IMPT-514 is the first-and-only known CD19/CD20 CAR T-cell therapy in development for multiple sclerosis Dual CD19/CD20 targeting is designed to enable broad depletion of pathogenic autoimmune cells Initiation of Phase 1 dose exploration trial expected first half of 2025 LOS ANGELES , Aug. 21, 2024 /PRNewswire/ -- ImmPACT Bio USA Inc. (ImmPACT Bio), a clinical-stage biopharmaceutical company developing a new generation of cellular therapies that have the potential to bring transformational benefits to patients, today announced the United States Food and Drug Administration (FDA) has cleared an investigational new drug application (IND) for IMPT-514, a CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with multiple sclerosis (MS).
ImmPACT Bio expects to initiate a Phase 1 dose escalation trial that will focus on patients who have suboptimal disease control despite prior treatment with high efficacy disease-modifying therapies in all forms of MS, with the intent to slow or stop the progression of disability accumulation. IMPT-514 is the only known CD19/CD20 CAR T-cell therapy in development for the treatment of MS. "IND clearance for our bispecific CAR T-cell therapy in MS marks an exciting achievement that further expands clinical development of our autoimmune program," said Sumant Ramachandra, M.
D., Ph.D.
, chief executive officer of ImmPACT Bio. "As an intended one-time treatment, IMPT-514 has the potential to reset the imm.