IDEAYA Biosciences has exercised its option to license Biocytogen's B7H3/PTK7 bispecific antibody-drug conjugate (BsADC), named IDE034, marking a significant step in developing novel therapies for solid tumors. The agreement grants IDEAYA an exclusive worldwide license, with plans to submit an Investigational New Drug (IND) application to the U.S. FDA in 2025, pending ongoing preclinical studies.
Novel Bispecific ADC Targeting B7H3 and PTK7
IDE034 is designed as a potential first-in-class BsADC that targets both B7H3 and PTK7, two proteins co-expressed in various solid tumors. According to the Human Protein Atlas database, B7H3/PTK7 co-expression is observed in approximately 30% of lung cancers, 46% of colorectal cancers, and 27% of head and neck cancers. The BsADC incorporates Biocytogen's proprietary topoisomerase I linker-payload, enhancing its cytotoxic effect on tumor cells.
Dr. Yuelei Shen, President and CEO of Biocytogen, stated, "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."
Preclinical Efficacy and Combination Potential
Preclinical studies have demonstrated significant tumor regression with IDE034, supporting its potential as a monotherapy. IDEAYA is also exploring its combination with their PARG inhibitor, IDE161. This combination strategy aims to leverage synergistic mechanisms to improve treatment outcomes in patients with solid tumors.
Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences, commented, "This promising, potential first-in-class B7H3/PTK7 topo-I-payload bispecific ADC has shown significant tumor regression in preclinical models... [underscoring] its potential as both a monotherapy and in combination with our PARG inhibitor, IDE161."
Financial Terms and Future Development
Under the option and license agreement, Biocytogen is set to receive upfront and option exercise fees from IDEAYA. Additional payments include development, regulatory, and commercial milestone payments, as well as royalties on net sales, potentially totaling $406.5 million, including up to $100 million in development and regulatory milestone payments. IDEAYA's focus remains on advancing IDE034 through clinical trials, with the goal of providing a new treatment option for patients with B7H3/PTK7-expressing solid tumors.
