South San Francisco, Calif.– Cellares and Sonoma Biotherapeutics have entered a collaboration to automate the manufacturing of SBT-77-7101, Sonoma’s lead engineered regulatory T cell therapy, using Cellares’ Cell Shuttle platform.
SBT-77-7101 is an autologous CAR-Treg cell therapy in Phase 1 clinical development for patients with poly-refractory rheumatoid arthritis who have exhausted available treatment options. It is the first regulatory T cell therapy program to be onboarded onto the Cell Shuttle.
Under the collaboration, Cellares will transfer Sonoma’s proprietary manufacturing process for SBT-77-7101 to the Cell Shuttle and automate in-process and release testing through Cell Q, its automated quality-control system.
The companies said regulatory T cell manufacturing requires precise handling and analytical controls to preserve cell identity and function. The collaboration is intended to support the program’s advancement toward late-stage clinical trials and potential commercial production.
“Tregs are uniquely sensitive to the manufacturing process, and the precision of our proprietary process drives their superior function. 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, MBBS, Ph.D., President, Chief Executive Officer and Board Chair of Sonoma Biotherapeutics.
Cellares operates a commercial-scale manufacturing facility in Bridgewater, New Jersey, and is constructing additional facilities in Europe and Japan. Its network is designed to support cell therapies from Phase 1 development through commercial-scale manufacturing.
“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,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. “Tregs are among the most technically demanding cell types to manufacture reliably. We are honored to partner with SonomaBio, the industry leader in this field, and demonstrate that our platform, which has already been robustly validated for CAR-T therapies in the clinic, can directly translate to Tregs.”
Sonoma Biotherapeutics is developing engineered regulatory T cell therapies for autoimmune and inflammatory diseases.
