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

Rhea-AI Summary

Mirati Therapeutics (NASDAQ: MRTX) has submitted an Investigational New Drug (IND) application to the FDA for MRTX1719, a PRMT5 inhibitor targeting methylthioadenosine phosphoylase (MTAP)-deleted cancers. Preclinical studies indicate that MRTX1719 selectively inhibits tumor cells with MTAP deletions, which occur in about 10% of cancers, including pancreatic and lung cancers. A Phase 1/2 clinical trial is planned for Q1 2022, pending FDA clearance. This marks a significant step in advancing Mirati's oncology pipeline and reinforces its commitment to innovative cancer therapies.

Positive

• Submission of IND application for MRTX1719 targeting MTAP-deleted cancers.
• MRTX1719 demonstrated potent selective inhibition in preclinical studies.
• Potential to address unmet needs in treatment of cancers with MTAP deletions.
• Plans for a Phase 1/2 clinical trial to advance MRTX1719.

Negative

• None.

SAN DIEGO, Nov. 17, 2021 /PRNewswire/ -- 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 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 MRTX1719 and its intended use?

MRTX1719 is a PRMT5 inhibitor developed by Mirati Therapeutics for treating methylthioadenosine phosphoylase (MTAP)-deleted cancers.

When does Mirati Therapeutics plan to start MRTX1719 clinical trials?

The Phase 1/2 clinical trial for MRTX1719 is expected to begin in the first quarter of 2022, pending FDA clearance.

What types of cancers are targeted by MRTX1719?

MRTX1719 targets cancers with MTAP deletions, which occur in approximately 10% of all cancers, including pancreatic, lung, and bladder cancers.

What is the significance of the IND application for Mirati Therapeutics?

The IND application submission for MRTX1719 marks a critical milestone in expanding Mirati's oncology pipeline and showcases their drug discovery capabilities.