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- Phase 1 clinical trials of ABL206 and ABL209 to be initiated by NEOK Bio in 1H2026
Seoul (South Korea) – March 3, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 1 clinical trial of ABL209 (NEOK002).
ABL209 is a bispecific antibody-drug conjugate (ADC) candidate that targets EGFR and MUC1 and is conjugated with a Topoisomerase I inhibitor. By simultaneously targeting two complementary antigens, ABL209 is expected to overcome the limitations of competing candidates that target either EGFR or MUC1 alone.
The development of ABL209, along with ABL206 (NEOK001)—another bispecific antibody-drug conjugate (ADC) that previously received U.S. IND clearance for a Phase 1 clinical trial—will be led by NEOK Bio, which holds the global development and commercialization rights to both candidates. NEOK Bio plans to initiate Phase 1 trials in 1H2026 and disclose initial clinical data for ABL206 and ABL209 in 2027.
Sang Hoon Lee, CEO of ABL Bio, stated, “Following ABL206, the FDA’s clearance of the IND for ABL209 marks the full-scale initiation of our next-generation ADC development program. NEOK Bio has already completed clinical preparations, led by experts with extensive experience in ADC development. Given their strong global reputation, we have high expectations for the upcoming clinical development of ABL206 and ABL209.”
Mayank Gandhi, CEO of NEOK Bio, commented, “Bispecific ADCs represent a novel solution that could expand the therapeutic window of conventional monospecific ADCs. We will advance the clinical development of ABL206 and ABL209 swiftly and efficiently to deliver innovative treatments that address the unmet medical needs of patients with solid tumors.”
About ABL Bio
ABL Bio is advancing a diverse pipeline of preclinical and clinical-stage programs based on its proprietary bispecific antibody platform, Grabody. Clinical development programs for ten pipeline assets—including ABL301 (SAR446159), ABL001 (Tovecimig), ABL111 (Givastomig), ABL503 (Ragistomig), ABL105 (Nesfrotamig), ABL104 (YH32364), ABL103, ABL202 (CS5001/LCB71), ABL206 (NEOK001), and ABL209 (NEOK002)—are underway across multiple countries, including the United States, China, Australia, and South Korea.
Following the completion of its Phase 1 clinical trial in the United States, further development of ABL301 (SAR446159) will be led by Sanofi. ABL001 (Tovecimig) has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). ABL111 (Givastomig), which is being co-developed with NovaBridge, has reported encouraging interim results from a Phase 1b study evaluating a triple combination regimen with nivolumab and chemotherapy. Additional data are expected 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 being continuously advanced through research and development.