Mirati Therapeutics, Inc. 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. 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.