Antibody-Drug Conjugate (ADC) corporations ABL Bio said on the 2nd that Neok Bio submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) on the 30th of last month (local time) to begin a phase 1 trial of ABL209, a new ADC drug candidate.
Neok Bio is a bispecific ADC clinical development biotech corporations that ABL Bio established in the United States. Neok Bio holds global development and commercialization rights for the bispecific ADC candidates ABL209 and ABL206. The company plans to begin phase 1 trials for both candidates in the middle of this year and release early clinical data next year.
ABL209 is a bispecific ADC candidate that combines an EGFR- and MUC1-targeting bispecific antibody with a topoisomerase I inhibitor. In prior nonclinical studies, it showed better efficacy than single-antibody ADCs. By simultaneously targeting two complementary antigens, the company expected it to demonstrate improved efficacy and safety over competing agents that target only EGFR or only MUC1.
Mayank Gandhi, CEO of Neok Bio, said, "Following the recent IND approval for ABL206, the swift submission of the IND for ABL209 shows our determination to drive innovation in the ADC field quickly and efficiently," and added, "We look forward to promptly initiating clinical trials for ABL206 and ABL209 and demonstrating the value of differentiated bispecific ADCs for patients with solid tumors."