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- Further development of ABL206 (NEOK001) to be led by NEOK Bio and Phase 1 trial is expected to begin by mid-2026 in the U.S.
ABL Bio, a company specializing in bispecific antibodies (CEO Sang Hoon Lee), announced that an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial of ABL206 (NEOK001) was submitted on December 19.
ABL206 is a bispecific antibody ADC candidate developed by ABL Bio. It is a conjugate in which a topoisomerase I inhibitor is linked to a bispecific antibody targeting ROR1 and B7-H3. In non-clinical studies, ABL206 demonstrated improved efficacy and safety compared to conventional monoclonal antibody ADCs, and it is expected to be developed into an innovative new therapy for patients with various solid tumors through future clinical trials.
ABL Bio has overseen the progression from non-clinical research to the IND submission for ABL206, and NEOK Bio will now take full charge, starting with the initiation of Phase 1 clinical trial. NEOK Bio is a U.S.-based company established by ABL Bio specializing in the development of bispecific antibody ADCs, and it fully owns the global development and commercialization rights for ABL206 as well as ABL209 (NEOK002), another bispecific antibody ADC candidate.
The IND submission for ABL209’s is scheduled for early next year. NEOK Bio plans to initiate Phase 1 trials for both candidates by mid-2026 and to disclose initial clinical data in 2027.
Sang Hoon Lee, CEO of ABL Bio, said, “With the IND submission for ABL206’s Phase 1 trial, the bispecific antibody ADC development programs of ABL Bio and NEOK Bio have officially begun in earnest. Since announcing our next-generation ADC development plan last year, we have dedicated our efforts to entering the bispecific ADC market swiftly, and as a result, we were able to complete clinical preparation according to schedule.” He continued, “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 advance next-generation ADC technologies. We ask for your continued interest and support.”
Mayank Gandhi, CEO of Neok Bio, said, “IND submission of NEOK001 is an important step towards our journey to becoming a clinical stage company and an outcome of strong collaboration between ABL and NEOK teams. We are excited about executing on a robust clinical development plan for NEOK001 and look forward to demonstrating the value of our differentiated bispecific ADCs in patients with solid tumors.”
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 8 pipelines, including ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), are underway for different indications in various countries, including the United States, China, Australia, and Korea. Currently, ABL Bio and Sanofi are in the process of transferring the clinical trial sponsorship of ABL301 (SAR446159) to Sanofi to conduct following 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 ESMO GI 2025. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).