-- Gilead Exercises Options to Arcus’s
Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b
Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule
CD73 Inhibitor) --
-- Arcus to Receive Option Payments Totaling
$725 million --
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc.
(NYSE: RCUS) today announced that Gilead has exercised its options
to three programs in Arcus’s clinical-stage portfolio, including
both anti-TIGIT molecules, domvanalimab and AB308, as well as
etrumadenant and quemliclustat. The companies also added a research
collaboration as described below. Today’s transaction is subject to
applicable antitrust clearance under the Hart-Scott Rodino
Antitrust Improvements Act and other customary closing conditions.
The parties expect the transaction to close by year-end.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20211118005582/en/
Domvanalimab is an Fc-silent anti-TIGIT antibody in Phase 2 and
Phase 3 studies in non-small cell lung cancer (NSCLC) and AB308 is
an Fc-enabled anti-TIGIT antibody under Phase 1 evaluation.
Etrumadenant is a dual adenosine A2a/A2b receptor antagonist in
Phase 1 and Phase 2 studies in NSCLC, colon cancer and prostate
cancer. Quemliclustat is a small molecule CD73 inhibitor in a Phase
1 study in metastatic pancreatic ductal adenocarcinoma (PDAC).
Gilead has been encouraged by early clinical data generated for
each of the three programs. By opting in early to all three
programs now, Gilead and Arcus are able to accelerate the clinical
development and advancement of these clinical-stage molecules and
facilitate the exploration of treatment combinations across the
portfolios. For example, Gilead will be able to pursue potential
chemotherapy-free regimens with Trodelvy® (sacituzumab
govitecan-hziy) in combination with therapies optioned from the
Arcus portfolio. Gilead will also have the flexibility to add
Gilead portfolio candidates to existing Arcus studies.
“Gilead is pursuing some of the most promising mechanisms of
action in oncology today, with the aim of achieving better
treatment outcomes for more patients,” said Daniel O’Day, Chairman
and Chief Executive Officer, Gilead Sciences. “The addition of
three mid- to late-stage clinical programs into our oncology
pipeline significantly expands the number of transformational
medicines we can potentially deliver to people with cancer, while
also enabling our pursuit of novel combinations.”
“Through the expanded partnership, we will be able to leverage
the combined portfolios of the two companies to enable rational
exploration of unique and innovative combination therapies within a
single integrated program,” said Terry Rosen, Ph.D., Chief
Executive Officer of Arcus. “The early exercise of Gilead’s options
will now ensure that Arcus is well positioned to accelerate and
expand clinical development activities so that it may deliver
benefit to patients with some of the most difficult to treat
cancers, including pancreatic, lung, colon and prostate.”
Terms of the Exercised Options and
Amendment to the Agreement
Under the terms of the parties’ Option, License and
Collaboration Agreement (the “2020 Agreement”), for the three
options that Gilead is exercising today, Arcus will receive option
payments totaling $725 million. The parties will co-develop and
share the global costs related to these programs. If the optioned
molecules achieve regulatory approval, Gilead and Arcus will
co-commercialize and equally share profits in the U.S. Gilead will
hold exclusive rights outside the U.S., subject to any rights of
Arcus’s existing collaboration partners, and Gilead will pay to
Arcus tiered royalties.
With Gilead’s early option exercises for all three programs,
Gilead and Arcus amended the 2020 Agreement, including as
follows:
- Arcus may be required to operationalize at least 50% of the
clinical studies, with costs to be shared by Gilead and Arcus.
- The royalties payable by Gilead to Arcus on sales for these
three programs outside of the U.S. were slightly reduced. The
reduced royalties range from the mid-teens to the low
twenties.
- Arcus will lead the discovery and early development of drug
candidates against two novel research targets jointly selected by
the parties.
- Upon closing of the transaction for all three programs, the
$100 million option continuation payment due in 2022 will not be
made by Gilead.
Summary of anti-TIGIT
Program
- ARC-7 is a Phase 2 study evaluating patients randomly allocated
to domvanalimab plus zimberelimab vs. zimberelimab alone vs.
domvanalimab plus zimberelimab plus etrumadenant as first-line
treatment for PD-L1 ≥ 50%, metastatic NSCLC. The study is actively
enrolling with a target total enrollment of 150 patients who are
being randomly allocated 1:1:1 to each group and treated until
disease progression or loss of clinical benefit. Gilead and Arcus
have jointly decided that results, including data on
progression-free survival, will be presented at a medical
conference in 2022.
- ARC-10 is an ongoing registrational Phase 3 study intended to
support the potential approvals of both zimberelimab monotherapy
and domvanalimab plus zimberelimab in first-line, locally advanced
or metastatic PD-L1≥50% NSCLC.
- PACIFIC-8 is a registrational Phase 3 study with a planned
initiation by the end of 2021 in collaboration with AstraZeneca.
PACIFIC-8 will evaluate domvanalimab plus durvalumab, an anti-PD-L1
antibody, with curative intent in unresectable Stage 3 NSCLC, where
durvalumab is standard of care.
- ARC-12 is a Phase 1 study evaluating AB308 plus zimberelimab in
advanced malignancies with five expansion cohorts currently open
for enrollment.
Summary of ATP-Adenosine Axis (CD73 and
A2a/A2b Receptor) Programs
- ARC-4 is a randomized Phase 1 study evaluating etrumadenant
plus zimberelimab and chemotherapy vs. zimberelimab plus
chemotherapy in EGFRmut tyrosine kinase inhibitor (TKI)-relapsed
and refractory NSCLC. Initial data are expected to be presented in
1H22.
- ARC-6 is a Phase 1b/2 platform study in metastatic
castration-resistant prostate cancer with a randomized cohort
evaluating docetaxel versus docetaxel plus etrumadenant and
zimberelimab. Initial results are expected in 2022.
- ARC-7 is an open-label randomized Phase 2 study as noted
above.
- ARC-8 is an ongoing Phase 1 study evaluating quemliclustat plus
zimberelimab and gemcitabine/nab-paclitaxel in first-line
pancreatic cancer, with a randomized cohort comparing against
quemliclustat plus gemcitabine/nab-paclitaxel. Gilead and Arcus
have jointly decided that results, including data on
progression-free survival, will be presented at a medical
conference in 2022.
- ARC-9 is a randomized Phase 1b/2, open-label, multi-center
platform study to evaluate the efficacy of etrumadenant in
combination with zimberelimab and FOLFOX with or without
bevacizumab in second- and third-line metastatic colorectal
cancer.
- Additional clinical studies are expected to be initiated in
2022.
Zimberelimab, domvanalimab, AB308, etrumadenant and
quemliclustat are investigational agents and have not been proven
safe and efficacious. Durvalumab, docetaxel,
gemcitabine/nab-paclitaxel, FOLFOX and bevacizumab are owned by
companies other than Arcus and Gilead.
About the Gilead
Collaboration
In May 2020, Gilead and Arcus entered into a 10-year
collaboration that provided Gilead immediate rights to zimberelimab
and the right to opt into all other Arcus programs arising during
the collaboration term. In November 2021, Gilead and Arcus amended
the collaboration in connection with Gilead’s option exercise for
three of Arcus’s then-clinical stage programs. For all other
programs that are in clinical development or new programs that
enter clinical development thereafter, the opt-in payments are $150
million per program. Gilead’s option, on a program-by-program
basis, expires after a specified period of time following the
achievement of a development milestone for such program and Arcus’s
delivery to Gilead of the requisite qualifying data package.
Concurrent with the May 2020 collaboration agreement, Gilead and
Arcus entered into a stock purchase agreement under which Gilead
made a $200 million equity investment in Arcus. That stock purchase
agreement was amended and restated in February 2021 in connection
with Gilead’s increased equity stake in Arcus from 13% to 19.7%,
with an additional $220 million investment.
Upon closing of Gilead’s exercise of its option to a program,
the two companies will co-develop and share global development
costs for the joint development program, subject to certain opt-out
rights of Arcus in some cases and expense caps on its spending and
related subsequent adjustments. For each optioned program, provided
that Arcus has not exercised its opt-out rights, if any, Arcus has
an option to co-promote in the United States with equal profit
share. Gilead has the right to exclusively commercialize any
optioned programs outside of the U.S., subject to the rights of
Arcus’s existing collaboration partners to any territories, and,
for clinical stage programs that Gilead has opted into, Gilead will
pay Arcus tiered royalties as a percentage of revenues ranging from
the mid or high teens to the low twenties.
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
partners, patients and physicians around the world, Arcus is
expediting the development of first- or best-in-class medicines
against well characterized biology 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 six investigational medicines into clinical
studies, including new combination approaches that target TIGIT,
PD-1, the adenosine axis (CD73 and dual A2a/A2b) and most recently,
HIF-2alfa. For more information about Arcus Biosciences’s clinical
and pre-clinical programs, please visit www.arcusbio.com or follow
us on Twitter.
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 and cancer. Gilead operates in more than 35
countries worldwide, with headquarters in Foster City,
California.
Arcus Biosciences Forward-Looking
Statements
This press release contains forward-looking statements. All
statements regarding events or results to occur in the future
contained herein, including, but not limited to, the ability of the
parties to complete this transaction in a timely manner or at all
or achieve the expected benefits of this transaction, the
broadening of treatment combinations across the two companies, the
expansion of Arcus's clinical development activities, future growth
and the timing of future initiation of, enrolment in and data
releases from clinical trials, 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. 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:
the ability to obtain regulatory approval for the transaction;
dependence on the collaboration with Gilead for the successful
development and commercialization of Arcus’s investigational
products; difficulties associated with the management of the
collaboration activities or expanded clinical programs; risks
associated with preliminary and interim data; the unexpected
emergence of adverse events or other undesirable side effects; the
inherent uncertainty associated with the COVID-19 pandemic,
including the duration and/or severity of the pandemic and actions
by government authorities to contain or slow the spread of the
virus; 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 its quarterly report on Form 10-Q for the
quarter ended September 30, 2021, filed on November 8, 2021, with
the SEC. 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 parties’ ability to receive antitrust clearance under
the Hart-Scott Rodino Antitrust Improvements Act and close this
transaction in a timely manner or at all, Gilead’s ability to
realize the anticipated benefits from the collaboration;
difficulties or unanticipated expenses in connection with the
collaboration and the potential effects on Gilead’s earnings; the
ability of the companies to initiate, progress or complete clinical
trials within currently anticipated timelines or at all, including
those involving domvanalimab, AB308, etrumadenant and
quemliclustat; the possibility of unfavorable results from ongoing
or additional trials, including those involving domvanalimab,
AB308, etrumadenant and quemliclustat; uncertainties relating to
regulatory applications and related filing and approval timelines,
including the risk that regulatory authorities may not approve such
applications in the anticipated timelines or at all; the
possibility that the parties may make a strategic decision to
discontinue development of any of the investigational agents under
the collaboration and therefore these investigational agents may
never be successfully commercialized; the possibility that the
parties may make a strategic decision to terminate the
collaboration; 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, 2021, 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. Investors are cautioned that
any such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties and are 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.
Trodelvy, Gilead and the Gilead logo are trademarks of Gilead
Sciences, Inc., or its related companies.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211118005582/en/
Gilead Contacts:
Jacquie Ross, Investors (650) 358-1054
Nathan Kaiser, Media (650) 522-1853
Arcus Contact:
Holli Kolkey VP of Corporate Communications (650) 922-1269
hkolkey@arcusbio.com
Arcus Biosciences (NYSE:RCUS)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Arcus Biosciences (NYSE:RCUS)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024