Initial data expected in 2021

COM902 and COM701 will allow the Company to clinically evaluate the dual blockade of PVRIG and TIGIT inhibitory pathways in the DNAM axis

HOLON, Israel I April 6, 2020 ICompugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced that the first patient has been dosed in its Phase 1 clinical trial of COM902, an immuno-oncology therapeutic antibody targeting TIGIT, in patients with advanced malignancies.

This Phase 1 open-label clinical trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of escalating doses of COM902 monotherapy in patients with advanced malignancies who have exhausted all available standard therapies. The study will be conducted in multiple leading oncology clinical centers in the United States.

Manish Sharma, M.D., Associate Director of Clinical Research at START Midwest (Grand Rapids, MI) and a Principal Investigator in the Phase 1 COM902 study, said, “Being part of Compugen’s ongoing COM701 Phase 1 study, we are excited to expand our relationship with the Company and enroll patients in this clinical trial evaluating the inhibition of TIGIT, a part of the DNAM axis, with COM902. There remains a high unmet medical need to evaluate novel investigational agents in patients unresponsive to PD-1 or PDL-1 inhibitors. The two studies enable us to evaluate COM701 and COM902 in these patient populations.”

Anat Cohen-Dayag, Ph.D., President and CEO of Compugen, added “Advancing COM902 through Phase 1 studies is an important step towards testing the clinical effect of the dual blockade of PVRIG and TIGIT, two parallel inhibitory pathways in the DNAM axis. Our preclinical work suggests that the simultaneous blockade of TIGIT and PVRIG may be essential for inducing robust antitumor immune responses in patient populations where these two pathways are operative. This is further reinforced by our initial clinical data demonstrating preliminary antitumor activity by COM701 targeting PVRIG and pharma’s increasing focus on the blockade of TIGIT, which we and others discovered in 2009. As the only company, to our knowledge, currently with clinical programs targeting both TIGIT and PVRIG, we are uniquely positioned to synergistically target both immune checkpoints.”

Dr. Cohen-Dayag continued, “Our various clinical studies targeting PVRIG and TIGIT, including the Phase 1/2 trial designed to evaluate the triple blockade of PVRIG, TIGIT and PD-1 expected to initiate in the second half of 2020, build our science-driven clinical pipeline designed to address the significant unmet need of patients who are non-responsive and refractory to currently approved cancer immunotherapies. We look forward to the multiple anticipated data readouts from our clinical studies, including updated data from our ongoing COM701 monotherapy and combination therapy dose escalation studies later this year, and from our COM701 Phase 1 monotherapy expansion cohorts and COM902 Phase 1 studies in 2021.”

Additional information on the COM902 Phase 1 study will be available shortly at www.clinicaltrials.gov.

About COM902

COM902 is a high affinity, fully human antibody that blocks the interaction of TIGIT with PVR, its ligand, and consequently enhances T cell function. It is currently being evaluated in a Phase 1 clinical trial in patients with advanced malignancies who have exhausted all available standard therapies. Compugen has demonstrated in preclinical studies that simultaneous inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM axis, can increase antitumor immune responses, which may be further enhanced with the addition of PD-1 blockade. These data suggest that treatment with COM701 and COM902, targeting PVRIG and TIGIT, respectively, alone or in combination with a PD-1 inhibitor, has the potential to expand immuno-oncology treatment to patient populations who are non-responsive or refractory to existing immunotherapies.

The discovery of TIGIT, using the Company’s computational discovery platform, was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).

About Compugen

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop therapeutics in the field of cancer immunotherapy. The Company’s lead product candidate, COM701, a first-in-class anti-PVRIG antibody, for the treatment of solid tumors, is undergoing a Phase 1 clinical study. In addition, COM902, Compugen’s antibody targeting TIGIT, is in a Phase 1 clinical study. The Company’s therapeutic pipeline also includes early stage immuno-oncology programs focused largely on myeloid targets. Compugen’s business model is to selectively enter into collaborations for its novel targets and related drug product candidates at various stages of research and development. The Company is headquartered in Israel, with offices in South San Francisco, CA. Compugen’s shares are listed on the Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. For additional information, please visit Compugen’s corporate website at www.cgen.com.

SOURCE: Compugen