IL-12 P40 Monomer, Monoclonal Antibody Against P40 Homodimer and the Combination of the Two for Autoimmune Disease Treatment

Abstract

A novel approach to discover new drugs against MS and other autoimmune diseases is disclosed. The p40 family of cytokines has four members which include interleukin-12 (IL-12), the p40 monomer (p40), the p40 homodimer (p40 2 ), and the IL-23. To facilitate the studies on p40 2 and p40, neutralizing monoclonal antibodies (mAb) against mouse p40 2 and p40 were generated for the first time. MS and other autoimmune disease drug therapies including recombinant p40 and/or monoclonal antibody against p40 2 (mAb-p40 2 a3-1d) are disclosed.

1 . A composition for the treatment of autoimmune diseases, the composition comprising:
 a recombinant p4 monomer if Interleukin 12 (IL-12) and at least one monoclonal antibody against p40 2  homodimer of IL-12.   
     
     
         2 . The composition of  claim 1  wherein the autoimmune diseases are selected from the group consisting of multiple sclerosis, lupus, thyrioditis, rheumatoid arthritis, Sjogren's syndrome, Addison's disease and combinations thereof. 
     
     
         3 - 8 . (canceled) 
     
     
         9 . A method for treating an autoimmune disease in a mammal comprising administering a combination of a recombinant p40 monomer of IL-12 and at least one monoclonal antibody against p40 2  homodimer of IL-12 to the mammal for treating an autoimmune disease in the mammal. 
     
     
         10 . The method of  claim 9 , wherein the recombinant p40 monomer of IL-12 is administered in a plurality doses. 
     
     
         11 . The method of  claim 9 , wherein the at least one monoclonal antibody against p40 2  homodimer of IL-12 is administered in a single dose. 
     
     
         12 . The method of  claim 9 , wherein the recombinant p40 monomer of IL-12 is administered in a plurality doses and the at least one monoclonal antibody against p40 2  homodimer of IL-12 is administered in a single dose. 
     
     
         13 . The method of  claim 9 , wherein the administration ameliorates one or more of symptoms of the autoimmune disease, the one or more symptoms comprising demyelination, blood-brain barrier permeability, blood-spinal cord barrier permeability and combinations thereof. 
     
     
         14 . The method of  claim 9 , wherein the administration ameliorates one or more of the autoimmune diseases selected from the group consisting of multiple sclerosis, lupus, thyrioditis, rheumatoid arthritis, Sjogren's syndrome, Addison's disease and combinations thereof. 
     
     
         15 . The method of  claim 9 , wherein the at least one monoclonal antibody against the p40 2  homodimer of IL-12 comprises mAb-p40 2  a3-1d.