Cellares and Cabaletta Bio (NASDAQ:CABA) announced a landmark regulatory achievement Monday, with the FDA clearing an Investigational New Drug (IND) Amendment to manufacture the autoimmune-focused CAR T therapy, rese-cel, using Cellares’ fully automated platforms.
The clearance marks the first time Cellares’ "Cell Shuttle" and "Cell Q" technologies will be utilized to support an active clinical program.
Unlike traditional manual manufacturing, which is labor-intensive and difficult to scale, the Cellares system provides a software-defined, end-to-end automated workflow.
This transition is viewed as critical for the autoimmune market, where patient populations are significantly larger than the orphan-disease oncology markets that CAR T therapies have historically served.
"Achieving scalability in these larger indications is a differentiated feature of the Cellares platform," CEO Fabian Gerlinghaus said in a statement.
The partnership successfully demonstrated "split apheresis comparability," proving that the automated process produces a drug product consistent with manual methods.
Cabaletta Bio, a leader in the "CARTA" (Chimeric Antigen Receptor T cells for Autoimmunity) space, expects to dose the first patient using the Cellares-manufactured rese-cel in the first half of 2026.
The therapy is currently being evaluated in the RESET™ clinical trials for a range of conditions, including lupus, myositis, and systemic sclerosis.
By leveraging the Cell Shuttle’s ability to process up to 16 batches in parallel, Cabaletta aims to bypass the manufacturing bottlenecks that have plagued the first generation of cell therapies.
The news comes as Cellares continues to build out its "Smart Factory" network, including a newly announced European headquarters in the Netherlands.
The company’s "IDMO" (Integrated Development and Manufacturing Organization) model is designed to reduce batch prices by up to 50% and decrease process failure rates by 75% through the elimination of human error.