# US 12,215,130 B2 · Cytokine-albumin binding moiety fusion proteins and uses thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,215,130 B2 - Document ID: US12215130B2 - Status: Granted - Kind: B2 - Application number: 17/253,481 - Filed: 2019-06-17 - Published: 2021-07-29 - Granted: 2025-02-04 - Earliest claimed: 2018-06-18 - Assignees: Anwita Biosciences, Inc. - Applicants: Anwita Biosciences, Inc. - Inventors: Ziyang Zhong; Fan Ye; Matthew Siegel; Jianing Huang; Eric Liao; Ella Li - Web page: https://patentgrep.com/patent/US12215130B2 ## CPC - C07K 14/54: Interleukins [IL] - A61K 38/20: Interleukins [IL] - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 35/00: Antineoplastic agents - A61P 37/00: Drugs for immunological or allergic disorders - C07K 14/5443: {IL-15} - C07K 14/765: Serum albumin, e.g. HSA - C07K 16/18: against material from animals or humans - C07K 16/28: against receptors, cell surface antigens or cell surface determinants - C07K 16/30: from tumour cells - C07K 16/32: against translation products of oncogenes - C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids} - A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00) - A61K 2039/505: {comprising antibodies} - A61K 2039/507: {Comprising a combination of two or more separate antibodies} - C07K 2317/22: from camelids, e.g. camel, llama or dromedary - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07K 2317/31: multispecific - C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity - C07K 2317/41: Glycosylation, sialylation, or fucosylation - C07K 2317/565: Complementarity determining region [CDR] - C07K 2317/569: Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody® - C07K 2317/62: comprising only variable region components - C07K 2317/732: Antibody-dependent cellular cytotoxicity [ADCC] - C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value - C07K 2319/00: Fusion polypeptide - C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto - C07K 2319/31: fusions, other than Fc, for prolonged plasma life, e.g. albumin - 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) - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present application provides fusion proteins that comprise a cytokine fused to an albumin binding moiety. The fusion proteins may further comprise an antigen binding moiety such as a therapeutic antibody. The present application also provides methods of making and using the fusion proteins. The present application also provides methods of treatment comprises administering a fusion protein comprising a cytokine fused to a half-life extending domain and a second agent. ## Claims ### Claim 1 A fusion protein comprising: a) an IL-21 and b) an albumin binding moiety that is a single domain antibody (sdAb) comprising: (1) a CDR1 comprising the amino acid sequence of SEQ ID NO: 69; a CDR2 comprising the amino acid sequence of SEQ ID NO: 70; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 71; (2) a CDR1 comprising the amino acid sequence of SEQ ID NO: 72; a CDR2 comprising the amino acid sequence of SEQ ID NO: 73; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 74; (3) a CDR1 comprising the amino acid sequence of SEQ ID NO: 75; a CDR2 comprising the amino acid sequence of SEQ ID NO: 76; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 77; (4) a CDR1 comprising the amino acid sequence of SEQ ID NO: 78; a CDR2 comprising the amino acid sequence of SEQ ID NO: 79; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 80; (5) a CDR1 comprising the amino acid sequence of SEQ ID NO: 81; a CDR2 comprising the amino acid sequence of SEQ ID NO: 82; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 83; (6) a CDR1 comprising the amino acid sequence of SEQ ID NO: 84; a CDR2 comprising the amino acid sequence of SEQ ID NO: 85; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 86; (7) a CDR1 comprising the amino acid sequence of SEQ ID NO: 87; a CDR2 comprising the amino acid sequence of SEQ ID NO: 88; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 89; (8) a CDR1 comprising the amino acid sequence of SEQ ID NO: 90; a CDR2 comprising the amino acid sequence of SEQ ID NO: 91; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 92; or (9) a CDR1 comprising the amino acid sequence of SEQ ID NO: 93; a CDR2 comprising the amino acid sequence of SEQ ID NO: 94; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 95. ### Claim 2 (depends on 1) The fusion protein of claim 1, wherein the IL-21 comprises the amino acid sequence of SEQ ID NO: 1, 2, 126, 171, or 172. ### Claim 3 (depends on 1) The fusion protein of claim 1, wherein the IL-21 is truncated IL-21 comprising the amino acid sequence of SEQ ID NO: 126, 171, or 172. ### Claim 4 (depends on 1) The fusion protein of claim 1, wherein the fusion protein comprises the amino acid sequence of any one of SEQ ID NOs: 120, 121, 129-150, 163, and 164. ### Claim 5 (depends on 1) A pharmaceutical composition comprising the fusion protein of claim 1 and a pharmaceutically acceptable carrier. ### Claim 6 (depends on 1) The fusion protein of claim 1, wherein the single domain antibody (sdAb) comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 78; a CDR2 comprising the amino acid sequence of SEQ ID NO: 79; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 80. ### Claim 7 (depends on 1) The fusion protein of claim 1, wherein the single domain antibody (sdAb) comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 81; a CDR2 comprising the amino acid sequence of SEQ ID NO: 82; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 83. ### Claim 8 (depends on 1) The fusion protein of claim 1, wherein the single domain antibody (sdAb) comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 84; a CDR2 comprising the amino acid sequence of SEQ ID NO: 85; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 86. ### Claim 9 (depends on 1) The fusion protein of claim 1, wherein the single domain antibody (sdAb) comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 87; a CDR2 comprising the amino acid sequence of SEQ ID NO: 88; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 89. ### Claim 10 (depends on 1) The fusion protein of claim 1, wherein the single domain antibody (sdAb) comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 90; a CDR2 comprising the amino acid sequence of SEQ ID NO: 91; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 92. ### Claim 11 (depends on 1) The fusion protein of claim 1, wherein the single domain antibody (sdAb) comprises a CDR1 comprising the amino acid sequence of SEQ ID NO: 93; a CDR2 comprising the amino acid sequence of SEQ ID NO: 94; and a CDR3 comprising the amino acid sequence of SEQ ID NO: 95. ### Claim 12 (depends on 1) The fusion protein of claim 1, wherein the single domain antibody (sdAb) comprises the amino acid sequence of any one of SEQ ID NOs: 60 to 68 and 168. ### Claim 13 (depends on 1) The fusion protein of claim 1, wherein the single domain antibody (sdAb) comprises the amino acid sequence of SEQ ID NO: 168. ### Claim 14 (depends on 1) The fusion protein of claim 1, wherein the fusion protein comprises the amino acid sequence of SEQ ID NO: 139. ### Claim 15 (depends on 1) The fusion protein of claim 1, wherein the fusion protein comprises the amino acid sequence of SEQ ID NO: 140. ### Claim 16 (depends on 1) The fusion protein of claim 1, wherein the fusion protein comprises the amino acid sequence of SEQ ID NO: 145. ### Claim 17 (depends on 1) The fusion protein of claim 1, wherein the fusion protein comprises the amino acid sequence of SEQ ID NO: 148. ### Claim 18 (depends on 1) The fusion protein of claim 1, wherein the IL-21 comprises the amino acid sequence of SEQ ID NO: 1.