ABL Bio (298380.KQ) said Monday that it filed an Investigational New Drug (IND) application for ABL206 (NEOK001) Phase 1 clinical trial with the U.S. Food and Drug Administration on January 19.
ABL206 is a bispecific antibody-drug conjugate (ADC) candidate developed by ABL Bio. It consists 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 ADCs," an ABL Bio official said. "It will be developed as an innovative new drug for patients with various solid tumors through clinical trials."
ABL Bio led preclinical research and the IND filing for ABL206, while its U.S. subsidiary Neok Bio will take over overall development starting from Phase 1 clinical trials. Neok Bio is a bispecific ADC clinical development company established by ABL Bio in the United States, holding global development and commercialization rights for ABL206 and another bispecific ADC candidate ABL209 (NEOK002).
The Phase 1 IND filing for 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.
"The Phase 1 IND filing for ABL206 marks the full-scale advancement of bispecific ADC development by ABL Bio and Neok Bio according to schedule," said Lee Sang-hoon, CEO of ABL Bio. "Internally, ABL Bio is actively conducting R&D on various platforms including bispecific ADCs and dual-payload ADCs as part of efforts to develop next-generation ADCs."
"The IND submission for ABL206 is an important milestone for Neok Bio's evolution into a clinical-stage company and represents the fruit of close collaboration between ABL Bio and Neok Bio," said Mayank Gandhi, CEO of Neok Bio. "We will demonstrate the value of differentiated bispecific ADCs for solid tumor patients through systematic clinical development of ABL206."
