On January 21, 2026 NEOK Bio, Inc., an oncology therapeutics company focused on the development of novel antibody drug conjugates (ADCs) for improving outcomes for cancer patients, reported 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.

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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."

Backed by ABL Bio, a global leader in antibody engineering, NEOK Bio was launched last year to advance a pipeline of differentiated bispecific ADCs. NEOK001 is the first program to enter clinical development, representing the company’s commitment to advancing next-generation ADCs and positioning NEOK Bio as an emerging leader in ADC innovation in the U.S.

(Press release, Neok Bio, JAN 21, 2026, View Source [SID1234662145])