ImmPACT Bio Announces FDA Clearance of IND Application

Dual CD19 and CD20-targeting CAR T therapy offers broad immune targeting and potential to reset immune system

 No neurotoxicity and only Grade 1 cytokine release syndrome in ongoing UCLA investigator-led study in lymphoma

West Hills, Calif., August 15, 2023 – 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 cleared an investigational new drug (IND) application for IMPT-514, a bispecific CD19/CD20 CAR T therapy for the treatment of active, refractory systemic lupus erythematosus (SLE).

“FDA clearance to initiate clinical development of IMPT-514, the first bispecific CD19/CD20 CAR T therapy being investigated for the treatment of systemic lupus erythematosus, marks a pivotal milestone for our autoimmune disease clinical program,” said Sumant Ramachandra, M.D., Ph.D., president and chief executive officer of ImmPACT Bio. “The robust data package for IMPT-514 includes compelling Phase 1 safety data from an ongoing investigator-led study in lymphoma at UCLA demonstrating no neurotoxicity and only Grade 1 cytokine release syndrome to date. We have also successfully manufactured active product with cells derived from heavily treated patients with autoimmune diseases and are encouraged with the potent autologous B-cell killing properties and limited cytokine production displayed by IMPT-514 in vitro. The differentiated bispecific approach of IMPT-514 is designed for broader targeting of autoreactive B cells with the enhanced tissue and lymphoid organ penetration characteristic of CAR T cells. This offers the potential for a one-time treatment administration capable of resetting the immune response for durable remission.”

The company will evaluate IMPT-514 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 lupus nephritis. Additional patients with and without active proliferative nephritis will be enrolled during the Phase 2 portion of the clinical trial.