Philadelphia-based Cabaletta Bio, a late-stage clinical biotechnology company, and California-based Cellares, a company providing global cell therapy development and manufacturing services, recently entered a commercial agreement regarding one of Cabaletta Bio’s drugs.
Under the terms of the agreement, Cellares will use automated manufacturing and quality-control platforms to provide a future commercial supply of rese-cel, a cell therapy designed specifically for the treatment of autoimmune diseases. The drug is pending FDA approval.
The companies believe Cellares’ platforms will enable the low-cost production of thousands of batches annually of rese-cel with minimal capital investment and that the per-batch cost will be among the lowest in the industry for autologous cell therapy production.
“As we advance rese-cel to our planned BLA (biologics license application) submission in myositis next year, we believe industrialized automated manufacturing has the potential to support our ability to expand patient access to thousands of patients per year with minimal capital investment,” Dr. Steven Nichtberger, Cabaletta CEO, said. “By providing a flexible, scalable, efficient, low-cost and globally transferable manufacturing supply platform for rese-cel, our partnership with Cellares expands our already robust supply chain and complements our current CDMO (contract development and manufacturing organization) partners.”
In 2023, the companies agreed to automate and industrialize rese-cel.