Cabaletta Bio, a Philadelphia-based biotechnology company focused on engineered T cell therapies for B-cell mediated autoimmune diseases, received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its drug CABA-201. CABA-201 is a CAR T cell investigational therapy designed to deplete CD19-positive B cells and improve disease activity in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN). Cabaletta, which is in partnership with Penn, has been cleared to initiate a Phase 1/2 clinical trial of CABA-201.
“We believe the FDA’s decision to grant Fast Track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta. “We look forward to initiating the Phase 1/2 trial for CABA-201 and further evaluating its therapeutic potential for patients in need.” Read more here.