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Sana Biotechnology Announces Fast Track Designation for SC291 in Relapsed/Refractory Systemic Lupus Erythematosus
Fast Track designation is designed to expedite clinical development and regulatory review timelines Enrolling patients in the GLEAM trial for SC291 in B-cell
About this update from Sana Biotechnology, Inc.
[{"type":"text","content":"Fast Track designation is designed to expedite clinical development and regulatory review timelines Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases, including systemic lupus erythematosus; expect to report initial clinical data in 2025 SEATTLE, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for SC291 in relapsed/refractory systemic lupus erythematosus (SLE), 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 (HIP)-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 (ANCA)-associated vasculitis. Sana is enrolling patients in this study and expects to share initial data in 2025. “We are pleased to receive Fast Track designation from the FDA for SC291, which highlights the need for new treatment options for patients with relapsed/refractory SLE,” said Dhaval Patel, M.D., Ph.D., Chief Scientific Officer of Sana. “As a HIP-modified allogeneic CAR T therapy with a scaled manufacturing process that produces hundreds of patient doses per manufacturing run, SC291 has the potential to serve as a universal off-the-shelf therapy that can address this large unmet need. We look forward to sharing initial data from the ongoing GLEAM trial.” About SC291 in B-cell mediated Autoimmune DiseasesSC291 is a CD19-directed allogeneic CAR T cell therapy developed using Sana’s hypoimmune platform. Our allogeneic T cell programs use T cells from healthy donors to generate CAR T therapies that, in this case, target CD19, a protein expressed on the cell surface of B cells. B cells drive disease pathology in many autoimmune diseases, and therapies that target B cells have been efficacious across multiple autoimmune diseases. Emerging data in the field support the concept that deeper tissue B cell depletion can be associated with greater efficacy and a reasonable safety p...