BURLINGAME, CA, USA I October 25, 2022 I Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced the initiation of 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/2 study is being conducted by the Kidney Cancer Research Consortium (KCRC) and is led by The University of Texas MD Anderson Cancer Center, one of seven partner institutions that make up the KCRC. The study is expected to enroll up to 60 patients at KCRC partner institutions.

“Ciforadenant is one of the most studied adenosine receptor antagonists and we have presented encouraging clinical data in very advanced refractory patients with renal cell cancer, demonstrating its anti-tumor activity as a monotherapy and in combination with anti-PD-L1 therapy,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “In addition, we published preclinical data in Cancer Immunology Research in 2018 that showed that ciforadenant combined with anti-CTLA-4 and anti-PD-1 therapy is highly active, which resulted in complete elimination of tumors, even in the setting of treatment of established tumors. Further laboratory studies have uncovered a novel mechanism of action that we believe may synergize with anti-CTLA-4 therapy. Together we believe this provides strong rationale for this Phase 1b/2 clinical trial in first line renal cell cancer and we are excited to partner with the Kidney Cancer Research Consortium, who is leading the clinical trial. And given this is an open-label study, we hope to have preliminary results relatively early in the trial.”

About the Ciforadenant Phase 1b/2 Trial
The open-label Phase 1b/2 clinical trial is expected to enroll up to 60 patients with newly diagnosed or recurrent stage IV clear cell RCC that have not received any prior systemic therapy. Patients will receive ciforadenant 100 mg oral, twice-daily in combination with ipilimumab (anti-CTLA-4) 1mg/kg given once every three weeks for twelve weeks (4 doses) and nivolumab (anti-PD-1) 3mg/kg given once every three weeks. In the Phase 1b portion of the clinical trial (N=8), the primary endpoints are safety, tolerability and anti-tumor activity. In the Phase 2 portion of the clinical trial, the primary endpoint is the percent of patients that achieve a deep response, defined as complete response or depth of partial response of >50% tumor reduction. Historical data has shown that deep responses correlate with prolonged progression free survival and is seen in approximately 35% of patients receiving ipilimumab and nivolumab. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research, which demonstrated antitumor control and complete elimination of tumors in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.

About the Kidney Cancer Research Consortium
The KCRC is comprised of seven partner institutions at top academic research institutions across the country. The pooled expertise of KCRC members ensures the highest quality of clinical study design, accelerated execution of clinical trials, cost-effective access to multiple research centers, and accurate interpretation and reporting of results. The KCRC was founded in 2018 through the Department of Defense (DoD) Consortium Development Award and was subsequently awarded the DoD Clinical Consortium Award in 2020. For more information, visit www.kidneycancerconsortium.org.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is CPI-818, an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies and is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. The Company’s second clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. Its third clinical program, mupadolimab (CPI-006), is a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. For more information, visit www.corvuspharma.com.

About Ciforadenant
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine triphosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity.

SOURCE: Corvus Pharmaceuticals