Compugen Ltd (NASDAQ:CGEN) Receives FDA IND Clearance For Phase 1/2 COM701 Study With Opdivo and Anti-TGIT Inhibitor

Compugen Ltd (NASDAQ:CGEN) has announced that the FDA has approved its Investigational New Drug Application for the Phase 1/2 study. The study will evaluate the triple combination of COM701, its anti-PVRIG antibody, Bristol Myers Squibb’s Opdivo, the PD-1 checkpoint immune inhibitor, as well as BMS-986207 the anti-TIGIT antibody in patients with advanced solid tumors.

Compugen study to accelerate the evaluation of DNAM axis hypothesis

The company has designed the triple combination trial to assess the three checkpoint immune pathways’ (TIGIT, PD-1, and PVRIG) blockade. The evaluation study will speed up the clinical evaluation of the company’s DNAM axis proposition as well as the biomarker-focused approach in advanced solid tumors patients. This includes those patients who are non-responsive or refractor to the standard of care checkpoint immune inhibitors.

Compugen CEO and President Anat Cohen-Dayat indicated that the expected study will complement the company’s clinical strategy that has been designed to evaluate PVRIG blockade as a monotherapy. This will be combined with the interconnecting DNAM axis mechanisms to fully demonstrate the role of the foundational axis in cancer immunotherapy. He added that Phase 1 COM701 clinical study produced encouraging results from the evaluation of the targeted PVRIG and clinical TIGIT pathway validation.

Anat stated that the encouraging results leave the company optimistic regarding the science-driven mechanism of evaluating the two distinct pathways that are complementary in combination with PD-1. Further, the CEO affirmed that as the only company with wholly-owned TIGIT and PVRIG candidates, they are better positioned to address the DNAM axis’s role.

COM701 shows partial responses with nivolumab

Henry Adewoye, the company’s Chief Medical Officer and SVP, indicated that the evaluation of COM701 in combination with nivolumab and BMS-986207 fits the company’s clinical development strategy for proprietary therapies in various cancers with an unmet medical need. The company previously reported partial COM701 responses in combination with nivolumab.

Under the IND, Compugen is planning to commence a Phase ½ study to evaluate tolerability, safety, and initial antitumor activity of COM701 in combination with BMS-986207 and Opdivo.