IDEAYA Biosciences has announced the nomination of IDE034 as a development candidate. IDE034 is a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC). The company also exercised its option for an exclusive worldwide license from Biocytogen for the IDE034 program.
The company is targeting an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) in 2025 for IDE034, contingent on the successful completion of ongoing preclinical and IND-enabling studies. This will enable the initiation of first-in-human clinical trials.
Dual-Targeting Approach
IDE034's bispecific design targets both B7H3 and PTK7, which are co-expressed in several 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. This co-expression profile suggests a significant addressable market for IDE034.
Strategic Objectives and Potential Combinations
"We are pleased to nominate development candidate IDE034, a promising potential first-in class B7H3/PTK7 topo-I-payload bispecific ADC, which has demonstrated robust monotherapy tumor regressions in multiple preclinical models," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences. He also highlighted the potential for combination therapy with the company's PARG inhibitor, IDE161.
Yujiro S. Hata, Chief Executive Officer and Founder of IDEAYA Biosciences, noted that the IDE034 program aligns with several strategic objectives for the company, including the potential for monotherapy activity, application in multiple priority solid tumor types such as lung and colorectal cancer, and the ability to enable wholly-owned rational combinations with their internal pipeline.
Collaboration with Biocytogen
The exclusive worldwide license from Biocytogen involves upfront and option exercise fees, along with potential development, regulatory, and commercial milestone payments, as well as royalties on net sales, totaling $406.5 million, including up to $100 million in development and regulatory milestone payments.
"We are excited to have IDEAYA exercise their option to license the worldwide rights to our B7H3/PTK7 BsADC IDE034 with a proprietary topoisomerase linker-payload. This important milestone in our partnership further validates Biocytogen's RenLite® platform and brings us one step closer to making an impact on patients with solid tumors," added Dr. Yuelei Shen, President and CEO of Biocytogen.
