ImmPACT Bio Awarded $8 Million CIRM Grant for Phase 1b/2 Development of IMPT-514, a CD19/CD20 Bispecific CAR T-Cell Therapy for Refractory Lupus Nephritis and Systemic Lupus Erythematosus

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

Designed to reset the immune system, IMPT-514 is a one-time treatment option with potential to replace the need for chronic immune suppression

Initial efficacy and safety data from Phase 1b/2 dose escalation trial expected 2H 2024

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 that the Company has been awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to ImmPACT Bio's ongoing Phase 1b/2 study evaluating IMPT-514 for the treatment of refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE). IMPT-514 is a potentially first-in-class CD19/CD20 bispecific CAR T-cell therapy designed for deep and extensive depletion of autoreactive immune cells.

"CAR T-cell therapies have transformed the treatment of blood cancers, but their therapeutic potential in autoimmune diseases is a promising opportunity," said Abla Creasey, Ph.D., vice president of therapeutics development at CIRM. "We are pleased to award ImmPACT Bio this funding to help advance their dual-targeting CAR T-cell therapy approach outside the realm of oncology. Importantly, we believe the ImmPACT Bio approach with IMPT-514 as a one-time treatment holds significant potential to change the treatment paradigm and clinical care of severe, refractory lupus."

Jonathan Benjamin, M.D., Ph.D., chief medical officer of ImmPACT Bio stated, "We are extremely grateful that CIRM has recognized the scientific merit and technical feasibility of our clinical trial evaluating IMPT-514 for the treatment of both LN and SLE. Lupus is a debilitating, multi-organ disease that primarily affects women, often in young adulthood. There is a critical unmet medical need for well-tolerated therapies that offer improved efficacy and durable disease remission. Based on the promising responses and a favorable safety profile observed in the UCLA trial in non-Hodgkin lymphoma, we are encouraged that IMPT-514 has potential to alleviate symptoms and spare patients the need for chronic immune suppression. We expect initial efficacy and safety data from our Phase 1b/2 dose escalation trial in the second half of 2024."

"It is important to understand that due to the heterogeneity of lupus, no two patients are alike. No 'one size fits all' treatment exists for complex individuals like me," said Kathleen A. Arntsen, president and CEO of Lupus and Allied Diseases Association, Inc. "What works in one person may not work in another. Therefore, our physicians need an arsenal of therapies to treat lupus and lupus nephritis."

IMPT-514 is being evaluated in an open label Phase 1b/2 dose escalation clinical trial in participants with active, refractory SLE that have been treated with at least two prior standard-of-care therapies and have a SLE Disease Activity Index score (SLEDAI-2K) > 8. The Phase 1 dose escalation cohort is limited to patients with active, biopsy-proven, proliferative LN. Additional patients with and without active proliferative LN will be enrolled during the Phase 2 portion of the clinical trial.

IMPT-514 has received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of both active and refractory LN and SLE.

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