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Cellares and Cabaletta Bio signed a 10-year commercial supply agreement to support large-scale manufacturing of rese-cel, an investigational CAR-T therapy for autoimmune diseases.

The deal positions Cellares as the long-term manufacturing partner, with its automated Cell Shuttle and Cell Q platforms designed to enable production of thousands of batches annually at lower cost. The key step advancers expanding cell therapy beyond oncology into much larger patient populations.

The agreement builds on other recent clinical progress, as NJBIZ previously reported. Patients previously received the successful dosing in Cabaletta’s RESET program using rese-cel manufactured on Cellares’ automated platform. That milestone helped validate both the manufacturing model and the underlying supply chain, reinforcing the feasibility of scaling autologous therapies.

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“Cell therapy has proven it has the potential to transform patients’ lives,” said Fabian Gerlinghaus, co-founder and CEO of Cellares. “For years, autologous cell therapies were constrained by manual processes that had difficulty scaling to meet commercial demand. This 10-year agreement represents a fundamental shift toward automated manufacturing that is demonstrably ready.

“That is exactly what we built Cellares for.”

Building on that progress, Steven Nichtberger, CEO of Cabaletta Bio, said the first two doses of rese-cel manufactured on the Cell Shuttle met all release specifications. He added patients received the delivery and infusion on time in the RESET clinical program, “validating the automated manufacturing model and supply chain logistics we committed to in 2023.”

“This 10-year commercial agreement with Cellares provides the cost-efficient foundation we need to expand access to rese-cel while building a profitable business,” said Nichtberger.

The deal builds on a collaboration dating back more than three years, during which the companies transferred and validated the rese-cel manufacturing process on Cellares’ automated platform, secured U.S. Food and Drug Administration clearance for clinical use, and successfully treated initial patients.

The new agreement marks the next phase of that partnership, shifting from development to long-term commercial production.