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Mirati Therapeutics Submits IND to FDA for PRMT5 Inhibitor in MTAP-Deleted Cancers

NEW YORK – Mirati Therapeutics said on Wednesday that it has submitted an investigational new drug application to the US Food and Drug Administration to begin human trials evaluating its PRMT5 inhibitor, MRTX1719, for cancers with MTAP gene deletions.

Specifically, Mirati aims to begin a Phase I/II clinical trial — potentially during the first quarter of 2022 and contingent on FDA IND clearance — evaluating the safety, pharmacokinetics, and initial clinical activity of the drug. It also will aim to identify a recommended Phase II dose of MRTX1719 in patients with MTAP-deleted cancers such as pancreatic, lung, and bladder cancers. Roughly 10 percent of cancers harbor MTAP gene deletions.

According to Mirati, preclinical studies have shown that MRTX1719 can potently and selectively inhibit the PRMT5/methylthioadenosine (MTA) complex, which is elevated in MTAP-deleted cancers, while sparing healthy tissue.

"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," James Christensen, Mirati's CSO, said in a statement.

Beyond MRTX1719, the San Diego-based firm has several key targeted oncology agents in its pipeline, including the KRAS inhibitor adagrasib, which is currently in registration-directed trials for certain KRAS G12C-mutated cancers.