ImmPACT Bio has secured investigational new drug (IND) application approval from the US Food and Drug Administration (FDA) for CD19/CD20-targeting chimeric antigen receptor (CAR) T-cell therapy, IMPT-514, which helps to prepare for a clinical trial to treat adult patients with multiple sclerosis (MS).

The company is set to initiate the Phase I dose escalation trial targeting all forms of MS, with the goal of slowing or halting the progression of disability.

The trial aims to assess IMPT-514, which stands out as the sole CD19/CD20 CAR T-cell therapy currently in development for MS.

ImmPACT Bio CEO Sumant Ramachandra said: “IND clearance for our bispecific CAR T-cell therapy in MS marks an exciting achievement that further expands the clinical development of our autoimmune programme.

“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.”

The IMPT-514 therapy uses a bispecific CAR and a 4-1BB costimulatory domain, sharing its CAR construct with IMPT-314, which is being developed for certain types of non-Hodgkin's lymphoma.

In preclinical studies, the therapy has shown positive results, demonstrating efficient manufacturing even for patients with significant immunosuppression due to autoimmune diseases.

It has also exhibited potent autologous B-cell elimination and a moderate cytokine profile.

ImmPACT Bio chief medical officer Jonathan Benjamin said: “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.”