BIOCYTOGEN-B (02315) business partner IDEAYA obtains FDA approval for IDE034 IND in the United States

BIOCYTOGEN-B (02315) announces that its partner, IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a company focused on the development of precision oncology drugs, has received approval from the U.S. Food and Drug Administration for an Investigational New Drug (IND) application to advance the Phase I clinical trial of the novel B7H3/PTK7 bispecific antibody-drug conjugate (ADC) project IDE034. IDEAYA expects to enroll patients in the first quarter of 2026 to evaluate solid tumor types co-expressing B7H3 and PTK7, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecological cancers. IDE034 is a potential first-in-class dual-target B7H3/PTK7 TOP1 ADC developed by the company and licensed to IDEAYA in July 2024. The approval of this IND marks an important milestone in the collaboration between the two parties, laying the foundation for the advancement of the clinical development of IDE034 and showcasing the company's technical expertise in the field of bispecific ADC discovery and development. The approval of the IND for IDE034 represents an important step for IDEAYA in expanding the TOP1 ADC pipeline to a dual-specific, precision targeting strategy, as well as a significant research and development advancement for the company's licensed projects. This validates the company's RenLite platform and proprietary linker-payload technology in the discovery and optimization of bispecific ADCs. The company anticipates that IDE034 will demonstrate clinical potential in a variety of solid tumors co-expressing B7H3 and PTK7, offering patients new treatment options. Preclinical studies have shown that IDE034 as a monotherapy exhibits deep and sustained tumor regression in various B7H3/PTK7 positive tumor models, demonstrating potent anti-tumor activity. Additionally, IDEAYA plans to explore combination therapy strategies of IDE034 with its PARG inhibitor IDE161 to enhance efficacy durability, and intends to share additional data supporting the mechanism of combination therapy of PARG and TOP1 ADC at a major medical conference in the first half of 2026. The co-expression rates of B7H3 and PTK7 in solid tumors such as lung cancer, colorectal cancer, and head and neck cancer are approximately 30%, 46%, and 27%, respectively, indicating the broad clinical potential of IDE034. In the future, the company will continue to provide high-quality lead molecules for its partners through its "Thousands of Mice, Millions of Antibodies" approach, driving the clinical translation of licensed projects, and actively exploring external licensing opportunities for more early-stage potential assets.