Corvus Pharmaceuticals Announces IND Acceptance for Phase 1/1b Clinical Trial of CPI-818 in China
BURLINGAME, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced that an IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), for the initiation of a Phase 1/1b clinical trial of Corvus’ small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T cell lymphomas has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). Angel Pharma plans to initiate the trial before the end of 2021 and will be responsible for all expenses related to executing the trial in China.
“The pending initiation of a Phase 1/1b clinical trial of CPI-818 in China through our partner Angel Pharma is an important milestone for our pipeline and our global growth strategy,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “In China, there is a higher prevalence of T cell lymphomas, which have limited treatment options, leaving a significant opportunity to improve clinical outcomes. Based on its proposed mechanism, CPI-818 also has the potential to expand into the treatment of autoimmune diseases over time. CPI-818 is the first-and-only clinical stage ITK-inhibitor in China and we believe that Angel Pharma is well-positioned to accelerate its development for this market and globally.”
CPI-818 is an investigational, orally bioavailable, covalent inhibitor of ITK designed to have low nanomolar affinity. In vitro studies have shown that it potently inhibited T cell receptor signal transduction. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize CPI-818 in greater China.
Corvus is studying CPI-818 in a Phase 1/1b clinical trial that was designed to select the optimal dose of CPI-818 and evaluate its safety, pharmacokinetics (PK), target occupancy, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies. As of March 4, 2021, of seven patients with PTCL, there has been one complete response lasting over 15 months and one partial response lasting for over five months; both responses are ongoing. The interim data was presented at the 62ND American Society of Hematology (ASH) Annual Meeting & Exposition in December 2020.
Separately, Corvus announced that in July 2021 Angel Pharma launched new research centers in Jiaxing, Zhejiang Province, in China and in Burlingame, CA in the United States. The new research center in China occupies over 30,000 square feet of state-of-the-art research and development facilities including chemistry, molecular biology and pharmaceutical development laboratories. The new research center in the United States occupies more than 1,000 square feet dedicated to research and development. Since its launch in October 2020, Angel Pharma has built an experienced R&D team with expertise in clinical sciences, clinical operations, pharmacovigilance, CMC, regulatory, early discovery and pharmacology.
About Angel Pharmaceuticals
Angel Pharma is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharma was launched through a collaboration with U.S.-based Corvus Pharmaceuticals and investments from investors in China. Angel Pharma licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – mupadolimab, CPI-818 and ciforadenant – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus initially retained a 49.7% equity stake in Angel Pharma and designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is mupadolimab (CPI-006), a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical studies. The Company’s second clinical program, CPI-818, is 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. Its third clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor. For more information, visit www.corvuspharma.com.
CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. Corvus is conducting a Phase 1/1b trial in patients with refractory T-cell lymphomas in the United States and Angel Pharma, which has rights to CPI-818 in China, is leading a global Phase 1/1b trial in patients with relapsed/refractory (R/R) T-cell lymphomas.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of mupadolimab, CPI-818 and ciforadenant, the Company’s ability and Angel Pharma’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including Angel Pharma’s plans to initiate a clinical trial of CPI-818 before the end of 2021 and whether CPI-818 has the potential to expand into the treatment of autoimmune diseases over time. 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, 2021, filed with the Securities and Exchange Commission on or about August 2, 2021, 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 mupadolimab, CPI-818 and ciforadenant; 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 impact of the COVID-19 pandemic on the Company’s operations and clinical development plans, as well as the operations of its partners and suppliers; 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.
Chief Financial Officer
Corvus Pharmaceuticals, Inc.