NEOK Bio Receives FDA IND Approval for NEOK001, A First-In-Class B7-H3/ROR1 Bispecific ADC for Treatment of Solid Tumor Cancers
Company plans to initiate a Phase 1 clinical study by 1H2026 and share data in 2027
Excerpt from the Press Release:
PALO ALTO, Calif.–(BUSINESS WIRE)–NEOK Bio, Inc., an oncology therapeutics company focused on the development of novel antibody drug conjugates (ADCs) for improving outcomes for cancer patients, announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for NEOK001, enabling initiation of a Phase 1 clinical trial.
NEOK001 is a bispecific ADC designed to target B7-H3 and ROR1, two surface proteins highly expressed in cancer cells. The therapy is conjugated with a topoisomerase I inhibitor payload via a linker. Preclinical NEOK001 studies have shown superior in vivo efficacy in solid tumors compared to traditional monovalent ADCs.
“We are thrilled to receive IND clearance for NEOK001, a milestone that allows NEOK Bio to advance this first-in-class bispecific ADC into clinical development. We look forward to studying its potential to address significant unmet needs for patients with cancers that co-express these targets,” said Mayank Gandhi, CEO of NEOK Bio. “We anticipate dosing the first patient in the coming months and expect to share initial clinical data in 2027.”
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