HOLON, Israel, May 20, 2019 /PRNewswire/ -- 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.
Forward-Looking Statement
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.
Company contact:
Elana
Holzman
Director, Investor Relations and Corporate
Communications
Compugen Ltd.
Email: elanah@cgen.com
Tel: +972-(3)-765-8124
Investor Relations contact:
Burns McClellan, Inc.
Jill Steier
Email: jsteier@burnsmc.com
Tel: +1-212-213-0006
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SOURCE Compugen Ltd.