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IDEAYA Announces IND Clearance Enabling Phase 1/2 Clinical Trial for Combination of IDE397 and AMG 193 in MTAP-Deletion Solid Tumors
IDE397 (MAT2A) and AMG 193 (PRMT5) combination being evaluated in an Amgen-sponsored Phase 1/2 clinical trial in MTAP-deletion solid tumorsPotential
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"IDE397 (MAT2A) and AMG 193 (PRMT5) combination being evaluated in an Amgen-sponsored Phase 1/2 clinical trial in MTAP-deletion solid tumorsPotential first-in-class synthetic lethality combination targets mechanistically complementary nodes of the MTAP methylation pathway – MAT2A and PRMT5Compelling preclinical anti-tumor efficacy presented at AACR 2023 with durable CRs for IDE397 / AMG 193 combination, each at doses below maximally efficacious doseSOUTH SAN FRANCISCO, Calif., May 22, 2023 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Amgen-sponsored Investigational New Drug (IND) application and concluded that the proposed clinical study may proceed to evaluate IDE397 in combination with AMG 193 in solid tumors having MTAP deletion.\n\n \n \n \n \n \n \n\n \n\"We are pleased to collaborate with Amgen to clinically evaluate the IDE397 and AMG 193 combination as a potential first-in-class treatment for patients having solid tumors with MTAP deletion. We believe that evaluation of this combination represents an exciting and highly rational clinical study for patients with MTAP-deletion tumors, based on the observed preclinical efficacy, tolerability and selectivity,\" said Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.\n\"We have a deep understanding of the underlying biological rationale for this combination of a MAT2A inhibitor and an MTA-cooperative PRMT5 inhibitor. As presented at AACR 2023, gene expression analysis of hallmark pathways, alternative splicing analysis and retained intron analysis collectively demonstrate that combined pharmacological inhibition of MAT2A and PRMT5 deepens the biological response through maximal pathway suppression. The enhanced combination effect was observed selectively in MTAP-null models,\" said Dr. Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.\nIDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A). IDEAYA is clinically evaluating IDE397 as monotherapy in a Phase 1/2 clinical trial in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, with ongoing...