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

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. Yuelei Shen, Chairman and CEO of Biocytogen, said: "The IND clearance for IDE034 is an important milestone in the development of this first-in-class TOP1 ADC licensed project, representing a significant advancement for IDEAYA in expanding its clinical pipeline with bispecific, precision-targeted strategies. It also validates our RenLite^® platform and proprietary linker-payload technologies that enable the discovery and optimization of bispecific ADCs. We look forward to seeing IDE034 demonstrate clinical potential across multiple B7H3/PTK7 co-expressing solid tumors, offering new therapeutic options for patients."

Preclinical studies have shown that IDE034 monotherapy induces deep and durable tumor regressionsin multiple B7H3/PTK7-positive tumor models, demonstrating strong anti-tumor activity. In addition, IDEAYA plans to explore combination strategies with its PARG inhibitor IDE161 to enhance the durability of response and intends to present additional preclinical data supporting the combination rationale at a major medical conference in H1 2026. B7H3 and PTK7 are co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46%, and 27%, respectively, indicating the broad clinical potential of IDE034.

Looking ahead, Biocytogen will continue to provide high-quality source antibodies through RenBiologics to support the clinical translation of licensed projects and actively explore additional early-stage assets for external licensing opportunities.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice^® platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of June 30, 2025, approximately 280 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice^® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit https://biocytogen.com.

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