Clinical-stage biopharmaceutical company ImmPACT Bio USA Inc. (ImmPACT Bio) announced on Wednesday that it has received approval from the United States Food and Drug Administration (FDA) for the investigational new drug application (IND) for IMPT-514, a CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy, intended for the treatment of adult patients with multiple sclerosis (MS).

The company expects to commence a Phase one 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 aim of slowing or stopping the progression of disability accumulation. IMPT-514 is the only known CD19/CD20 CAR T-cell therapy in development for the treatment of MS.

Sumant Ramachandra, MD, PhD, ImmPACT Bio chief executive officer, said, 'IND clearance for our bispecific CAR T-cell therapy in MS marks an exciting achievement that further expands clinical development of our autoimmune program. As an intended one-time treatment, IMPT-514 has the potential to reset the immune system by depleting a broad range of autoreactive immune cells implicated in the pathogenesis of MS in patients. We expect to dose the first patient in the first half of 2025.'