Incyte And Mirati Therapeutics Enter Into Clinical Trial Collaboration and Supply Agreement to Evaluate INCB99280 and Adagrasib in Patients with KRASG12C-Mutated Solid Tumors

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 KRAS^G12C 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 KRAS^G12C-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 KRAS^G12C-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 KRAS^G12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRAS^G12C-mutated cancers, as the KRAS^G12C 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 KRAS^G12C 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 KRAS^G12C 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 KRAS^G12D 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 KRAS^G12C-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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