On September 8, 2020 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 Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, with Bristol Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), and their investigational anti-TIGIT antibody, BMS-986207 (Press release, Compugen, SEP 8, 2020, View Source [SID1234564717]).
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The triple combination study is designed to evaluate the simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen’s DNAM axis hypothesis and biomarker strategy in patients with advanced solid tumors, including those who are refractory or unresponsive to standard-of-care immune checkpoint inhibitors. Compugen’s DNAM axis hypothesis suggests that PVRIG and TIGIT are two parallel and complementary inhibitory pathways in the axis and that blocking both PVRIG and TIGIT may be required in certain tumor types in order to generate or enhance an anti-tumor immune response.
"Dosing the first patient in this triple combination study propels our clinical development plan for COM701 forward, continuing our rapid execution in investigating what we believe is a foundational axis in immuno-oncology," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The science we have elucidated behind this axis, combined with the preliminary antitumor activity observed in our Phase 1 COM701 study, suggest that our highly differentiated clinical path of targeting PVRIG simultaneously with TIGIT and PD-1 blockers has the potential to expand cancer immunotherapy treatment options to new patient populations."
Dr. Cohen-Dayag added, "We are thrilled to have Bristol Myers Squibb as our partner in this study and are very pleased with their continued support and commitment to our collaboration."
Henry Adewoye, M.D., Senior Vice President and Chief Medical Officer, said, "While immunotherapies have been transformative in oncology, the majority of cancer patients do not respond to immunotherapy or relapse with currently available treatments. Our expectation is that inhibiting PVRIG and TIGIT, two distinct inhibitory checkpoints in the DNAM axis, together with PD-1, has the potential to translate to clinical benefit for patients by increasing response rates and durability of responses, thereby expanding the reach of this important class of drugs. We are highly encouraged by the durable partial responses observed in the monotherapy and dual combination dose escalation arms of our study evaluating COM701 and thus look forward to the results of this ongoing trial."
The open-label Phase 1/2 trial is 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 preliminary antitumor activity in tumor types selected for expansion in a biomarker-driven approach (to initially include ovarian cancer, endometrial cancer and a biomarker-driven arm of tumor types with high expression of PVRL2). An investigation of the contribution of the component parts of the triplet will be enabled in the context of the ovarian expansion cohort. Dose levels for Opdivo and BMS-986207 combinations have already been determined through prior testing by Bristol Myers Squibb, allowing for dose escalation of COM701 with fixed doses of Opdivo and BMS-986207. The study will initially enroll approximately 100 patients.
About COM701
COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, and blocks the interaction with its ligand, PVRL2. TIGIT, an immune checkpoint discovered computationally by Compugen in 2009, and PVRIG constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory receptor on T cells and NK cells. Preclinical data suggest that the blockade of PVRIG induces a robust anti-tumor immune response and demonstrates synergistic activity when used in combination with inhibitors of TIGIT and/or PD-1. Currently, COM701 is being evaluated in a Phase 1 clinical study. Data from the ongoing study have shown that COM701 is well-tolerated and demonstrated preliminary signals of anti-tumor activity in a heavily pretreated patient population.