The Integrated Development and Manufacturing Organisation (IDMO) Cellares and clinical-stage biotech firm Sonoma Biotherapeutics have announced they will collaborate to automate manufacturing of Sonoma's lead programme, SBT-77-7101, using Cellares' Cell Shuttle platform.
SBT-77-7101 is an autologous CAR-Treg cell therapy currently in Phase I trials for poly-refractory rheumatoid arthritis (RA).
The news comes just a month after Cellares raised more than $277m in a Series D financing round.
CAR-Treg cell therapy an emerging, next-generation immunotherapy that genetically engineers Regulatory T cells (Tregs) with Chimeric Antigen Receptors (CAR) to suppress overactive immune responses.
The programme will be the first Treg cell therapy to be onboarded to the Cell Shuttle, extending the automated manufacturing platform into a modality that demands precise handling and analytical control to preserve Treg identity and function.
Under the agreement, Cellares will translate SonomaBio's proprietary SBT-77-7101 manufacturing process onto the Cell Shuttle, automating in-process and release testing through Cell Q (Cellares' automated quality control system).
Treg cell manufacturing is hugely labour-intensive and sensitive, particularly at scale. Cellares said that it plans to utilise Sonoma’s expertise to enhance the efficiency and cost-effectiveness of producing SBT-77-7101 for late-stage clinical trials and commercial readiness.
Cellares's first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, is already operational, with additional facilities under construction in Europe and Japan.
"Tregs are uniquely sensitive to the manufacturing process and the precision of our proprietary process drives their superior function," said Dr Stephen Dilly, President, CEO and Board Chair of Sonoma Biotherapeutics.
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.
"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,” added Fabian Gerlinghaus, co-founder and CEO of Cellares.
"Tregs are among the most technically demanding cell types to manufacture reliably. We are honoured to partner with SonomaBio 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 programmes in the clinic and we look forward to contributing to their clinical success as they bring this groundbreaking therapy to patients.
