mupadolimab (CPI-006) / Corvus Pharma, Angel Pharma - LARVOL DELTA

Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "Corvus is collaborating with the Kidney Cancer Research Consortium in a Phase 1b/2 clinical trial...The clinical trial is expected to enroll up to 60 patients and as of May 31, 2024 a total of 32 patients were enrolled in the trial....As of May 31, 2024, the interim analysis of the clinical trial has met the threshold for efficacy and therefore enrollment continues....Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in an expansion cohort of a Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC)....Research and development expenses for the three months ended June 30, 2024 totaled $4.1 million compared to $4.0 million for the same period in 2023. The increase of $0.1 million was primarily due to higher clinical trial costs associated with the development of soquelitinib."

Commercial • Enrollment status • Trial status • Genito-urinary Cancer • Hematological Malignancies • Kidney Cancer • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Peripheral T-cell Lymphoma • Renal Cell Carcinoma • Solid Tumor • T Cell Non-Hodgkin Lymphoma

CBO421: A novel drug Fc-conjugate to prevent tumor immune evasion via the CD73/adenosine pathway (AACR 2024) - "In vivo efficacy of CBO421 monotherapy was evaluated in a syngeneic mouse model.Results CBO421 exhibited a binding affinity to human CD73 (KD = 0.8 nM) that was comparable to or greater to the affinity observed with small molecule inhibitors (AB680, OP-5244) and CD73-targeting mAbs (oleclumab, mupadolimab biosimilars). CBO421 demonstrated high potency in functional cell-based assays and robust antitumor efficacy in a syngeneic mouse model. Currently, CBO421 is being advanced as a clinical development candidate for the treatment of solid cancers."

Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD4 • CD73 • CD8 • NT5E

CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=117 | Completed | Sponsor: Corvus Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed | N=378 ➔ 117 | Trial completion date: Dec 2025 ➔ Feb 2023 | Trial primary completion date: Dec 2023 ➔ Dec 2022

Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatology • Lung Cancer • Lymphoma • Metastatic Castration-Resistant Prostate Cancer • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • MSI

Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2023 Financial Results (GlobeNewswire) - "Corvus Pharmaceuticals, Inc...today provided a business update and reported financial results for the third quarter ended September 30, 2023...The Kidney Cancer Research Consortium is enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1)...The clinical trial is expected to enroll up to 60 patients and initial data is anticipated in early 2024....Research and development expenses for the three months ended September 30, 2023 totaled $4.0 million compared to $10.4 million for the same period in 2022. The decrease of $6.4 million was primarily due to lower clinical trial and manufacturing costs associated with the development of mupadolimab."

Commercial • Enrollment status • P1/2 data • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2023 Financial Results (Corvus Pharmaceuticals Press Release) - "The Kidney Cancer Research Consortium (KCRC) is enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The Phase 1b portion of this trial has been completed and patients are now being enrolled in the Phase 2 portion. The clinical trial is expected to enroll up to 60 patients and initial data is anticipated before the end of 2023....Research and development expenses for the three months ended June 30, 2023 totaled $4.0 million compared to $4.9 million for the same period in 2022. The decrease of $0.9 million was primarily due to lower clinical trial and manufacturing costs associated with the development of mupadolimab."

Commercial • P1/2 data • Trial status • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Thoracic Cancer

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "The Kidney Cancer Research Consortium (KCRC) is enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The clinical trial is expected to enroll up to 60 patients and initial data is anticipated before the end of 2023. Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in a Phase 1/1b clinical trial of mupadolimab in patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers."

P1/2 data • Trial status • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer

Activating CD73 on B cells as a target for immunotherapy of COVID-19 and viral associated cancers: Clinical activity in human papilloma virus positive (HPV) head and neck squamous cell cancers (HNSCC) (SITC 2021) - P1 | "Background Mupadolimab (mupa) is a humanized FcγR binding-deficient IgG1 anti-CD73 antibody that has agonistic properties.1 CD73 is involved in production of adenosine and in cellular trafficking...Cross blocking and cellular internalization studies showed that mupa is distinct from other anti-CD73 antibodies such as MEDI9447 and AD2...This activity supports a strategy to combine mupa with pembrolizumab to enhance both humoral and cellular immunity in the treatment of viral associated cancers such as HPV+HNSCC, and viral infections. Trial Registration NCT03454451"

Clinical • IO biomarker • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD69 • CD73 • NT5E • SDC1

[VIRTUAL] Immunotherapy with B cell activating antibody CPI-006 in patients (pts) with mild to moderate COVID-19 stimulates anti-SARS-CoV-2 antibody response, memory B cells and memory T effector cells (SITC 2020) - P1 | "Low baseline titers of antibodies to virus were increased following CPI-006 in all treated pts. Immunomodulation with CPI-006 represents a novel therapy for COVID-19 aimed at stimulating more robust and prolonged anti-SARS-CoV-2 immunity potentially after infection or with vaccination."

Clinical • IO Biomarker • Oncology • CD8

[VIRTUAL] Immunotherapy with B cell activating antibody CPI-006 in patients (pts) with mild to moderate COVID-19 stimulates anti-SARS-CoV-2 antibody response, memory B cells and memory T effector cells (SITC 2020) - P1 | "Low baseline titers of antibodies to virus were increased following CPI-006 in all treated pts. Immunomodulation with CPI-006 represents a novel therapy for COVID-19 aimed at stimulating more robust and prolonged anti-SARS-CoV-2 immunity potentially after infection or with vaccination."

Clinical • IO Biomarker • Oncology • CD8

Heji Pharmaceutical announced the completion of the dosing of the first patient in the Phase I/Ib clinical trial of anti-CD73 monoclonal antibody in China [Google Translation] (Stockstar) - "Heji Pharmaceutical...announced that the anti-CD73 humanized monoclonal antibody Mupadolimab monotherapy and pembrolizumab combination for the treatment of advanced solid tumors Led by Professor Guo Ye from the Oncology Department of Dongfang Hospital Affiliated to Tongji University, the Phase I/Ib clinical trial successfully completed the first Chinese patient's drug administration."

Trial status • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Kidney Cancer • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Anti-CD73 antibody activates human B cells, enhances humoral responses and induces redistribution of B cells in patients with cancer. (PubMed, J Immunother Cancer) - P1 | "Mupadolimab activates B cells and stimulates the production of antigen specific antibodies. The effects in patients with cancer suggest that activated, CD69 B cells redistribute to lymphoid tissues. Minor tumor regression was observed in several patients. These results support further investigation of mupadolimab as an immunotherapy for cancer and its potential use as a vaccine adjuvant."

IO biomarker • Journal • Immune Modulation • Immunology • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Oncology • Respiratory Diseases • CD27 • CD69 • CD86 • NT5E • SDC1

Corvus Pharmaceuticals Announces Partner Angel Pharmaceuticals Received IND Approval for Phase 1/1b Clinical Trial of Mupadolimab (Anti-CD73) in China (GlobeNewswire) - "Corvus Pharmaceuticals...announced that the IND application to initiate a Phase 1/1b clinical trial of mupadolimab (formerly CPI-006) has been approved by the Center for Drug Evaluation of the China National Medical Products Administration. The study will be conducted by Angel Pharmaceuticals Ltd. (Angel Pharma), Corvus’ partner in China. Mupadolimab is a humanized monoclonal antibody designed to be directed against CD73 with a proposed unique mechanism of activating B cells to generate immune responses to tumor antigens and viruses, in patients with relapsed refractory non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers (HNSCC)."

New P1 trial • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=378 | Active, not recruiting | Sponsor: Corvus Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatology • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • MSI

Corvus Pharmaceuticals Provides Program Updates at R&D Symposium (GlobeNewswire) - "Specifically, mupadolimab, ciforadenant, and CPI-818 all interact with distinct and connected components of the tumor-immunity axis to enhance immunity to cancers: (i) Mupadolimab is designed to induce the activation of B cells involved in antibody production, and antigen presentation in the tumor, blood and in LN (ii) Ciforadenant is designed to block adenosine-induced immunosuppression in tumors and in LN (iii) CPI-818 is designed to induce the activation and expansion of T cell subsets involved in killing cancer cells in tumor, in LN and in blood through the skewing of T cell differentiation to a Th1 helper T cell phenotype. The formation of Th1 cells leads to production of T cells that are capable of killing cancer cells and viral infected cells"

Clinical protocol • Hematological Malignancies • Oncology

CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers (clinicaltrials.gov) - P1 | N=378 | Recruiting | Sponsor: Corvus Pharmaceuticals, Inc. | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Mar 2022 ➔ Dec 2023

Combination therapy • Trial completion date • Trial primary completion date • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Hepatology • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • MSI

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2021 Financial Results (GlobeNewswire) - "The Company plans to initiate a randomized Phase 2 clinical trial evaluating mupadolimab as a front-line therapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC)....The Company continues to enroll its two Phase 1b/2 clinical trial expansion cohorts of patients with (1) head and neck cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy and (2) relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up to 15 patients will be enrolled in each expansion cohort and initial results are anticipated to be presented in the second half of 2022."

New P2 trial • P1/2 data • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AK119, A CD73 Targeting Antibody with Dual Mechanism of Action (SITC 2021) - "The in-vivo activity of AK119 was further studied in bleomycin-induced pulmonary fibrosis model in human CD73 transgenic mouse...AK119 show significantly higher bioactivity to induce B cells activation in comparison with MEDI9447 or CPI006 (figure 4)...Results from non-clinical pharmacology studies reveal potent bioactivities as well as favorable safety properties of AK119. AK119 is intended for advanced solid tumors, pulmonary fibrosis and therapy of COVID-19."

Oncology • Solid Tumor • CD69 • CD73 • NT5E

Corvus Pharmaceuticals Presents Updated Data from Mupadolimab (Anti-CD73) Phase 1/1b Clinical Trial at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - P1, N=378; NCT03454451; Sponsor: Corvus Pharmaceuticals, Inc.; "The data presented at SITC showed that mupadolimab doses of 12mg/kg are optimal, resulting in complete occupancy of the CD73 target and maximal effects on B cell activation. In the assessment of anti- tumor activity in patients receiving optimal doses of mupadolimab, tumor regression (not meeting the threshold for partial response by RECIST) was seen in five patients who had progressive disease as best response to most recent therapy, which included anti-PD(L)1 therapy....In vitro studies showed that T cell functions are inhibited by adenosine monophosphate (AMP) and restored by the addition of mupadolimab....Corvus enrolling additional patients with these cancers in a Phase 1b/2 trial, with additional data anticipated in 2022."

P1 data • P1/2 data • Preclinical • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2021 Financial Results (GlobeNewswire) - "The Company is enrolling a Phase 1b/2 clinical trial in patients with HPV+ oropharyngeal cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the clinical trial is response rate and initial results are anticipated in 2022; In September 2021, the Company began enrolling patients in a Phase 1b/2 clinical trial in patients with relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the trial is response rate and results are anticipated to be reported in 2022."

P1/2 data • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Oropharyngeal Cancer

Corvus Pharmaceuticals to Present Updated Mupadolimab (Anti-CD73) Data at 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Corvus Pharmaceuticals...announced that it will present data from its Phase 1/1b trial of mupadolimab at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place on November 10-14, 2021. The updated data from the mupadolimab study will be presented in a poster at SITC."

P1 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

ADENOSINE AND AMP GENE EXPRESSION PROFILES PREDICT RESPONSE TO ADENOSINE PATHWAY THERAPIES AND INDICATE A NEED FOR DUAL BLOCKADE OF CD73 AND A2AR WITH CD73 INHIBITORS. (SITC 2019) - P1; "Renal cell cancer (RCC) tumor biopsies collected from patients treated with ciforadenant (100 mg BID) either as a single agent (n=18) or in combination with atezolizumab (n=14). A2AR agonists and AMP induce specific GEPs dominated by immunosuppressive mediators of MDSC and monocyte/macrophage biology. These GEPs may be used as biomarkers for patient selection. CD73 antagonists alone may be limited by the induction of compensatory immunosuppressive pathways mediated by AMP accumulation."

Gene Expression Profile • PD(L)-1 Biomarker • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • BIRC5 • CCL2 • CDK1 • CXCL1 • CXCR2 • IL1B • THBS1

Preclinical and initial phase I clinical characterization of CPI-006: an anti-CD73 monoclonal antibody with unique immunostimulatory activity (SITC 2018) - P1; "B cell activation was independent of adenosine and completely blocked by the BTK inhibitor ibrutinib (0.1µM). Expression of CD69 and reversible reduction of circulating B cells is consistent with B cell activation and redistribution to lymphoid tissues through inhibition of S1P1 receptors [2]. These effects may have immunotherapeutic potential for patients with Cancer."

IO biomarker • P1 data • Oncology

Corvus Pharmaceuticals Provides Updates on Mupadolimab (Anti-CD73) Programs in Oncology and Infectious Disease (GlobeNewswire) - “Mupadolimab also is currently being studied in a Phase 1b/2 clinical study in patients with HPV+ oropharyngeal cancers and non small cell lung cancers (NSCLC) that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Data from the Phase 1b/2 clinical study has been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) annual meeting in November.”

P1/2 data • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer

A phase 1/1b study to evaluate the humanized anti-CD73 antibody, CPI-006, as a single agent, in combination with CPI-444, and in combination with pembrolizumab in adult patients with advanced cancers (SITC 2019) - P1; "N/A"

Clinical • Combination therapy • IO biomarker • P1 data • PD(L)-1 Biomarker • Bladder Cancer • Breast Cancer • Cervical Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Thoracic Cancer • Triple Negative Breast Cancer • Urothelial Cancer

A Phase I/Ib multicenter study to evaluate the humanized anti-CD73 antibody, CPI-006, as a single agent, in combination with CPI-444, and in combination with pembrolizumab in adult patients with advanced cancers. (ASCO 2019) - P1; "Study Design. Clinical trial information: NCT03454451"

Clinical • Combination therapy • IO biomarker • P1 data • PD(L)-1 Biomarker • Bladder Cancer • Genito-urinary Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Sarcoma • Thoracic Cancer • Triple Negative Breast Cancer