ImmPACT Bio, a clinical-stage company, has received an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support the Phase 1b/2 study of IMPT-514, a novel CAR T-cell therapy. This treatment is unique as it targets both CD19 and CD20, aiming to treat lupus nephritis and systemic lupus erythematosus (SLE) by depleting autoreactive immune cells. The therapy is designed as a one-off procedure that could eliminate the requirement for ongoing immune suppression, offering a new approach to managing autoimmune diseases beyond cancer treatment.
The company anticipates releasing initial data regarding the therapy's efficacy and safety in the second half of 2024. IMPT-514 has been granted Fast Track Designation by the FDA for both active and refractory lupus nephritis and SLE. The disease affects over 200,000 patients in the U.S., with lupus nephritis being a severe complication that can lead to end-stage renal disease and higher mortality rates. Despite current treatments, there is a significant need for more effective and safer therapies.
The clinical trial for IMPT-514 is an open-label, dose-escalation study involving patients with active, refractory SLE who have undergone at least two standard treatments and have a high SLE Disease Activity Index score. The therapy has shown promise in preclinical studies, demonstrating the ability to effectively target and eliminate B cells from lupus patients while maintaining a moderate cytokine profile.
The Lupus and Allied Diseases Association, Inc. emphasizes the complexity of lupus, noting the lack of a one-size-fits-all treatment and the importance of a diverse therapeutic arsenal. ImmPACT Bio's technology is based on the pioneering work of scientists from the University of California, Los Angeles, and the company's CAR T-cell platforms are designed to address specific challenges in cancer and autoimmune disease treatment. The CIRM, with its mission to expedite stem cell therapies for patients with unmet medical needs, has a significant role in advancing such innovative treatments.
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