Immpact Bio announced that the FDA has cleared its IND application for a CD19/CD20, a bispecific CAR-T cell therapy for treating multiple sclerosis (MS). The therapy is designed to target and eliminate the B cells implicated in MS and offers a potential new treatment option for patients with this autoimmune disease. This clearance allows the company to proceed with clinical trials.

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 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.”

Jonathan Benjamin, M.D., Ph.D., chief medical officer of ImmPACT Bio stated, “The dual-targeting nature of IMPT-514 offers a unique opportunity to potentially ablate autoreactive B cells and the likely pathogenic CD20-expressing T-cells. Moreover, the ability of CAR T-cells to cross the blood brain barrier (BBB) could potentially overcome the limitations of current disease-modifying therapies such as anti-CD20 antibodies that are not effective at crossing the BBB, where potentially pathogenic cells reside. We are pleased to receive IND clearance and further evaluate the therapeutic potential of IMPT-514 to deliver long-lasting protection against MS.”

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