Compugen Doses First Patient in COM701/Opdivo® Combination Study in Patients

Compugen 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," said 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.

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.

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