Regulatory B-cells (Breg) play an important role in reducing autoimmunity and reduced levels of these cells are implicated in etiology of several auto-inflammatory diseases. Despite their impact in many diseases, their physiological inducers are unknown.  Given that Bregs are a very rare B-cell, identifying factors that promote their development would allow in vivo modulation of Breg levels and ex-vivo production of large amounts of antigen-specific Bregs to use in immunotherapy for auto-inflammatory diseases.
 
Researchers at NEI's Molecular Immunology Section developed a method for the ex-vivo production of Breg. The method of production involves treating isolated primary B-cells or B-cell lines with IL-35 to induce their conversion into IL-10, producing Breg. Using this method, B-regulatory cells can be produced in large quantity and used in a Breg-based therapy against autoimmune diseases including, but not limited to, uveitis and sarcoidosis. In vivo animal data are available.

Competitive Advantages:

• There is no known biological or chemical agent that can induce Bregs ex-vivo
• This method produces large quantities of Bregs and can therefore aid in Breg-based therapy
• Pre-clinical mouse model data available that uses the Bregs to treat experimental autoimmune uveitis (EAU)

Commercial Applications:

• In vivo modulation of Breg levels
• Supplement the low population of Breg in a patient suffering from an autoimmune disease where it is known that B-regulatory cell populations are severely reduced (i.e. uveitis)
• Use in immunotherapy for the treatment of other autoimmune diseases such as multiple sclerosis, sarcoidosis, colitis, and arthritis.