ABL Bio Receives FDA IND Approval for Phase 1 Clinical Trial of Bispecific Antibody ADC 'ABL209'

ABL Bio announced on March 3 that it received approval from the U.S. Food and Drug Administration (FDA) on February 27 (local time) for its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of ABL209 (NEOK002).

ABL209 is a bispecific antibody-drug conjugate (ADC) candidate that targets both EGFR and MUC1 and is conjugated with a topoisomerase I inhibitor. ABL209 is expected to overcome the limitations of competitor candidates that target only EGFR or MUC1 by simultaneously targeting these two complementary antigens.

The development of ABL209, as well as another bispecific antibody ADC, ABL206 (NEOK001), which previously received IND approval for a Phase 1 clinical trial in the U.S., will be carried out by NEOK Bio, which holds the global development and commercialization rights for both candidates. NEOK Bio plans to release early clinical data for ABL206 and ABL209 in 2027.

ABL Bio CEO Sanghoon Lee stated, "With the FDA's approval of the Phase 1 IND for ABL209 following ABL206, the development of next-generation ADCs has officially begun. NEOK Bio has already completed clinical preparations with a team of experts experienced in ADC development. Given that these are globally recognized experts, we have high expectations for the upcoming clinical development of both ABL206 and ABL209."

Mayank Gandhi, CEO of NEOK Bio, said, "Bispecific antibody ADCs could offer new solutions by expanding the limited therapeutic range of conventional monoclonal antibody ADCs. We will rapidly and efficiently advance the clinical trials of ABL206 and ABL209, striving to deliver innovations that address the unmet needs of patients with solid tumors."

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