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A method for Ex-vivo Production of Regulatory B-Cells for Use in Auto-immune Indications


Breg or Regulatory B-cells are a rare subset of B cells that play an important role in regulating a variety of cell types. In vivo modulation of Breg levels and ex-vivo production of large amounts of antigen-specific Breg finds use in autologous immunotherapy for auto-inflammatory diseases.

Technology: A method of ex-vivo production of autologous Breg cells that involves treating isolated primary B cells or B cell lines with rIL-35 to induce their conversion into IL-10- producing Breg cells. Using this method, Breg can be produced in large quantities and used in a Breg-based therapy against autoimmune diseases including, but not limited to, uveitis, sarcoidosis, colitis and arthritis.


Clinical scores of EAU induced mice treated or not with Breg cells

Competitive Advantage: This is a novel technology to produce Breg ex-vivo. The method produces large quantities of Breg that can be used in immunotherapy. The cells have been demonstrated in pre-clinical mouse modelsto treat experimental autoimmune uveitis (EAU). The technology for production of rIL-35 is also proprietary and available for licensing. 


Proliferation of CD19+ human B cells in the presence or absence of hIL-35

Ren-Xi Wang and Egwuagu et al. Interleukin-35 induces regulatory B cells that suppress autoimmune disease. Nat Med. 2014 Jun; 20 (6):633-41


Intellectual Property: NEI/NIH has secured intellectual property of this technology which is available for co-development, non-exclusive/exclusive license consideration.


Mala Dutta, Ph.D
Office of Translational Research

Last updated: May 18, 2020