Taiho Pharmaceutical Exercises Option for an Exclusive License to Quemliclustat in Japan and Certain Territories in Asia
08 Julio 2024 - 5:00PM
Business Wire
Arcus Biosciences, Inc. (NYSE:RCUS) and Taiho Pharmaceutical
Co., Ltd. (“Taiho”) today announced that Taiho exercised its option
for quemliclustat (International Nonproprietary Name; development
code: AB680), an investigational small molecule CD73 inhibitor, in
Japan and certain other territories in Asia (excluding mainland
China). This option exercise is based on an option and license
agreement between Taiho and Arcus contracted in September 2017.
This is the fourth option exercise by Taiho to an Arcus
program.
In exchange for the exclusive license of quemliclustat, Taiho
will make an option exercise payment, as well as additional
payments upon achievement of clinical, regulatory and
commercialization milestones, and, if any products from the program
are approved, will pay royalties on net sales of such products.
Quemliclustat is an investigational small molecule CD73
inhibitor. In 2024, Arcus plans to initiate the global,
registrational Phase 3 study PRISM-1, comparing quemliclustat plus
chemotherapy to chemotherapy alone as a treatment for patients with
previously untreated metastatic pancreatic ductal adenocarcinoma
(mPDAC). Advancement to a Phase 3 study is based on overall
survival results observed in the Phase 1b ARC-8 study that were
presented earlier this year at the American Society of Clinical
Oncology Gastrointestinal (ASCO GI) Cancers Symposium.
Through this collaboration, Taiho will further support the
development and potential commercialization of quemliclustat and
will operationalize the PRISM-1 study in Japan as part of its
mission to deliver innovative drugs to patients and medical
professionals.
About Quemliclustat
Quemliclustat is an investigational small molecule CD73
inhibitor. CD73 is the primary enzymatic producer of
immunosuppressive adenosine in the tumor microenvironment, and high
CD73 expression is associated with significantly poorer prognosis
in several tumor types. Quemliclustat has been shown to block the
production of adenosine. Once the immunosuppressive effects of
adenosine are removed, activation of antitumor immune cells may be
restored, resulting in cancer cell death.
In addition to the planned registrational Phase 3 study PRISM-1
by Arcus, quemliclustat is being co-developed by Arcus and Gilead
Sciences in combination with other molecules within the companies’
portfolios with chemotherapy, including Phase 2 studies in lung and
upper gastrointestinal cancers. Quemliclustat is an investigational
medicine and is not approved for use globally.
About Taiho and Arcus Agreement
Based on the option and license agreement that Taiho and Arcus
entered into in 2017, Taiho has obtained exclusive development and
commercialization rights to a total of four programs in Japan and
certain other territories in Asia (excluding mainland China): (1)
quemliclustat, CD73 inhibitor program, announced today; (2)
etrumadenant, a dual A2a/b adenosine receptor antagonist program in
2018; (3) zimberelimab, the anti-PD-1 program in 2019; and 4)
domvanalimab and AB308, both the anti-TIGIT program in 2021.
For other territories in the world, Gilead obtained the rights
to commercialize in the U.S. and to co-promote with Arcus, and
Gilead has exclusive rights to develop and commercialize outside
the U.S.
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- and 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 pre-clinical programs, please
visit www.arcusbio.com.
About Taiho Pharmaceutical Co., Ltd. (Japan)
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd.
(https://www.otsuka.com/en/), is an R&D-driven specialty pharma
focusing on the fields of oncology and immune-related diseases. Its
corporate philosophy takes the form of a pledge: “We strive to
improve human health and contribute to a society enriched by
smiles.” In the field of oncology, in particular, Taiho
Pharmaceutical is known as a leading company in Japan for
developing innovative medicines for the treatment of cancer, a
reputation that is rapidly expanding through their extensive global
R&D efforts. In areas other than oncology, as well, the company
creates and markets quality products that effectively treat medical
conditions and can help improve people’s quality of life. Always
putting customers first, Taiho Pharmaceutical also aims to offer
consumer healthcare products that support people’s efforts to lead
fulfilling and rewarding lives. For more information about Taiho
Pharmaceutical, please visit https://www.taiho.co.jp/en
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: statements regarding
events or results to occur in the future contained herein,
including, but not limited to, Arcus’s receipt of milestones or
royalties; the planning and initiation of additional clinical
development activities, including activities related to PRISM-1;
and realization of any potential benefits from this transaction.
All forward-looking statements involve known and unknown risks and
uncertainties and other important factors that may cause Arcus’
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: difficulties associated with the management
of the collaboration activities or expanded clinical programs; data
from ARC-8 may not be replicated in future studies evaluating the
same investigational molecules or regimen, including PRISM-1; the
unexpected emergence of adverse events or other undesirable side
effects 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 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 except to the extent required by
law.
The Arcus name and logo are trademarks of Arcus Biosciences,
Inc. All other trademarks belong to their respective owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20240708514610/en/
Arcus Investor Inquiries: Pia Eaves Head of Investor
Relations & Strategy (617) 459-2006 peaves@arcusbio.com
Arcus Media Inquiries: Holli Kolkey VP of Corporate
Communications (650) 922-1269 hkolkey@arcusbio.com
Taiho Pharmaceutical Co., Ltd. Inquiries: Yuji Kawahara
Strategic Communications +81-3-3293-2878 th-koho@taiho.co.jp
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