IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance

Core Insights - Biocytogen's partner IDEAYA Biosciences has received FDA IND clearance for IDE034, a bispecific antibody-drug conjugate targeting B7H3 and PTK7, marking a significant milestone in its clinical development [1][2][3] Group 1: Product Development - IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024 [2] - The IND clearance allows IDEAYA to initiate a Phase 1 clinical trial, with patient enrollment expected to begin in Q1 2026, focusing on solid tumors expressing B7H3 and PTK7 [1][3] - Preclinical studies indicate that IDE034 monotherapy shows strong anti-tumor activity, inducing deep and durable tumor regressions in multiple tumor models [3] Group 2: Clinical Strategy - IDEAYA plans to explore combination strategies with its PARG inhibitor IDE161 to enhance the durability of response, with additional preclinical data to be presented at a major medical conference in H1 2026 [3] - B7H3 and PTK7 are co-expressed in various cancers, with expression rates of approximately 30% in lung, 46% in colorectal, and 27% in head and neck cancers, indicating broad clinical potential for IDE034 [3] Group 3: Company Capabilities - The IND clearance validates Biocytogen's RenLite platform and proprietary linker-payload technologies, showcasing its capabilities in bispecific ADC discovery and development [2][3] - Biocytogen continues to provide high-quality source antibodies through its RenBiologics platform to support clinical translation and is actively seeking additional early-stage assets for licensing opportunities [4]