Cabaletta Bio Signs Cellares Supply Deal as Rese-cel BLA Submission Approaches in 2027

A long-term commercial supply agreement with Cellares positions Cabaletta Bio to manufacture resecabtagene autoleucel (rese-cel) at industrial scale ahead of a planned BLA submission in 2027, with early comparability data suggesting the automated Cell Shuttle platform matches current clinical supply partners on CAR T cell expansion and B cell depletion kinetics.

The manufacturing comparability read is consequential for QA and regulatory teams tracking the transition from clinical to commercial supply. Two evaluable patients treated with Cellares-manufactured rese-cel demonstrated CAR T cell expansion and B cell depletion at similar magnitudes and on similar timeframes relative to rese-cel produced by existing clinical supply partners. For process validation leads, that equivalence data will form a critical pillar of any comparability package submitted under 21 CFR Part 211 and ICH Q10 quality system expectations as the program moves toward licensure.

On the clinical side, PC-free data presented today at the ASGCT 2026 Annual Meeting showed drug-free clinical responses in half of pemphigus vulgaris patients through six months of follow-up at the lowest dose cohort, administered without preconditioning. The RESET-Myositis pivotal cohort is advancing with an outpatient dosing option to support the first planned BLA submission. A second pivotal indication is expected to be announced following presentation of complete Phase 1/2 lupus and scleroderma data at the June 2026 EULAR Congress.

The Cellares agreement is structured as a long-term commercial supply arrangement, with the company citing potential capacity for thousands of patients per year and what it describes as among the lowest cost of goods in the CAR-T sector with minimal capital investment. For plant heads evaluating autologous cell therapy infrastructure, the Cellares Cell Shuttle platform represents a fully automated, industrialized approach that reduces the facility footprint typically associated with patient-specific manufacturing at scale.

Initial PC-free data from the lowest dose cohort in the RESET-SLE lupus program is expected in the first half of 2026, with longer-term PC-free data from both RESET-PV and RESET-SLE, including higher-dose cohorts, anticipated in the second half of the year.

The comparability dataset from Cellares-manufactured rese-cel, once expanded beyond two patients, will be the measurable outcome that determines whether the commercial supply chain can be locked ahead of BLA filing.

Source: Cabaletta Bio, Inc. via GlobeNewswire, May 14, 2026.