Cellares and Sonoma Biotherapeutics Agree to Automate Engineered Treg Cell Therapy Manufacturing

Officials at Cellares and Sonoma Biotherapeutics say their companies will automate the manufacturing of SBT-77-7101, an engineered regulatory T cell (Treg) therapy for autoimmune and inflammatory diseases. The product is in Phase I clinical development for poly-refractory rheumatoid arthritis (RA) in patients who have exhausted all available treatment options.

Cellares plans to translate SonomaBio’s SBT-77-7101 manufacturing process onto its Cell Shuttle and automate in-process and release testing through the Cell Q™ quality control system. The company operates its first commercial-scale Smart Factory in Bridgewater, NJ, with additional facilities under construction in Europe and Japan.

“Tregs are uniquely sensitive to the manufacturing process. Cellares brings the Cell Shuttle platform, and global infrastructure to help us deliver on our clinical ambitions at scale for the hardest-to-treat RA patients.” said Stephen Dilly, PhD, president, CEO, and board chair of Sonoma Biotherapeutics.

“Every new cell therapy modality we bring to the Cell Shuttle and Cell Q expands what is possible for the field and for patients in need,” added Fabian Gerlinghaus, co-founder and CEO of Cellares. “Tregs are among the most technically demanding cell types to manufacture reliably. We are honored to partner with SonomaBio and demonstrate that our platform can directly translate to Tregs.

“SonomaBio has developed one of the most advanced Treg programs in the clinic, and we look forward to contributing to their clinical success as they bring this groundbreaking therapy to patients.”