FDA grants fast track status to Allogene’s autoimmune therapy

Allogene Therapeutics, a biotech company, has received “Fast Track” status from the U.S. Food and Drug Administration (FDA) for its new therapy, ALLO-329, aimed at treating autoimmune diseases like systemic lupus erythematosus (SLE), immune-mediated inflammatory diseases (IIM), and systemic sclerosis (SSc). This designation is granted to expedite the development and review of drugs that address serious conditions with unmet medical needs. ALLO-329 is designed to target specific immune cells—CD19+ B cells and CD70+ T cells—that play a role in the development of autoimmune diseases. Allogene plans to begin a Phase 1 clinical trial, named RESOLUTION, in mid-2025 to evaluate the safety and initial effectiveness of ALLO-329 in patients with these conditions. The trial will explore different pre-treatment options, including one without the need for traditional chemotherapy, which could make the therapy more accessible. Initial results from this study are expected by the end of 2025. It’s important to note that while Fast Track status facilitates the development process, it doesn’t guarantee the therapy will be approved or become commercially available.