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IDEAYA Biosciences Announces US FDA IND-Clearance for IDE849, a Potential First-in-Class DLL3 TOP1 ADC, for a Phase 1 Study in Solid Tumors
Targeting to evaluate IDE849 (SHR-4849) in SCLC, NETs, and other DLL3-upregulated solid tumors, and in combination with IDE161/PARG to potentially enhance
About this update from Ideaya Biosciences, Inc.
[{"type":"text","content":"Targeting to evaluate IDE849 (SHR-4849) in SCLC, NETs, and other DLL3-upregulated solid tumors, and in combination with IDE161/PARG to potentially enhance durabilityTargeting to present clinical data of over 40 SCLC patients, including the dose escalation and expansion, from partner Hengrui at medical conference in Q3 2025SOUTH SAN FRANCISCO, Calif., May 6, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE849 (SHR-4849), a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, in solid tumors.\n\n \n \n \n \n \n \n\n \n\"We are excited to advance IDE849, a potential first-in-class DLL3 TOP1 ADC, into a Phase 1 study in the U.S. DLL3 is upregulated in multiple solid tumor types, including small cell lung cancer (SCLC), neuroendocrine tumors (NETs), non-small cell lung cancer (NSCLC), melanoma, among other solid tumors, highlighting the potential to have a pipeline in a single asset. We look forward to the IDE849 clinical data update in SCLC at a medical conference in Q3 2025, including at multiple expansion doses,\" said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.\n\"IDE849 is a potential first-in-class DLL3 TOP1 ADC, a target antigen that has demonstrated preliminary monotherapy clinical validation in SCLC. In addition, IDE849 aligns with our strategy to develop rational combination therapies, particularly with our potential first-in-class Phase 1 PARG inhibitor IDE161, where we have generated preclinical combination data with TOP1-based ADCs that demonstrates combination synergy and enhanced durability,\" said Dr. Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.\nIDE849 is in an ongoing multi-site open label Phase 1 clinical trial for advanced solid tumors (NCT06443489) by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma, SHA: 600276). In this ongoing Phase 1 study, IDE849 has reached therapeutic dose levels where multiple partial responses have been observed as of the data cut-off date of December 10, 20...