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

CAR-T Digest - August 2020

Weekly Digest - May 2025

06 May 2025: 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

IDEAYA Biosciences received FDA clearance to initiate a U.S. Phase 1 clinical trial for IDE849, a potential first-in-class DLL3-targeting Topo-I antibody-drug conjugate (ADC) for treating various solid tumors
IDE849 has shown preliminary efficacy in an ongoing Phase 1 trial by Hengrui Pharma, with multiple partial responses and mostly mild to moderate treatment-related side effects
DLL3 is overexpressed in several solid tumors such as SCLC, NETs, NSCLC, and melanoma, and its limited expression in normal tissue makes it a promising therapeutic target
IDEAYA plans to present clinical data on IDE849 in SCLC and preclinical combination data with its PARG inhibitor IDE161 in Q3 2025, aiming to enhance therapeutic durability and synergy