Date: 29-May-2020

Compugen Begins Patient Dosing In Anti-PVRIG Antibody Phase 1 Trial Of COM701

Compugen Ltd, a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, announced that the first patient has been dosed in the monotherapy expansion cohort of its ongoing phase 1 clinical trial of COM701, a first-in-class anti-PVRIG antibody.

The selected indications for the monotherapy expansion cohort focus on those more likely to respond to treatment with COM701 based on biomarker expression studies and clinical data collected to date. As such, the trial will enroll patients with non-small cell lung, ovarian, breast, endometrial and colorectal cancers.

Erika Hamilton, M.D., director of Breast Cancer and Gynecologic Cancer Research Program at Sarah Cannon Research Institute and principal investigator in the COM701 phase 1 study, said, "There is a significant need to develop novel treatments for patients with advanced cancer who are unresponsive to or relapse following treatment with the currently available standard of care immune checkpoint inhibitors. The preliminary signs of anti-tumor activity observed in the heavily pretreated, all-comer patient population included two confirmed partial responses in patients with microsatellite stable colon and platinum resistant primary peritoneal cancer which are tumor types typically unresponsive to immune checkpoint inhibitors. We are excited to advance to the monotherapy expansion stage of the study potentially offering patients a new effective cancer immunotherapy treatment."

Anat Cohen-Dayag, Ph.D, Compugen's president and chief executive officer, added, "While this monotherapy expansion cohort targets tumor types that are typically unresponsive to cancer immunotherapy, we believe that they are more likely to respond to treatment with COM701 based on our expression studies and initial clinical results. Furthermore, in this study we will be collecting biopsies before and during COM701 treatment to allow retrospective analyses of our biomarker approach and to help inform our future clinical development plan for COM701. We are encouraged by the progress across our clinical programs and the data we have presented on PVRIG and COM701 to date, as well as the possible clinical validation of the TIGIT pathway published by others, which we believe supports our long-standing hypothesis concerning the potential role of the DNAM axis as a foundational axis for cancer immunotherapy."

The monotherapy expansion cohort of the ongoing phase 1 open-label COM701 clinical trial is designed to assess the safety, tolerability and preliminary anti-tumor activity of 20 mg/kg IV Q4 weeks COM701 monotherapy in approximately 20 patients with advanced non-small cell lung, ovarian, breast, endometrial and colorectal cancers who have progressed on standard of care treatment. Expansion cohorts were selected based on preclinical biomarker expression and clinical data.

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 molecule 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. 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