Compugen Doses First Patient in COM701/Opdivo® (nivolumab) Phase 1b Cohort Expansion Study

On June 30, 2021 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the first patient has been dosed in the combination expansion cohort of its ongoing Phase 1 clinical trial evaluating COM701, Compugen’s first-in-class anti-PVRIG antibody, in combination with Opdivo (nivolumab) (Press release, Compugen, JUN 30, 2021, View Source [SID1234584523]). The indications for the combination therapy expansion cohort, ovarian, breast, endometrial and colorectal cancers were selected based on preclinical biomarker assessments.

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"The data generated from the combination study of COM701 with Opdivo (nivolumab) in the dose escalation setting are encouraging, including a confirmed complete response in one patient and durable anti-tumor activity observed beyond one year in multiple highly refractory patients," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The activity observed strengthens our confidence that dual blockade of PVRIG and PD-1 may be key to driving antitumor immune responses in certain patient populations and we look forward to continued evaluation of this potentially promising regimen in the indications selected for the expansion cohort. The dosing of the first patient in the cohort expansion phase of this study follows expansion of our collaboration with Bristol Myers Squibb and speaks to our steady execution in the clinic. As the only company with clinical-stage candidates against both PVRIG and TIGIT, we believe that this study strengthens our first-mover advantage in evaluating the DNAM axis as a potential new foundational immunotherapy axis in cancer immunotherapy."

The Phase 1b combination cohort expansion study is part of the Phase 1 open-label clinical trial designed to assess the safety, tolerability and preliminary anti-tumor clinical activity of administering escalating doses of COM701 monotherapy, as well as in combination with Bristol-Myers Squibb’s Opdivo in patients with advanced solid tumors. The Phase 1b combination cohort expansion arm is currently recruiting patients in the United States. Additional information is available at www.clinicaltrials.gov (NCT03667716).

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated in preclinical studies potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. PVRIG and TIGIT, also discovered by Compugen’s computational discovery platform in 2009, constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. As such, preclinical data suggest that the inhibition of PVRIG together with TIGIT and/or PD-1 has the potential to further enhance anti-tumor immune response and improve patient outcomes in a broad variety of tumor types.