Allogene Therapeutics Inc. (ALLO), a clinical-stage biotechnology company specializing in allogeneic CAR T-cell therapies, announced on Tuesday that the U.S. Food and Drug Administration or FDA has cleared its Investigational New Drug or IND application for ALLO-329.
This approval paves the way for a Phase 1 RESOLUTION trial, designed to evaluate ALLO-329's safety and preliminary efficacy in treating autoimmune diseases such as systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathies, and systemic sclerosis.
ALLO-329 is a next-generation allogeneic CAR T-cell therapy that targets both CD19+ B-cells and CD70+ T-cells, offering a dual-targeted approach to address immune system dysfunction in autoimmune diseases.
The therapy incorporates Allogene's proprietary Dagger technology, which has the potential to reduce or eliminate the need for traditional lymphodepletion treatments, simplifying the process for patients.
The RESOLUTION trial will begin in mid-2025 and aims to provide important insights into ALLO-329's ability to reset the immune system in autoimmune disease patients. If successful, the trial could open the door for broader applications of allogeneic CAR T therapies in autoimmune diseases.
Allogene plans to expand its research and continue exploring ALLO-329's potential to transform treatment options for autoimmune conditions, bringing innovative, off-the-shelf CAR T therapies to more patients.
Currently, ALLO is trading at $1.96 up by 1.81%.
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