IDEAYA Secures Exclusive Global License for Biocytogen’s First-In-Class BsADC, B7H3/PTK7 Topo-I Payload (IDE034), Validating Biocytogen’s RenLite® Antibody Discovery Platform

IND Application for IDE034 Expected in 2025, Setting the Stage for First Clinical Evaluation of a B7H3/PTK7 BsADC in Solid Tumors

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biopharmaceutical company specializing in novel antibody and ADC discovery,  announced that IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company committed to developing targeted therapies, has exercised its option for an exclusive global license for Biocytogen’s bispecific antibody-drug conjugate (BsADC) program, IDE034. This BsADC, targeting B7H3/PTK7 and conjugated with a topoisomerase inhibitor, has now been selected as a candidate for clinical development.

“This milestone in our partnership with IDEAYA validates the capabilities of Biocytogen’s RenLite® platform and moves us closer to providing effective treatments for patients with solid tumors,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “We look forward to supporting IDEAYA as they advance this program to clinical evaluation.”

Dr. Michael White, Chief Scientific Officer of IDEAYA Biosciences, stated, “We are thrilled to nominate IDE034 for development. This B7H3/PTK7 bispecific ADC with a topo-I payload has demonstrated significant tumor regression in preclinical models, making it a compelling and potentially first-in-class candidate. The high prevalence of B7H3/PTK7 co-expression in solid tumors, including lung, colorectal, and head and neck cancers, underscores its potential both as a monotherapy and in combination with our PARG inhibitor, IDE161.”

IDEAYA aims to submit an Investigational New Drug (IND) application to the U.S. FDA in 2025 for IDE034, pending the completion of ongoing preclinical and IND-enabling studies, with plans to initiate the first clinical trials in humans.

Under the option and license agreement between Biocytogen and IDEAYA, Biocytogen will receive an upfront payment and option exercise fees, along with additional milestone payments for development, regulatory, and commercial achievements, plus royalties on net sales. The total value of the agreement could reach up to $406.5 million, including up to $100 million in development and regulatory milestone payments.

According to the Human Protein Atlas database, B7H3/PTK7 is co-expressed in various solid tumor types, with prevalence rates of approximately 30% in lung cancer, 46% in colorectal cancer, and 27% in head and neck cancer. This high co-expression highlights IDE034’s potential to address unmet needs in cancer treatment.