Mirati Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration of MRTX1719 to Treat MTAP-Deleted Cancers

SAN DIEGO, CA, USA I November 17, 2021 I Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate the Company's synthetic lethal PRMT5 inhibitor, MRTX1719, for the treatment of methylthioadenosine phosphoylase (MTAP)-deleted cancers.

MRTX1719 has demonstrated in preclinical studies to be a potent, selective inhibitor of the PRMT5 / methylthioadenosine (MTA) complex. This targeting strategy leverages the abnormally elevated levels of MTA present in MTAP-deleted cancers. As a result, MRTX1719 is able to selectively target the essential PRMT5 protein in MTAP-deleted cancer cells while sparing healthy non-tumor cells. MTAP gene deletions occur in approximately 10% of all cancers including pancreatic, lung, and bladder cancers, as well as other patient populations that have limited treatment options. Preclinical data for MRTX1719 were first presented at the 2021 AACR-NCI-EORTC Virtual International Conference.

"We are excited to take this next step in the advancement of MRTX1719 to clinical trials," said James Christensen, Ph.D., chief scientific officer, Mirati Therapeutics, Inc. "MRTX1719 was discovered and developed internally at Mirati, representing an important milestone for the Company's continued expansion of its pipeline and further reinforcing our differentiated end-to-end drug discovery and development capabilities. We look forward to further evaluating MRTX1719 as a potentially best-in-class treatment for patients living with MTAP-deleted cancers."

The Phase 1/2 clinical development strategy for MRTX1719 is designed to establish a Phase 2 dose and assess the safety, pharmacokinetics and initial clinical activity of MRTX1719 in patients with MTAP-deleted cancers. The Company expects to initiate a Phase 1/2 clinical trial in the first quarter of 2022, pending IND clearance from the FDA.

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, 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.  

SOURCE: Mirati Therapeutics

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