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Angel Pharmaceuticals Announces First Patient Dosed in China in Phase I/Ib Trial of CPI-818, the World's First ITK Inhibitor to Enter Clinical Development
Jiaxing, China and Burlingame, Calif., U.S.A. – January 14, 2022 – Angel Pharmaceuticals today announced that the first Chinese patient has been dosed in the Phase I/Ib clinical trial of CPI-818, the world's first ITK inhibitor to enter clinical development, for the treatment of relapsed/refractory T-cell lymphomas. The dosing was conducted under the leadership of Professor Song Yuqin from the Department of Lymphoma at Peking University Cancer Hospital. This clinical trial aims to evaluate the preliminary safety, tolerability, and dosing regimen of CPI-818 in patients with relapsed/refractory T-cell lymphomas, primarily targeting peripheral T-cell lymphoma (PTCL), angioimmunoblastic T-cell lymphoma (AITL), NK T-cell lymphoma, and other T-cell lymphomas. Angel Pharmaceuticals holds the rights to CPI-818 in Greater China.
CPI-818 is a first-in-class, oral, potent inhibitor of ITK kinase. In ongoing first-in-human clinical trials in the United States, South Korea, and Australia, it has already demonstrated clear efficacy and favorable safety and tolerability. As of February 17, 2021, a total of 25 patients worldwide (16 in the dose-escalation phase and 9 in the expansion phase) had received CPI-818 treatment. Preliminary clinical data suggest that CPI-818 has a good safety and tolerability profile, with no dose-limiting toxicities (DLTs) observed during dose escalation. In patients with primary cutaneous T-cell lymphoma (CTCL), one patient with CTCL-Sezary syndrome showed a reduction in target lymph nodes, with no FDG-avid lesions, achieving a complete response (CR) in lymph nodes. In the dose-escalation phase, among 7 patients with peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) who received CPI-818 at ≥ 200 mg BID, 2 achieved responses. One PTCL-NOS patient achieved a durable CR lasting 15 months, and one patient achieved a confirmed partial response (PR) lasting 5 months and successfully underwent allogeneic transplantation while in PR.
Dr. Richard Miller, Co-founder and Chairman of Angel Pharmaceuticals, stated, "We are very excited that the first patient has been enrolled in China for the Phase I/Ib trial of CPI-818. Clinical data from outside China have preliminarily demonstrated its potential to bring clinical benefit to patients across multiple T-cell lymphoma subtypes. Together with leading lymphoma experts in China, we will fully advance the clinical trial progress and strive to bring this first-in-class and innovative ITK inhibitor to market approval in China as soon as possible, offering a revolutionary solution for patients with relapsed/refractory T-cell lymphomas."
Professor Song Yuqin, Council Member of the Chinese Society of Clinical Oncology (CSCO), Secretary-General of the CSCO Anti-Lymphoma Alliance, and the Chinese Lead Investigator for the CPI-818-001 clinical trial, from the Department of Lymphoma at Peking University Cancer Hospital, commented: "China has a large number of T-cell lymphoma patients worldwide. Currently, the five-year survival rate for patients with relapsed/refractory T-cell lymphomas is only 10–30%, representing a critical unmet clinical need. We are very pleased to see that Angel Pharmaceuticals has brought the world's first ITK inhibitor to enter the clinical stage to China. We hope the clinical trial proceeds smoothly and look forward to CPI-818 providing greater benefits for numerous patients with relapsed/refractory T-cell lymphomas in the clinic."
About CPI-818
CPI-818 potently inhibits ITK kinase with high selectivity and does not affect normal T-cell proliferation or immune responses. Interleukin-2-inducible T-cell kinase (ITK), first discovered in 1992 as a 72 kDa protein kinase, plays an essential role in the activation, differentiation, and proliferation of Th2 cells. T-cell lymphomas are rare and aggressive subtypes of non-Hodgkin lymphoma with heterogeneous characteristics. ITK has been shown to play a key role in T-cell signaling, differentiation, development, and cytokine production, making it a highly promising target for the treatment of T-cell lymphoproliferative disorders.
About Angel Pharmaceuticals
Angel Pharmaceuticals is an innovative drug company dedicated to oncology and autoimmune diseases. With the mission of benefiting Chinese patients, Angel is committed to bringing globally top-tier innovative drugs for serious diseases such as cancer and autoimmune disorders to China. Angel's pipeline includes innovative products targeting various pathways, with rights in Greater China to three clinical-stage assets: CPI-818, an ITK inhibitor; CPI-006, a humanized anti-CD73 monoclonal antibody; and CPI-444, an adenosine A2A receptor antagonist, as well as global commercial rights and patents for a next-generation BTK inhibitor. In October 2020, Angel Pharmaceuticals completed a RMB 280 million Series A financing round co-invested by Beta Fund, Hisun Pharmaceuticals, Tigermed, and Puhua Investment, and established a strategic partnership with Corvus Pharmaceuticals (CRVS) of the U.S. For more information, please visit www.angelpharma.com.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus's lead product candidate is mupadolimab (CPI-006), a humanized anti-CD73 monoclonal antibody that has demonstrated immunomodulatory activity and immune cell activation in preclinical studies. Its second clinical program, CPI-818, is an investigational oral small molecule that selectively inhibits ITK in preclinical studies and is currently being evaluated in a multicenter Phase 1b/2 clinical trial in patients with various T-cell lymphomas. Its third clinical program, ciforadenant (CPI-444), is an oral small molecule inhibitor of the A2A receptor. For more information, please visit www.corvuspharma.com.
The above article is sourced from PR Newswire. https://www.prnasia.com/story/348553-1.shtml
