There is an unmet need for safe, effective, long-term therapies for autoimmune disorders. NIH inventors have isolated a population of mammalian cells comprising about 75% or higher B-1a regulatory cells (Bregs) and methods of preparation of such cell populations as a therapeutic for immune-related autoimmune disorders. These disorders include but are not limited to, age-related macular degeneration (AMD), graft-versus-host-disease (GVHD), multiple sclerosis (MS), and transplant rejection. There is currently no FDA-approved B-cell therapy for the treatment of autoimmune disease.

The i27-Bregs have many advantages over systemic administration of interleukin-27 (IL-27) as IL-27 is expensive to synthesize and rapidly degrades in the body. i27-Bregs provide several therapeutic advantages over current therapeutics:

1. Self-renewal after administration and thereby sustained Il-27 production in host tissues, 
2. Reprograms recipient lymphocytes into Bregs and Tregs (regulatory T cells), 
3. Provides effective suppression of the host’s overreactive immune system, and
4. There is no requirement of prior activation, providing a potential therapeutic advantage over other disease-specific cell therapies. 

Additionally, immune system suppression by i27-Bregs administration can be used in conjunction with solid organ or allogenic cell transplants to reduce potentially fatal transplant rejection.

Competitive advantages of the i27-Bregs include:

• They can be co-administered with other currently approved therapies.
• They are self-renewing. 
• Interleukins produced after treatment provide a longer-lasting effect than currently approved monoclonal antibody therapies. 
• There are potentially fewer side effects because IL-27 extended release avoids the systemic administration of monoclonal antibodies or immunosuppressive drugs. 
• They can be further genetically modified during ex-vivo preparation to enhance efficacy.  
  Activation is not required to inhibit autoimmunity.

Inventors at the NIH National Eye Institute (NEI) are seeking a licensee and/or collaborator to further develop this cell therapy for severe CNS autoimmune disease, GVHD, transplants, encephalomyelitis, or multiple sclerosis. For more information or to contact the licensing manager, please view the abstract: Interleukin-27 Producing B-Cell Population and Uses Thereof