On November 11, 2024 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the selection of IDE034, a potential first-in-class B7H3/PTK7 topo-I-payload BsADC, as a development candidate and the exercise of its option for an exclusive worldwide license from Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315) for potential first-in-class B7H3/PTK7 BsADC program (Press release, Ideaya Biosciences, NOV 11, 2024, View Source [SID1234648088]).

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"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. 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," said Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences. "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," said Yujiro S. Hata, Chief Executive Officer and Founder, IDEAYA Biosciences.

"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," added Dr. Yuelei Shen, President and CEO of Biocytogen.

IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) in 2025 for IDE034, subject to satisfactory completion of ongoing preclinical and IND-enabling studies, to enable first-in-human study initiation.

The option was exercised for an exclusive worldwide license from Biocytogen pursuant to the option and license agreement between IDEAYA and Biocytogen. IDEAYA will pay Biocytogen 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.

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, based on the Human Protein Atlas database.