US2017008956A1PendingUtilityA1

Compositions and methods for increasing muscle mass and muscle strength by specifically antagonizing gdf8 and or activin a

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Assignee: REGENERON PHARMAPriority: Nov 14, 2011Filed: Mar 22, 2016Published: Jan 12, 2017
Est. expiryNov 14, 2031(~5.3 yrs left)· nominal 20-yr term from priority
Inventors:Trevor StittEsther Latres
A61P 21/00A61P 21/06A61K 2039/507C07K 2317/565C07K 2317/56C07K 2317/76A61K 2039/505C07K 16/22A61K 39/3955C07K 16/468A61K 2039/545C07K 2317/31
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Claims

Abstract

The present invention provides compositions and methods which involve specifically antagonizing GDF8 and Activin A. In certain embodiments, compositions are provided which comprise a GDF8-specific binding protein and an Activin A-specific binding protein. For example, the invention includes compositions comprising an anti-GDF8 antibody and an anti-Activin A antibody. In other embodiments, antigen-binding molecules are provided which comprise a GDF8-specific binding domain and an Activin A-specific binding domain. For example, the invention includes bispecific antibodies that bind GDF8 and Activin A. The compositions of the present invention are useful for the treatment of diseases and conditions characterized by reduced muscle mass or strength, as well as other conditions which are treatable by antagonizing GDF8 and/or Activin A activity.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A composition comprising a GDF8-specific binding protein and an Activin A-specific binding protein. 
     
     
         2 . The composition of  claim 1 , wherein the GDF8-specific binding protein is an anti-GDF-8 antibody or antigen-binding fragment thereof. 
     
     
         3 . The composition of  claim 1 , wherein the Activin A-specific binding protein is an anti-Activin A antibody or antigen-binding fragment thereof. 
     
     
         4 . The composition of  claim 1 , wherein the GDF8-specific binding protein is an anti-GDF-8 antibody or antigen-binding fragment thereof, and wherein the Activin A-specific binding protein is an anti-Activin A antibody or antigen-binding fragment thereof. 
     
     
         5 . The composition of  claim 2 , wherein the anti-GDF8 antibody or antigen-binding fragment thereof comprises the heavy chain complementarity determining regions (HCDRs) of a heavy chain variable region (HCVR) comprising SEQ ID NO:9, and the light chain complementarity determining regions (LCDRs) of a light chain variable region (LCVR) comprising SEQ ID NO:13. 
     
     
         6 . The composition of  claim 5 , wherein the anti-GDF8 antibody or antigen-binding fragment thereof comprises three HCDRs comprising SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:12, and three LCDRs comprising SEQ ID NO:14, SEQ ID NO:15, and SEQ ID NO:16. 
     
     
         7 . An antigen-binding molecule comprising a GDF8-specific binding domain and an Activin A-specific binding domain. 
     
     
         8 . The antigen-binding molecule of  claim 7 , wherein the GDF8-specific binding domain comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR). 
     
     
         9 . The antigen-binding molecule of  claim 7 , wherein the Activin A-specific binding domain comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR). 
     
     
         10 . The antigen-binding molecule of  claim 8 , wherein the HCVR comprises three heavy chain complementarity determining regions (HCDRs) comprising SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:12, and wherein the LCVR comprises three light chain complementarity determining regions (LCDRs) comprising SEQ ID NO:14, SEQ ID NO:15, and SEQ ID NO:16. 
     
     
         11 . The antigen-binding molecule of  claim 7 , wherein the GDF8-specific binding domain comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR), and wherein the Activin A-specific binding domain comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR). 
     
     
         12 . The antigen-binding molecule of  claim 11 , wherein the antigen-binding molecule is a bispecific antibody. 
     
     
         13 . A method for increasing muscle mass or strength in a subject, the method comprising administering to the subject an Activin A-specific binding protein. 
     
     
         14 . The method of  claim 13 , wherein the Activin A-specific binding protein is an anti-Activin A antibody or antigen-binding fragment thereof. 
     
     
         15 . A method for increasing muscle mass or strength in a subject, the method comprising administering to the subject a GDF8-specific binding protein and an Activin A-specific binding protein. 
     
     
         16 . The method of  claim 15 , wherein the GDF8-specific binding protein is an anti-GDF8 antibody or antigen-binding fragment thereof. 
     
     
         17 . The method of  claim 15 , wherein the Activin A-specific binding protein is an anti-Activin A antibody or antigen-binding fragment thereof. 
     
     
         18 . The method of  claim 15 , wherein the GDF8-specific binding protein is an anti-GDF8 antibody or antigen-binding fragment thereof, and wherein the Activin-A-specific binding protein is an anti-Activin A antibody or antigen-binding fragment thereof. 
     
     
         19 . The method of  claim 16 , wherein the anti-GDF8 antibody or antigen-binding fragment thereof comprises the heavy chain complementarity determining regions (HCDRs) of a heavy chain variable region (HCVR) comprising SEQ ID NO:9, and the light chain complementarity determining regions (LCDRs) of a light chain variable region (LCVR) comprising SEQ ID NO:13. 
     
     
         20 . The method of  claim 19 , wherein the anti-GDF8 antibody or antigen-binding fragment thereof comprises three HCDRs comprising SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:12, and three LCDRs comprising SEQ ID NO:14, SEQ ID NO:15, and SEQ ID NO:16. 
     
     
         21 . A method for increasing muscle mass or strength in a subject, the method comprising administering to the subject an antigen-binding molecule comprising a GDF8-specific binding domain and an Activin A-specific binding domain. 
     
     
         22 . The method of  claim 21 , wherein the GDF8-specific binding domain comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR). 
     
     
         23 . The method of  claim 21 , wherein the Activin A-specific binding domain comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR). 
     
     
         24 . The method of  claim 22 , wherein the HCVR comprises three heavy chain complementarity determining regions (HCDRs) comprising SEQ ID NO:10, SEQ ID NO:11, and SEQ ID NO:12, and wherein the LCVR comprises three light chain complementarity determining regions (LCDRs) comprising SEQ ID NO:14, SEQ ID NO:15, and SEQ ID NO:16. 
     
     
         25 . The method of  claim 21 , wherein the GDF8-specific binding domain comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR), and wherein the Activin A-specific binding domain comprises a heavy chain variable region (HCVR) and a light chain variable region (LCVR). 
     
     
         26 . The method of  claim 25 , wherein the antigen-binding molecule is a bispecific antibody. 
     
     
         27 . A method for treating a disease or disorder characterized by decreased muscle mass or strength, the method comprising administering to a subject in need thereof an Activin A-specific binding protein. 
     
     
         28 . A method for treating a disease or disorder characterized by decreased muscle mass or strength, the method comprising administering to a subject in need thereof a GDF8-specific binding protein and an Activin A-specific binding protein. 
     
     
         29 . A method for treating a disease or disorder characterized by decreased muscle mass or strength, the method comprising administering to a subject in need thereof an antigen-binding molecule comprising a GDF8-specific binding domain and an Activin A-specific binding domain.

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