Sunday, November 17, 2019
Breaking Medical Device Industry News

Compugen Announces FDA Clearance of IND Application for COM902

Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020 Clinical development of COM902 will enable testing the combination treatment with COM701, Compugen's anti-PVRIG inhibitor

Sunday, November 17, 2019

Compugen Ltd. is a clinical-stage cancer immunotherapy company and a leader in predictive target discovery.  Today, the company announced that the U.S. Food and Drug Administration has cleared its investigational new drug (IND) application for COM902, its immuno-oncology therapeutic antibody targeting TIGIT in patients with advanced malignancies.

Under this IND, the Company intends to initiate a Phase 1 clinical trial in patients with advanced malignancies for whom the standard of care therapies are currently ineffective. Expected to begin in early 2020, the clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of COM902. The study is planned to be conducted at multiple centers in the United States and site selection activities are currently underway.

“IND clearance for COM902 is an important milestone that marks the third program based on new drug targets we discovered to be evaluated in the clinic,” said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. “We believe that TIGIT inhibitors may have an important role in the immunotherapy landscape and that our biology driven approach of combining anti-TIGIT and anti-PVRIG inhibitors, with or without PD-1 blockers, has the potential to improve clinical responses in patients who are unresponsive and refractory to currently approved immunotherapies. As the only company with clinical candidates targeting both PVRIG and TIGIT, we hold a differentiated position in the crowded immuno-oncology space.”

Dr. Cohen-Dayag continued, “We are proud of our tremendous progress in recent years, transforming into a clinical-stage company with three anticipated Phase 1 programs in the clinic expected in 2020, two of which we are being developed internally. Importantly, these three programs address targets which originated from our unique computational discovery platform, highlighting the power and value of our computational capabilities to discover new, potentially significant biological pathways and targets for innovative therapeutics.”

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