Cellares, Cabaletta Bio Ink 10-Year Commercial Supply Pact for Investigational CAR-T Therapy

Cellares and Cabaletta Bio have signed a 10-year commercial supply agreement for automated manufacture of rese-cel (resecabtagene autoleucel). Rese-cel is Cabaletta’s investigational chimeric antigen receptor T-cell (CAR-T) therapy for autoimmune diseases.

In securing long-term manufacturing capacity and supply predictability, the two companies cited global patient demand for rese-cel. That demand follows the companies’ first dosing milestone: patients dosed with an autologous CAR-T therapy manufactured on an automated platform.

Why Autologous CAR-T?

According to Cellares and Cabaletta, autologous CAR-T therapies have transformative potential in oncology as well as autoimmune diseases. In that latter therapeutic area, patient populations can be “orders of magnitude” larger, the companies say, than in blood cancers.

Much of Cellares and Cabaletta’s work to date is thanks to Cellares’ Cell Shuttle platform. This is the first cell therapy manufacturing platform to receive the FDA’s Advanced Manufacturing Technology designation.

Cellares’ Platforms Benefit to Cabaletta

The Cell Shuttle, and Cellares’ other fully automated platform, Cell Q, stand to play critical roles in rese-cel supply. Because larger indications encompassing autoimmune diseases require commercial scale, manufacturing infrastructure must produce thousands of batches annually. And, these batches must demonstrate consistent quality, fast turnaround, and accessible cost structure.

Cellares says the Cell Shuttle offers up to 10x higher throughput than conventional CDMO approaches.

CEOs Respond

“The first two doses of rese-cel manufactured on the Cell Shuttle met all specifications,” said Cabaletta CEO Steven Nichtberger, MD. He added these doses were delivered and infused on time to patients in a clinical program.

“Cell therapy has proven it has the potential to transform patients’ lives,” said Fabian Gerlinghaus, Cellares co-founder and CEO. “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.”