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Drug intelligence / Profile preview
FMC63 is a murine IgG2a monoclonal antibody that specifically targets human CD19, a cell surface antigen widely expressed on B-lineage cells and B-cell malignancies. The single-chain variable fragment (scFv) derived from FMC63 serves as the antigen-recognition domain for several FDA-approved CD19-directed chimeric antigen receptor (CAR) T-cell therapies, including tisagenlecleucel (Kymriah), axicabtagene ciloleucel (Yescarta), brexucabtagene autoleucel (Tecartus), and lisocabtagene maraleucel (Breyanzi). While FMC63 itself is primarily a research tool and the foundational binder for CAR-T therapies, Converge BIO has utilized FMC63 as a demonstration case study for its ConvergeAB™ platform. Using generative AI, Converge BIO re-engineered the FMC63 scFv to humanize and de-immunize the sequence, improving its thermal stability and developability while maintaining its clinically validated CD19-binding affinity.
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