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Bristol Myers announces updated data from Phase 1 study of CD19

Bristol Myers (BMY) Squibb announced updated data and first disclosure of results in chronic, refractory autoimmune diseases from the Phase 1 Breakfree-1 study of its investigational, autologous CD19-targeted NEX-T CAR T cell therapy BMS-986353. The data, evaluating a total of 71 treated patients across the systemic sclerosis, SSc, systemic lupus erythematosus, SLE, and idiopathic inflammatory myopathies, IIM, cohorts, are being featured at the American College of Rheumatology, ACR, Convergence 2025, taking place from October 24-29 in Chicago, Illinois. Key results: Positive, early results from 71 patients treated across three disease cohorts – systemic sclerosis, systemic lupus erythematosus and idiopathic inflammatory myopathies – are being disclosed; Across all cohorts, results support potential for immune reset, with 94% of evaluable patients remaining off chronic immunosuppressive therapy at the time of analysis; Results demonstrate BMS’ steady advancement toward its goal of bringing the science of cell therapy beyond blood cancer into autoimmune diseases.

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