US2022017584A1PendingUtilityA1

Growth differentiation factor 15 fusion proteins

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Assignee: AMGEN INCPriority: Apr 9, 2018Filed: Oct 5, 2021Published: Jan 20, 2022
Est. expiryApr 9, 2038(~11.7 yrs left)· nominal 20-yr term from priority
Inventors:Yumei XiongKenneth W. WalkerMurielle Marie Veniant Ellison
C07K 14/495C07K 2319/30A61K 38/00A61P 3/04C12N 15/00A61P 3/10
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Claims

Abstract

GDF15 molecules are provided herein. In some embodiments, the GDF15 molecule is a GDF15-Fc fusion, in which a GDF15 region is fused to an Fc region. In some embodiments, the GDF15 region is fused to the Fc region via a linker. Also, provided herein are methods for making and using GDF15 molecules.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A fusion protein comprising a GDF15 region joined to an Fc region via a linker, wherein the GDF15 region comprises the amino acid sequence of SEQ ID NO: 6 and at least one mutation, wherein at least one of the mutations is of the aspartate at position 5. 
     
     
         2 . The fusion protein of  claim 1 , wherein the aspartate at position 5 is mutated to glutamate. 
     
     
         3 . The fusion protein of  claim 2 , wherein the GDF15 region comprises the amino acid sequence of SEQ ID NO: 16. 
     
     
         4 . The fusion protein of  claim 1  or  2 , wherein the GDF15 region further comprises a mutation of the asparagine at position 3. 
     
     
         5 . The fusion protein of  claim 3 , wherein the asparagine at position 3 mutated to glutamine. 
     
     
         6 . The fusion protein of  claim 5 , wherein the GDF15 region comprises the amino acid sequence of SEQ ID NO: 18. 
     
     
         7 . The fusion protein of any one of  claims 1 - 6 , wherein the linker is a (G4S)n or (G4Q)n linker, wherein n is greater than 0. 
     
     
         8 . The fusion protein of  claim 7 , wherein n is 1 or 2. 
     
     
         9 . A fusion protein comprising a GDF15 region joined to an Fc region via a linker, wherein the GDF15 region comprises the amino acid sequence of SEQ ID NO 6 and at least one mutation, wherein at least one of the mutations is of the asparagine at position 3 or the aspartate at position 5, and wherein the linker is a (G 4 Q) n  linker and n is greater than 2. 
     
     
         10 . The fusion protein of  claim 7  or  9 , wherein the n is 3 or 4. 
     
     
         11 . The fusion protein of  claim 9  or  10 , wherein the GDF15 region comprises a mutation of aspartate at position 5 to glutamate. 
     
     
         12 . The fusion protein of  claim 11 , wherein the GDF15 region comprises the amino acid sequence of SEQ ID NO: 16. 
     
     
         13 . The fusion protein of any one of  claims 9 - 11 , wherein the GDF15 region comprises a mutation of the asparagine at position 3 to glutamine. 
     
     
         14 . The fusion protein of  claim 13 , wherein the GDF15 region comprises the amino acid sequence of SEQ ID NO: 18. 
     
     
         15 . The fusion protein of any one of  claims 1 - 14 , wherein the Fc region comprises a charged pair mutation. 
     
     
         16 . The fusion protein of any one of  claims 1 - 14 , wherein the Fc region comprises a truncated hinge region. 
     
     
         17 . The fusion protein of any one of  claims 1 - 10 , wherein the Fc region is selected from Table 3. 
     
     
         18 . A method for treating a metabolic condition or disorder comprising administering a a fusion protein of any one of  claims 1 - 17 .

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