On September 3, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE892, a potential best-in-class MTA-cooperative inhibitor of PRMT5 (Press release, Ideaya Biosciences, SEP 3, 2025, View Source [SID1234655741]). The company is targeting to begin a Phase 1 dose escalation trial of IDE892 in MTAP-deleted lung cancer in the fourth quarter of 2025, with the goal of advancing into combination trials with IDE397, IDEAYA’s proprietary MAT2A inhibitor, in the first half of 2026.
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Approximately 15-20% of non-small cell lung cancer (NSCLC) is MTAP-deleted. Extensive studies indicate that elevated MTA/SAM ratios in MTAP-deleted cancers create a tumor-specific vulnerability to MTA-cooperative PRMT5 inhibition. This effect is substantially enhanced in combination with MAT2A inhibition, leading to an important combination therapy opportunity in an area of substantial unmet need. In addition to MTAP-deleted lung cancer, IDEAYA will target to clinically evaluate other high priority MTAP solid tumor indications as both IDE892 monotherapy and in combination with IDE397.
"We are excited to advance IDE892 into clinical studies for patients with MTAP-deleted lung cancer, where we believe the inhibition of PRMT5 in combination with MAT2A could have synergistic anti-tumor activity," said Michael White, Chief Scientific Officer, IDEAYA Biosciences. "IDE892 is the culmination of a comprehensive optimization of the biophysical and pharmacokinetic properties required to maximize therapeutic benefit as a combination partner with IDE397, and to generate a potential best-in-class MTA-cooperative PRMT5 inhibitor profile."
Registration for IDEAYA’s 10-Year Anniversary R&D Day can be accessed here or at the investors section of the IDEAYA website at View Source