Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and Sonoma Biotherapeutics, Inc., a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, today announced a collaboration to automate manufacturing of lead SonomaBio® program, SBT-77-7101, on the Cellares Cell Shuttle.
SBT-77-7101 is an autologous CAR-Treg cell therapy in Phase 1 clinical development for poly-refractory rheumatoid arthritis (RA), the most challenging RA patients, who have exhausted all available treatment options. The program is the first Treg cell therapy to onboard to the Cell Shuttle, extending Cellares’ automated manufacturing platform into a modality that demands precise handling and analytical control to preserve Treg identity and function.
Under the collaboration, Cellares will translate SonomaBio’s proprietary SBT-77-7101 manufacturing process onto the Cell Shuttle and automate in-process and release testing through Cell Q™, Cellares’ automated quality control system. Treg manufacturing is among the most labor-intensive and sensitive processes in cell therapy, a challenge that becomes acute at scale. With a global manufacturing network and automated platforms, Cellares can build on Sonoma’s deep Treg understanding to deliver the economics and throughput to advance SBT-77-7101 toward late-stage clinical trials and commercial readiness.
Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan, providing partners with a global manufacturing footprint built to support cell therapies from Phase 1 to commercial scale.
“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, PhD, President, Chief Executive Officer 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,” 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. Built on Nobel-Prize-winning science, 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.”
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