ABL Bio and NEOK Bio Submit IND for Phase 1 Clinical Trial of ABL206 in the U.S.

ABL Bio, a company specializing in bispecific antibodies, announced on December 22 that it submitted an Investigational New Drug (IND) application for a Phase 1 clinical trial of ABL206 (NEOK001) to the U.S. Food and Drug Administration (FDA) on December 19 (local time).

ABL206 is a bispecific antibody-drug conjugate (ADC) candidate developed by ABL Bio, consisting of a bispecific antibody targeting ROR1 and B7-H3, conjugated with a topoisomerase I inhibitor. In preclinical studies, ABL206 demonstrated improved efficacy and safety compared to conventional monospecific antibody ADCs. The company aims to develop it as an innovative new drug for patients with various solid tumors through future clinical trials.

ABL Bio has led the preclinical research and IND application for ABL206, while NEOK Bio will be responsible for the overall development starting from the Phase 1 clinical trial. NEOK Bio is a U.S.-based biotech company established by ABL Bio, specializing in clinical development of bispecific antibody ADCs. NEOK Bio holds the global development and commercialization rights for both ABL206 and another bispecific ADC candidate, ABL209 (NEOK002).

The IND application for the Phase 1 clinical trial of ABL209 is scheduled for early next year. NEOK Bio plans to initiate Phase 1 clinical trials for both candidates next year and release initial clinical data in 2027.

Lee Sanghoon, CEO of ABL Bio, stated, "With the IND submission for the Phase 1 clinical trial of ABL206, the development of bispecific antibody ADCs by ABL Bio and NEOK Bio has officially begun. Since announcing our next-generation ADC development plan last year, we have devoted all our efforts to quickly enter the bispecific ADC market, and as a result, we were able to complete clinical preparations on schedule." He added, "Within ABL Bio, we are actively conducting research and development on various platforms, including bispecific ADCs and dual payload ADCs, as part of our efforts to develop next-generation ADCs. We ask for your continued interest and support going forward."

Mayank Gandhi, CEO of NEOK Bio, commented, "The IND submission for ABL206 marks a significant milestone in NEOK Bio's transition to a clinical-stage company and is the result of close collaboration between ABL Bio and NEOK Bio. We are excited to move forward with a systematic clinical development plan for ABL206, and we will continue to demonstrate the differentiated value of bispecific ADCs for patients with solid tumors."