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- Dual-targeting approach expected to mitigate target-related toxicity seen in conventional monoclonal ADCs
- Currently in Phase 1 clinical trials in the U.S.; initial data expected in 2027
Seoul (South Korea) – April 21, 2026, ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that a paper on the preclinical data of ABL209 (NEOK002) has been published in Molecular Cancer Therapeutics, an international oncology journal published by the American Association for Cancer Research (AACR).
ABL209 is a bispecific antibody-drug conjugate (ADC) candidate that targets EGFR and MUC1 and is conjugated with a topoisomerase I inhibitor (TOP1i) payload. It is currently undergoing a Phase 1 clinical trial in the United States, led by NEOK Bio, a U.S.-based biotech company established by ABL Bio.
The paper, titled “Designing an EGFRxMUC1 bispecific TOP1i ADC with promising anti-tumor activity and enhanced therapeutic window,” was published online on April 20 and presents the design and preclinical efficacy of ABL209.
EGFR is a well-established oncology target expressed across various cancer types; however, therapies targeting EGFR are often associated with skin-related toxicities. MUC1 is also a key oncology target, but its expression levels vary across tumor types, and its tendency to shed from tumor cells can limit therapeutic efficacy.
Compared to monoclonal ADCs targeting either EGFR or MUC1 alone, ABL209 demonstrated enhanced binding affinity to cancer cells and improved intracellular drug delivery. Notably, no skin-related toxicity was observed in vitro studies. In addition, in vivo studies using patient-derived xenograft (PDX) models showed strong anti-tumor activity across multiple cancer types, including lung, esophageal, pancreatic, colorectal, bladder, and head and neck cancers.
In non-human primate studies, ABL209 exhibited favorable pharmacokinetics (PK), with a half-life of 5.2 days at a dose of 10 mg/kg and demonstrated good tolerability at doses of up to 40 mg/kg.
Sang Hoon Lee, CEO of ABL Bio, stated, “We are pleased to see ABL209 study publication in a prestigious AACR journal in the field of oncology. ABL Bio actively encourages scientific publications to enhance the credibility of our technology and increase corporate visibility. NEOK Bio is currently conducting the Phase 1 clinical trial of ABL209 in the U.S., with initial clinical data expected in 2027. We hope ABL209 will establish itself as an innovation in the ADC field.”
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 10 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), currently in Phase 2/3 trial for biliary tract cancer patients, has received both Fast Track and Orphan Drug Designations from the FDA. ABL111 (givastomig), which is being co-developed with NovaBridge, has initiated a Phase 2 clinical trial in combination with nivolumab and chemotherapy, and plans to present additional data from the Phase 1b study at a global 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.