SOUTH SAN FRANCISCO, Calif., April 07, 2025 – Allogene Therapeutics (Nasdaq: ALLO) has achieved a significant regulatory milestone with the FDA granting three Fast Track Designations to its novel dual-targeted (CD19/CD70) AlloCAR T product, ALLO-329. These designations cover its potential use in treating active refractory moderate-to-severe systemic lupus erythematous (SLE), active severe/refractory idiopathic inflammatory myopathy (IIM) – including dermatomyositis, immune mediated necrotizing myopathy, and anti-synthetase syndrome – and active refractory diffuse systemic sclerosis (SSc).
ALLO-329 represents a next-generation AlloCAR T therapy engineered with CRISPR-based site-specific integration for the co-expression of CARs targeting both CD19+ B cells and CD70+ T cells, both key players in autoimmune disease pathways. Recognizing the challenges associated with lymphodepletion in autoimmune patients, Allogene has integrated its clinically validated Dagger® technology into ALLO-329. This technology is designed to enhance CAR T cell expansion and persistence, potentially allowing for a reduction or even elimination of the need for this pre-treatment.
To evaluate the safety and preliminary efficacy of this innovative therapy, Allogene plans to initiate the Phase 1 RESOLUTION basket trial in mid-2025. This trial will enroll patients with SLE, IIM, and SSc and will feature a unique design with two distinct lymphodepletion arms: one utilizing a standard cyclophosphamide regimen and another exploring a lymphodepletion-free approach. The company anticipates generating initial proof-of-concept data from the RESOLUTION trial by the end of 2025, which will be crucial in determining the potential of ALLO-329 to revolutionize the treatment landscape for these severe autoimmune conditions. The FDA’s Fast Track designation will help to expedite the development and review of this promising therapy aimed at addressing significant unmet medical needs.
https://ir.allogene.com/news-releases/news-release-details/allogene-granted-three-us-fda-fast-track-designations-ftd-allo
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