Compugen: FDA Allows Phase 1/2 Study Evaluating COM701 With BMS-986207 And Nivolumab

(RTTNews) - Compugen Ltd. (CGEN) said the U.S. FDA has cleared the investigational new drug application for its Phase 1/2 study evaluating the triple combination of COM701 with Bristol Myers Squibb's Opdivo (Nivolumab) and TIGIT Inhibitor. Under the IND, the company intends to initiate an open-label Phase 1/2 trial designed to evaluate the safety, tolerability and preliminary antitumor activity of COM701 in combination with Opdivo and BMS-986207 during dose escalation, as well as anti-tumor activity in selected tumor types in the expansion cohorts. The company expects to begin the study in the second half of 2020.

"This study complements our clinical strategy designed to evaluate the blockade of PVRIG as a monotherapy and in combination with intersecting DNAM axis components to fully elucidate the role of this potentially foundational axis for cancer immunotherapy," said Anat Cohen-Dayag, CEO of Compugen.