Immunoglobulin constant region fc receptor binding agents

Abstract

IVIG replacement compounds are derived from recombinant and/or biochemical creation of immunologically active biomimetic(s). These replacement compounds are then screened in vitro to assess each replacement compound's efficiency at modulating immune function. Particular replacement compounds are selected for further in vivo validation and dosage/administration optimization. Finally, the replacement compounds are used to treat a wide range of diseases, including inflammatory and autoimmune diseases.

1 .- 20 . (canceled) 
     
     
         21 . A method of treating an autoimmune or inflammatory disease comprising administering to a subject in need thereof a composition comprising a cluster stradomer comprising at least two multimerized cluster stradomer units,
 wherein each of said cluster stradomer units comprises at least one multimerizing region selected from an IgG2 hinge or an isoleucine zipper and at least one Fc domain comprising a CH2 domain and a CH3 domain from IgG1 or IgG3 or a combination thereof,   wherein the multimerizing region(s) of the at least two cluster stradomer units multimerize to form the cluster stradomer, and   wherein the cluster stradomer is capable of specifically binding to at least two Fc receptors.   
     
     
         22 . The method of  claim 21 , wherein the cluster stradomer comprises two multimerized cluster stradomer units. 
     
     
         23 . The method of  claim 21 , wherein the cluster stradomer comprises at least three multimerized cluster stradomer units. 
     
     
         24 . The method of  claim 21 , wherein the cluster stradomer comprises at least four multimerized cluster stradomer units. 
     
     
         25 . The method of  claim 21 , wherein the cluster stradomer comprises at least five multimerized cluster stradomer units. 
     
     
         26 . The method of  claim 21 , wherein the at least one Fc domain comprises an IgG1 hinge, an IgG1 CH2 domain, and an IgG1 CH3 domain. 
     
     
         27 . The method of  claim 21 , wherein the at least one Fe domain comprises an IgG3 hinge, an IgG3 CH2 domain, and an IgG3 CH3 domain. 
     
     
         28 . The method of  claim 21 , wherein at least one of the cluster stradomer units comprises two or more Fc domains. 
     
     
         29 . The method of  claim 21 , wherein each of the cluster stradomer units is capable of specifically binding to at least one FcR. 
     
     
         30 . The method of  claim 29 , wherein the at least one FcR is human Fcγ receptor I, human Fcγ receptor II, human Fcγ receptor III, or human Fcγ receptor IV. 
     
     
         31 . The method of  claim 30 , wherein the human Fcγ receptor III is human Fcγ receptor IIIa. 
     
     
         32 . The method of  claim 21 , wherein the at least one multimerizing region is an IgG2 hinge. 
     
     
         33 . The method of  claim 21 , wherein the cluster stradomer is administered intravenously, subcutaneously, orally, intranasally, rectally, intraperitoneally, sublingually, buccally, transdermally, by subdermal implant, or intramuscularly. 
     
     
         34 . The method of  claim 21 , wherein the subject in need thereof suffers from an autoimmune or inflammatory disease that can be treated by IVIG. 
     
     
         35 . The method of  claim 21 , wherein the inflammatory disease is idiopathic thrombocytopenic purpura. 
     
     
         36 . The method of  claim 21 , wherein the autoimmune disease is systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, myasthenia gravis, chronic inflammatory demyelinating polyradiculoneuropathy or type 1 diabetes. 
     
     
         37 . A method of treating an autoimmune or inflammatory disease comprising administering to a subject in need thereof a composition comprising a cluster stradomer comprising at least two multimerized cluster stradomer units,
 wherein each of said cluster stradomer units comprises an IgG2 hinge multimerizing region and an IgG1 Fc domain comprising a CH2 and CH3 domain,   wherein the IgG2 hinge multimerizing region of the at least two cluster stradomer units multimerize to form the cluster stradomer, and   wherein the cluster stradomer is capable of specifically binding to at least two Fcγ receptors.   
     
     
         38 . A method of treating an autoimmune or inflammatory disease comprising administering to a subject in need thereof a composition comprising a cluster stradomer comprising at least two multimerized cluster stradomer units,
 wherein each of said cluster stradomer units comprises an IgG2 hinge multimerizing region and an IgG3 Fc domain comprising a CH2 and CH3 domain,   wherein the IgG2 hinge multimerizing region of each of the at least two cluster stradomer units multimerize to form the cluster stradomer, and   
       wherein the cluster stradomer is capable of specifically binding to at least two Fcγ receptors.