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Mirati Therapeutics' KRAS G12D Inhibitor Cleared by FDA to Begin Phase I/II Trial

NEW YORK – Mirati Therapeutics on Thursday said the US Food and Drug Administration cleared its investigational new drug (IND) application for MRTX1133, a KRAS G12D inhibitor, to be evaluated in clinical trials.

San Diego-based Mirati expects to begin a Phase I/II clinical trial of MRTX1133 early this year in patients with KRAS G12D-mutant tumors, with planned expansion cohorts in pancreatic, colorectal, and lung cancers.

"The clearance by the FDA to initiate clinical evaluation of MRTX1133, the third program in our KRAS franchise to enter clinical development, is illustrative of the innovative approach to drug discovery and demonstrates the best-in-class capabilities of the Mirati team," Mirati CSO James Christensen said in a statement. "This particular mutation has been difficult to target, and we are confident in our novel oral formulation strategy, which we believe will enable near-complete target inhibition over the full dosing interval."

KRAS G12D mutations occur in approximately 180,000 patients in the US and Europe, according to Mirati, more than twice as prevalent as KRAS G12C mutations.

In December, Mirati received its first FDA approval of its KRAS G12C inhibitor Krazati (adagrasib) in advanced KRAS G12C-mutant non-small cell lung cancer. The firm has two other programs in clinical studies: sitravatinib, a spectrum-selective kinase inhibitor being studied in NSCLC, and PRMT5 inhibitor MRTX1719 in MTAP-deleted cancers.