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- Further development of ABL209 (NEOK002) to be led by NEOK Bio and Phase 1 trial is expected to begin by mid-2026 in the U.S.
ABL Bio announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on January 30 for a Phase 1 clinical trial of ABL209 (NEOK002).
ABL209 is a bi-specific antibody–drug conjugate (ADC) candidate that combines an EGFR- and MUC1-targeting bispecific antibody with a topoisomerase I inhibitor. In preclinical studies, ABL209 demonstrated superior efficacy compared to monospecific antibody ADCs. By simultaneously targeting two complementary antigens, ABL209 is expected to demonstrate improved efficacy and safety compared to competing agents that target only EGFR or MUC1.
NEOK Bio is a bispecific ADC clinical development company established by ABL Bio in the United States and holds global development and commercialization rights to ABL209, as well as another bi-specific ADC candidate, ABL206 (NEOK001). ABL206’s Phase 1 IND was approved by the FDA on January 16, 2026. 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, “NEOK Bio has already completed preparations for clinical development together with an advisory group with extensive experience in ADC development and clinical research organizations (CROs). Following IND approval, NEOK plans to promptly enter full-scale clinical trials. Global interest in bispecific ADCs is currently very high, and we held numerous related meetings together with NEOK at the recent JPM Healthcare Conference. We ask for continued interest in ABL Bio’s next-generation ADC development, which will be advanced through ABL206 and ABL209.”
Mayank Gandhi, CEO of NEOK Bio, said, “Recent IND approval of NEOK001 followed quickly by NEOK002 IND submission reflects our commitment to rapidly and efficiently advance ADC innovation. We can’t wait to initiate a robust clinical development plan for both NEOK001/002 and demonstrate the value of our differentiated bispecific ADCs in patients with solid tumors.”
About ABL Bio
ABL Bio is developing a wide range of clinical and preclinical pipelines based on its proprietary bi-specific antibody platforms, including Grabody. A total of nine pipeline programs—ABL301 (SAR446159), ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105 (YH32367), ABL104 (YH32364), ABL103, and ABL202 (CS5001/LCB71), ABL206 (NEOK001)—are currently in clinical development across multiple countries, including the United States, China, Australia, and South Korea. Follow-up clinical development of ABL301 (SAR446159), which has completed Phase 1, will be conducted by Sanofi, while ABL001 (tovecimig) has received Fast Track designation from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has reported encouraging interim Phase 1b data in a triple-combination regimen with nivolumab and chemotherapy, with additional data to be presented at a global scientific conference in the second half of this year. In addition, multiple preclinical programs, including bispecific ADCs and dual-payload ADCs, are under continuous research and development.