Steve Harr, Sana Biotechnology CEO

Four years in, Sana gets first FDA go-ahead to bring can­cer treat­ment in­to the clin­ic

Sana Biotech­nol­o­gy is fi­nal­ly head­ed to the clin­ic.

Thurs­day af­ter­noon, the biotech an­nounced the FDA had cleared its ap­pli­ca­tion to start a clin­i­cal tri­al for its al­lo­gene­ic, or “off-the-shelf,” CAR-T cell ther­a­py tar­get­ing the anti­gen CD19 for pa­tients with B-cell lym­phomas and leukemias. Sana said its ther­a­py, dubbed SC291, was de­signed to evade the im­mune sys­tem, which could help cell ther­a­py pro­duce a more durable re­sponse in pa­tients, a con­cern that has fol­lowed such off-the-shelf ther­a­pies that use donor cells as op­posed to a pa­tient’s own cells.

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