ABL Bio, a bispecific antibody specialist, announced on Tuesday that it received the U.S. Food and Drug Administration (FDA) approval for its Investigational New Drug (IND) application for ABL209 (NEOK002) Phase 1 clinical trials on February 27.
ABL209 is a bispecific antibody-drug conjugate (ADC) candidate that combines Epidermal Growth Factor Receptor (EGFR) and Mucin 1, Cell Surface Associated (MUC1) targeting antibodies with a topoisomerase I inhibitor.
By simultaneously targeting two complementary antigens, EGFR and MUC1, ABL209 aims to overcome the limitations of competing candidates that target only one of these antigens.
Neok Bio, which holds global development and commercialization rights for both candidates, will spearhead the development of ABL209 and ABL206 (NEOK001), another bispecific antibody ADC that previously received FDA approval for its IND in the U.S.
The company plans to release early clinical data for both ABL206 and ABL209 in 2027.
Lee Sang-hoon, Chief Executive Officer (CEO) of ABL Bio, stated that with FDA approval for ABL209’s Phase 1 IND following that of ABL206, they’ve officially launched the next-generation ADC development program. He added that Neok Bio has completed clinical preparations with a team of seasoned ADC development experts.
Mayank Gandhi, CEO of Neok Bio, commented that bispecific antibody ADCs offer a novel approach to expand the limited therapeutic scope of existing monoclonal antibody ADCs. He emphasized that they’re committed to expediting clinical trials for ABL206 and ABL209 to deliver innovative solutions that address the unmet needs of solid tumor patients.