Cellares and Sonoma Biotherapeutics Collaborate to Automate Manufacturing of SBT-77-7101 Engineered Treg Cell Therapy on the Cell Shuttle® Platform

First regulatory T cell program to onboard to the Cell Shuttle, bringing automated cGMP manufacturing and QC infrastructure to Treg cell therapies

SOUTH SAN FRANCISCO, Calif. & SEATTLE--(BUSINESS WIRE)--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 SonomaBio® lead 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.”

About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring immune system balance. Founded by pioneers in Treg biology and cell therapy, including Dr. Fred Ramsdell, whose foundational research in Treg biology was recognized with a 2025 Nobel Prize, Sonoma Biotherapeutics combines deep scientific expertise with proprietary platform technologies to advance a new generation of targeted and durable Treg cell therapies.

In addition to its lead, proprietary Treg program, SBT-77-7101, Sonoma Biotherapeutics is collaborating with Regeneron to advance a pipeline of Treg cell therapies for autoimmune diseases.

For more information, visit sonomabio.com and follow Sonoma Biotherapeutics on X (formerly Twitter) and LinkedIn.

About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables drug sponsors to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.

Cellares' fully automated platforms — Cell Shuttle® for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control — are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry. The Cell Shuttle is the first cell therapy manufacturing platform to receive the FDA's Advanced Manufacturing Technology (AMT) designation, and has demonstrated a 100% automation success rate across more than a dozen automated processes.

Cellares has achieved key clinical validation milestones, including a successful IND Amendment enabling active clinical manufacturing on the Cell Shuttle platform, and the successful dosing of first patients in a partner clinical trial — marking the platform's transition from development-stage technology to clinically validated manufacturing infrastructure. These milestones span multiple therapeutic areas and cell therapy modalities, including both oncology and autoimmune indications.

Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.