Study based on well-tolerated doses with no reported DLTs of COM701 identified in monotherapy dose escalation arm of Phase 1 study
HOLON, Israel, May 20, 2019 /PRNewswire/ -- Compugen Ltd. (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.
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.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and describe opinions about possible future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model. Moreover, the development and commercialization of therapeutic candidates involve many inherent risks, including failure to progress to clinical trials or, if they progress to or enter clinical trials, failure to advance through clinical development or receive regulatory approval. These and other factors, including the ability to finance the Company, are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
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