Bioosetu-B (02315) business partner IDEAYA obtained IND approval from the US Food and Drug Administration for IDE034

According to Zhitong Finance App, Biosetu-B (02315) announced that its partner IDEAYA Biosciences, Inc. (Nasdaq: IDYA) (IDEAYA) (IDEAYA), a company focusing on the development of precision cancer treatment drugs, has obtained the US Food and Drug Administration's New Drug (IND) approval to advance phase I clinical trials of the B7H3/PTK7 bispecific antibody conjugate (ADC) project IDE034. IDEAYA is expected to begin enrolling patients in the first quarter of 2026 to initially evaluate the types of solid tumors where B7H3 and PTK7 are co-expressed, including lung cancer, colorectal cancer, head and neck cancer, and ovarian/gynecologic tumors.

IDE034 is a potentially first-of-its-kind dual-target B7H3/PTK7 TOP1 ADC. It was independently developed by the company and licensed to IDEAYA in July 2024. The approval of IND marks an important milestone in cooperation between the two parties, laying the foundation for advancing clinical development after IDE034, and also highlights the company's technical strength in the field of dual-antibody ADC discovery and development.

IDE034's approval of IND is an important step for IDEAYA to expand its first TOP1 ADC pipeline to a dual-specific, precise targeting strategy. It is also an important R&D progress made by the company's externally authorized projects. This fully validates the leading capabilities of the company's RenLite® platform and proprietary Linker-Payload technology in dual-antibody ADC discovery and optimization. The company expects IDE034 to show clinical potential in a variety of B7H3/PTK7 co-expressed solid tumors and provide patients with new treatment options.

Preclinical studies have shown that IDE034 monotherapy showed deep and long-lasting tumor contraction in various B7H3/PTK7 positive tumor models, showing strong anti-tumor activity. Furthermore, IDEAYA plans to explore combined treatment strategies with IDE034 and its PARG inhibitor IDE161 to enhance the sustainability of efficacy, and plans to share more data supporting the combined treatment mechanism of PARG and TOP1 ADC at key medical conferences in the first half of 2026. The co-expression ratios of B7H3 and PTK7 in solid tumors such as lung cancer, colorectal cancer, and head and neck cancer were about 30%, 46%, and 27%, respectively, indicating the potential of IDE034 for a wide range of clinical indications.

In the future, the company will continue to use “thousands of antibodies” to provide partners with high-quality source molecules, promote clinical transformation of authorized programs, and actively explore more external licensing opportunities for potential early assets.