CAR T-cell therapy IMPT-514 gets FDA fast track designation for lupus
Investigational treatment targets active, resistant lupus nephritis and SLE
The U.S. Food and Drug Administration (FDA) has granted fast track designation to IMPT-514, a CAR T-cell therapy being developed by Immpact Bio for people with active, treatment-resistant lupus nephritis and systemic lupus erythematosus (SLE).
Lupus nephritis is a serious complication of lupus characterized by kidney inflammation.
Fast track status is given to investigational treatments with the potential to fill an unmet medical need in serious conditions. It allows the therapy’s developer to have earlier and more frequent communication with the FDA throughout the development process.
Therapies placed on the fast track also may be eligible for future designations, such as accelerated approval and priority review, if other conditions are met.
“Current [lupus] treatment approaches have demonstrated clinical improvements, but are limited by broad and severe immune suppression, lack of tissue penetration, and chronic administration. To address these limitations, IMPT-514 was designed as a one-time treatment option with potential to reset the immune system through deep [immune] B-cell depletion,” Sumant Ramachandra, MD, PhD, Immpact’s president and CEO, said in a company press release.
Potential to reduce disease activity
In August, the FDA cleared Immpact to launch a Phase 1b/2 clinical trial to test IMPT-514. That study will involve people with active and refractory, or treatment-resistant, SLE, with or without lupus nephritis.
“We look forward to dosing the first patient in our Phase 1b/2 trial for the treatment of active, refractory SLE expected in early 2024,” Ramachandra said.
In lupus, the immune system launches an inflammatory attack that damages the body’s own healthy tissue. This attack is driven in large part by self-reactive antibodies, which are made by a class of immune cells called B-cells.
IMPT-514 is designed to destroy B-cells, thereby lessening the autoimmune attack that drives disease in lupus.
As a CAR T-cell therapy, it uses another type of immune cell called T-cells. These are genetically engineered in the lab to have a chimeric antigen receptor, or CAR — a human-made protein that directs the cell to attack a particular molecular target.
In IMPT-514, T-cells collected from a patient are genetically modified to be equipped with a CAR that specifically targets CD19 and CD20, two proteins found on the surface of B-cells.
Receiving [fast track designation] from the FDA reinforces the therapeutic promise that IMPT-514 holds as the first CD19/CD20 dual targeting CAR T-cell therapy with potential to improve disease activity and [kidney] outcomes for patients with lupus.
By infusing the modified T-cells back into the patient, the therapy aims to effectively wipe out the body’s B-cells, thereby reducing lupus disease activity.
Data from a previous Phase 1 trial showed that IMPT-514 had a favorable safety profile, without reports of serious adverse events known to be associated with CAR T-cell therapies.
“Receiving [fast track designation] from the FDA reinforces the therapeutic promise that IMPT-514 holds as the first CD19/CD20 dual targeting CAR T-cell therapy with potential to improve disease activity and [kidney] outcomes for patients with lupus,” Ramachandra said.