IDE034, a Bispecific ADC Licensed by Biocytogen to IDEAYA, Receives FDA IND Clearance5.12.2025 02:00:00 EET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company, has received 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 of IDE034, a potential first-in-class B7H3/PTK7 bispecific antibody-drug conjugate (ADC). IDEAYA expects to begin patient enrollment in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck, and ovarian/gynecological cancers. IDE034 is a bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. The IND clearance marks an important milestone for this licensed program, supporting subsequent clinical development of IDE034, while highlighting Biocytogen’s technical capabilities in bispecific ADC discovery and development. Dr. Yue
