Exelixis & StemSynergy Enter into Exclusive Licensing Agreement for the Discovery & Development of Novel Anticancer Therapies
January 08 2018 - 8:00AM
Business Wire
� Companies will partner on preclinical
activities and early-stage studies for program targeting Wnt
signaling pathway –
� StemSynergy’s novel approach has the
potential to address a major pathway deregulated in many cancers
–
Exelixis, Inc. (NASDAQ: EXEL) today announced that it has
entered into an exclusive collaboration and license agreement with
StemSynergy Therapeutics, Inc., (StemSynergy) for the discovery and
development of novel oncology compounds targeting Casein Kinase 1
alpha (CK1α), a component of the Wnt signaling pathway implicated
in key oncogenic processes. The agreement is part of Exelixis’
ongoing strategy to build an innovative pipeline beyond its two
internally-discovered, commercially available compounds,
cabozantinib and cobimetinib.
Under the terms of the agreement, Exelixis will partner with
StemSynergy to conduct preclinical and clinical studies with
compounds from StemSynergy’s CK1α Activator Program. Exelixis will
pay StemSynergy an upfront payment of $3M and up to $3.5M in
initial research and development funding. StemSynergy will be
eligible for a variety of milestones for the first product to
emerge from the collaboration, including preclinical and clinical
development and regulatory milestone payments, commercial
milestones, as well as single-digit royalties on worldwide sales.
Exelixis will be solely responsible for the commercialization of
products that arise from the collaboration.
“Supported by revenues from its commercial products and
collaborations, Exelixis is on a growth trajectory and now actively
focused on augmenting our pipeline both through targeted business
development and internal drug discovery activities,” said Peter
Lamb, Ph.D., Executive Vice President, Discovery Research and Chief
Scientific Officer of Exelixis. “CK1α activation is an
underexplored and intriguing mechanism for addressing the
Wnt/β-catenin axis, a major pathway deregulated in multiple
cancers. We look forward to working with StemSynergy to advance
this compelling program as we build the next generation of Exelixis
medicines.”
The CK1α Activator Program is representative of StemSynergy’s
focus on treating cancer by targeting developmental processes that
are reactivated in cancer cells. The Wnt signaling pathway is a
prominent example of this process: the pathway plays an important
role in embryonic development, but can support oncogenic processes
when deregulated in adult tissues. Activation of β-catenin, a key
downstream component of the pathway, is increased in multiple
tumors, including a majority of colorectal cancers, where mutations
in the APC gene that result in beta-catenin stabilization are
prevalent. CK1α Activator Program compounds have been shown to
induce degradation of β-catenin and pygopus, another member of the
pathway, in preclinical CRC models, and to inhibit the growth of
tumors. Importantly, their GI-sparing qualities may help overcome
limitations of other approaches targeting the Wnt pathway.
“StemSynergy is developing compounds that can specifically
address developmental pathways reactivated in cancer cells to
potentially deliver greater benefit to patients,” said Anthony J.
Capobianco, Ph.D., President and Co-Founder of StemSynergy. “Our
CK1α Activator Program has been supported in part by the National
Cancer Institute through the SBIR program. With deep drug discovery
and development expertise and a proven track record of successfully
bringing medicines to market, Exelixis is a natural partner for our
CK1α Activator Program as it advances. We look forward to
collaborating with the experienced Exelixis team to move the
program forward.”
About StemSynergy
StemSynergy Therapeutics is a biopharmaceutical company focused
on the discovery and development of novel small-molecule drugs that
target developmental pathways fundamental to cancer. Our mission is
to optimize efficacy against developmental pathways that drive
cancer cells, such as the Wnt, Sonic Hedgehog and Notch signaling
pathways. For more information, visit www.stemsynergy.com.
About Exelixis
Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is a
commercially successful, oncology-focused biotechnology company
that strives to accelerate the discovery, development and
commercialization of new medicines for difficult-to-treat cancers.
Following early work in model genetic systems, we established a
broad drug discovery and development platform that has served as
the foundation for our continued efforts to bring new cancer
therapies to patients in need. We discovered our lead compounds,
cabozantinib and cobimetinib, and advanced them into clinical
development before entering into partnerships with leading
biopharmaceutical companies in our efforts to bring them to
patients globally. We are steadfast in our commitment to prudently
reinvest in our business to maximize the potential of our pipeline.
We intend to supplement our existing therapeutic assets with
targeted business development activities and internal drug
discovery – all to deliver the next generation
of Exelixis medicines and help patients recover stronger
and live longer. Exelixis recently earned a spot on
Deloitte’s Technology Fast 500 list, a yearly award program
honoring the 500 fastest-growing companies over the past four
years. For more information about Exelixis, please
visit www.exelixis.com or follow @ExelixisInc on
Twitter.
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements,
including, without limitation, statements related to: Exelixis’
strategy to build an innovative pipeline beyond cabozantinib and
cobimetinib; Exelixis’ plans to conduct preclinical and clinical
studies with compounds from StemSynergy’s CK1α Activator Program;
Exelixis’ immediate and potential future financial obligations
under the collaboration and license agreement with StemSynergy;
Exelixis’ responsibility for the commercialization of products that
arise from the collaboration and license agreement with
StemSynergy; Exelixis’ growth trajectory and focus on augmenting
its pipeline both through targeted business development and
internal drug discovery activities; the clinical and therapeutic
potential of the StemSyngery CK1α Activator Program and ability to
deliver greater benefit to patients; Exelixis’ commitment to
reinvesting in its business to maximize the potential of its
pipeline; and Exelixis’ mission to deliver the next generation
of Exelixis medicines and help patients recover stronger
and live longer. Words such as “strategy,” “will,” “focused,” “look
forward,” “potential,” “may,” “commitment,” “intend,” or other
similar expressions identify forward-looking statements, but the
absence of these words does not necessarily mean that a statement
is not forward-looking. In addition, any statements that refer to
expectations, projections or other characterizations of future
events or circumstances are forward-looking statements. These
forward-looking statements are based upon Exelixis’ current plans,
assumptions, beliefs, expectations, estimates and projections.
Forward-looking statements involve risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in the forward-looking statements as a result of these
risks and uncertainties, which include, without limitation:
Exelixis’ ability and the ability of its collaborators to conduct
preclinical studies and clinical trials of the products in its
pipeline sufficient to achieve a positive completion; risks related
to the potential failure of the products in Exelixis’ pipeline to
demonstrate safety and efficacy in clinical testing; risks and
uncertainties related to regulatory review and approval processes
and Exelixis’ compliance with applicable legal and regulatory
requirements; the level of costs associated with Exelixis’
commercialization, research and development and other activities;
competition in the area of business development activities and the
inherent uncertainty of the drug discovery process; Exelixis’
dependence on its relationships with its cabozantinib collaboration
partners, including, the level of their investment in the resources
necessary to successfully commercialize cabozantinib in the
territories where it is approved; Exelixis’ dependence on its
relationship with Genentech/Roche with respect to cobimetinib
and Exelixis’ ability to maintain its rights under the
collaboration; market acceptance of CABOMETYX, COMETRIQ, and
COTELLIC and the availability of coverage and reimbursement for
these products; Exelixis’ dependence on third-party vendors for the
development, manufacture and supply of its products; Exelixis’
ability to protect the company’s intellectual property rights;
market competition; changes in economic and business conditions,
and other factors discussed under the caption “Risk Factors” in
Exelixis’ quarterly report on Form 10-Q filed with
the Securities and Exchange Commission (SEC)
on November 1, 2017, and in Exelixis’ future filings with
the SEC. The forward-looking statements made in this press
release speak only as of the date of this press
release. Exelixis expressly disclaims any duty,
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Exelixis’ expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statements are based.
Exelixis, the Exelixis logo,
CABOMETYX, COMETRIQ and COTELLIC are registered U.S.
trademarks.
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version on businesswire.com: http://www.businesswire.com/news/home/20180108005735/en/
Investors Contact:Exelixis, Inc.Susan Hubbard,
650-837-8194EVP, Public Affairs and Investor
Relationsshubbard@exelixis.comorMedia Contact:For Exelixis,
Inc.Hal Mackins, 415-994-0040hal@torchcommunications.com
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