Biocytogen Announces IDEAYA’s Nomination of Development Candidate IDE034, a Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC and Option Exercise

• IDEAYA has exercised the option for an exclusive worldwide license on Biocytogen’s potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody-drug conjugate (BsADC), BCG034 (IDE034)
• This milestone further validates Biocytogen’s proprietary RenLite^® antibody discovery platform, demonstrating its potential to advance innovative therapies for patients
• IND application for IDE034 expected in 2025 to enable first-in-human clinical evaluation of B7H3/PTK7 topo-I-payload BsADC program
• IDE034 has the potential to be developed as a monotherapy and in combination with IDEAYA's PARG inhibitor IDE161

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody/ADC therapeutics, announced that IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, has exercised the option for an exclusive worldwide license for Biocytogen's B7H3/PTK7 BsADC program, IDE034, and has nominated it as a development candidate.

“We are excited that IDEAYA has chosen to exercise their option to license the worldwide rights to our B7H3/PTK7 BsADC IDE034, which incorporates our proprietary topoisomerase linker-payload,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This important milestone in our collaboration further validates the capabilities of Biocytogen’s RenLite® platform, bringing us closer to impactful treatments for patients with solid tumors. We look forward to supporting IDEAYA as they advance this program to clinical stages.”

Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences, commented, “We are pleased to nominate IDE034 as a development candidate. This promising, potential first-in-class B7H3/PTK7 topo-I-payload bispecific ADC has shown significant tumor regression in preclinical models. The high prevalence of B7H3/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscore its potential as both a monotherapy and in combination with our PARG inhibitor, IDE161.”

IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. FDA in 2025 for IDE034, pending the completion of ongoing preclinical and IND-enabling studies, to facilitate the initiation of first-in-human trials.

Under the option and license agreement between Biocytogen and IDEAYA, Biocytogen will receive upfront and option exercise fees, along with additional development and regulatory milestone payments, commercial milestone payments, and royalties on net sales, totaling $406.5 million, including up to $100 million in development and regulatory milestone payments.

Based on the Human Protein Atlas database, B7H3/PTK7 has been reported to be co-expressed in multiple solid tumor types, including in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively.

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^® (RenMab™/ RenLite^®/ RenNano^®/ RenTCR-mimic™ ) 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 >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2024, approximately 150 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and nearly 50 target-nominated RenMice^® licensing projects have been established with over 60 global pharmaceutical and biotech companies, 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), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.

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