Incyte And Mirati Therapeutics Enter Into Clinical Trial Collaboration And Supply Agreement

WILMINGTON, Del. & SAN DIEGO, Calif.–(BUSINESS WIRE)–Incyte and Mirati Therapeutics, 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.

“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.