Our team has decades of industry-leading experience and published works in the fields of Treg biology, cell therapy, and immune tolerance.

Please peruse this curated collection of published works.

Sonoma Bio presented a poster at IMMUNOLOGY2023™, the American Association of Immunologists (AAI) Annual Meeting. The study presented assessed the Company’s development of engineered Treg cells containing a chimeric cytokine receptor that provides an IL-2 signal, in order to address Treg durability in low IL-2 environments. Results of the study demonstrated the successful generation of Tregs with self-sufficient IL-2 signaling for clinical use in low IL-2 environments.

Regulatory T (Treg) cells are essential for maintaining peripheral tolerance, preventing autoimmunity, and limiting chronic inflammatory diseases. This small CD4+ T cell population can develop in the thymus and in the peripheral tissues of the immune system through the expression of an epigenetically stabilized transcription factor, FOXP3.

We report on manufacturing outcomes for 41 autologous polyclonal regulatory T cell (PolyTreg) products for 7 different Phase 1 clinical trials over a 10-year period (2011-2020). Data on patient characteristics, manufacturing parameters, and manufacturing outcomes were collected from manufacturing batch records and entered into a secure database.

Type 1 diabetes (T1D) is an autoimmune disease in which T cells attack and destroy the insulin-producing β cells in the pancreatic islets. Genetic and environmental factors increase T1D risk by compromising immune homeostasis. Although the discovery and use of insulin have transformed T1D treatment, insulin therapy does not change the underlying disease or fully prevent complications.

Cellular therapies using regulatory T (Treg) cells are currently undergoing clinical trials for the treatment of autoimmune diseases, transplant rejection and graft-versus-host disease. In this Review, we discuss the biology of Treg cells and describe new efforts in Treg cell engineering to enhance specificity, stability, functional activity, and delivery. Finally, we envision that the success of Treg cell therapy in autoimmunity and transplantation will encourage the clinical use of adoptive Treg cell therapy for non-immune diseases, such as neurological disorders and tissue repair.

Our proprietary manufacturing process produces robust yields of engineered Treg cells.