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IDEAYA Biosciences Announces IND Submission for IDE892, a Potential Best-In-Class PRMT5 Inhibitor for MTAP-Deletion Solid Tumors
Prnewswire· 2025-09-03 10:00
Core Insights - IDEAYA Biosciences has submitted an IND application to the FDA for IDE892, a potential best-in-class MTA-cooperative inhibitor of PRMT5, targeting MTAP-deleted lung cancer [1][2] - The company plans to initiate a Phase 1 dose escalation trial for IDE892 in Q4 2025 and aims to start combination trials with IDE397 in H1 2026 [1][6] Company Overview - IDEAYA is focused on precision medicine in oncology, developing transformative therapies for cancer through small-molecule drug discovery, structural biology, and bioinformatics [4] - The company has a robust pipeline targeting synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications [4] Market Opportunity - Approximately 15-20% of non-small cell lung cancer (NSCLC) cases are MTAP-deleted, presenting a significant unmet need for targeted therapies [2] - The combination of IDE892 and IDE397 is expected to enhance anti-tumor activity, creating a promising combination therapy opportunity [2][3] Upcoming Events - IDEAYA will present the preclinical profile of IDE892 and its combination rationale with IDE397 at the 10-Year Anniversary R&D Day on September 8, 2025 [6]
IDEAYA Biosciences Announces Phase 1/2 Expansion for IDE397 and Trodelvy® Combination in MTAP-Deletion Urothelial Cancer
Prnewswire· 2025-04-10 10:00
Core Insights - IDEAYA Biosciences has initiated a Phase 1/2 expansion clinical trial for IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy for treating MTAP-deletion urothelial cancer based on preliminary safety and efficacy data [1][10]. Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics to identify patient populations that would benefit most from its therapies [8]. Clinical Development - The combination of IDE397 and Trodelvy is being explored due to the high unmet medical need in MTAP-deletion urothelial cancer, where no approved therapies currently exist [3]. - The prevalence of MTAP-deletion in urothelial cancer is estimated to be around 26% [2][10]. - A clinical program update regarding the IDE397 and Trodelvy combination is expected in 2025, alongside other studies for IDE397 as a monotherapy in MTAP-deletion non-small cell lung cancer (NSCLC) and urothelial cancer [5]. Collaboration and Rights - IDEAYA and Gilead retain commercial rights to their respective compounds under a clinical study collaboration and supply agreement, with IDEAYA acting as the study sponsor [6].