On August 16, 2021 Angel Pharmaceuticals Ltd. ("Angel Pharma") reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its IND application for the initiation of a Phase 1/1b clinical trial of its small molecule ITK inhibitor CPI-818 for treatment of relapsed/refractory T-cell lymphomas (Press release, Angel Pharmaceuticals, AUG 16, 2021, View Source [SID1234586655]). Angel Pharma plans to initiate the trial before the end of 2021.
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CPI-818, the first-and-only ITK inhibitor in clinical development in China, has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase) without effect on related kinases such as RLK (resting lymphocyte kinase) and BTK (Bruton’s tyrosine kinase). ITK is a 72 kDa protein kinase that plays an essential role in the activation, differentiation and proliferation of T-cells. There is evidence that ITK may play a role in the development and growth of T-cell lymphomas. Based on these properties, ITK is a promising treatment target for autoimmune diseases and for lymphoproliferative diseases such as T-cell lymphomas (TCL), which comprise an aggressive and heterogeneous subtype of non-Hodgkin lymphoma.
Angel Pharma licensed the rights to CPI-818 from Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS) for development, manufacturing and commercialization in China. Corvus is studying CPI-818 in a multi-center Phase 1/1b clinical trial in patients with several types of TCL in the U.S. and Asia. As of February 17, 2021, 25 patients (16 in dose escalation and 9 in expansion) have received CPI-818 treatment. Overall, CPI-818 has been shown to be well-tolerated, and has shown anti-tumor activity in peripheral T-cell lymphomas (PTCL) and in cutaneous T-cell lymphomas. As reported at the annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2020, 2 of 7 patients with refractory PTCL experienced responses to treatment with CPI-818; one complete response and one partial response.
"The NMPA’s acceptance of the IND for CPI-818 is an important step towards bringing this innovative product candidate to patients in China," said Richard A. Miller, M.D., co-founder and chairman of Angel Pharmaceuticals. There is a need for novel effective therapies for patients with T-cell lymphoma since current treatment options are limited and outcomes are often poor. Angel Pharma has a robust pipeline and the advancement of CPI-818 is only the first step in developing several potential first-in-class therapeutic opportunities. T-cell lymphomas are more common in China than in the U.S., highlighting the potential synergies of the collaboration between Angel Pharma and Corvus, which could accelerate development of our drugs for global markets."
Dr. Ted Wang, co-founder and general manager of Angel Pharmaceuticals, commented, "The aspiration of Angel Pharma is to gather world-class resources to bring innovative therapies to benefit Chinese people. With CPI-818, we will be able to potentially provide a safer, highly differentiated therapy for patients suffering from T-cell lymphoma and potentially other indications such as autoimmune diseases."
Separately, Angel Pharma announced the launch of its research centers in China and the U.S in July 2021. The new research center in China, based in Jiaxing, Zhejiang Province, occupies over 3,000 square meters of state-of-the-art research and development facilities including chemistry, molecular biology and pharmaceutical development laboratories. The U.S. research center, located in Burlingame, CA, occupies more than 1,000 square meters dedicated to research and development. Since its launch in October 2020, Angel Pharma has built an experienced R&D team, including expertise in clinical sciences, clinical operations, pharmacovigilance, CMC, regulatory, early discovery and pharmacology.