Cabaletta Bio Inc. (NASDAQ: CABA) and Cellares announced a 10-year commercial supply agreement for the production of rese-cel, an investigational cell therapy for autoimmune diseases.

The agreement enables Cellares to provide commercial supply of rese-cel using its automated Cell Shuttle platform and future Cell Q platform, pending FDA approval. Under the terms, Cabaletta secured capacity to supply thousands of batches annually with what the companies describe as minimal capital investment.

Cabaletta plans to submit a biologics license application for rese-cel in myositis in 2027. The company will present initial translational data from the first two patients treated with Cellares-manufactured rese-cel at the American Society of Gene and Cell Therapy conference in May 2026.

"As we advance rese-cel to our planned BLA submission in myositis next year, we believe industrialized automated manufacturing has the potential to support our ability to expand patient access to thousands of patients per year with minimal capital investment," said Steven Nichtberger, Cabaletta's chief executive officer.

Rese-cel is an autologous CAR T cell therapy designed to deplete CD19-positive cells for treating autoimmune diseases. The therapy is currently being evaluated across multiple therapeutic areas including rheumatology, neurology and dermatology.

Cellares operates automated manufacturing facilities in New Jersey, Netherlands and Japan. The company's Cell Shuttle platform received FDA's Advanced Manufacturing Technology designation and has demonstrated what it calls a 100% automation success rate across automated processes.

The collaboration builds on an existing partnership between the companies that began in 2023. Longer-term clinical data from patients receiving Cellares-manufactured rese-cel are expected in the second half of 2026.