ABL Bio (298380) announced on the 3rd that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1 clinical trial of its bispecific antibody-drug conjugate (ADC) candidate ABL209 (NEOK002).
ABL209 is a next-generation bispecific ADC candidate that combines a bispecific antibody targeting both EGFR and MUC1 with a topoisomerase I inhibitor. By targeting both antigens simultaneously, the drug is expected to overcome limitations of competing candidates that target only EGFR or MUC1.
NEOK Bio, ABL Bio's U.S. subsidiary, will lead global development and commercialization of ABL209 and ABL206 (NEOK001), another bispecific ADC that previously received FDA IND approval for Phase 1 trials. NEOK Bio plans to release early clinical data for both candidates next year.
"Following ABL206, the consecutive FDA IND approval for ABL209 marks the full-scale launch of our next-generation bispecific ADC development," said Lee Sang-hoon, CEO of ABL Bio. "With global experts experienced in ADC development leading the trials, we have high expectations for clinical progress of both ABL206 and ABL209."
Mayank Gandhi, CEO of NEOK Bio, said, "Bispecific ADCs will offer a new solution to expand the limited therapeutic scope of conventional monospecific ADCs. We will pursue clinical trials for ABL206 and ABL209 swiftly and efficiently to deliver innovations that address unmet needs of solid tumor patients."