Compugen Doses First Patient in COM701/Opdivo® (Nivolumab) Combination Arm of Phase 1 Study in Patients With Advanced Solid Tumors

Study based on well-tolerated doses with no reported DLTs of COM701 identified in monotherapy dose escalation arm of Phase 1 study

HOLON, Israel I May 20, 2019 I Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, today announced that it has dosed the first patient in the combination arm of its Phase 1 study, combining escalating doses of COM701 with a fixed dose of Opdivo® (nivolumab) in patients with advanced solid tumors. The combination dose escalation arm was initiated following the determination of well-tolerated doses with no dose-limiting toxicities reported of COM701 from the monotherapy dose escalation arm of the trial.  Bristol-Myers Squibb will supply Opdivo, a PD-1 inhibitor, for the combination arms of the Phase 1 study under the clinical trial collaboration announced in October 2018. 

"Our successful progression through the COM701 monotherapy dose escalation arm, enabled us to initiate the combination study with COM701 and Opdivo," stated Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Enrollment in the monotherapy dose escalation arm is expected to be completed by the end of the third quarter, while the combination dose escalation arm is expected to finish enrolling patients later this year. As a first-in-class drug candidate against a novel drug target backed by a solid biological rationale and biomarker strategy, COM701 has generated interest in our Phase 1 study.  We look forward to exploring the clinical potential of the therapy to improve response rates in patients with refractory or relapsed disease across multiple indications with the study's investigators and our strategic partner, Bristol-Myers Squibb."

The Phase 1 study now has ten participating sites, having recently added Columbia University, MD Anderson Cancer Center, UCLA, the Cleveland Clinic and START Midwest. The primary endpoints for the study are safety and tolerability; secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics. 

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as combination administration with Bristol-Myers Squibb's Opdivo® in patients with advanced solid tumors. Additionally, the trial will evaluate evidence of preliminary antitumor activity of COM701 as monotherapy as well as in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer.  The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting patients in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).

About the Compugen-Bristol-Myers Squibb Clinical Collaboration

In October 2018, Compugen entered into a clinical trial collaboration with Bristol-Myers Squibb to evaluate the safety and tolerability of Compugen's COM701 in combination with Bristol-Myers Squibb's PD-1 inhibitor Opdivo® (nivolumab), in patients with advanced solid tumors. Under the terms of the collaboration agreement, Compugen will sponsor the ongoing two-part Phase 1 trial, which includes the evaluation of the combination of COM701 and Opdivo in four tumor types, including non-small cell lung, ovarian, breast and endometrial cancer. The collaboration is also designed to address potential future combinations, including trials sponsored by Bristol-Myers Squibb to investigate combined inhibition of checkpoint mechanisms, such as PVRIG and TIGIT. The clinical combination of multiple immune checkpoint inhibition is designed to test the biological rationale of the PVRIG pathway and its synergistic activity with other checkpoint inhibitors demonstrated in preclinical models. In conjunction with this collaboration, Bristol-Myers Squibb made a strategic $12 million investment in Compugen.

About Compugen

Compugen is a clinical-stage, therapeutic discovery and development company utilizing its broadly applicable computational discovery platforms to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. The Company's therapeutic pipeline consists of immuno-oncology programs against novel drug targets it has discovered computationally, including T cell immune checkpoints and other early-stage immuno-oncology programs focused largely on myeloid targets. Compugen's business model is to 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 facilities in South San Francisco, CA. Compugen's ordinary shares are listed on 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: COM701

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