- New approach to harness cytokine biology to treat cancer
patients advances to the clinic
- First patient dosed with potential first-in-class anti-IL-18
binding protein antibody, COM503, licensed to Gilead Sciences,
Inc.
- Phase 1 dose escalation and dose expansion trial to assess the
safety and tolerability of COM503 as monotherapy and in combination
for patients with advanced solid tumors
- Compugen responsible for running the Phase 1 trial
HOLON, Israel, Jan. 8, 2025
/PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE:
CGEN), a clinical-stage cancer immunotherapy company and a pioneer
in computational target discovery, today announced that the
first patient was dosed in a Phase 1 clinical trial with COM503, a
potential first-in-class antibody against
IL-18 binding protein licensed by Compugen to Gilead.
Compugen is responsible for running the Phase 1 trial.
This Phase 1 multi-center dose escalation and dose expansion
trial will evaluate the safety, tolerability, and pharmacokinetics
of COM503 as monotherapy and in combination with Gilead's anti-PD1,
zimberelimab in patients with advanced solid tumors. The trial was
initiated in the fourth quarter of 2024 as planned.
"We are delighted to advance COM503, our antibody that provides
a new and potentially differentiated approach to harness cytokine
biology for cancer therapeutics, quickly into the clinic," said
Anat Cohen-Dayag, Ph.D., President,
and CEO of Compugen. "Compugen's discovery engine
Unigen™, identified that the tumors of patients with
cancer express high levels of IL-18. However, the anti-tumor
activity of IL-18 is blocked by an endogenous IL-18-binding
protein, rendering it ineffective in fighting cancer. By blocking
this endogenous IL-18 binding protein, COM503 presents a unique
opportunity to release naturally occurring IL-18 locally within the
tumors, where it can potentiate anti-tumor immune responses,
thereby potentially overcoming the limitations of systemically
administered cytokines."
Manish Sharma, M.D., Co-Director
of Clinical Research, at the START Center for Cancer
Research-Midwest (START Midwest) in Grand
Rapids, Michigan, added, "Having COM503 as an additional
novel investigational treatment option with a unique mechanism of
action to offer our cancer patients is exciting. We, at START
Midwest, were delighted to be the first to dose a patient with
COM503 and look forward to swiftly enrolling additional patients in
this first dose escalation part of the trial with a focus on
evaluating the safety and pharmacokinetics of COM503
monotherapy."
About the COM503 Phase 1 trial:
The primary objectives of this trial are to assess the safety
and tolerability of COM503 as a monotherapy and in combination with
zimberelimab in patients with advanced solid tumors and to identify
the maximum tolerated dose /maximum administered dose and/or the
recommended dose of COM503 as monotherapy and in combination with
zimberelimab. For more information about the Phase 1 clinical
trial, visit clinicaltrials.gov, NCT06759649.
About the Compugen-Gilead license agreement
In December 2023, Compugen and
Gilead entered into a license agreement, pursuant to which Gilead
was granted exclusive rights to develop and commercialize
anti-IL-18 binding protein antibodies, including the COM503 drug
candidate. Compugen managed the preclinical development of COM503
and is responsible for the Phase 1 trial evaluating the safety and
tolerability of COM503. Thereafter, Gilead will have sole right to
develop and commercialize COM503. Gilead paid Compugen $60 million as upfront payment and $30 million as COM503 IND clearance milestone.
Compugen is eligible to receive up to an additional $758 million in future development, regulatory
and commercial milestone payments, with a total deal value of up to
$848 million. Compugen is also
eligible to receive single-digit to low double-digit tiered
royalties on worldwide net sales.
About Compugen
Compugen is a clinical-stage therapeutic discovery and
development company utilizing its broadly applicable predictive
computational discovery platform (Unigen™) to identify
new drug targets and biological pathways for developing cancer
immunotherapies. Compugen has two proprietary product candidates in
Phase 1 development: COM701, a potential first-in-class anti-PVRIG
antibody and COM902, a potential best-in-class antibody
targeting TIGIT for the treatment of solid tumors. Rilvegostomig, a
PD-1/TIGIT bispecific antibody where the TIGIT component is derived
from Compugen's clinical stage anti-TIGIT antibody, COM902, is in
Phase 3 development by AstraZeneca through a license agreement for
the development of bispecific and multispecific
antibodies. COM503, a potential first-in-class, high affinity
anti-IL-18 binding protein antibody, which is in Phase 1
development is licensed to Gilead. In addition, the Company's
therapeutic pipeline of early-stage immuno-oncology programs
consists of programs aiming to address various mechanisms of immune
resistance. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are
listed on Nasdaq and the Tel Aviv Stock Exchange under the
ticker symbol CGEN.
Compugen Forward-Looking Statements
This press release contains
"forward-looking statements" within the meaning
of the Securities Act of 1933 and the Securities Exchange
Act of 1934, as amended, and the safe-harbor provisions of the
Private Securities Litigation Reform Act of 1995. Such
forward-looking statements are based on the current beliefs,
expectations, and assumptions of Compugen.
Forward-looking statements can be identified using terminology such as "will,"
"may," "expects," "anticipates," "believes," "potential," "plan,"
"goal," "estimate," "likely," "should,"
"confident," and "intends," and similar expressions that are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements include, but are not limited to,
statement regarding our belief that by blocking IL-18 binding
protein, COM503 presents a unique opportunity to release naturally
occurring IL-18 locally within the tumors, where it can potentiate
anti-tumor immune responses, thereby potentially overcoming the
limitations of systemically administered cytokines. 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: the clinical trials of any product
candidates that Compugen, or any current or future collaborators,
may develop may fail to satisfactorily demonstrate safety and
efficacy to the FDA, and Compugen, or any collaborators, may incur
additional costs or experience delays in completing, or ultimately
be unable to complete, the development and commercialization of
these product candidates; 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;
Compugen's approach to the discovery of therapeutic products is
based on its proprietary computational target discovery
infrastructure, which is unproven clinically; general market,
political and economic conditions in the countries in which
Compugen operates, including Israel; the
effect of the evolving nature of the recent war
in Gaza;
and Compugen does not know whether it will be able to discover and develop additional
potential product candidates or products of commercial value. These
risks and other risks 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:
Yvonne
Naughton, Ph.D.
VP, Head of Investor Relations, and Corporate Communications
Email: ir@cgen.com
Tel: +1 (628) 241-0071
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SOURCE Compugen Ltd.
