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

Core Insights - IDEAYA Biosciences has received FDA clearance for an IND application to initiate a Phase 1 clinical trial for IDE849, a potential first-in-class DLL3-targeting Topo-I-payload ADC in solid tumors [1][2] Group 1: Clinical Development - IDE849 is advancing into a Phase 1 study in the U.S., targeting DLL3, which is upregulated in various solid tumors such as SCLC, NETs, and NSCLC, indicating a strong potential for a single asset pipeline [2][6] - The ongoing multi-site open label Phase 1 clinical trial for IDE849 has shown multiple partial responses, with treatment-related adverse events primarily being Grade 1 or 2, and no drug-related discontinuations reported [4][8] - IDEAYA plans to present clinical efficacy and safety data on IDE849 from over 40 SCLC patients at a medical conference in Q3 2025 [4][10] Group 2: Combination Therapies - IDE849 aligns with IDEAYA's strategy to develop rational combination therapies, particularly with the potential first-in-class Phase 1 PARG inhibitor IDE161, which has shown preclinical synergy with TOP1-based ADCs [3][5] - The company aims to evaluate IDE849 in combination with IDE161/PARG to enhance the durability of its ADC pipeline [5][7] Group 3: Market Potential - DLL3's limited expression in normal tissues and its upregulation in multiple solid tumor types highlight its promise as a therapeutic target, addressing significant unmet medical needs in oncology [6][11] - IDEAYA's approach integrates capabilities in identifying translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies [11]