. Example 6: Exposure-efficacyAttorney Ref: 092295.0162 EIK-1019-WO Based on combined data from two clinical studies (Table 21), efficacy metrics [Clinical benefit or Best Overall Response defined as PR+CR+SD, or Maximal Change from Baseline for Target Lesion (≤ -10%)] were evaluated for their relationship to EIK1001 exposure and peak changes in key PD biomarkers. Table 21. Dataset for Exposure vs. Efficacy Logistic Regression Analysis. BDB001 + BDB001 + BDB001 Overall Efficacy metric Pembrolizumab Atezolizumab (N=35) (N=94) (N=28) (N=31) Best Overall Response PR / CR 2 (5.7%) 4 (14.3%) 2 (6.5%) 8 (8.5%) SD 12 (34.3%) 10 (35.7%) 14 (45.2%) 36 (38.3%) PD 16 (45.7%) 12 (42.9%) 9 (29.0%) 37 (39.4%) Missing* 5 (14.3%) 2 (7.1%) 6 (19.4%) 13 (13.8%) Maximal Change from Baseline for Target Lesion (%) <= -10% 4 (11.4%) 7 (25.0%) 5 (16.1%) 16 (17.0%) -9 to +19% 16 (45.7%) 10 (35.7%) 13 (41.9%) 39 (41.5%) >=+20 % 9 (25.7%) 9 (32.1%) 7 (22.6%) 25 (26.6%) Missing** 6 (17.1%) 2 (7.1%) 6 (19.4%) 14 (14.9%)Responders: PR = Partial Response, CR = Complete Response, SD = Stable Disease, OR Maximal Change fromBaseline for Target Lesion ≤ -10% Non-responders: PD = Progressive Disease, OR Maximal Change from Baseline for Target Lesion -9% to ≥ +20% Subjects with missing data for Best Overall Response* and Target Lesion** The Exposure-Efficacy and PD-Efficacy relationship was explored via logistics regression model by dividing exposure or PD by quartiles. If the relationship was statistically significant then further analysis was conducted to identify covariates for that specific efficacy parameter. Results of these analyses are summarized in Table 22. Table 22. Summary of Exposure vs. Efficacy Logistic Regression Analysis. Maximal Change Best Overall Response from Baseline for Independent Variable (PR / CR + SD vs PD) Target Lesion (≤- Covariates P<0.05? 10%) P<0.05?Attorney Ref: 092295.0162 EIK-1019-WO BDB001 Cmax,ss No Yes Not identifiable BDB001 AUCt,ss No Yes Not identifiable Fold change from baseline at peak for IL-6 No No NA Fold change from baseline at peak for IFNg No No NA Fold change from baseline at peak for IP-10 No No NA Among the various relationships examined, only EIK1001 exposure (AUC^,ss and Cmax,ss) showed a significant relationship with efficacy metric [Maximal Change from Baseline for Target Lesion (≤ 10%)]. A graphical display of logistic regression analysis for the Maximal Change from Baseline for Target Lesion (≤ 10%) versus AUC^,ss and Cmax,ss is shown in Figure 7. The figure shows distribution of probabilities of this efficacy metric across four quadrants of exposure. The probability of efficacy for 0.60 mg / m2Cmax,ss (dash-dotted bolded line: Median = 9.20 ng / mL; Figure 7) was lower than that for 0.75 mg / m2Cmax,ss (solid bolded line: Median = 13.2 ng / mL; Figure 7). Similar observation was made for AUC (Figure 8). The distribution profile of responders vs. non-responders showed that responders were maximal when Cmax,ss was between the 0.60 mg / m2and 0.75 mg / m2doses, whereas responders were maximally associated with AUC^,ss of 0.60 mg / m2. Overall, the data suggest that efficacy profiles of 0.60 mg / m2and 0.75 mg / m2may overlap. Example 7: Exposure-Safety Based on the mechanism of action of EIK1001 and observed AEs in two clinical studies, the following AEs were evaluated for their relationship to EIK1001 exposure: CRS, fatigue, chills, pyrexia, infusion-related reactions, and AE Grade ≥ 3. The exposure vs. AE relationship was explored via logistics regression model by dividing exposure by quartiles. If the relationship was statistically significant then further analysis was conducted to identify risk factor for that specific AE. Results of these analyses are summarized in Table 23. To get an overall assessment of safety, a composite AE group of pooled AEs (CRS, chills, pyrexia and infusion-related reactions) filtered for AE Grade ≥ 3 was attempted. However, this resulted in only one subject with a CRS event. Therefore, the final composite AE analysis was attempted for All AE Grades as shown in Table 23. Table 23. Summary of Exposure vs. Safety Logistic Regression Analysis.Attorney Ref: 092295.0162 EIK-1019-WO AE Frequency PK Parameter p<0.05?Covariate (Risk Factor) Presence (N=5) AUCt,ss No CRS NA Absence (N=89) Cmax,ss No Presence (N=38) AUCt,ss No Fatigue NA Absence (N=56) Cmax,ss No Presence (N=25) AUCt,ss No Chills ECOG 1&2 Absence (N=69) Cmax,ss Yes Presence (N=31) AUCt,ss Yes Race / White Pyrexia Absence (N=63) Cmax,ss Yes ECOG 1&2 Presence (N=6) AUCt,ss No Infusion-related reactions NA Absence (N=88) Cmax,ss No Presence (N=45) AUCt,ss Yes AE Grade ≥3 Nonidentifiable Absence (N=49) Cmax,ss Yes Presence (N=44) AUCt,ss No Composite AE* Nonidentifiable Absence (N=50) Cmax,ss Yes *Composite AE = All grades of CRS, Chills, Pyrexia and Infusion-related reactions Abbreviations: AUC = area under the curve; AE = adverse event; Cmax = maximum serum concentration; CRS = cytokine release syndrome; ECOG = Eastern Cooperative Oncology Group; N = sample size; NA = not applicable Among the various AEs examined, since chills, pyrexia and AE Grade ≥3 showed a significant relationship with drug exposure, Composite AE was selected to get an overall and inclusive assessment of AE profile. Composite AEs showed a significant relationship with Cmax,ss. A graphical display of logistic regression analysis for the Composite AE versus Cmax,ss is shown in Figure 9. The figure shows distribution of probabilities of Composite AEs across four quadrants of exposure. The probability of Composite AEs for 0.60 mg / m2Cmax,ss (dash-dotted bolded line: Median = 9.20 ng / mL; Figure 9) was lower than that for 0.75 mg / m2Cmax,ss (solid bolded line: Median = 13.2 ng / mL; Figure 9). Example 8: Risk-Benefit Analysis by Monte Carlo Simulation To select a dose for future clinical investigations with EIK1001, a holistic assessment of benefit and risk was performed using the available exposure-safety and exposure-efficacy relationships. Due to variability in PD data (IFN^ and IP-10), it was assumed that PK was the primary driver of response. Since there is no impact of DDI (pembrolizumab or atezolizumab) on the PK of EIK1001, the simulations are applicable for both monotherapy and combination. Based on the final population PK model of EIK1001, Monte Carlo simulations were performedAttorney Ref: 092295.0162 EIK-1019-WO in a total of 1000 virtual subjects (500 males and 500 females) for each of 3 dosing scenarios (0.45 mg / m2QW, 0.60 mg / m2QW and 0.75 mg / m2QW). A distribution of weight and height based on actual population was generated, assuming a correlation between the two parameters. Then the BSA was derived based on Mosteller formula to calculate the actual EIK1001 dose administered. The BSA of the virtual population was used to obtain dose of drug per simulated subject. Rich concentration-time profiles were simulated with a population PK model to derive exposure parameters such as area under the plasma concentration-time curve over a dosing interval (AUC^,ss) and maximum plasma concentration over a dosing interval (Cmax,ss) under steady state conditions. Exposure parameters were summarized with descriptive statistics according to dosing regimen. Model predicted AUC^,ss and Cmax,ss of EIK1001 in virtual patients were used as an input into the exposure-response models of safety (Table 23) and efficacy (Table 22) endpoints presenting statistically significant relationships. Predictions of maximum change from baseline of target lesion (≤ -10%), AE Grade ≥ 3 and Composite AE (All grades of CRS, Chills, Pyrexia and Infusion-related reactions) were derived based on the logistic regression models, including uncertainties on parameters. Estimated probabilities (95% CI) computed based on the median levels for simulated dose levels were generated. Odd Ratios (OR) of efficacy and safety metric for 0.45 mg / m2(Test group) and 0.75 mg / m2(Test group) compared to 0.60 mg / m2QW (Control group) were computed (Table 24). Overall results suggest that while 0.75 mg / m2dose was associated with a marginal 15% increase in the odds of efficacy over 0.60 mg / m2dose, the odds of increased safety events were 37%. Table 24. Summary of Monte Carlo Simulations. Efficacy metric Safety metric Maximal Change AE Grade ≥3 Composite AE* Median Median from Baseline for (AUCt,ss) (Cmax,ss) Target Lesion (≤- Doses AUCt,ss Cmax,ss 10%) (ng.h / mL) (ng / mL) OR OR OR Probability Probability Probability 95% 95% CI 95% CI 95% CI 95% CI 95% CI CI 0.872 0.845 0.730 0.45 15.7 41.3 38.5 mg / m250.5 7.57 [0.780, [0.734, [0.576, [8.97, 26.0] [31.0, 52.4] [27.7, 50.6] 0.975] 0.973] 0.926]Attorney Ref: 092295.0162 EIK-1019-WO 0.60 17.6 45.4 46.2 2 67.4 10.1 - - - mg / m [10.5, 27.9] [35.2, 56.0] [36.0, 56.7] 1.15 1.18 1.37 0.75 19.6 49.6 54.0 mg / m284.2 12.6 [1.03, [1.03, [1.08, [12.0, 30.4] [38.6, 60.6] [42.2, 65.5] 1.28] 1.36] 1.74] *Composite AE = All grades of CRS, Chills, Pyrexia and Infusion-related reactions OR = Odds Ratio Example 9: Phase 2 Study of EIK1001 (EIK1001-005) Immune checkpoint inhibitors (ICIs) boost antitumor immune responses by relieving immunosuppression of tumor-reactive T cells. Combining ICIs with chemotherapy (chemo) improves survival in advanced NSCLC, but not all patients benefit. EIK1001 activates dendritic cells via both innate and adaptive pathways, a mechanism distinct from ICIs, with clinical activity as monotherapy. This supports the rationale to add EIK1001 to the chemo + ICI standard of care (SOC) for Stage 4 NSCLC. The present example illustrates an ongoing multicenter, Phase 2, open-label study (EIK1001-005) of intravenous EIK1001 combined with SOC pembrolizumab (pembro) and chemo (carboplatin plus either pemetrexed or paclitaxel) in treatment-naïve participants (pts) with histologically confirmed Stage 4 nonsquamous (NSQ) or squamous (SQ) NSCLC (life expectancy ≥ 3 months, no prior therapy for advanced NSCLC, ECOG score 0 to 1, confirmation that first-line mutation-directed therapy is not indicated, and at least 1 RECIST 1.1 measurable lesion). Briefly, EIK1001 is administered weekly by IV infusion at a dose of 0.60 mg / m2until the end of Cycle 8 (each cycle being a 3-week time period), then every 3 weeks (Q3W) until the end of Cycle 35. Pembrolizumab is administered by IV infusion at a fixed dose of 200 mg Q3W. For nonsquamous NSCLC, after pembrolizumab administration, pemetrexed (500 mg / m2) is administered via IV Q3W. Participants receiving pemetrexed are supplemented with vitamin B12, folic acid, and corticosteroid prophylaxis. Once pemetrexed is completely administered, carboplatin (AUC 5 mg / mL / min) is administered IV Q3W for up to 4 cycles in the absence of disease progression or unacceptable toxicity. The dosage of carboplatin for nonsquamous NSCLC participants does not exceed 750 mg. For squamous NSCLC, after the pembrolizumab infusion is complete, paclitaxel (200 mg / m2) is administered Q3W for 4 cycles . Once paclitaxel is completely administered, carboplatin (AUC 6 mg / mL / min) is administeredAttorney Ref: 092295.0162 EIK-1019-WO Q3W for up to 4 cycles in the absence of disease progression or unacceptable toxicity. The dosage of carboplatin for squamous NSCLC participants should not exceed 900 mg. The presently disclosed study includes a safety run-in period (n = 6) and an expansion (n = 25) for each NSCLC subtype. As of May 1, 2025, 48 patients had been treated for a median follow up of 4 months: 34 pts with NSQ and 14 pts with SQ NSCLC. No dose-limiting toxicities were observed during safety run-in. Responders had a median reduction of 57% in target lesions within the first 3 months, with a PR / CR rate of 63%. Interim results are in Table 25. Table 25. Summary of Phase 2 results. Total Pts Treated (N) N = 48 Patient characteristics Months of follow up, median (range) 4 (1-16) Age, years, median (range) 68 (23-83) Sex Male (n / N) 35 / 48 Safety Results Treatment emergent adverse event (TEAE) (n / N) 42 / 48 At least 1 ≥ Grade 3 TEAE (n / N) 27 / 48aSerious adverse events (SAEs) (n / N) 13 / 48bEfficacy Results Efficacy Evaluable Patients (n) 35 NSQ (N=23) SQ (N=12) Partial Response (PR) / Complete Response (CR) % (n / N) 61% (14 / 23) 67% (8 / 12) Disease Control (DCR) %(n / N) 87% (20 / 23) 100% (12 / 12) a19 of which were related to treatment regimen,bconsistent with the underlying SOC regimens

[0001] First-line therapy using EIK1001 combined with chemotherapy + ICIs produced a substantial response rate (63%) in advanced NSCLC and did not increase adverse events (AEs) relative to that expected from SOC alone. The response rate has continued to improve with successive efficacy assessments. Thus far, the improvement with successive scans in a short time on treatment and suggests that the efficacy of the combination may be an underestimate at this point. * * * Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, the descriptions and examplesAttorney Ref: 092295.0162 EIK-1019-WO should not be construed as limiting the scope of the invention. The disclosures of all patent and scientific literature cited herein are expressly incorporated in their entirety by reference.

Claims

Attorney Ref: 092295.0162 EIK-1019-WO CLAIMS1. A method of treating cancer in a human subject, the method comprising administeringto the subject a) 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol(EIK1001) or a pharmaceutically acceptable salt thereof; and b) a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1)antagonist; wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2.

2. The method of claim 1, wherein the EIK1001 is administered intravenously at a weeklydose of 0.60 mg / m2.

3. The method of claim 1, wherein the EIK1001 is administered intravenously at a weeklydose of 0.75 mg / m2.

4. The method of any of claims 1-3, wherein the EIK1001 is administered as a weeklydose over 20 to 30 weeks.

5. The method of any of claims 1-4, wherein the EIK1001 is administered as a weeklydose over 27 weeks.

6. The method of claim 4 or 5, wherein the EIK1001 is thereafter administered once everythree weeks.

7. The method of claim 6, wherein the EIK1001 is administered as a weekly dose if thesubject experiences progressive disease after beginning administration once every three weeks.

8. The method of any of claims 1-4, wherein the EIK1001 is administered as a weeklydose over 24 weeks.

9. The method of claim 8, wherein the EIK1001 is thereafter administered once everythree weeks.

10. The method of claim 9, wherein the EIK1001 is administered as a weekly dose if thesubject experiences progressive disease after beginning administration once every three weeks.

11. The method of any of claims 1-10, wherein the PD-1 antagonist is selected from thegroup consisting of pembrolizumab, cemiplimab, dostarlimab, tislelizumab, nivolumab, retifanlimab, and toripalimab.Attorney Ref: 092295.0162 EIK-1019-WO12. The method of any of claims 1-10, wherein the PD-L1 antagonist is selected from thegroup consisting of atezolizumab, avelumab, durvalumab, sugemalimab, andcosibelimab.

13. The method of any of claims 1-11, wherein the PD-1 antagonist is pembrolizumab andis administered intravenously at a dose of 200 mg once every 3 weeks.

14. The method of any of claims 1-13, wherein the cancer is selected from the groupconsisting of lung cancer, melanoma, breast cancer, colorectal cancer, endometrial cancer, gastric cancer, glioblastoma, head and neck cancer, hepatocellular cancer, ovarian cancer, pancreatic cancer, prostate cancer, renal cell carcinoma, esophageal cancer, non-melanoma skin cancers, and gallbladder cancer.

15. The method of claim 14, wherein the cancer is melanoma.

16. The method of claim 14, wherein the cancer is squamous non-small cell lung cancer(NSCLC).

17. The method of claim 14, wherein the cancer is nonsquamous NSCLC.

18. The method of claim 16 or 17, further comprising administering to the subject achemotherapeutic agent.

19. The method of claim 18, wherein the chemotherapeutic agent is selected fromcarboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof.

20. The method of claim 18, wherein the cancer is squamous NSCLC and thechemotherapeutic is a) carboplatin and paclitaxel, or b) carboplatin and nab-paclitaxel.

21. The method of claim 18, wherein the cancer is nonsquamous NSCLC and thechemotherapeutic is a) carboplatin and pemetrexed, or b) cisplatin and pemetrexed.

22. The method of any of claims 1-21, wherein administration results in an increase in thelevel of a TLR7 or TLR8 activation biomarker.

23. The method of claim 22, wherein the biomarker is IL-6, IL-8, IFN^, or IP-10.

24. The method of claim 22 or 23, wherein the biomarker is increased at least 1.5-fold, 2-fold, 4-fold or more over baseline.

25. The method of claim 24, wherein the biomarker is increased at least 2-fold overbaseline.

26. The method of any of claims 1-25, wherein the administration results in an objectiveresponse as measured by RECIST 1.1.

27. The method of any of claims 1-26, wherein the administration results in a partialresponse, a complete response, or a stable disease.Attorney Ref: 092295.0162 EIK-1019-WO28. The method of any of claims 1-27, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with hematological toxicity.

29. The method of claim 28, further comprising administering EIK1001 at the prioradministered weekly dose when the Grade 3 event or the Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 7 days.

30. The method of claim 28, further comprising administering EIK1001 at a weekly dosebelow the previously administered dose when the Grade 3 event or Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2 and 0.45 mg / m2, and when the previously administered doseis 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

31. The method of claim 30, further comprising administering EIK1001 at a weekly dosebelow the previously administered dose when the Grade 3 event or the Grade 4 event associated with hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 7 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2.

32. The method of any of claims 1-27, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with non-hematological toxicity.

33. The method of claim 32, further comprising administering EIK1001 at the prioradministered weekly dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days.

34. The method of claim 32, further comprising administering EIK1001 at a weekly dosebelow the previously administered dose when the Grade 3 event associated with non- hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2 and 0.45 mg / m2, and when the previously administered doseis 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.Attorney Ref: 092295.0162 EIK-1019-WO35. The method of claim 32, further comprising administering EIK1001 at a weekly dosebelow the previously administered dose when the Grade 3 event associated with non- hematological toxicity resolves to a Grade 1 event or lower within 21 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

36. The method of claim 34, further comprising administering EIK1001 at a weekly dosebelow the previously administered dose when a Grade 3 event associated with non- hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2.

37. The method of claim 32, further comprising administering EIK1001 at a weekly dosebelow the previously administered dose when a Grade 4 event associated with non- hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

38. The method of any of claims 1-27, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction.

39. The method of claim 38, further comprising administering EIK1001 at a reducedinfusion rate when the infusion reaction resolves.

40. The method of claim 38, further comprising administering EIK1001 at half infusionrate when the infusion reaction resolves within 24 hours.

41. The method of any of claims 1-27, further comprising withholding administration ofthe PD-1 or PD-L1 antagonist when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction.

42. The method of claim 41, further comprising administering the PD-1 or PD-L1antagonist at a reduced infusion rate when the Grade 2 infusion reaction resolves within 1 hour.Attorney Ref: 092295.0162 EIK-1019-WO43. The method of claim 41, further comprising administering the PD-1 or PD-L1antagonist at half infusion rate when the Grade 2 infusion reaction resolves within 1 hour.

44. The method of any of claims 1-27, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with cytokine release syndrome.

45. The method of claim 44, further comprising administering EIK1001 when the eventassociated with cytokine release syndrome resolves.

46. The method of any of claims 1-27, further comprising withholding administration ofEIK1001 when the subject experiences a recurrent Grade 2 event associated with cytokine release syndrome.

47. The method of any of claims 1-27, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 2 immune-related adverse reaction (iAE), a Grade 3 iAE, or a Grade 4 iAE.

48. The method of claim 47, further comprising administering EIK1001 when the eventassociated with immune-related adverse reaction resolves.

49. The method of any of claims 1-27, further comprising withholding administration ofEIK1001 when the subject experiences a persistent Grade 2 immune-related adverse reaction.

50. A method of inducing an immune response in a human subject, the method comprisingadministering to the subject 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5- c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof; and wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2.

51. The method of claim 50 further comprising administering to the subject a programmedcell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) antagonist.

52. The method of claim 51, wherein the PD-1 antagonist is selected from the groupconsisting of pembrolizumab, cemiplimab, dostarlimab, tislelizumab, nivolumab, retifanlimab, and toripalimab.

53. The method of claim 51, wherein the PD-L1 antagonist is selected from the groupconsisting of atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab.

54. The method of any of claims 51-53, wherein the PD-1 antagonist is pembrolizumaband is administered intravenously at a dose of 200 mg once every 3 weeks.Attorney Ref: 092295.0162 EIK-1019-WO55. The method of any of claims 50-54, further comprising administering to the subject achemotherapeutic agent.

56. The method of claim 55, wherein the chemotherapeutic agent is selected fromcarboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof.

57. The method of claim 55, wherein the chemotherapeutic is a) carboplatin and paclitaxel,or b) carboplatin and nab-paclitaxel.

58. The method of claim 55, wherein the chemotherapeutic is a) carboplatin andpemetrexed, or b) cisplatin and pemetrexed.

59. The method of claim 50-58, wherein the EIK1001 is administered as a weekly doseover 20 to 30 weeks.

60. The method of claim 59, wherein the EIK1001 is administered as a weekly dose over27 weeks.

61. The method of claim 60, wherein the EIK1001 is thereafter administered once everythree weeks.

62. The method of claim 61, wherein the EIK1001 is administered as a weekly dose if thesubject experiences progressive disease after beginning administration once every three weeks.

63. The method of claim 59, wherein the EIK1001 is administered as a weekly dose over24 weeks.

64. The method of claim 63, wherein the EIK1001 is thereafter administered once everythree weeks.

65. The method of claim 64, wherein the EIK1001 is administered as a weekly dose if thesubject experiences progressive disease after beginning administration once every three weeks.

66. The method of any of claims 50-65, wherein the inducing the immune response isindicated by an increase in a biomarker associated with TLR7 and or TLR8 activation.

67. The method of claim 66, wherein the biomarker is IL-6, IL-8, IFN^, or IP-10.

68. The method of claim 66 or 67, wherein the biomarker is increased at least 1.5-fold, 2-fold, 4-fold or more over baseline.

69. The method of claim 68, wherein the biomarker is increased at least 2-fold overbaseline.Attorney Ref: 092295.0162 EIK-1019-WO70. The method of any of claims 50-69, further comprising withholding administration ofEIK1001 if the subject experiences a Grade 3 event or a Grade 4 event associated with hematological toxicity.

71. The method of claim 70, further comprising administering the EIK1001 at the prioradministered weekly dose when the Grade 3 event or the Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 7 days.

72. The method of claim 70, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when the Grade 3 event or Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2 and 0.45 mg / m2, and when the previously administered doseis 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

73. The method of claim 72, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when a Grade 3 event or a Grande 4 event associated with hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 7 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2.

74. The method of any of claims 50-69, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with non-hematological toxicity.

75. The method of claim 74, further comprising administering the EIK1001 at the prioradministered weekly dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days.

76. The method of claim 74, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2 and 0.45 mg / m2, and when the previously administered doseis 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.Attorney Ref: 092295.0162 EIK-1019-WO77. The method of claim 74, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 21 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

78. The method of claim 76, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity recurs a second time and resolves within to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2.

79. The method of claim 74, further comprising administering EIK1001 at a weekly dosebelow the previously administered dose when a Grade 4 event associated with non- hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

80. The method of any of claims 50-69, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction.

81. The method of claim 80, further comprising administering the EIK1001 at a reduceinfusion rate when the infusion reaction resolves.

82. The method of claim 80, further comprising administering the EIK1001 at half infusionrate when the infusion reaction resolves within 24 hours.

83. The method of any of claims 50-69, further comprising withholding administration ofthe PD-1 or PD-L1 antagonist when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction.

84. The method of claim 83, further comprising administering the PD-1 or PD-L1antagonist at a reduced infusion rate when the Grade 2 infusion reaction resolves within 1 hour.Attorney Ref: 092295.0162 EIK-1019-WO85. The method of claim 83, further comprising administering the PD-1 or PD-L1antagonist at half infusion rate when the Grade 2 infusion reaction resolves within 1 hour.

86. The method of any of claims 50-69, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with cytokine release syndrome.

87. The method of claim 86, further comprising administering the EIK1001 when the eventassociated with cytokine release syndrome resolves.

88. The method of any of claims 50-69, further comprising withholding administration ofEIK1001 when the subject experiences a recurrent Grade 2 event associated with cytokine release syndrome.

89. The method of any of claims 50-69, further comprising withholding administration ofEIK1001 when the subject experiences a Grade 2 immune-related adverse reaction (iAE), a Grade 3 iAE, or a Grade 4 iAE.

90. The method of claim 89, further comprising administering the EIK1001 when the eventassociated with immune-related adverse reaction resolves.

91. The method of any of claims 50-69, further comprising withholding administration ofEIK1001 when the subject experiences a persistent Grade 2 immune-related adverse reaction.

92. A method of inducing an increase in expression of a biomarker associated with TLR7and or TLR8 activation in a human subject, the method comprising administering to the subject 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1- ethanol (EIK1001) or a pharmaceutically acceptable salt thereof; and wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2or 0.75 mg / m2.

93. The method of claim 92, further comprising administering to the subject a programmedcell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) antagonist.

94. The method of claim 93, wherein the PD-1 antagonist is selected from the groupconsisting of pembrolizumab, cemiplimab, dostarlimab, tislelizumab, nivolumab, retifanlimab, and toripalimab.

95. The method of claim 93, wherein the PD-L1 antagonist is selected from the groupconsisting of atezolizumab, avelumab, durvalumab, sugemalimab, and cosibelimab.Attorney Ref: 092295.0162 EIK-1019-WO96. The method of any of claims 93-95, wherein the PD-1 antagonist is pembrolizumaband is administered intravenously at a dose of 200 mg once every 3 weeks97. The method of any of claims 92-96, further comprising administering to the subject achemotherapeutic agent.

98. The method of claim 97, wherein the chemotherapeutic agent is selected fromcarboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or a combination thereof.

99. The method of claim 97, wherein the chemotherapeutic is a) carboplatin and paclitaxel,or b) carboplatin and nab-paclitaxel.

100. The method of claim 97, wherein the chemotherapeutic is a) carboplatin andpemetrexed, or b) cisplatin and pemetrexed.

101. The method of any one of claims 92-100, wherein the EIK1001 is administered as aweekly dose over 20 to 30 weeks.

102. The method of claim 101, wherein the EIK1001 is administered as a weekly doseover 27 weeks.

103. The method of claim 102, wherein the EIK1001 is thereafter administered once everythree weeks.

104. The method of claim 103, wherein the EIK1001 is administered as a weekly dose ifthe subject experiences progressive disease after beginning administration once every three weeks.

105. The method of claim 101, wherein the EIK1001 is administered as a weekly doseover 24 weeks.

106. The method of claim 105, wherein the EIK1001 is thereafter administered once everythree weeks.

107. The method of claim 107, wherein the EIK1001 is administered as a weekly dose ifthe subject experiences progressive disease after beginning administration once every three weeks.

108. The method of any of claims 92-107, wherein the biomarker is IL-6, IL-8, IFN^, orIP-10.

109. The method of any of claims 92-108, wherein the biomarker is increased at least 1.5-fold, 2-fold, 4-fold or more over baseline.

110. The method of claim 109, wherein the biomarker is increased at least 2-fold overbaseline.Attorney Ref: 092295.0162 EIK-1019-WO111. The method of any of claims 92-110, further comprising withholding administrationof EIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with hematological toxicity.

112. The method of claim 111, further comprising administering the EIK1001 at the prioradministered weekly dose when the Grade 3 event or the Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 7 days.

113. The method of claim 111, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when the Grade 3 event or Grade 4 event associated with hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2 and 0.45 mg / m2, and when the previously administered doseis 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

114. The method of claim 113, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when a Grade 3 event or a Grande 4 event associated with hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 7 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2.

115. The method of any of claims 92-110, further comprising withholding administrationof EIK1001 when the subject experiences a Grade 3 event or a Grade 4 event associated with non-hematological toxicity.

116. The method of claim 115, further comprising administering EIK1001 at the prioradministered weekly dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days117. The method of claim 115, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.75 mg / m2the dose below is selected from 0.60 mg / m2 and 0.45 mg / m2, and when the previously administered doseis 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.Attorney Ref: 092295.0162 EIK-1019-WO118. The method of claim 115, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when the Grade 3 event associated with non-hematological toxicity resolves to a Grade 1 event or lower within 21 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

119. The method of claim 117, further comprising administering the EIK1001 at a weeklydose below the previously administered dose when a Grade 3 event associated with non-hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2, and when the previously administered dose is 0.45 mg / m2the dose below is 0.30 mg / m2.

120. The method of claim 115, further comprising administering EIK1001 at a weekly dosebelow the previously administered dose when a Grade 4 event associated with non- hematological toxicity recurs a second time and resolves to a Grade 1 event or lower within 14 days, wherein when the previously administered dose is 0.60 mg / m2the dose below is selected from 0.45 mg / m2and 0.30 mg / m2.

121. The method of any of claims 92-110, further comprising withholding administrationof EIK1001 when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction.

122. The method of claim 121, further comprising administering the EIK1001 at a reducedinfusion rate when the infusion reaction resolves.

123. The method of claim 121, further comprising administering the EIK1001 at halfinfusion rate when the infusion reaction resolves within 24 hours.

124. The method of any of claims 92-110, further comprising withholding administrationof the PD-1 or PD-L1 antagonist when the subject experiences a Grade 2 infusion reaction, a Grade 3 infusion reaction, or a Grade 4 infusion reaction.

125. The method of claim 124, further comprising administering the PD-1 or PD-L1antagonist at a reduced infusion rate when the Grade 2 infusion reaction resolves within 1 hour.Attorney Ref: 092295.0162 EIK-1019-WO126. The method of claim 124, further comprising administering the PD-1 or PD-L1antagonist at half infusion rate when the Grade 2 infusion reaction resolves within 1 hour.

127. The method of any of claims 92-110, further comprising withholding administrationof EIK1001 when the subject experiences a Grade 2 event, a Grade 3 event, or a Grade 4 event associated with cytokine release syndrome.

128. The method of claim 127, further comprising administering the EIK1001 when theevent associated with cytokine release syndrome resolves.

129. The method of any of claims 92-110, further comprising withholding administrationof EIK1001 when the subject experiences a recurrent Grade 2 event associated with cytokine release syndrome.

130. The method of any of claims 92-110, further comprising withholding administrationof EIK1001 when the subject experiences a Grade 2 immune-related adverse reaction (iAE), a Grade 3 iAE, or a Grade 4 iAE.

131. The method of claim 130, further comprising administering the EIK1001 when theevent associated with immune-related adverse reaction resolves.

132. The method of any of claims 92-110, further comprising withholding administrationof EIK1001 when the subject experiences a persistent Grade 2 immune-related adverse reaction.

133. A pharmaceutical composition comprising 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol (EIK1001) or a pharmaceutically acceptable salt thereof for use in the treatment of cancer, wherein the pharmaceutical composition is formulated for administration to a human subject in a dosage of 0.60 mg / m2or 0.75 mg / m2to be administered intravenously once a week.

134. The pharmaceutical composition for use of claim 133, wherein the compositionfurther comprises a programmed cell death protein 1 (PD-1) or programmed death- ligand 1 (PD-L1) antagonist and optionally a chemotherapeutic agent.

135. The pharmaceutical composition for use of claim 133 or 134, wherein the EIK1001is administered as a weekly dose over 20 to 30 weeks.

136. The pharmaceutical composition for use of any of claims 133-135, wherein theEIK1001 is administered as a weekly dose over 27 weeks.

137. The pharmaceutical composition for use of claim 136, wherein the EIK1001 isthereafter administered once every three weeks.Attorney Ref: 092295.0162 EIK-1019-WO138. The pharmaceutical composition for use of claim 137, wherein the EIK1001 isadministered as a weekly dose if the subject experiences progressive disease after beginning administration once every three weeks.

139. The pharmaceutical composition for use of of any of claims 133-135, wherein theEIK1001 is administered as a weekly dose over 24 weeks.

140. The pharmaceutical composition for use of claim 139, wherein the EIK1001 isthereafter administered once every three weeks.

141. The pharmaceutical composition for use of claim 140, wherein the EIK1001 isadministered as a weekly dose if the subject experiences progressive disease after beginning administration once every three weeks142. The pharmaceutical composition for use of any of claims 134-141, wherein the PD-1antagonist is pembrolizumab, cemiplimab, dostarlimab, tislelizumab, nivolumab, retifanlimab, or toripalimab.

143. The pharmaceutical composition for use of any of claims 134-141, wherein the PD-L1 antagonist is atezolizumab, avelumab, durvalumab, sugemalimab, or cosibelimab.

144. The pharmaceutical composition for use of any of claims 134-142, wherein the PD-1 antagonist is pembrolizumab to be administered intravenously at a dose of 200 mg once every 3 weeks.

145. The pharmaceutical composition for use of any of claims 134-144, wherein thechemotherapeutic agent is selected from carboplatin, cisplatin, paclitaxel, nab- paclitaxel, pemetrexed, or a combination thereof.

146. A method of treating melanoma in a human subject, the method comprisingadministering to the subject a) 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol(EIK1001) or a pharmaceutically acceptable salt thereof; and b) pembrolizumab;wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2over 27 weeks and is thereafter administered once every three weeks at a dose of 0.60 mg / m2; and wherein the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks.

147. A method of treating melanoma in a human subject, the method comprisingadministering to the subjectAttorney Ref: 092295.0162 EIK-1019-WO a) 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol(EIK1001) or a pharmaceutically acceptable salt thereof; and b) pembrolizumab;wherein the EIK1001 is administered intravenously at a weekly dose of 0.75 mg / m2over 27 weeks and is thereafter administered once every three weeks at a dose of 0.75 mg / m2; and wherein the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks.

148. A method of treating nonsquamous NSCLC in a human subject, the methodcomprising administering to the subject a) 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol(EIK1001) or a pharmaceutically acceptable salt thereof; and b) pembrolizumab;wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2over 24 weeks and is thereafter administered once every three weeks at a dose of 0.60 mg / m2; and wherein the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks.

149. The method of claim 148, further comprising administering to the subject a)carboplatin and pemetrexed, or b) cisplatin and pemetrexed.

150. A method of treating squamous NSCLC in a human subject, the method comprisingadministering to the subject a) 4-amino-2-(ethoxymethyl)-a,a-di-methyl-1H-imidazo[4,5-c]quinoline-1-ethanol(EIK1001) or a pharmaceutically acceptable salt thereof; and b) pembrolizumab;wherein the EIK1001 is administered intravenously at a weekly dose of 0.60 mg / m2over 24 weeks and is thereafter administered once every three weeks at a dose of 0.60 mg / m2; and wherein the pembrolizumab is administered intravenously at a dose of 200 mg once every 3 weeks.

151. The method of claim 150, further comprising administering to the subject a)carboplatin and paclitaxel, or b) carboplatin and nab-paclitaxel.

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