$8M CIRM Grant Supports IMPT-514 CAR T-Cell Therapy for Lupus

ImmPACT Bio, a company at the forefront of developing innovative CAR T-cell therapies, has received an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support their Phase 1b/2 clinical trial of IMPT-514. This therapy is a novel CD19/CD20 bispecific CAR T-cell treatment, which is being developed to address the unmet needs of patients with lupus nephritis and systemic lupus erythematosus (SLE).

IMPT-514 is a groundbreaking approach that aims to reset the immune system, offering a one-time treatment that could potentially eliminate the requirement for long-term immune suppression. The therapy is designed to target and deplete autoreactive immune cells, which are implicated in the pathogenesis of lupus. Lupus is a complex and debilitating autoimmune disease that primarily affects women, particularly in their young adult years, and can lead to severe organ damage and reduced life expectancy.

The clinical trial for IMPT-514 is an open-label, dose-escalation study involving participants with active, refractory SLE who have not responded to at least two standard treatments and have a high SLE Disease Activity Index score. The FDA has granted Fast Track Designation to IMPT-514, reflecting the urgency and significance of finding effective treatments for these conditions.

Abla Creasey, Ph.D., from CIRM, highlighted the transformative impact CAR T-cell therapies have had on blood cancers and expressed optimism about their potential in treating autoimmune diseases like lupus. The grant from CIRM is a testament to the belief in the potential of IMPT-514 to revolutionize lupus treatment.

Jonathan Benjamin, M.D., Ph.D., ImmPACT Bio's Chief Medical Officer, expressed gratitude for CIRM's recognition of the clinical trial's scientific and technical merit. He emphasized the importance of developing well-tolerated therapies that can provide long-lasting remission for lupus patients, given the heterogeneity of the disease and the lack of a one-size-fits-all treatment.

The Lupus and Allied Diseases Association, Inc. (LADA), a national patient advocacy organization, underscores the need for a diverse range of therapies to address the unique challenges each lupus patient faces. The development of IMPT-514 is a step towards expanding the therapeutic arsenal against lupus and lupus nephritis.

IMPT-514 is based on the work of Yvonne Chen, Ph.D., and Sarah Larson, M.D., from UCLA, and utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. Preclinical studies have shown its effectiveness in eliminating autologous B cells and maintaining a moderate cytokine profile, which is crucial for a balanced immune response.

ImmPACT Bio's technology is licensed from UCLA and is designed to overcome key biological challenges in cancer and autoimmune disease treatment. The company's platforms are aimed at depleting B cells, preventing antigen escape, and tackling the immunosuppressive tumor microenvironment.

CIRM, with its mission to accelerate stem cell treatments for patients with unmet medical needs, has a significant role in partnering with both academia and industry to fast-track the development of promising stem cell technologies. With substantial funding and a diverse portfolio of active stem cell programs, CIRM is a key player in advancing cellular medicine.

The initial efficacy and safety data from the Phase 1b/2 dose escalation trial of IMPT-514 are anticipated in the latter half of 2024, offering hope for a new era in lupus treatment.