In This Article:
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IDEAYA has exercised the option for an exclusive worldwide license on Biocytogen’s potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody-drug conjugate (BsADC), BCG034 (IDE034)
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This milestone further validates Biocytogen’s proprietary RenLite® antibody discovery platform, demonstrating its potential to advance innovative therapies for patients
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IND application for IDE034 expected in 2025 to enable first-in-human clinical evaluation of B7H3/PTK7 topo-I-payload BsADC program
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IDE034 has the potential to be developed as a monotherapy and in combination with IDEAYA's PARG inhibitor IDE161
BEIJING & SOUTH SAN FRANCISCO, Calif., November 11, 2024--(BUSINESS WIRE)--Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody/ADC therapeutics, announced that IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, has exercised the option for an exclusive worldwide license for Biocytogen's B7H3/PTK7 BsADC program, IDE034, and has nominated it as a development candidate.
"We are excited that IDEAYA has chosen to exercise their option to license the worldwide rights to our B7H3/PTK7 BsADC IDE034, which incorporates our proprietary topoisomerase linker-payload," said Dr. Yuelei Shen, President and CEO of Biocytogen. "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."
Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences, commented, "We are pleased to nominate IDE034 as a development candidate. This promising, potential first-in-class B7H3/PTK7 topo-I-payload bispecific ADC has shown significant tumor regression in preclinical models. The high prevalence of B7H3/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscore its potential as both a monotherapy and in combination with our PARG inhibitor, IDE161."
IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. FDA in 2025 for IDE034, pending the completion of ongoing preclinical and IND-enabling studies, to facilitate the initiation of first-in-human trials.
Under the option and license agreement between Biocytogen and IDEAYA, Biocytogen will receive 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.