Angel Pharma Pushes First-In-Class ITK Inhibitor into Trial in China

China’s Angel Pharmaceuticals (Angel Pharma) announced the IND approval of the oral ITK inhibitor, CPI-818, by China’s Center for Drug Evaluation (CDE), making it the first ITK inhibitor to enter trials in China. The trial will investigate the efficacy and safety profile of CPI-818 in patients with relapsed/refractory T-cell lymphomas (TCL), with an expected launch in late 2021.

Key Roles of ITK inhibitor

Relapsed/refractory T-cell lymphoma is a deadly illness with a 5-year survival rate of 10% to 30%. It is more common in China than in the US. CPI-818 is undergoing clinical trials in Asia and the US. The approval from the CDE will pave the way for Angel Pharma to venture into the Chinese market.

ITK is a highly expressed protein on T-cells and is essential in T-cell receptor signaling, T-cell differentiation, and proliferation. By inhibiting the site, CPI-818 is able to block malignant T-cell growth and modulate the immune response. Currently, the drug is the first and only ITK inhibitor that can selectively suppress ITK without affecting related kinases such as RLK and BTK.

“This marks an important milestone in our efforts to bring this potential first-in-class innovative drug to patients in China,” said Richard A. Miller, M.D., co-founder and chairman of Angel Pharma. “We are excited about working with top lymphoma experts in China to accelerate the development of CPI-818 to address the unmet clinical need.” 

Angel Pharma gained the development rights to CPI-818 in China from US biotech Corvus Pharmaceuticals. The drug is also in Phase 1b/2 trial for several types of TCL in the US and Asia, has demonstrated anti-tumor activity in peripheral T-cell lymphomas (PTCL) and in cutaneous T-cell lymphomas.

Licensing Deal with Corvus

Founded in 2020 October, Angel Pharma struck a licensing deal Corvus which covered three drugs: adenosine A2A receptor inhibitor CPI-444, CD73-targeting cancer monoclonal antibody CPI-006, and CPI-818. The same month, the firm raised $43 million in the Series A round. In addition, it launched research centers in Zhejiang, China, and California, the US, in July 2021.

Author

Tyler Chen

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