IDEAYA Biosciences has announced the nomination of IDE034 (BCG034), a potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC), as a development candidate. The company also exercised its option for an exclusive worldwide license for IDE034 from Biocytogen Pharmaceuticals.
Targeting B7H3 and PTK7 Co-Expression
IDE034 is designed to target the co-expression of B7H3 and PTK7, which are found in several solid tumors. According to the Human Protein Atlas database, B7H3/PTK7 co-expression has been reported in approximately 30% of lung cancers, 46% of colorectal cancers, and 27% of head and neck cancers. This co-expression profile suggests a potential addressable market for IDE034, both as a monotherapy and in combination with other therapies.
Preclinical Evidence and Development Strategy
Preclinical models have demonstrated robust monotherapy tumor regressions with IDE034. IDEAYA is planning to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in 2025, contingent on the successful completion of ongoing preclinical and IND-enabling studies. This IND filing would pave the way for the initiation of first-in-human clinical trials.
Combination Therapy Potential
IDEAYA envisions developing IDE034 as both a monotherapy and in combination with its PARG inhibitor, IDE161. This combination strategy aims to leverage synergistic effects to enhance therapeutic efficacy in target patient populations.
Executive Perspectives
"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. "The co-expression of B7H3/PTK7 in several solid tumors, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, highlights the potential addressable market, both as monotherapy and in combination with PARG inhibitor IDE161."
Yujiro S. Hata, Chief Executive Officer and Founder of IDEAYA Biosciences, added, "We are excited to nominate our 6th development candidate in IDE034 and this program achieves several strategic objectives for IDEAYA, including the potential for monotherapy activity, application in multiple priority solid tumor types of lung and colorectal cancer, and the ability to enable wholly-owned rational combinations with our internal pipeline."
Dr. Yuelei Shen, President and CEO of Biocytogen, stated, "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. We look forward to our continued partnership with IDEAYA as they advance this program to the clinic."
Financial Terms
Under the option and license agreement, IDEAYA will pay Biocytogen upfront and option exercise fees, along with development, regulatory, and commercial milestone payments, and royalties on net sales, totaling $406.5 million. This includes up to $100 million in development and regulatory milestone payments.
