Sana Biotechnology, Inc. (NASDAQ: SANA) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SC291 for the treatment of relapsed/refractory systemic lupus erythematosus (SLE), including lupus nephritis and extrarenal lupus. This designation is intended to expedite the development and review process for drugs that treat serious conditions and fill unmet medical needs.
SC291 is a hypoimmune (HIP)-modified, CD19-directed allogeneic CAR T-cell therapy. It is currently being evaluated in the Phase 1 GLEAM trial (NCT06294236), which is assessing its safety, tolerability, and potential clinical benefits in patients with B-cell-mediated autoimmune conditions, including lupus nephritis, extrarenal lupus, and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Sana Biotechnology expects to share initial data from the GLEAM trial in 2025.
SC291: A Novel Approach to SLE Treatment
SC291 leverages Sana's hypoimmune platform to develop allogeneic CAR T-cell therapies. These therapies use T-cells from healthy donors to target CD19, a protein found on the surface of B-cells. B-cells are known to drive disease pathology in many autoimmune diseases, and therapies targeting B-cells have demonstrated efficacy across multiple autoimmune conditions. The goal is to develop SC291 as a readily available, off-the-shelf therapy that can address the unmet needs of a large patient population.
GLEAM Trial Details
The ongoing GLEAM trial is a 24-month study designed to primarily assess the safety and tolerability of SC291. Secondary endpoints include changes in renal function, measured by estimated glomerular filtration rate (eGFR), and proteinuria, assessed by urine protein creatinine ratio (UPCR). Additional outcomes include duration of remission without medication, time to disease relapse, and changes in disease activity using metrics such as the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and Birmingham Vasculitis Activity Score version 3 (BVAS v3). Levels of SC291 CAR+ T cells in blood samples will also be monitored over the 24-month period.
Expert Commentary
"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."
