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- Phase 1 clinical development to be initiated by NEOK Bio in the U.S. by the first half of this year
- Initial clinical data will be disclosed in 2027
ABL Bio today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for a Phase 1 clinical trial of ABL206 (NEOK001).
ABL206 is a first-in-class bispecific antibody–drug conjugate (ADC) targeting B7-H3 and ROR1 , conjugated with a topoisomerase I inhibitor payload via a linker. Leveraging its proprietary bispecific antibody technology and extensive experience in monoclonal antibody ADC development, ABL Bio is advancing next-generation ADC programs, including bispecific ADCs. Among these, ABL206 is the first candidate from ABL Bio’s next-generation ADC pipeline to enter the clinical stage.
The clinical development of ABL206 will be conducted by NEOK Bio, a bispecific ADC-focused biotechnology company established by ABL Bio in the United States. NEOK Bio holds global development and commercialization rights to ABL206 as well as another bispecific ADC candidate, ABL209 (NEOK002). NEOK Bio plans to initiate the Phase 1 clinical trial for both programs in the first half of this year and aims to disclose initial clinical data in 2027.
Sang Hoon Lee, CEO of ABL Bio, stated, “With ABL206, our first bispecific ADC candidate, entering Phase 1 clinical trials, we have taken the first step in our journey toward developing next-generation ADCs. We are very pleased to have successfully obtained IND approval without any issues, thanks to the close collaboration and dedicated R&D efforts of ABL Bio and NEOK Bio. We will continue to accelerate our research and development to introduce a diverse range of next-generation ADC candidates following ABL206.”
Mayank Gandhi, CEO of NEOK Bio, said, “The timely IND submission and approval represents a significant milestone in NEOK Bio’s evolution into a clinical-stage company and reflects the strong collaboration between ABL Bio and NEOK Bio. We are excited to advance a rigorous clinical development program and look forward to demonstrating the differentiated potential of this novel bispecific ADC for patients with solid tumors of high unmet need”
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 9 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), ABL206(NEOK001) are underway for different indications in various countries, including the United States, China, Australia, and Korea. Following the completion of the Phase 1 clinical trial of ABL301 (SAR446159), Sanofi will conduct the subsequent clinical studies. ABL001 (tovecimig) has received Fast Track designation by the U.S. Food and Drug Administration (FDA). In addition, ABL111 (givastomig), co-developed with NovaBridge, has presented encouraging data from the Phase 1b clinical trial evaluating the triple combination therapy with nivolumab and chemotherapy. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).