Summary: 
The National Eye Institute (NEI) seeks research co-development partners and/or licensees to advance the production and uses of interleukin-27 (IL-27) producing B-regulatory cell (i27-Breg) therapy 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.

Description of Technology: 
Autoimmune diseases in which the immune system attacks the body's own tissues or organs include: graft-vs-host disease (GVHD), age-related macular degeneration (AMD), multiple sclerosis (MS), uveitis and encephalomyelitis.  These diseases can result in blindness, paralysis, and significant morbidity impacting quality of life.  In GVHD, the allogeneic transplant views the recipient’s body as foreign, and the transplant attacks the body.  Uveitis is comprised of a diverse group of potentially sight-threatening intraocular inflammatory diseases of infectious or autoimmune etiology.  Similarly, autoimmune processes contribute significantly to the progression of retinal degeneration associated with AMD.  MS is caused in part by immune cells that attack and/or destroy neurons, thereby interfering with normal neurological function. Steroids and monoclonal antibodies are temporarily effective therapies; serious adverse effects preclude their prolonged use. Therefore, an unmet need remains for safe, effective long-term therapies for autoimmune disorders.

The invention consists of an isolated population of mammal cells comprising about 75 % or higher B-1a regulatory cells and methods of preparation of such cell populations. i27-Bregs have distinct advantages over  systemic administration of interleukin-27 (IL-27) since the latter is costly to synthesize and rapidly degrades in the body. i27-Bregs provide several therapeutic advantages over current standard of care:  (i) self-renewal after administration and thereby sustained IL-27 production in host tissues; (ii) reprograms recipient lymphocytes into Bregs and Tregs (regulatory T cells) (iii) effective suppression of the host’s overreactive immune system; (iv) no requirement of prior activation, providing a potential therapeutic advantage over other disease-specific cell therapies. Immune system suppression by i27-Bregs administration can also be used in conjunction with solid organ or allogenic cell transplants to reduce potentially fatal transplant rejection. 

This technology is available for development under a license for the above-mentioned disorders. Inventors at the National Eye Institute are interested in participating under a CRADA collaboration to further develop the technology toward clinical applications or will assist to transfer the technological know-how for licensing.   

Potential Commercial Applications: 

• Cell therapy for severe CNS autoimmune disease, GVHD, transplants, encephalomyelitis, or multiple sclerosis

Competitive Advantages:

• Can be co-administered with other currently approved therapies currently 
• No FDA approved B cell therapy for the treatment of auto immune disease
• Self-renewing
• Excreted interleukins following administration provide a longer-lasting effect than currently approved monoclonal antibody therapies
• Potentially fewer side effects since IL-27 extended release avoids the systemic administration of monoclonal antibodies or immunosuppressive drugs
• Ex-vivo preparation can be further genetically modified to enhance efficacy
• Activation not required to inhibit autoimmunity