Cabaletta Bio reports data from the RESET trials evaluating rese-cel

Cabaletta Bio (CABA) announced new clinical and translational data from the ongoing RESET-Myositis, RESET-SLE and RESET-SSc trials evaluating rese-cel. These data are being presented in three oral presentations at the ongoing European Alliance of Associations for Rheumatology, or EULAR, 2025 Congress, which is being held from June 11-14 in Barcelona, Spain. “These new clinical and translational findings reinforce our belief that a single, weight-based dose of rese-cel leads to deep B cell depletion and compelling clinical data in patients with myositis, lupus and systemic sclerosis, with nearly all patients off immunomodulators and steroids. Patients are seeking a drug-free, symptom-free life, which is rarely, if ever, achieved with currently approved therapies. We believe the clinical data on rese-cel indicate its potential to achieve this aspiration and ultimately change treatment paradigms for autoimmune diseases,” said David J. Chang, Chief Medical Officer of Cabaletta. Cabaletta is presenting new clinical and translational data from 18 evaluable patients who were dosed with rese-cel across the RESET-Myositis, RESET-SLE and RESET-SSc trials at the EULAR 2025 Congress in three oral presentations. As of the data cut-off dates of May 6, 2025, for the RESET-Myositis and RESET-SSc trials and June 2, 2025, for the RESET-SLE trial, key clinical and translational insights from these patients include: RESET-Myositis: 7 out of 8 patients achieved a clinical response off all immunomodulators, while off or actively tapering steroids. All 4 antisynthetase syndrome and dermatomyositis patients achieved a clinically meaningful total improvement score response, with 3 of these patients having achieved a major TIS response as of the data cut-off date. RESET-SLE: 7 out of 7 patients achieved a clinical response off all immunomodulators and glucocorticoids. All non-renal systemic lupus erythematosus patients without nephropathy achieved DORIS as of the latest follow-up. RESET-SSc: Both of the patients reported in the severe skin cohort had meaningful modified Rodnan Skin Score improvements after discontinuing immunomodulatory drugs and steroids, which was sustained out to 6 months in the first patient. Rese-cel Translational Profile: Peak rese-cel expansion was observed within approximately two weeks. B cells were rapidly and transiently reduced in peripheral blood within the first month and their repopulation was observed beginning approximately two months after infusion, generally expressing a transitional, naive phenotype.