Cabelletta Bio announced that the U.S. Food and Drug Administration has granted clearance of an Investigational New Drug (IND) amendment that allows the company to manufacture and release its lead CAR‑T therapy, rese‑cel, on Cellares’ fully automated Cell Shuttle™ and Cell Q™ platforms. The approval removes a key regulatory hurdle and enables Cabaletta to begin clinical manufacturing and first‑in‑human dosing in the first half of 2026, a critical step toward its planned 2027 Biologics License Application (BLA) for myositis and other autoimmune indications.
The clearance specifically authorizes the use of Cellares’ automated platforms, the first time these systems will support an active clinical program. By leveraging the Cell Shuttle™ and Cell Q™ platforms, Cabaletta can scale production to meet the larger patient populations expected in autoimmune diseases, reducing manual touchpoints, improving consistency, and potentially lowering manufacturing costs. The partnership has been in development since 2023, with a Technology Adoption Program completed in March 2025, positioning the company to meet its clinical timelines without the delays that typically accompany manual manufacturing.
This regulatory milestone aligns with Cabaletta’s strategy to deliver a drug‑free, outpatient‑friendly therapy. The ability to manufacture rese‑cel efficiently supports the company’s vision of a scalable, patient‑centric treatment that can be administered outside of the hospital setting. The clearance also strengthens Cabaletta’s position to secure future funding or a strategic partnership, as investors increasingly prioritize companies that can demonstrate efficient, scalable manufacturing for large‑volume indications.
CEO Steven Nichtberger said the technical data generated in collaboration with Cellares “supported the IND clearance for clinical manufacturing of rese‑cel in our ongoing clinical program.” Cellares CEO Fabian Gerlinghaus highlighted the platform’s scalability for autoimmune indications, noting that “autoimmune cell therapy programs operate at a fundamentally different scale of patient demand than oncology, and achieving scalability in these larger indications is a differentiated feature of the Cellares platform.”
The FDA clearance positions Cabaletta to advance its clinical program toward the 2027 BLA submission, while reinforcing its commitment to a drug‑free, outpatient‑friendly therapy that could transform treatment for myositis, systemic sclerosis, lupus, and other autoimmune diseases.
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