Cabaletta Bio , a late-stage clinical biotechnology company focused on developing and launching targeted cell therapies designed specifically for patients with autoimmune diseases, today announced new clinical data supporting rese-cel (resecabtagene autoleucel) as a potential treatment for multiple autoimmune diseases, including findings that further inform Cabaletta’s registrational strategy in myositis and systemic sclerosis as well as its preconditioning-free (PC-free) program in lupus. These data are being presented in multiple oral and poster presentations, as well as in a company-sponsored satellite symposium, at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, being held June 3-6, 2026, in London, UK.
Also Read: King Faisal Hospital Ranks 12th Globally in Brand Finance 2026
“Over 80% of the Phase 1/2 dermatomyositis patients would have achieved the pivotal primary endpoint and all five of these patients maintained their response through the latest follow-up as long as 1.5 years. Based on a conservatively high control group response rate, the registrational cohort requires no more than 50% of patients to achieve the 16-week primary endpoint for a positive study,” said David J. Chang, M.D., Chief Medical Officer of Cabaletta Bio.
“In addition, the emerging durability of rese-cel is promising. The vast majority of dermatomyositis and lupus patients maintained their immunomodulator-free responses and most systemic sclerosis patients demonstrated continued increases in the magnitude of response with longer follow-up. Beyond the emerging durability data, we are encouraged by the safety profile of rese-cel, which we believe supports outpatient administration. The unanticipated clinical activity at the lowest dose of PC-free rese-cel further supports the potential to expand the market, and we believe that with the optimal dose, preconditioning may not be required for many patients to achieve immune reset in lupus and other autoimmune diseases.”
At the EULAR 2026 Congress, Cabaletta’s presentations include data from 52 evaluable autoimmune disease patients living with myositis (17), lupus (20) and systemic sclerosis (15) who were treated with rese-cel, including the first juvenile dermatomyositis (JDM) patient and the first two lupus patients treated with PC-free rese-cel. Rese-cel exhibited a predictable translational profile when administered with and without preconditioning, consistent across each indication evaluated.
