Cabaletta Bio Advances 17-Patient Myositis Trial, 2027 BLA Goal, 1H26 Manufacturing Data
Cabaletta Bio’s 17-patient registrational dermatomyositis and antisynthetase syndrome cohort is enrolling with a 16-week primary endpoint, targeting a 2027 BLA submission. Automated rese-cel manufacturing via Cellares’ Cell Shuttle™ begins clinical assessment in 1H26, with durability data from multiple RESET™ trials expected throughout 2026.
1. 2025 Financial Results and Business Update
Cabaletta reported its fourth quarter and full-year 2025 financial results and provided a detailed business update, emphasizing progress across its autoimmune cell therapy pipeline and upcoming program catalysts.
2. Registrational Myositis Cohort Enrollment
The registrational dermatomyositis and antisynthetase syndrome cohort is enrolling 17 patients in a single-arm study with a 16-week primary endpoint measuring moderate or major improvement off immunomodulators, aiming for a BLA submission in 2027.
3. Automated Manufacturing with Cellares
Initial GMP readiness and clinical experience using rese-cel manufactured by Cellares’ Cell Shuttle™ are expected in 1H26, with longer-term outcome data in 2H26 to validate scalable production for thousands of patients per year with minimal capital.
4. No-Preconditioning Programs and Pivotal Designs
Initial data from the no-preconditioning RESET-SLE trial will be shared in 1H26, followed by durability data in 2H26, while pivotal single-arm cohorts for SLE and lupus nephritis are active and a systemic sclerosis design is due in 1H26.