– Investment Reinforces Companies’ Conviction
in TIGIT Pathway and Provides Opportunity to Accelerate the
Anti-TIGIT Program –
– Additional Equity Investment of $320M,
Raising Gilead’s Ownership Stake in Arcus to 33% –
– Amendment Provides Gilead with One Additional
Seat on the Arcus Board –
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc.
(NYSE: RCUS) today announced an amendment to their collaboration
agreement and a separate equity investment by Gilead of $320
million in Arcus common stock at $21.00 per share. The equity
investment and collaboration amendment enable accelerated growth of
the companies’ joint development programs that span multiple
indications. Additionally, Johanna Mercier, Chief Commercial
Officer at Gilead Sciences, will join the Arcus Board, bringing
Gilead’s total director designees to three. The amendment also
includes governance enhancements enabling streamlined
decision-making and reflecting the continued growth of the
collaboration.
“This amendment allows Gilead to accelerate the domvanalimab
program and enables Arcus to focus on progressing multiple pipeline
assets, including both Gilead-optioned and non-optioned programs,”
said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead
Sciences. “We look forward to strengthening our collaboration as we
explore the collective power of our cross-portfolio combinations to
help transform how cancer is treated.”
Gilead and Arcus have reprioritized the joint domvanalimab
development program to focus on advancing and potentially
accelerating the Phase 3 studies STAR-121 (lung cancer) and
STAR-221 (gastrointestinal cancer), which are both expected to be
fully enrolled by year-end. This prioritization focuses on
domvanalimab-containing regimen research in areas where it may have
significant impact in combination with chemotherapy and in settings
with high unmet need through all-comer study designs. The companies
also plan to initiate STAR-131, a new registrational Phase 3 lung
cancer study that includes the domvanalimab plus zimberelimab
regimen. This prioritization reflects the companies’ continued
conviction in the TIGIT pathway and the Fc-silent design of
domvanalimab, which has the potential for differentiation in both
efficacy and safety.
“Since the inception of our partnership with Gilead in 2020, the
companies have moved increasingly closer in all aspects of our
research and development efforts,” said Terry Rosen, Ph.D., Chief
Executive Officer, Arcus. “This investment and prioritization
enable both companies to leverage their respective strengths and
focus on efficiently advancing novel combinations that have the
potential to change the landscape of cancer treatment. The
additional investment by Gilead, which extends our cash runway into
2027, will enable us to fund our Phase 3 studies of quemliclustat
in pancreatic cancer and AB521 in kidney cancer, as well as to
begin preparation for our first potential product approvals.”
Additional changes during this prioritization will include
discontinuing further enrollment in the Phase 3 ARC-10 study
evaluating domvanalimab plus zimberelimab compared to pembrolizumab
monotherapy in first-line locally advanced or metastatic PD-L1-high
NSCLC. The discontinuation of the ARC-10 study is based on
strategic prioritization to advance and potentially accelerate the
Phase 3 studies STAR-121 and STAR-221, which have the potential to
address a higher unmet need for patients with lung and
gastrointestinal cancers.
Gilead and Arcus are grateful to the patients and investigators
who have made the choice to participate in ARC-10, which will
continue to generate data and insights that will be shared at
future scientific conferences. Patients currently enrolled in
ARC-10, or who consented prior to January 29, 2024, and choose to
enroll in the study, may continue their treatment and be monitored
according to the study protocol. No changes to the safety and
efficacy profile of domvanalimab and zimberelimab have been
observed.
Also, under the terms of the amended collaboration agreement,
the planned Phase 3 first-line study in pancreatic cancer
evaluating the investigational small molecule CD73 inhibitor
quemliclustat will become an Arcus independent study.
Domvanalimab, zimberelimab and quemliclustat are investigational
molecules. Neither Gilead nor Arcus has received approval from any
regulatory authority for any use of these molecules, and their
safety and efficacy for the treatment of lung, gastrointestinal and
pancreatic cancers have not been established.
About Domvanalimab
Domvanalimab is the first Fc-silent investigational monoclonal
antibody in pivotal trials which was designed to block and bind to
the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a
protein on immune cells that acts as a brake on the immune
response. Cancer cells can exploit TIGIT to avoid detection by the
immune system. By binding to TIGIT, domvanalimab is designed to
free up immune activating pathways and activate immune cells to
attack and kill cancer cells. Domvanalimab has demonstrated
complete target coverage on all TIGIT-expressing immune cells in
the blood of patients.
Domvanalimab is being evaluated in three registrational Phase 3
studies across lung and gastrointestinal cancers, including: (1)
STAR-121, evaluating domvanalimab plus zimberelimab and
chemotherapy versus pembrolizumab plus chemotherapy in first-line
all comer NSCLC regardless of PD-L1 expression levels; (2)
STAR-221, evaluating domvanalimab plus zimberelimab and
chemotherapy versus nivolumab plus chemotherapy in first-line
locally advanced, unresectable or metastatic gastric, esophageal
and gastro-esophageal junction adenocarcinomas; and (3) PACIFIC-8,
being operationalized by AstraZeneca, evaluating domvanalimab plus
durvalumab in unresectable Stage 3 NSCLC.
About Zimberelimab
Zimberelimab is an anti-programmed cell death protein-1 (PD-1)
monoclonal antibody that binds PD-1, with the goal of restoring the
antitumor activity of T cells. As a differentiated next-generation,
fully human antibody, zimberelimab has demonstrated high affinity,
selectivity and potency in various tumor types.
Guangzhou Gloria Biosciences Co. Ltd., who holds
commercialization rights for zimberelimab in greater China, has
obtained approval for zimberelimab as the first and only anti-PD-1
antibody to treat recurrent or metastatic cervical cancer
(September 2023). Additionally, in China, zimberelimab is approved
to treat relapsed or refractory classical Hodgkin's lymphoma
(August 2021). Zimberelimab is not approved for any use in the U.S.
or other regions outside of China. Gloria conducts its development
and commercialization activities independent of Arcus and
Gilead.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical
company developing differentiated molecules and combination
medicines for people with cancer. In partnership with industry
collaborators, patients and physicians around the world, Arcus is
expediting the development of first- or best-in-class medicines
against well-characterized biological targets and pathways and
studying novel, biology-driven combinations that have the potential
to help people with cancer live longer. Founded in 2015, the
company has expedited the development of multiple investigational
medicines into clinical studies, including new combination
approaches that target TIGIT, PD-1, the adenosine axis (CD73 and
dual A2a/A2b receptor), HIF-2a, CD39 and AXL. For more information
about Arcus Biosciences’ clinical and preclinical programs, please
visit www.arcusbio.com.
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.
Arcus Forward-Looking
Statements
This press release contains forward-looking statements. All
statements regarding events or results to occur in the future
contained herein are forward-looking statements reflecting the
current beliefs and expectations of management made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including, but not limited to, the statements
regarding: the initiation of new studies and continuation or
discontinuation of existing studies and indications; the ability of
Arcus to advance its pipeline; Arcus’s expectations regarding the
completion of enrollment of STAR-121 and STAR-221 in 2024; Arcus’s
expectations regarding the extension of its cash runway into 2027;
and the potential of domvanalimab-containing regimens to be
differentiated and potentially transformative in the treatment of
certain cancers. All forward-looking statements involve known and
unknown risks and uncertainties and other important factors that
may cause our actual results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to: dependence on
the collaboration with Gilead for the successful development and
commercialization of Arcus’s investigational products, including
domvanalimab and zimberelimab; difficulties associated with the
management of the collaboration activities or expanded clinical
programs; the emergence of new or unexpected adverse events or
unfavorable results from ongoing or future clinical trials with
domvanalimab, zimberelimab or quemliclustat; the inherent
uncertainty associated with pharmaceutical product development and
clinical trials; delays in Arcus’s clinical trials due to
difficulties or delays in the regulatory process, enrolling
subjects or manufacturing or supplying product for such clinical
trials; and changes in the competitive landscape for Arcus’s
programs. Risks and uncertainties facing Arcus are described more
fully in the “Risk Factors” section of Arcus’s most recent periodic
report that has been filed with the U.S. Securities and Exchange
Commission. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this
press release. Arcus disclaims any obligation or undertaking to
update, supplement or revise any forward-looking statements
contained in this press release.
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 the risk that Gilead may not realize the potential
benefits of amended collaboration and investment agreement with
Arcus or its other investments in oncology; difficulties or
unanticipated expenses in connection with the collaboration and the
potential effects on Gilead’s revenues and earnings; the risk that
Gilead’s investment in Arcus will lose value for any number of
reasons; 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 ongoing or
additional clinical trials, including those involving domvanalimab,
zimberelimab and/or quemliclustat (such as STAR-121, STAR-131,
STAR-221 and PACIFIC-8); uncertainties relating to regulatory
applications for these and other candidates and related filing and
approval timelines; Gilead’s ability to receive regulatory
approvals for such candidates in a timely manner or at all, and the
risk that any such approvals may be subject to significant
limitations on use; the possibility that the parties may make a
strategic decision to terminate the collaboration at any time, or
to discontinue development of programs for indications currently
under evaluation and as a result, such programs and/or indications
may never be 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.
The Arcus name and logo are trademarks of Arcus Biosciences,
Inc., and Gilead and the Gilead logo are trademarks of Gilead
Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s
website at www.gilead.com, follow Gilead on X/Twitter
(@GileadSciences) and LinkedIn (@Gilead-Sciences).
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version on businesswire.com: https://www.businesswire.com/news/home/20240129480564/en/
Gilead Contacts:
Jacquie Ross, Investors investor_relations@gilead.com
Meaghan Smith, Media public_affairs@gilead.com
Arcus Contacts:
Pia Eaves, Investors peaves@arcusbio.com, (617) 459-2006
Holli Kolkey, Media hkolkey@arcusbio.com, (650) 922-1269
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