# US 11,028,375 B2 · Methods for treating anemia in a subject in need thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,028,375 B2 - Document ID: US11028375B2 - Status: Granted - Kind: B2 - Application number: 16/808,010 - Filed: 2020-03-03 - Published: 2020-06-25 - Granted: 2021-06-08 - Earliest claimed: 2008-08-14 - Assignees: Acceleron Pharma Inc. - Applicants: Acceleron Pharma Inc. - Inventors: Jasbir Seehra; Robert Scott Pearsall; Ravindra Kumar - Web page: https://patentgrep.com/patent/US11028375B2 ## CPC - C12N 9/12: transferring phosphorus containing groups, e.g. kinases (2.7) - A61K 38/179: {for growth factors; for growth regulators} - A61K 38/1796: {for hormones (for neuromediators A61K38/1787)} - C07K 14/47: from mammals - C07K 14/475: Growth factors; Growth regulators - C12Q 1/6897: involving reporter genes operably linked to promoters - C12Y 207/1103: Receptor protein serine/threonine kinase (2.7.11.30) - C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - C12Y: ENZYMES ## Abstract In certain aspects, the present invention provides compositions and methods for increasing red blood cell and/or hemoglobin levels in vertebrates, including rodents and primates, and particularly in humans. ## Claims ### Claim 1 A method of treating anemia in a subject in need thereof, the method comprising administering to the subject an aqueous formulation, wherein the aqueous formulation comprises a polypeptide comprising an amino acid sequence that is at least 90% identical to the sequence of amino acids 29-109 of SEQ ID NO: 1, wherein the polypeptide comprises an acidic amino acid at the amino acid position corresponding to position 79 of SEQ ID NO: 1; wherein the polypeptide binds to GDF11 and/or myostatin; and wherein the formulation comprises Tris, a buffer, and/or a polyol. ### Claim 2 (depends on 1) The method of claim 1, wherein the polypeptide comprises an amino acid sequence that is at least 95% identical to the sequence of amino acids 29-109 of SEQ ID NO: 1. ### Claim 3 (depends on 2) The method of claim 2, wherein the acidic amino acid is glutamic acid. ### Claim 4 (depends on 2) The method of claim 2, wherein the acidic amino acid is aspartic acid. ### Claim 5 (depends on 2) The method of claim 2, wherein the polypeptide comprises an amino acid sequence that is at least 90% identical to SEQ ID NO: 28. ### Claim 6 (depends on 2) The method of claim 2, wherein the polypeptide comprises an amino acid sequence that is at least 95% identical to SEQ ID NO: 28. ### Claim 7 (depends on 2) The method of claim 2, wherein the polypeptide comprises an amino acid sequence that is at least 99% identical to SEQ ID NO: 28. ### Claim 8 (depends on 2) The method of claim 2, wherein the polypeptide comprises the amino acid sequence of SEQ ID NO: 28. ### Claim 9 (depends on 1) The method of claim 1, wherein the polypeptide comprises one or more modified amino acid residues selected from: a glycosylated amino acid, a PEGylated amino acid, a farnesylated amino acid, an acetylated amino acid, a biotinylated amino acid, an amino acid conjugated to a lipid moiety, and an amino acid conjugated to an organic derivatizing agent. ### Claim 10 (depends on 1) The method of claim 1, wherein the polypeptide binds to GDF11. ### Claim 11 (depends on 1) The method of claim 1, wherein the polypeptide binds to myostatin. ### Claim 12 (depends on 1) The method of claim 1, wherein the polypeptide binds to myostatin and GDF11. ### Claim 13 (depends on 1) The method of claim 1, wherein the polypeptide inhibits signaling by GDF11 and myostatin in a cell-based assay. ### Claim 14 (depends on 1) The method of claim 1, wherein the polypeptide further comprises a constant region of an immunoglobulin. ### Claim 15 (depends on 14) The method of claim 14, wherein the constant region is derived from an IgG heavy chain. ### Claim 16 (depends on 15) The method of claim 15, wherein the constant region of an immunoglobulin is an Fc domain. ### Claim 17 (depends on 16) The method of claim 16, wherein the polypeptide forms a homodimer. ### Claim 18 (depends on 1) The method of claim 1, wherein the polypeptide comprises the sequence of amino acids 29-109 of SEQ ID NO: 1, but wherein the polypeptide comprises an acidic amino acid at the position corresponding to position 79 of SEQ ID NO: 1. ### Claim 19 (depends on 1) The method of claim 1, wherein the polypeptide comprises an amino acid sequence that is at least 90% identical to the sequence of amino acids 25-131 of SEQ ID NO: 1. ### Claim 20 (depends on 1) The method of claim 1, wherein the polypeptide comprises an amino acid sequence that is at least 95% identical to the sequence of amino acids 25-131 of SEQ ID NO: 1. ### Claim 21 (depends on 1) The method of claim 1, wherein the polypeptide comprises the sequence of amino acids 25-131 of SEQ ID NO: 1, but wherein the polypeptide comprises an acidic amino acid at the position corresponding to position 79 of SEQ ID NO: 1. ### Claim 22 (depends on 1) The method of claim 1, wherein the subject is receiving blood transfusions. ### Claim 23 (depends on 1) The method of claim 1, wherein the subject has myelodysplastic syndrome. ### Claim 24 (depends on 1) The method of claim 1, wherein the subject has a thalassemia. ### Claim 25 (depends on 1) The method of claim 1, wherein the polypeptide inhibits signaling by GDF11 in a cell-based assay. ### Claim 26 (depends on 1) The method of claim 1, wherein the polypeptide inhibits signaling by myostatin in a cell-based assay. ### Claim 27 (depends on 1) The method of claim 1, wherein the formulation comprises Tris. ### Claim 28 (depends on 1) The method of claim 1, wherein the formulation comprises a buffer. ### Claim 29 (depends on 1) The method of claim 1, wherein the formulation comprises a polyol. ### Claim 30 (depends on 1) The method of claim 1, wherein the formulation comprises Tris, a buffer and a polyol.