Incyte (NASDAQ:INCY) and Mirati Therapeutics, Inc.
(NASDAQ:MRTX), a clinical-stage targeted oncology company, today
announced a clinical trial collaboration and supply agreement to
investigate the combination of INCB99280, Incyte’s small molecule
PD-L1 inhibitor, and adagrasib, a KRASG12C selective inhibitor.
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“While monoclonal antibodies targeting PD‑L1 or PD-1 have
transformed the treatment landscape in oncology, they are limited
by their route of administration and long-half life and receptor
occupancy which can affect the management of immune-related adverse
events,” said Lance Leopold, M.D., Group Vice President, Clinical
Development Hematology and Oncology, Incyte. “Incyte’s small
molecule, oral PD-L1 program has shown promising safety and
efficacy in early studies – INCB99280’s shorter half life may
result in improved management of immune mediated adverse events and
better clinical outcomes. We are pleased to collaborate with Mirati
to conduct the first clinical trial of INCB99280 plus adagrasib,
two orally-bioavailable molecules, in patients with
KRASG12C-mutated solid tumors.”
“We are pleased to enter into this agreement with Incyte,
supplying adagrasib for evaluation in combination with INCB99280,”
said Charles Baum, M.D., Ph.D., President, Founder and Head of
Research and Development, Mirati Therapeutics, Inc. “This agreement
is part of our rational combination strategy for adagrasib and
further demonstrates our focus to evaluate this asset in a broad
range of combinations, including with novel approaches to
checkpoint inhibition, to benefit people living with
difficult-to-treat cancers.”
Under the terms of the agreement, Incyte will initiate and
sponsor the Phase 1/1b study of INCB99280 and adagrasib in patients
with KRASG12C-mutated solid tumors. Mirati will supply Incyte with
adagrasib for the study.
About INCB99280
INCB099280 is a potent and selective small molecule oral PD-L1
inhibitor which has demonstrated promising clinical activity and
safety in patients with solid tumors. INCB099280 will be evaluated
in Phase 2 studies as monotherapy and in combination with other
antitumor agents.
About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent
oral small-molecule inhibitor of KRASG12C that is optimized to
sustain target inhibition, an attribute that could be important to
treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates
every 24-48 hours. Studies of adagrasib have shown that the drug
has a long half-life and extensive tissue distribution, and is well
tolerated. In clinical trials, adagrasib also has shown, central
nervous system penetrance and single-agent responses in non-small
cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer and
other solid tumors with KRASG12C mutations. Adagrasib is being
evaluated in several clinical trials in combination with other
anti-cancer therapies in patients with advanced solid tumors.
Registration-enabling studies are ongoing in NSCLC and colorectal
cancer. For more information visit Mirati.com/science.
About Incyte
Incyte is a Wilmington, Delaware-based global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
About Mirati Therapeutics, Inc.
Mirati Therapeutics Inc., is a clinical-stage biotechnology
company whose mission is to discover, design and deliver
breakthrough therapies to transform the lives of patients with
cancer and their loved ones. The company is relentlessly focused on
bringing forward therapies that address areas of high unmet need,
including lung cancer, and advancing a pipeline of novel
therapeutics targeting the genetic and immunological drivers of
cancer. Mirati is using its scientific expertise to develop novel
solutions in two registration-enabling programs: adagrasib
(MRTX849), an investigational small molecule, potent and selective
KRASG12C inhibitor, as monotherapy and in combination with other
agents, and sitravatinib, an investigational spectrum-selective
inhibitor of receptor tyrosine kinases in combination with
checkpoint inhibitor therapies. Mirati is also advancing its
differentiated preclinical portfolio, including MRTX1133, an
investigational KRASG12D inhibitor, and other oncology discovery
programs. Unified for patients, Mirati's vision is to unlock the
science behind the promise of a life beyond cancer.
For more information about Mirati Therapeutics Inc., visit us at
Mirati.com or follow us on Twitter, LinkedIn and Facebook.
Incyte Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding the potential of INCB99280 and/or adagrasib to treat
patients with KRASG12C-mutated solid tumors or for any other
indication, contain predictions, estimates and other
forward-looking statements.
These forward-looking statements are based on Incyte‘s current
expectations and are subject to risks and uncertainties that may
cause actual results to differ materially, including unanticipated
developments in and risks related to: unanticipated delays; further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials; the
effects of the COVID-19 pandemic and measures to address the
pandemic on Incyte‘s clinical trials, supply chain, other
third-party providers and development and discovery operations;
determinations made by regulatory authorities; Incyte‘s dependence
on its relationships with its collaboration partners; the efficacy
or safety of Incyte‘s products and the products of Incyte‘s
collaboration partners; the acceptance of Incyte‘s products and the
products of Incyte‘s collaboration partners in the marketplace;
market competition; sales, marketing, manufacturing and
distribution requirements; and other risks detailed from time to
time in Incyte‘s reports filed with the Securities and Exchange
Commission, including its annual report and its quarterly report on
Form 10-Q for the quarter ended September 30, 2022. Incyte
disclaims any intent or obligation to update these forward-looking
statements.
Mirati Therapeutics, Inc. Forward Looking Statements
This press release contains forward-looking statements regarding
the business of Mirati Therapeutics, Inc. (“Mirati”). Any statement
describing Mirati's goals, expectations, financial or other
projections, intentions or beliefs, development plans and the
commercial potential of Mirati's drug development pipeline,
including without limitation adagrasib (selective KRASG12C
inhibitor), sitravatinib (TAM receptor inhibitor), MRTX1719 (MTA
cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and
MRTX1133 (selective KRASG12D inhibitor), is a forward-looking
statement and should be considered an at-risk statement. Such
statements are subject to risks and uncertainties, particularly
those challenges inherent in the process of discovering, developing
and commercialization of new drug products that are safe and
effective for use as human therapeutics, and in the endeavor of
building a business around such drugs.
Mirati’s forward-looking statements also involve assumptions
that, if they never materialize or prove correct, could cause its
results to differ materially from those expressed or implied by
such forward-looking statements. Although Mirati’s forward-looking
statements reflect the good faith judgment of its management, these
statements are based only on facts and factors currently known by
Mirati. As a result, you are cautioned not to rely on these
forward-looking statements. These and other risks concerning
Mirati’s programs are described in additional detail in Mirati’s
quarterly reports on Form 10-Q and annual reports on Form 10-K,
which are on file with the U.S. Securities and Exchange Commission
(the “SEC”) available at the SEC’s Internet site (www.sec.gov).
Mirati assumes no obligation to update the forward-looking
statements, or to update the reasons why actual results could
differ from those projected in the forward-looking statements,
except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20221106005116/en/
Incyte:
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
Mirati:
Media media@mirati.com
Investors ir@mirati.com
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