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ABL Bio Receives FDA Approval for Phase 1 IND of Bispecific Antibody ADC in the US

ABL Bio Receives FDA Approval for Phase 1 IND of Bispecific Antibody ADC in the US

ABL Bio, a biotechnology company specializing in bispecific antibodies, has announced that its bispecific antibody ADC candidate is entering the clinical stage in the United States.


On January 19, ABL Bio stated that the Investigational New Drug (IND) application for ABL206 (NEOK001) to conduct a Phase 1 clinical trial was approved by the U.S. Food and Drug Administration (FDA) on January 16 (local time).


ABL206 is a first-in-class bispecific antibody-drug conjugate (ADC) that simultaneously targets B7-H3 and ROR1, with a topoisomerase I inhibitor attached via a linker. This candidate is the first among ABL Bio's next-generation ADC pipeline to enter the clinical stage.


Neok Bio, ABL Bio's U.S.-based subsidiary specializing in bispecific antibody ADCs, plans to initiate a Phase 1 clinical trial of ABL206 in the first half of this year. The company also announced plans to release the initial clinical results by 2027.


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