ABL Bio announced on Monday that it received approval from the U.S. Food and Drug Administration (FDA) on January 16 for its Phase 1 clinical trial plan for ABL206 (also known as NEOK001).
ABL206 is a pioneering first-in-class dual antibody-drug conjugate (ADC) that combines a B7-H3·ROR1-targeting dual antibody with a topoisomerase I inhibitor as a linker.
Leveraging its expertise in dual antibody technology and experience in developing monoclonal antibody ADCs, ABL Bio is pushing forward with the development of next-generation ADCs, including dual antibody ADCs. ABL206 marks a significant milestone as the first candidate from ABL Bio’s next-generation ADC pipeline to advance to clinical trials.
Neok Bio, a U.S.-based biotech company established by ABL Bio specializing in dual antibody ADCs, will spearhead the clinical development of ABL206.
In addition to ABL206, Neok holds global development and commercialization rights for another promising dual antibody ADC candidate, ABL209 (known as NEOK002). The company aims to initiate Phase 1 trials for both candidates in the first half of this year, with plans to release preliminary clinical data by 2027.
Lee Sang-hoon, Chief Executive Officer (CEO) of ABL Bio, expressed his enthusiasm: The entry of ABL206, its first dual antibody ADC candidate, into Phase 1 trials marks a pivotal moment in the quest to develop next-generation ADCs. It is thrilled to have secured clinical plan approval smoothly, a testament to the synergistic efforts of ABL Bio and Neok Bio in the research and development endeavors.
He further committed that it will continue to intensify its research and development (R&D) efforts to introduce a diverse range of next-generation ADC candidates following ABL206.
Mayank Gandhi, CEO of Neok Bio, underscored the significance of this development: The timely submission and approval of this clinical trial plan represent a crucial milestone for Neok Bio as it evolves into a clinical-stage biotech company. It also highlights the strong collaborative relationship between ABL Bio and Neok Bio.
Gandhi added that they’re eager to advance a rigorous and systematic clinical development program. Its goal is to demonstrate the unique potential of this novel dual antibody ADC in addressing the high unmet needs of patients with solid tumors.