ImmPACT Bio Receives FDA Clearance for CD19/CD20 CAR-T Therapy in Multiple Sclerosis

ImmPACT Bio USA Inc. (ImmPACT Bio), a clinical-stage biopharmaceutical company, has announced that the United States Food and Drug Administration (FDA) has approved an investigational new drug application (IND) for their innovative therapy, IMPT-514. This therapy is a CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell treatment designed for adult patients with multiple sclerosis (MS). The therapy targets both CD19 and CD20 markers to deplete a broad range of pathogenic autoimmune cells.

Set to begin in the first half of 2025, ImmPACT Bio will launch a Phase 1 dose escalation trial. This trial will focus on patients whose disease remains uncontrolled despite prior treatments with high-efficacy disease-modifying therapies. The primary goal is to slow or halt the progression of disability accumulation in MS patients. Notably, IMPT-514 is the only known CD19/CD20 CAR T-cell therapy currently in development for MS.

Sumant Ramachandra, M.D., Ph.D., the chief executive officer of ImmPACT Bio, expressed enthusiasm about the IND clearance, highlighting its significance in the company’s broader autoimmune program. “IMPT-514 is designed as a one-time treatment that has the potential to reset the immune system by targeting and depleting a wide range of autoreactive immune cells responsible for MS. We anticipate dosing the first patient by the first half of 2025,” said Dr. Ramachandra.

Jonathan Benjamin, M.D., Ph.D., the chief medical officer at ImmPACT Bio, elaborated on the dual-targeting nature of IMPT-514. He pointed out that this characteristic offers a unique opportunity to eliminate autoreactive B cells and pathogenic CD20-expressing T-cells. Furthermore, the ability of CAR T-cells to cross the blood-brain barrier (BBB) could potentially address limitations posed by current disease-modifying therapies, such as anti-CD20 antibodies, which have difficulty crossing the BBB to reach pathogenic cells. “We are excited to further evaluate IMPT-514’s potential to provide long-lasting protection against MS,” added Dr. Benjamin.

IMPT-514 employs a potent bispecific CAR and a 4-1BB costimulatory domain, identical to the CAR construct used in ImmPACT’s IMPT-314, which is being developed for specific types of non-Hodgkin's lymphoma. The therapy is manufactured using the same process as IMPT-314. Preclinical studies have shown that IMPT-514 can be efficiently manufactured from heavily immunosuppressed patients with various autoimmune diseases. It also demonstrated potent elimination of autologous B-cells and exhibited a moderate cytokine profile.

ImmPACT Bio USA, Inc. is dedicated to developing advanced cellular therapies that have the potential to bring transformative benefits to patients. The company’s logic-gate-based CAR T-cell platforms, licensed from the University of California, Los Angeles (UCLA) Technology Development Group, are specifically engineered to tackle antigen escape, minimize toxicity, overcome immunosuppression in the tumor microenvironment, and enhance cell persistence. The company's technology is built on the pioneering work of scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., from UCLA.

In summary, with the FDA's IND clearance, ImmPACT Bio is poised to explore the full potential of IMPT-514 in treating multiple sclerosis, aiming to offer a groundbreaking solution for patients with this debilitating autoimmune disease.