Mirati Therapeutics to Collaborate with Sanofi on Phase 1/2 Study Evaluating Combination of adagrasib with a SHP2 Inhibitor in KRAS G12C-mutated Lung Cancer

Rhea-AI Summary

Mirati Therapeutics (NASDAQ: MRTX) announced a clinical collaboration with Sanofi to evaluate the combination of adagrasib, a KRAS^G12C inhibitor, with Sanofi's SAR442720 (RMC-4630), an SHP2 inhibitor. This Phase 1/2 study will focus on patients with previously-treated non-small cell lung cancer (NSCLC) harboring KRAS^G12C mutations. The collaboration aims to optimize clinical outcomes and shares study costs. Mirati is advancing a robust development program for adagrasib, targeting high unmet needs in oncology.

Positive

• Collaboration with Sanofi may enhance clinical outcomes for NSCLC patients.
• Strong scientific rationale for combining SHP2 and adagrasib to improve efficacy.
• Mirati is advancing a broad development program for adagrasib, focusing on high unmet medical needs.

Negative

• Risks associated with early-stage clinical trials and uncertainties in drug development.

SAN DIEGO, Oct. 7, 2021 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced a non-exclusive clinical collaboration agreement with Sanofi to evaluate the combination of adagrasib, the Company's investigational KRAS^G12C inhibitor, with Sanofi's investigational SHP2 inhibitor SAR442720, also known as RMC-4630. The Phase 1/2 dose escalation and expansion study will evaluate the combination in patients with previously-treated non-small cell lung cancer (NSCLC) and KRAS^G12C mutations.   

"Mirati is aggressively advancing a broad adagrasib development program, which includes pursuing novel combination approaches including through this collaboration with Sanofi," said Charles M. Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc. "There is strong scientific rationale for combining a SHP2 inhibitor with adagrasib, which may help optimize clinical outcomes for patients with KRAS^G12C-dependent tumors."

SHP2 is upstream of KRAS and mediates cellular signaling through the RAS/MAP kinase pathway and is frequently overactive in various types of cancer. KRAS^G12C inhibition and SHP2 inhibition have complementary mechanisms of action and have demonstrated additive anti-tumor activity in pre-clinical models. 

Under the terms of the agreement, Sanofi will be responsible for sponsoring and operating the Phase 1/2 study, and jointly with Mirati, will oversee and share costs of the study.

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. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRAS^G12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

About SAR442720 (RMC-4630)

SAR442720 (RMC-4630) is a potent and orally bioavailable small molecule that is designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a central role in modulating cell survival and growth by transmitting signals from receptor tyrosine kinases to RAS. SAR442720 (RMC-4630) is the focus of an exclusive global development and commercialization agreement between Sanofi and Revolution Medicines.

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, MRTX1719, an investigational PRMT5 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 and LinkedIn.   

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 (MRTX849), sitravatinib, MRTX1719 and MRTX1133, 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).These forward-looking statements are made as of the date of this press release, and 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. 

Mirati Contacts

Investor Relations: Temre Johnson | 858-332-3562 | ir@mirati.com

Media Relations: Priyanka Shah | 908-447-6134 | media@mirati.com

 

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SOURCE Mirati Therapeutics, Inc.

FAQ

What is the purpose of the Phase 1/2 study involving MRTX and Sanofi?

The study aims to evaluate the combination of adagrasib (MRTX849) and SAR442720 in patients with previously-treated non-small cell lung cancer (NSCLC) with KRAS^G12C mutations.

When was the collaboration between Mirati and Sanofi announced?

The collaboration was announced on October 7, 2021.

What are the expected outcomes of the adagrasib and SAR442720 combination study?

The study aims to optimize clinical outcomes for patients by leveraging the complementary mechanisms of action of both drugs.

What is the significance of the KRAS^G12C mutation in lung cancer?

KRAS^G12C mutations are commonly associated with non-small cell lung cancer and are a target for specific therapies like adagrasib.