PHILADELPHIA, PA & SOUTH SAN FRANCISCO, CA — Cabaletta Bio, Inc. (Nasdaq: CABA) and Cellares have entered a commercial agreement to manufacture rese-cel, an investigational cell therapy for autoimmune diseases, using automated production platforms designed to scale output to thousands of batches annually.
The agreement provides Cabaletta with access to Cellares’ Cell Shuttle manufacturing system and planned integration of its Cell Q quality control platform to support commercial supply, pending regulatory approval.
Under the terms, Cabaletta secured capacity to produce thousands of rese-cel batches per year over a 10-year period with limited capital investment. The companies expect per-batch manufacturing costs to rank among the lowest in the autologous cell therapy sector.
The deal expands an existing collaboration between the companies that began in 2023 to automate and scale production of rese-cel.
Cabaletta is advancing rese-cel toward a planned biologics license application submission for myositis and is developing a manufacturing strategy focused on scalability, cost efficiency, and supply redundancy.
Cellares will provide manufacturing and quality control services through its automated platforms, which are designed to reduce labor requirements, improve scheduling efficiency, and support global production expansion.
Initial translational data from the first two patients treated with Cellares-manufactured rese-cel are expected to be presented at the American Society of Gene and Cell Therapy Annual Meeting in May.
The data are intended to evaluate manufacturing performance, including supply chain logistics, under current Good Manufacturing Practice standards. Additional clinical data from patients receiving Cellares-manufactured rese-cel are expected in the second half of 2026.
Rese-cel, or resecabtagene autoleucel, is an investigational autologous CAR-T cell therapy targeting CD19-positive cells and is being studied across multiple autoimmune diseases in Cabaletta’s RESET clinical program.
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