ABL Bio–NEOK Bio receive U.S. IND clearance for phase 1 clinical trial of ABL209 (NEOK002)

CAR-T Digest - August 2020

Weekly Digest - March 2026

03 March 2026: ABL Bio–NEOK Bio receive U.S. IND clearance for phase 1 clinical trial of ABL209 (NEOK002)

ABL Bio and NEOK Bio have advanced their next-generation ADC pipeline after securing U.S. regulatory clearance, with the U.S. Food and Drug Administration approving an Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of their bispecific antibody-drug conjugate candidate ABL209 (NEOK002)
Building on this progress, development efforts will be spearheaded by NEOK Bio, which holds global development and commercialization rights for ABL209 as well as ABL206 (NEOK001)-another bispecific ADC from ABL Bio that has already received U.S. IND clearance
The newly cleared candidate represents an innovative approach in targeted oncology, as ABL209 is designed as a bispecific ADC that simultaneously targets EGFR and MUC1, while delivering a topoisomerase I inhibitor payload, aiming to improve tumor selectivity and overcome the limitations seen in therapies that target only one antigen
With both candidates now cleared for clinical testing, the companies are preparing for rapid clinical advancement, as NEOK Bio plans to initiate Phase 1 trials for ABL206 and ABL209 in the first half of 2026, with initial clinical data expected to emerge in 2027
Company leadership views this milestone as the formal launch of a broader next-generation ADC strategy, with ABL Bio highlighting NEOK Bio’s ADC development expertise, while NEOK Bio emphasized that bispecific ADCs could expand the therapeutic window of conventional ADCs and potentially address significant unmet needs in patients with solid tumors