Cabaletta Bio Announces 2026 Strategic Priorities

Core Insights - Cabaletta Bio is focused on advancing its investigational CAR T cell therapy, rese-cel, for autoimmune diseases, with a pivotal myositis trial actively enrolling and a planned Biologics License Application (BLA) submission in 2027 [1][2] Group 1: Strategic Priorities and Clinical Development - The company aims to translate registrational pathways for rese-cel into a product pipeline across various autoimmune diseases, with a specific focus on enrolling a 17-patient cohort for the myositis trial [3] - The FDA has aligned with Cabaletta on the design of registrational cohorts for systemic lupus erythematosus (SLE) and lupus nephritis (LN), evaluating a weight-based dose of 1 million cells/kg [3][4] - Cabaletta has received Regenerative Medicine Advanced Therapy (RMAT) designation for rese-cel in systemic sclerosis and is working on aligning registrational cohort designs for additional conditions [4] Group 2: Manufacturing and Scalability - The company has obtained clearance for an Investigational New Drug (IND) amendment to manufacture rese-cel using the Cellares platform, which is expected to enhance scalability and reduce costs [5] - Clinical manufacturing data is anticipated in the first half of 2026 to confirm Good Manufacturing Practice (GMP) readiness and supply chain logistics for Cellares-produced rese-cel [5] Group 3: Clinical Data and Innovations - New durability data from ongoing trials without preconditioning and higher dose initial clinical data from RESET-PV™ are expected in the first half of 2026 [1][8] - Complete Phase 1/2 data from trials in lupus, scleroderma, and myasthenia gravis are anticipated in the first half of 2026, which will provide insights into the therapy's efficacy [1][8] Group 4: Company Overview - Cabaletta Bio is a late-stage clinical biotechnology company dedicated to developing targeted cell therapies for autoimmune diseases, with its lead therapy, rese-cel, being evaluated in multiple ongoing trials [9]