Angel Pharmaceuticals Co., Ltd. ("Angel Pharma") today announced 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.
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 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."
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.
About Angel Pharmaceuticals
Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases. Angel Pharmaceuticals was launched with strategic collaboration with U.S. biopharmaceutical company Corvus Pharmaceuticals, Inc., with investments from Zhejiang Puissance Capital, Hisun Pharmaceuticals, Tigermed and fund associated with Betta Pharmaceuticals. Angel Pharmaceuticals' initial pipeline includes licensed rights to develop and commercialize three clinical-stage candidates, mupadolimab, CPI-818 and ciforadenant, in greater China, and global commercial and intellectual property rights for a pre-clinical stage new generation of BTK inhibitors. 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 1b/2 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.