Corvus Pharmaceuticals Announces Initiation of Phase 1b/2 Clinical Trial of Ciforadenant as Potential First Line Treatment for Patients with Renal Cell Cancer

Rhea-AI Summary

Corvus Pharmaceuticals (Nasdaq: CRVS) announced the launch of a Phase 1b/2 clinical trial for ciforadenant, aimed at treating metastatic renal cell cancer (RCC). The trial, conducted with the Kidney Cancer Research Consortium, will enroll up to 60 patients, evaluating ciforadenant combined with ipilimumab and nivolumab. The primary endpoints focus on safety and anti-tumor activity, with preliminary results expected early in the trial. The company highlights previous positive data on ciforadenant's efficacy, providing a strong rationale for this investigation.

Positive

• Initiation of a Phase 1b/2 clinical trial for ciforadenant in metastatic RCC.
• Expected enrollment of up to 60 patients indicates significant interest in the study.
• Strong historical data supporting the efficacy of ciforadenant in combination therapies.

Negative

• None.

BURLINGAME, Calif., Oct. 25, 2022 (GLOBE NEWSWIRE) -- 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.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-818, mupadolimab and ciforadenant; the Company’s ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1b/2 clinical trial with ciforadenant in collaboration with the KCRC; the timing of the availability and announcement of clinical data and certain other product development milestones, including the timing of initial results in the Phase 1b/2 clinical trial for ciforadenant; and the expected trial design and number of patients enrolled in the Company’s upcoming planned clinical trials such as the Phase 1b/2 clinical trial for ciforadenant. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the Securities and Exchange Commission on August 8, 2022, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of CPI-818, ciforadenant and mupadolimab; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the ability of third-parties to successfully conduct the Company’s clinical trials in a timely manner; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Aulani Capuchin
Real Chemistry
+1-559-355-2673
acapuchin@realchemistry.com

FAQ

What is the purpose of the Phase 1b/2 trial for ciforadenant?

The trial aims to evaluate the safety and anti-tumor activity of ciforadenant in combination with ipilimumab and nivolumab for treating metastatic renal cell cancer.

How many patients will be enrolled in the trial?

The trial is expected to enroll up to 60 patients with newly diagnosed or recurrent stage IV clear cell renal cell cancer.

What are the primary endpoints of the trial?

The primary endpoints include safety, tolerability, and the percentage of patients achieving a deep response, defined as a complete response or more than 50% tumor reduction.

What previous results support ciforadenant's use in this trial?

Previous studies have shown ciforadenant's anti-tumor activity in advanced refractory renal cell cancer patients and its effectiveness in combination with other therapies.

When can preliminary results from the trial be expected?

Preliminary results are anticipated relatively early in the trial due to its open-label design.