On April 22, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported selection of a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous non-small cell lung cancer (NSCLC), based on adverse event profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1 (Press release, Ideaya Biosciences, APR 22, 2024, View Source [SID1234642219]).
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"We are excited to select a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous NSCLC, based on AE profile and multiple responses observed at this dose. We believe MTAP-deletion squamous NSCLC is an area of high unmet medical need, and we are excited to further evaluate clinically our potential first-in-class MAT2A inhibitor IDE397 in this tumor setting, while in parallel advancing multiple rational combinations with our pharma collaborators and internal wholly owned pipeline," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
"We believe IDE397 is well positioned as a potential first-in-class MAT2A inhibitor and encouraged to see preliminary translation of our preclinical activities to the clinic in the MTAP-deletion squamous NSCLC setting. Next, through this year we look forward to the potential to clinically validate several important preclinical hypotheses we have generated on several mechanistically high conviction rational combinations in the MTAP-deletion setting," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.
IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2 alpha (MAT2A) in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The Company continues to focus on evaluating IDE397 in two trials, including as monotherapy and in multiple clinical combinations:
IDE397-001 (NCT04794699) is a Phase 2 monotherapy expansion of IDE397 in MTAP-deletion solid tumors
Phase 1/2 trial of IDE397 + AMG 193 in MTAP-Deletion NSCLC (Amgen-sponsored study, NCT05975073)
Phase 1 trial of IDE397 + Trodelvy in MTAP-deletion bladder cancer (IDEAYA-sponsored, NCT04794699)