Cabaletta Bio presents data, development updates for Rese-cel

Cabaletta Bio (CABA) announced positive clinical data and development updates across the RESET-Myositis, RESET-SSc and RESET-SLE trials evaluating rese-cel. These data are being presented in multiple oral and poster presentations at the ongoing American College of Rheumatology, ACR, Convergence 2025, which is being held at the McCormick Place Convention Center in Chicago, Illinois, from October 24-29, 2025. Key points: All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who met key registrational inclusion criteria exceeded the registrational primary endpoint, demonstrating major TIS responses with no immunomodulators; Myositis registrational trial being initiated this quarter with a planned cohort of 14 DM/ASyS patients and a 16-week primary endpoint – moderate or major TIS while off immunomodulators and on no or low-dose steroids – consistent with FDA alignment on key trial parameters; All systemic sclerosis patients with sufficient follow-up demonstrated ongoing, transformative clinical responses off all immunomodulators and steroids; Seven of 8 lupus patients with sufficient follow-up achieved DORIS or renal response; RESET-SLE trial expanding to include a no preconditioning cohort with initial clinical data expected in 2026