Cellares and Sonoma Biotherapeutics have announced a new collaboration to automate the manufacturing of SBT-77-7101, an investigational regulatory T cell (Treg) therapy being developed for patients with severe rheumatoid arthritis. The partnership aims to improve the production of the therapy using Cellares’ automated manufacturing platform, helping prepare the treatment for larger clinical trials and future commercial use.
Sonoma Biotherapeutics is a clinical-stage biotechnology company focused on developing engineered regulatory T cell therapies for autoimmune and inflammatory diseases. Cellares describes itself as the world’s first Integrated Development and Manufacturing Organization (IDMO), providing automated manufacturing solutions for cell therapies.
The companies said SBT-77-7101 is currently being evaluated in a Phase 1 clinical trial for patients with poly-refractory rheumatoid arthritis, a severe form of the disease affecting people who have not responded to all currently available treatment options.
The collaboration marks an important milestone because SBT-77-7101 becomes the first regulatory T cell therapy to be manufactured using Cellares’ Cell Shuttle platform.
Regulatory T cells, or Tregs, are specialized immune cells that help control the body’s immune response and prevent excessive inflammation. Scientists believe these cells could provide a new way to treat autoimmune diseases by restoring immune balance rather than simply suppressing the immune system.
Rheumatoid arthritis is a chronic autoimmune disease in which the immune system mistakenly attacks healthy joints, causing pain, swelling and progressive joint damage. Although several medicines are available, some patients continue to experience severe disease despite multiple treatments. These patients often have limited remaining therapeutic options.
SBT-77-7101 is an autologous CAR-Treg therapy, meaning the treatment is created using a patient’s own immune cells. The cells are collected, genetically modified in a laboratory to better target disease-causing immune activity, and then returned to the patient.
Producing these personalized therapies is highly complex. Unlike many traditional medicines, each treatment batch is made for an individual patient. Manufacturing Treg therapies is considered especially challenging because the cells are extremely sensitive and require precise handling to preserve their identity and biological function.
Under the agreement, Cellares will adapt SonomaBio’s proprietary manufacturing process for SBT-77-7101 onto its Cell Shuttle platform. The company will also automate quality testing using its Cell Q quality control system, which is designed to monitor the manufacturing process and ensure consistent product quality.
According to the companies, automation could reduce labor-intensive manufacturing steps, improve consistency, and increase production capacity as the therapy moves into larger clinical studies.
Cellares currently operates its first commercial-scale Smart Factory in Bridgewater, New Jersey. Additional manufacturing facilities are being built in Europe and Japan, creating a global network intended to support cell therapy production from early-stage clinical trials through commercial manufacturing.
Stephen Dilly, President, Chief Executive Officer and Board Chair of Sonoma Biotherapeutics, said regulatory T cells are highly sensitive to the manufacturing process and that maintaining precision is essential to preserving their therapeutic function.
He said Cellares’ Cell Shuttle platform and global manufacturing infrastructure will help SonomaBio scale production while supporting its clinical development plans for patients with the most difficult-to-treat forms of rheumatoid arthritis.
Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares, said every new type of cell therapy added to the company’s automated manufacturing platform expands its ability to support innovative treatments.
He noted that regulatory T cells are among the most technically demanding cell types to manufacture consistently. Gerlinghaus said SonomaBio has developed one of the most advanced Treg programs currently in clinical development and added that the collaboration will demonstrate how the Cell Shuttle platform, which has already been used for CAR-T cell therapies, can also support Treg manufacturing.
As cell therapies continue to gain attention for treating cancer and autoimmune diseases, manufacturers are increasingly looking for automated production systems that can improve efficiency, reduce costs and ensure consistent quality. The collaboration between Cellares and Sonoma Biotherapeutics is expected to support the future development of personalized Treg therapies while helping prepare SBT-77-7101 for late-stage clinical trials and potential commercialization.