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On August 21, ImmPACT Bio announced that the U.S. FDA approved the IND application for its CD19/CD20 bispecific CAR-T cell therapy IMPT-514, intended for the treatment of adult patients with multiple sclerosis (MS). IMPT-514 is the first CD19/CD20 CAR-T cell therapy for the treatment of multiple sclerosis.ImmPACT Bio is expected to launch a Phase 1 dose-escalation trial in the first half of 2025. The trial will primarily target patients who have previously received various forms of highly effective disease-modifying therapies for multiple sclerosis but have had suboptimal disease control, with the aim of slowing or halting the progression of disability accumulation. IMPT-514 is the only known CD19/CD20 CAR T-cell therapy currently in development for the treatment of multiple sclerosis.IMPT-514 is a chimeric antigen receptor (CAR) T-cell therapy targeting CD19/CD20, utilizing a potent bispecific CAR and a 4-1BB costimulatory domain. It shares the same CAR structure as ImmPACT's IMPT-314, which is under development for certain types of non-Hodgkin lymphoma and is manufactured using the same process. In preclinical studies, IMPT-514 was successfully and efficiently manufactured from severely immunosuppressed patients with various autoimmune diseases, demonstrating robust autologous B-cell depletion capability and a moderate cytokine profile.Multiple sclerosis (MS) is a neurodegenerative disease characterized by demyelination in the central nervous system, leading to permanent damage of the myelin sheath surrounding nerve fibers and affecting cognitive, emotional, motor, sensory, and visual functions. Symptoms may include weakness or numbness in the limbs, vision loss, mood disturbances, lack of coordination, or inability to walk. According to the World Health Organization, approximately 1.8 million people worldwide are affected by MS. Despite its prevalence, MS is difficult to diagnose in its early stages and treatment options remain limited, highlighting the unmet needs of this patient population. CAR-T cell therapy is gaining increasing attention as a potential treatment for MS, with the development of the CD19/CD20-targeting bispecific CAR, IMPT-514, marking a significant advancement in expanding therapeutic options for patients.Sumant Ramachandra, Ph.D., CEO of ImmPACT Bio, stated"Our bispecific CAR T-cell therapy receiving IND approval in the field of multiple sclerosis is an exciting achievement, further expanding the clinical development of our autoimmune program. As a one-time treatment, IMPT-514 has the potential to reset patients' immune systems by depleting various autoreactive immune cells associated with the pathogenesis of multiple sclerosis. We anticipate dosing the first patient in the first half of 2025."Jonathan Benjamin, MD, Chief Medical Officer of ImmPACT Bio, stated"IMPT-514’s dual targeting provides a unique opportunity to potentially deplete autoreactive B cells and pathogenic CD20-expressing T cells. Additionally, the ability of CAR-T cells to cross the blood-brain barrier (BBB) has the potential to overcome limitations of current disease-modifying therapies, such as the inability of anti-CD20 antibodies to effectively cross the BBB, which is a habitat for potentially pathogenic cells. We are thrilled to have received IND clearance and look forward to further evaluating the therapeutic potential of IMPT-514 to provide durable protection against multiple sclerosis."Reference: Company official website
