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

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.”

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.

About NEOK Bio
NEOK Bio is an oncology therapeutics company focused on developing novel antibody drug conjugates (ADCs) designed to improve outcomes for cancer patients. NEOK is rapidly advancing bispecific ADCs, which represent a cutting-edge advancement, leveraging bispecific antibodies that target two complementary antigens, potentially improving safety while enhancing efficacy of ADCs in a wider range of tumors. Backed by ABL Bio, a proven leader in antibody engineering, NEOK plans to initiate clinical studies for its two lead bispecific ADC candidates in solid tumor indications in 1Q 2026. For additional information, visit www.neokbio.com.