(RTTNews) - Sana Biotechnology, Inc. (SANA), a biotechnology company, today, announced that the FDA has given Fast-track Designation for SC91 in treating patients with relapsed/refractory (R/R) systemic lupus erythematosus.
The drug candidate SC91 is a hypo immune (HIP)-modified CD19-directed allogeneic CAR T therapy, being evaluated in the GLEAM trial in patients with B-cell mediated autoimmune diseases including R/R SLE, external lupus, and lupus nephritis.
CD19-directed CAR T therapy under allogenic T-cell programs, introduces CAR T as the effector cell that depletes B cells throughout the body.
The GLEAM trial is a Phase 1 clinical study that evaluates the safety and benefits of SC91.
The company is currently enrolling patients in this study and expects to share initial data in 2025.
SANA is currently trading at $2.87, up 3.23%
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