Sonoma Biotherapeutics to Automate its Treg Cell Manufacturing Using Cellares’ Cell Shuttle Platform

Key Points

• Cellares and Sonoma Biotherapeutics are working together to automate manufacturing of SBT-77-7101, an autologous (sourced from the patient) CAR-Treg therapy in Phase 1 for poly-refractory rheumatoid arthritis.
• The program is the first regulatory T cell therapy to be onboarded to Cellares’ Cell Shuttle platform.
• The collaboration includes automating both manufacturing and quality control, with the goal of supporting later-stage development and commercial scale-up.

More good news from Cellares, which has been making history this year in automated cell therapy manufacturing. They just announced that Sonoma Biotherapeutics will automate the manufacturing of its CAR-Treg therapy, SBT-77-7101, on the Cellares Cell Shuttle platform. SBT-77-7101 is an autologous (sourced from the patient) therapy in Phase 1 clinical development for poly-refractory rheumatoid arthritis, a group of patients who have exhausted available treatment options.

The Cell Shuttle Platform is a fully integrated, automated, and scalable “factory-in-a-box”, so to speak, designed for high-throughput cell therapy manufacturing.

Here’s a demo video of the shuttle:

https://www.youtube.com/watch?v=YFnkYun5AF8

Why this matters

This will be the first Treg therapy used in the shuttle, and it’s an important test because Treg manufacturing is generally considered more sensitive and labor-intensive than many other cell therapy processes, particularly at scale. The companies say they hope to preserve Treg identity and function while adding more standardized manufacturing and QC infrastructure.

“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… 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.”

Company and program context

Sonoma Biotherapeutics is developing engineered Treg therapies for autoimmune and inflammatory diseases. In addition to SBT-77-7101, the company is collaborating with Regeneron on a pipeline of Treg cell therapies for autoimmune diseases.

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