- FDA clearance triggers a $30
million milestone payment from Gilead
- Company on track to initiate a Phase 1 trial for COM503, a
differentiated antibody approach to harness cytokine biology for
cancer therapeutics as monotherapy and in combination in advanced
solid tumors in Q4 2024
HOLON, Israel, July 29,
2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq:
CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company
and a pioneer in computational target discovery,
today announced that the U.S. Food and Drug Administration
(FDA) has cleared the investigational new drug (IND) application to
initiate a Phase 1 trial for COM503, a potential first-in-class,
high affinity anti-IL-18 binding protein antibody licensed to
Gilead Sciences, Inc. (Gilead). The IND clearance triggered a
$30 million milestone payment from
Gilead and Compugen is on track to initiate the Phase 1 trial in
solid tumors, in the fourth quarter of 2024.
"We are thrilled to receive FDA IND clearance for COM503 which
triggers a $30 million milestone
payment from our partner Gilead, and the initiation of a Phase 1
trial will keep us on track to expedite COM503 development," said
Anat Cohen-Dayag, Ph.D., President,
and Chief Executive Officer of Compugen. "We are excited about the
potential of COM503, a differentiated antibody approach to harness
cytokine biology for cancer therapeutics which we discovered
through our computational discovery work at Compugen."
Dr. Cohen-Dayag added, "This achievement reflects our track
record in execution and diversity in our pipeline, adding another
clinical program discovered through our predictive computational
discovery engine. In addition, it further strengthens our balance
sheet with an expected cash runway sufficient to take us into 2027.
We look forward to the initiation of the Phase 1 trial in the
fourth quarter of this year, for which our preparation is
well-advanced."
About COM503 Phase 1 trial
The Phase 1 trial is a
first-in-human, dose escalation and dose expansion trial to assess
the safety and tolerability of COM503 as a monotherapy and in
combination with Gilead's anti-PD-1, zimberelimab in participants
with advanced or metastatic solid tumors globally.
About the Compugen-Gilead license agreement
In 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 is responsible for preclinical
development and the anticipated first- in-human Phase 1 trial
evaluating the safety and tolerability of COM503. Gilead will have
the sole right to develop and commercialize COM503 thereafter.
Gilead provided Compugen with a $60
million upfront payment and will make a $30 million payment for achievement of the
milestone of IND clearance of COM503, the subject of this press
release. Compugen will be 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
will also be 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
capabilities 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. In
addition, the Company's therapeutic pipeline of
early-stage immuno-oncology programs consists of
programs aiming to address various mechanisms of immune resistance,
of which the most advanced program, COM503, a potential
first-in-class, high affinity anti-IL-18 binding protein antibody,
which has been granted IND clearance from the FDA, is
licensed to Gilead. 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.
Forward-Looking Statement
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, statements relating to our expectation to
expedite COM503 development and that we are on track to initiate
the Phase 1 trial in solid tumors in the fourth quarter of 2024,
statements regarding our cash runway and statements relating to our
expectation to receive the milestone payment from
Gilead. 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 general market, political and
economic conditions in the countries in which Compugen
operates, including Israel;
and the effect of the evolving nature of the recent war in
Gaza between Israel and Hamas. 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.
Head of Investor Relations and Corporate
Communications
Email: ir@cgen.com
Tel: +1 (628) 241-0071
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SOURCE Compugen Ltd.
