FDA Grants Fast Track Status to Investigational Therapy IMPT-514 for Treatment of Both Active Refractory Lupus Nephritis and Systemic Lupus Erythematosus

IMPT-514, an investigational therapy by ImmPACT Bio USA, Inc. has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as a possible treatment for both active refractory lupus nephritis (LN, lupus related kidney disease in which people do not respond to first-line immunosuppressive drugs or quickly relapse after remission) and systemic lupus erythematosus (SLE).

IMPT is the first IMPT-514, and is a CAR-T cell therapy designed to target B cells (immune system cells involved in the production of autoantibodies and lupus disease activity). CAR-T cells are genetically altered cells that are designed to reset the immune system. To make CAR-T cells, scientists create or engineer new proteins called chimeric antigen receptors (CARs), and then introduce T-cells into them. IMPT-514 therapy uses T-cells that are designed with a CAR that instructs them to attack cells with proteins typically found in B-cells, specifically CD19 and CD20 which are associated with severe immune deficiency. The Phase 1b / 2clinical trial for people with active, refractory SLE is expected to begin in early 2024.

Fast Track designation by the FDA is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions, like lupus, and fill an unmet need with the goal of getting new drugs to patients sooner. Continue to follow the Lupus Foundation of America for IMPT-514 updates, as well as other lupus drug development news. Learn more about medications used to treat lupus.

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