Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company, has announced new clinical and translational data from its ongoing RESET-Myositis™, RESET-SLE™, and RESET-SSc™ trials. These trials are evaluating the efficacy of rese-cel (resecabtagene autoleucel) in treating autoimmune diseases. The data, based on 18 evaluable patients, are being presented at the European Alliance of Associations for Rheumatology (EULAR) 2025 Congress in Barcelona, Spain, held from June 11-14, 2025. Key findings include clinically meaningful responses in myositis patients, remission in SLE patients without nephropathy, and improvement in scleroderma patients, with most patients off immunomodulators and steroids. Safety data indicate a low incidence of CRS and ICANS. Cabaletta Bio plans to engage with the FDA on registrational program designs for various indications to advance the development of rese-cel as a targeted curative cell therapy for autoimmune diseases.
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