Sana Biotech Gets Fast Track for SC291 in Refractory Lupus

On December 2, 2024, Sana Biotechnology, Inc. (NASDAQ: SANA), a company dedicated to transforming possibilities for patients through engineered cells, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for SC291, a treatment for relapsed or refractory systemic lupus erythematosus (SLE). This designation is designed to speed up the development and review of drugs intended to treat serious conditions and address unmet medical needs.

SC291 is an allogeneic CAR T cell therapy that has been modified using Sana’s hypoimmune platform to target CD19, a protein found on the surface of B cells. B cells play a central role in the pathology of many autoimmune diseases, making them a key target for therapy. The treatment is currently being evaluated in the GLEAM clinical trial, which is enrolling patients with B-cell mediated autoimmune diseases such as lupus nephritis, extrarenal lupus, and ANCA-associated vasculitis. Sana aims to present initial clinical data from this study in 2025.

Dhaval Patel, M.D., Ph.D., Chief Scientific Officer of Sana, expressed satisfaction with the FDA's Fast Track designation for SC291, underscoring the urgent need for new treatment options for patients with relapsed or refractory SLE. Dr. Patel highlighted that SC291, as a hypoimmune-modified allogeneic CAR T therapy, has the potential to become a universal off-the-shelf treatment due to its scalable manufacturing process, capable of producing hundreds of patient doses per production run. He looks forward to sharing the initial findings from the GLEAM trial.

The underlying approach of SC291 involves using T cells from healthy donors to generate CAR T therapies that specifically target CD19 on B cells. This targeting is crucial as B cells are implicated in the disease mechanisms of various autoimmune disorders. Emerging data suggest that deeper and more comprehensive depletion of B cells in tissues could lead to improved efficacy while maintaining a reasonable safety profile. By employing CD19-directed CAR T therapy, SC291 aims to introduce a novel treatment option where the CAR T cells act as effector cells to deplete B cells throughout the body.

Sana's goal is to develop SC291 for broader applications, leveraging its hypoimmune allogeneic CAR T manufacturing platform to address significant unmet needs in treating autoimmune diseases. The company is committed to advancing engineered cell therapies to repair and control genes, replace damaged or missing cells, and make these therapies widely accessible to patients. Sana operates across various locations, including Seattle, Cambridge, South San Francisco, Bothell, and Rochester.

Overall, Sana Biotechnology, Inc. remains driven by a vision to revolutionize disease treatment by creating an enduring company dedicated to the development and delivery of engineered cell medicines.