UPDATE - Cabaletta Bio Announces Updated Clinical Data Demonstrating Deepening Clinical Responses across Multiple Indications with Rese-cel at February Scientific Meetings

Core Insights - Cabaletta Bio, Inc. has presented new clinical data indicating the efficacy of resecabtagene autoleucel (rese-cel) in treating autoimmune diseases, with significant improvements observed in patients with systemic lupus erythematosus (SLE), lupus nephritis (LN), and dermatomyositis [1][2][9] - The company aims to align with the FDA on registrational trial designs in the first half of 2025, leveraging the expanding clinical experience and enrollment pace across its RESET clinical development program [2][10] Clinical Data Summary - As of January 8, 2025, 10 patients have been dosed with rese-cel, showing promising results such as DORIS remission in SLE and complete renal response in LN, with patients off immunosuppressants and tapering steroids [3][9] - In the RESET-Myositis trial, the first adult dermatomyositis patient maintained a major total improvement score (TIS) at 3 months post-infusion, indicating potential for drug-free remission [3][9] Safety Profile - The safety profile of rese-cel appears favorable, with 90% of patients experiencing either no cytokine release syndrome (CRS) or Grade 1 CRS, and 90% experiencing no immune effector cell-associated neurotoxicity syndrome [4][9] - Deep B cell depletion was observed in all patients post-infusion, with a transitional naïve B cell phenotype upon repopulation, suggesting effective immune system resetting [4][9] Clinical Development Program - The RESET program includes six Phase 1/2 clinical trials targeting various autoimmune diseases, with a focus on rheumatology, neurology, and dermatology [2][6][7] - The company is actively recruiting at 50 clinical sites in the U.S. and Europe, with 26 patients enrolled as of February 13, 2025 [4][9]