Cellares reported that the first two patients have been dosed with Cabaletta Bio’s investigational CAR T cell therapy rese-cel (resecabtagene autoleucel) manufactured on Cellares’ Cell Shuttle instrument. The administration of an autologous cell therapy, which met all release criteria and was manufactured on an automated manufacturing platform, represents an important step on the journey to realizing a future where scalable manufacturing of autologous products to supply thousands of patients per year can be achieved with minimal capital investment and a low cost of goods, according to a Cellares spokesperson.

While the transformative clinical benefits of autologous CAR T cell therapy are well established in oncology, the high manufacturing costs, lack of scalability, process inconsistency, and operational inflexibility associated with the current highly manual way of manufacturing have created meaningful barriers to patient access, reducing patient accessibility to these therapies.

“This is an important milestone that reflects three years of focused collaboration between the teams at Cabaletta and Cellares,” said Steven Nichtberger, MD, co-founder, chairman, and CEO of Cabaletta Bio. “The dosing of these first two patients is an important demonstration of Cellares’ GMP manufacturing and supply chain capabilities with their automated manufacturing platform and thus represents a significant achievement toward our goal of securing high-capacity flexible supply with minimal capital investment and a low cost of goods.”

“This milestone is a transformative moment for the field of autologous cell therapy,” added Fabian Gerlinghaus, co-founder and CEO of Cellares. “For years, the promise of autologous CAR T has been constrained by manufacturing models that were never designed to scale.”

Rese-cel (formerly referred to as CABA-201) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion, rese-cel is intended to transiently and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy.

Cabaletta is evaluating rese-cel in the RESET (REstoring SElf-Tolerance) clinical development program, which includes multiple ongoing company-sponsored trials across a diverse and growing range of autoimmune diseases in rheumatology, neurology, and dermatology.

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