Sana Biotechnology, Inc. (SANA) announced Friday that the FDA has cleared its Investigational New Drug or IND application to initiate a study of SC262 in patients with relapsed or refractory B-cell malignancies, who have received prior CD19-directed CAR T therapy.
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SC262 expresses the same CAR, including the same CD22 binder, used in CD22-directed CAR T therapies tested in multiple academic clinical trials.
The company said, to date, these trials have shown durable complete responses in a substantial number of patients in the relapse setting following treatment with a CD19-directed CAR T therapy.
The company expects to present initial proof of concept data for SC262 later this year.
SC262 is a hypoimmune, CD22-directed allogeneic CAR T cell therapy derived from healthy donor CD4+ and CD8+ T cells.
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