On October 25, 2021 Angel Pharmaceuticals Co., Ltd. ("Angel Pharma") reported that its IND application for CPI-818, a small molecule ITK inhibitor, has been approved by the Center for Drug Evaluation (CDE) to initiate clinical trials in patients with relapsed/refractory T-cell lymphomas (TCL) in China (Press release, Angel Pharmaceuticals, OCT 25, 2021, prnewswire.com/news-releases/angel-pharmaceuticals-announces-approval-of-ind-application-in-china-for-itk-inhibitor-cpi-818-301407424.html [SID1234591915]).
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CPI-818, the first-and-only ITK inhibitor in clinical development, 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). 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 1b/2 clinical trial in patients with several types of TCL in the U.S. and Asia. 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.
"This marks an important milestone in our efforts to bring this potential first-in-class innovative drug to patients in China. We are excited about working with top lymphoma experts in China to accelerate the development of CPI-818 to address unmet clinical need." said Richard A. Miller, M.D., co-founder and chairman of Angel Pharmaceuticals.
Professor Song Yuqin, Director of the Chinese Society of Clinical Oncology (CSCO), Secretary-General of the Anti-Lymphoma Alliance of the CSCO, and Deputy Director of Lymphoma Department at Peking University Cancer Hospital, said: "Relapsed/refractory T-cell lymphoma is a challenging group of non-Hodgkin’s lymphoma. Current five-year overall survival rates for the majority of patients are 10-30%. We are very pleased that Angel Pharmaceuticals brought the only clinical phase ITK inhibitor to China. We hope that the clinical development of the product in China progress successfully to benefit patients with relapsed/refractory T-cell lymphoma."
About CPI-818
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 1b/2 trial in patients with refractory T-cell lymphomas in the U.S. and Angel Pharmaceuticals, which has rights to CPI-818 in China, is leading a global trial in patients with relapsed/refractory (R/R) T-cell lymphomas.