ImmPACT Bio Granted FDA Fast Track Designation for IMPT-514 for the Treatment of Both Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus

IMPT-514 is the first CD19/CD20 CAR T-cell therapy in development for lupus

Designed as a one-time treatment option, IMPT-514 has potential to reset the immune system through deep autoreactive B-cell depletion

Dosing of first patient in Phase 1b/2 dose escalation trial expected in early 2024

LOS ANGELES, Oct. 10, 2023 /PRNewswire/ -- ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for IMPT-514, a potential first-in-class CD19/CD20 CAR-T therapy for the treatment of patients with active refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE). In August 2023, ImmPACT Bio received FDA clearance to initiate clinical development of IMPT-514 in an open label Phase 1b/2 dose escalation trial in participants with active, refractory SLE.

"SLE is a systemic, chronic, multi-organ autoimmune disease associated with increased risk of mortality, progressive organ damage, and reduced health-related quality of life. Approximately half of patients with SLE have LN, the most severe manifestation of SLE. Current treatment approaches have demonstrated clinical improvements, but are limited by broad and severe immune suppression, lack of tissue penetration, and chronic administration," said Sumant Ramachandra, M.D., Ph.D., president, and chief executive officer of ImmPACT Bio. "To address these limitations, IMPT-514 was designed as a one-time treatment option with potential to reset the immune system through deep B-cell depletion. Receiving FTD 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 renal outcomes for patients with lupus. 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."

Fast Track Designation is designed to help drugs reach patients faster by facilitating the development and expediting the review of drugs with the potential to fill an unmet medical need and treat serious or life-threatening conditions. Programs receiving FTD benefit from early and frequent interactions with the FDA during the clinical development process and, if relevant criteria are met, the FDA may consider reviewing portions of a marketing application before the sponsor submits the complete application.

About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE), commonly known as lupus, is a chronic, often severe, systemic autoimmune disease. Systemic lupus erythematosus results from an immune attack on healthy tissues and the development of widespread inflammation that results in tissue damage throughout the body. B cells are known to play an early and central role in disease pathogenesis. Lupus afflicts more than 200,000 patients in the U.S. alone, with approximately 50 percent having lupus nephritis, the most severe manifestation of SLE which can result in end-stage renal disease and increased mortality. Despite various therapies used for the treatment of SLE, including approved biologics, there remains a significant unmet need for safe and highly effective therapies for this disease.

About IMPT-514
IMPT-514 is a CD19/CD20-targeting chimeric antigen receptor (CAR) T-cell therapy that utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. It is the same CAR construct as ImmPACT's IMPT-314, which is under development for certain types of non-Hodgkin's lymphoma. IMPT-314 and IMPT-514 are based on work by Yvonne Chen, Ph.D., associate professor, and Sarah Larson, M.D., associate professor of medicine, both of the University of California, Los Angeles. In preclinical studies, IMPT-514 was successfully and efficiently manufactured from heavily immunosuppressed patients with lupus nephritis and systemic lupus erythematosus and showed potent elimination of autologous B cells and a moderate cytokine profile.

About ImmPACT Bio
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA. For more information, visit http://www.immpact-bio.com.

SOURCE ImmPACT Bio