Cabaletta automates manufacturing of autoimmune disease CAR-T asset using Cellares platform

Cellares and Cabaletta Bio have concluded their Technology Adoption Program (TAP) utilizing Cellares’ automated cell therapy manufacturing platform for Cabaletta’s lead clinical candidate, a CD19-targeting CAR-T cell therapy for patients with autoimmune diseases.

The TAP, which was first announced in 2023, successfully delivered automated, concurrent manufacture of multiple batches of Cabaletta’s rese-cel on a single Cellares Cell Shuttle platform. Cabaletta Bio and Cellares are now working towards the goal of manufacturing CGMP cell therapy batches to be delivered to patients.

According to Cellares, the Cell Shuttle performed all unit operations in an automated manner, including cell isolation, enrichment, gene editing, activation, and expansion. Each unit operation met predefined in-process requirements. The automated process delivered drug products that met pre-defined quality ranges.

Rese-cel is a 4-1BB-containing fully human CD19-CAR-T cell therapy for patients with autoimmune diseases where B cells contribute to the initiation and/or maintenance of disease. Following a one-time infusion of a weight-based dose, rese-cel is designed to transiently and deeply deplete all CD19-positive cells in both the peripheral circulation and within tissues. This approach has the potential to reset the immune system and result in profound clinical responses without chronic therapy requirements in patients.

Cellares says its network of smart factories could allow Cabaletta to achieve the global scale required to meet the total patient demand across multiple autoimmune diseases, including myositis (~70,000 patients in the U.S.), scleroderma (~90,000 patients in the U.S.) and lupus nephritis (~100,000 patients in the U.S.), in a fraction of the time and initial investment it would typically take to develop and deliver global supply for these large patient populations. 

Cellares’ TAP has attracted companies like investor Bristol Myers Squibb, who joined the program in 2023 after participating in Cellares’ Series C financing. A year later, BMS signed a $380 million worldwide capacity reservation and supply agreement with Cellares for the manufacture of CAR-T cell therapies.