– Gilead Will Have Exclusive Rights to Later
Stage Development and Commercialization of Anti-IL18 Binding
Protein Antibodies with Potential to Treat Various Tumor Types
–
– Gilead to Make $60 Million Upfront Payment
and $30 Million in a Near Term Milestone Payment with a Total Deal
Value of up to $848 Million –
Gilead Sciences, Inc. (Nasdaq: GILD) today announced an
agreement with Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a
clinical-stage cancer immunotherapy company and a pioneer in
computational target discovery, headquartered in Holon, Israel, to
exclusively license its potential first-in-class, pre-clinical
antibody program against IL-18 binding protein, including the
COM503 drug candidate.
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Compugen utilizes its broadly applicable predictive
computational discovery capabilities to identify new drug targets
and biological pathways for developing novel cancer
immunotherapies. COM503 is a potential first-in-class, high
affinity antibody which blocks the interaction between IL-18
binding protein and IL-18, thereby releasing natural IL-18 in the
tumor microenvironment and inhibiting cancer growth.
“We are very pleased to add COM503 to our pipeline of
investigational immuno-oncology therapies that have the potential
to transform care for patients with cancer,” said Flavius Martin,
M.D., Executive Vice President, Research, Gilead Sciences. “We
believe that this collaboration complements our strategy of
developing modalities which promote immune-mediated tumor killing
and may enable new combination therapies with programs in our
growing oncology portfolio.”
“We are delighted to enter into this collaboration with Gilead
and believe that Gilead’s confidence in our differentiated approach
to harness cytokine biology for cancer therapeutics speaks to the
quality of our computational discovery capabilities as well as our
ability to translate our novel discoveries into investigational
drugs in the clinic and we look forward to working together to
bring new treatment options to patients,” said Anat Cohen-Dayag,
Ph.D., President, and CEO at Compugen. “IL-18 is one of the rare
cytokines which is naturally inhibited by an endogenous binding
protein, presenting a unique opportunity to use a blocking antibody
to increase the local concentrations of IL-18 within the tumor
where it can potentiate anti-tumor immune responses, thereby
potentially overcoming the limitations of systemically administered
cytokines.”
Terms of the Partnership
Under the terms of the agreement, Compugen will be responsible
for the ongoing pre-clinical development and the future Phase 1
study of COM503. Thereafter, Gilead will have the sole right to
develop and commercialize COM503.
Gilead will make Compugen an upfront payment of $60 million and
$30 million in a near term milestone payment subject to IND
clearance of COM503 expected in 2024. Compugen will also be
eligible to receive up to an additional $758 million in future
development, regulatory and commercial milestone payments, with a
total deal value of $848 million. Compugen will also be eligible to
receive single-digit to low double-digit tiered royalties on
worldwide net sales.
Beginning in the first quarter of 2022, consistent with recent
industry communications from the U.S. Securities and Exchange
Commission (SEC), Gilead no longer excludes acquired IPR&D
expenses from its non-GAAP financial measures. This transaction
with Compugen is expected to reduce Gilead’s GAAP and non-GAAP 2023
EPS by approximately $0.03 - $0.05.
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 developed two proprietary product candidates: 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. Compugen also has a clinical stage partnered
program, rilvegostomig (previously AZD2936), a PD-1/TIGIT
bispecific antibody where the TIGIT component is derived from
Compugen’s clinical stage anti-TIGIT antibody, COM902, 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, is in IND enabling studies. COM503 is a potential
first-in-class, high affinity antibody which blocks the interaction
between IL-18 binding protein and IL-18, thereby freeing natural
IL-18 in the tumor microenvironment to inhibit cancer growth.
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.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis, COVID-19, and cancer. Gilead operates in more than
35 countries worldwide, with headquarters in Foster City,
California.
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
expectation from the collaboration, statement regarding our belief
that using a blocking antibody to increase the local concentrations
of IL-18 within the tumor where, can potentiate anti-tumor immune
responses, thereby potentially overcoming the limitations of
systemically administered cytokines and statement regarding the
expected time for IND clearance of COM503. 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.
Gilead Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including Gilead’s ability to realize the anticipated benefits from
the collaboration with Compugen; difficulties or unanticipated
expenses in connection with the collaboration, and the potential
effects on Gilead’s earnings; the ability of the parties to
initiate, progress or complete clinical trials within currently
anticipated timelines or at all, and the possibility of unfavorable
results from trials, including those involving COM503, and
additional programs that may become subject of the collaboration;
the possibility that the parties may make a strategic decision to
terminate the collaboration or discontinue development of any of
the investigational agents under the collaboration, and therefore
these investigational agents may never be successfully
commercialized; and any assumptions underlying any of the
foregoing. These and other risks, uncertainties and other factors
are described in detail in Gilead’s Quarterly Report on Form 10-Q
for the quarter ended September 30, 2023, as filed with the U.S.
Securities and Exchange Commission. These risks, uncertainties and
other factors could cause actual results to differ materially from
those referred to in the forward-looking statements. All statements
other than statements of historical fact are statements that could
be deemed forward-looking statements. The reader is cautioned that
any such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties and is cautioned
not to place undue reliance on these forward-looking statements.
All forward-looking statements are based on information currently
available to Gilead, and Gilead assumes no obligation and disclaims
any intent to update any such forward-looking statements.
Gilead and the Gilead logo are trademarks of
Gilead Sciences, Inc., or its related companies. The Compugen name
and logo are trademarks of Compugen Ltd.
For more information about Gilead, please visit
the company’s website at www.gilead.com, follow Gilead on Twitter
(@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5
or 1-650-574-3000.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231218814564/en/
Compugen Ltd. Yvonne
Naughton, Ph.D., Investors and Media ir@cgen.com
Gilead Investors: Jacquie
Ross investor_relations@gilead.com
Media: Meaghan Smith public_affairs@gilead.com
Compugen (NASDAQ:CGEN)
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Compugen (NASDAQ:CGEN)
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