On October 27, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1/1b clinical trial of Corvus’ small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T-cell lymphomas (TCL) in China (Press release, Corvus Pharmaceuticals, OCT 27, 2021, View Source [SID1234592123]).
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Corvus co-founded Angel Pharma to develop its pipeline in greater China and currently holds an equity stake of 49.7% in the company. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize CPI-818 in greater China and is responsible for all expenses related to its development in China.
"Our strategy to partner with Angel Pharma to accelerate global development of our products is advancing," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "There is a higher incidence and prevalence of T-cell lymphomas in China, and a significant need for new treatment options. The Angel Pharma team has been efficiently moving the development process forward and has partnered with top lymphoma clinical experts. CPI-818 is the only clinical stage ITK-inhibitor in China, and is positioned to become a potential novel therapy for T-cell lymphoma and more broadly for autoimmune diseases, which we plan to explore over time."
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. 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 reported in December 2020 at the American Society of Hematology (ASH) (Free ASH Whitepaper), of seven patients with peripheral T cell lymphoma, there has been one complete response lasting over 15 months and one partial response lasting for over five months.