Stable Anti-OSMR Antibody Formulation

Abstract

The present invention provides, among other things, stable formulations comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation.

1 . A stable formulation comprising an anti-oncostatin M receptor (OSMR) antibody and having a pH ranging from approximately 6.0-7.6, wherein less than approximately 5% of the anti-OSMR antibody exists as high molecular weight (HMW) species in the formulation. 
     
     
         2 . The stable formulation of  claim 1 , wherein less than 5%, 4%, 3%, 2%, 1%, or 0.5% of the anti-OSMR antibody exists as HMW species in the formulation. 
     
     
         3 - 12 . (canceled) 
     
     
         13 . The stable formulation of  claim 1 , wherein the pH of the formulation is approximately 6.2, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, 7.0, 7.2 7.4 or 7.6. 
     
     
         14 . The stable formulation of  claim 1 , wherein the anti-OSMR antibody is present at a concentration of at least approximately 50 mg/mL. 
     
     
         15 - 16 . (canceled) 
     
     
         17 . The stable formulation of  claim 1 , wherein the anti-OSMR antibody has a pI ranging from 6.5-8.5. 
     
     
         18 - 53 . (canceled) 
     
     
         54 . A stable, injectable formulation of an anti-oncostatin M receptor (OSMR) antibody, comprising:
 50-250 mg/mL of the anti-OSMR monoclonal antibody,   10-150 mM arginine,   10-150 mM histidine,   25-150 mM sodium chloride (NaCl),   0.05%-0.5% (w/v) polysorbate 80 (PS80),   pH range 6.0-7.6,   wherein the formulation is an isotonic solution, and   wherein at least 90% of the antibody exists as stable intact monomeric IgG at about −70° C. or at about 5° C. temperature for at least 1 month.   
     
     
         55 - 61 . (canceled) 
     
     
         62 . The stable formulation of  claim 54 , wherein the anti-OSMR antibody is present at a concentration of approximately 200 mg/mL. 
     
     
         63 - 105 . (canceled) 
     
     
         106 . A method of treating a disease, disorder or condition associated with OSMR comprising administering into a subject in need of treatment a stable formulation of  claim 1 . 
     
     
         107 . The method of  claim 106 , wherein the formulation is administered intravenously. 
     
     
         108 . The method of  claim 106 , wherein the formulation is administered subcutaneously. 
     
     
         109 - 115 . (canceled) 
     
     
         116 . The method of  claim 106 , wherein the anti-OSMR antibody comprises:
 a light chain complementary-determining region 1 (LCDR1) defined by SEQ ID NO: 8, a light chain complementary-determining region 2 (LCDR2) defined by SEQ ID NO: 9, and a light chain complementary-determining region 3 (LCDR3) defined by SEQ ID NO: 10; and   a heavy chain complementary-determining region 1 (HCDR1) defined by SEQ ID NO: 5, a heavy chain complementary-determining region 2 (HCDR2) defined by SEQ ID NO: 6, and a heavy chain complementary-determining region 3 (HCDR3) defined by SEQ ID NO: 7.   
     
     
         117 - 121 . (canceled) 
     
     
         122 . The method of  claim 106 , wherein the formulation is administered in a volume of less than 5 mL, 4 mL, 3 mL, or 2 mL. 
     
     
         123 - 125 . (canceled) 
     
     
         126 . The method of  claim 106 , wherein less than 5%, 4%, 3%, 2%, 1%, or 0.5% of the anti-OSMR antibody exists as HMW species in the formulation. 
     
     
         127 . The method of  claim 106 , wherein the relative amount of HMW species in the formulation increases less than 5%, 4%, 3%, 2%, 1%, or 0.5% upon storage at 25° C. for more than 2 weeks. 
     
     
         128 - 131 . (canceled) 
     
     
         132 . The formulation of  claim 54 , wherein the formulation is stable at 25° C. following 1, 2 or 3 freeze/thaw cycles for at least three months. 
     
     
         133 . The formulation of  claim 54  wherein storage of the formulation at −70° C. for about at least 3 months results in the formulation comprising less than about 5% aggregates, and greater than at least 90% intact antibody IgG monomer. 
     
     
         134 . The formulation of  claim 54  wherein storage of the formulation at 5-8° C. for about at least 3 months results in the formulation comprising less than about 5% aggregates, and greater than about 90% intact antibody. 
     
     
         135 . The formulation of  claim 54  wherein storage of the formulation at 25° C. results in the formulation comprising less than 5% aggregates, greater than 90% intact antibody for up to at least 1 month. 
     
     
         136 . The formulation of  claim 54  wherein storage of the formulation at 25° C. results in the formulation comprising less than 5% aggregates, greater than 90% intact antibody for up to at least 3 months.