Sana Biotechnology (SANA) announced that the U.S. Food and Drug Administration granted Fast Track designation for SC291 in relapsed/refractory systemic lupus erythematosus, which includes extrarenal lupus and lupus nephritis. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. SC291, a hypoimmune-modified CD19-directed allogeneic CAR T therapy, is being evaluated in Sana’s GLEAM trial in patients with B-cell mediated autoimmune diseases including lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody-associated vasculitis. Sana is enrolling patients in this study and expects to share initial data in 2025.
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