Cellares and Cabaletta Bio sign 10-year manufacturing deal for rese-cel
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Cellares has entered into a 10-year commercial supply agreement with Cabaletta Bio Inc. (NASDAQ: CABA) to manufacture rese-cel, Cabaletta's investigational CAR T cell therapy for autoimmune diseases.
The agreement follows the companies' recent milestone of dosing the first patients with rese-cel manufactured on Cellares' automated Cell Shuttle platform. According to the press release, the first two doses met all release specifications and were delivered on time to patients in Cabaletta's RESET clinical program.
Rese-cel is an autologous CAR T cell therapy designed to treat autoimmune diseases by targeting CD19-positive cells. The therapy is being evaluated across multiple autoimmune conditions in rheumatology, neurology and dermatology through Cabaletta's RESET clinical development program.
Cellares operates as an Integrated Development and Manufacturing Organization, providing automated cell therapy manufacturing through its Cell Shuttle and Cell Q platforms. The company operates facilities in South San Francisco, California; Bridgewater, New Jersey; Leiden, Netherlands; and Kashiwa City, Japan.
"The first two doses of rese-cel manufactured on the Cell Shuttle met all release specifications and were delivered and infused on time to patients in the RESET clinical program," said Steven Nichtberger, Chief Executive Officer of Cabaletta Bio.
The collaboration between the companies began more than three years ago and included adapting the rese-cel manufacturing process to the Cell Shuttle platform and securing FDA clearance for clinical manufacturing using the automated system.
Cabaletta Bio is a late-stage clinical biotechnology company focused on developing cell therapies for autoimmune diseases. The company is headquartered in Philadelphia.
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