# US 10,370,421 B2 · Recombinant polypeptides and methods of use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,370,421 B2 - Document ID: US10370421B2 - Status: Granted - Kind: B2 - Application number: 16/138,224 - Filed: 2018-09-21 - Published: 2019-06-27 - Granted: 2019-08-06 - Earliest claimed: 2017-12-27 - Assignees: Imunami Laboratories Pte. Ltd. - Applicants: Imunami Laboratories Pte. Ltd. - Inventors: Ya-Huei Chen; Ting-Long Lin - Web page: https://patentgrep.com/patent/US10370421B2 ## CPC - C07K 14/465: from birds - A61P 35/00: Antineoplastic agents - 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) - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - 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) ## Abstract The present disclosure provides recombinant polypeptides, nucleic acids encoding the recombinant polypeptides and methods for using these polypeptides and/or nucleic acids in enhancing or inducing an immune response in a subject in need thereof. The present disclosure also provides methods of treating a cell proliferative disorder, such as cancer, by administering the disclosed polypeptides and/or nucleic acids to a subject in need thereof. ## Claims ### Claim 1 A method of enhancing or inducing an immune response against a cancer cell in a subject in need thereof comprising administering to said subject a recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1, or a nucleic acid encoding the recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1, wherein i. the recombinant polypeptide is acidic as determined by isoelectric point (pI); ii. the pI of the recombinant polypeptide is lower than the pI of SEQ ID NO: 1; and iii. aspartic acid, glutamic acid and leucine are each independently present in an amount greater than, or equal to, the amount of any other amino acid residue present within the recombinant polypeptide sequence. ### Claim 2 (depends on 1) The method of claim 1, wherein the immune response comprises immunogenic cell death of the cancer cell. ### Claim 3 (depends on 2) The method of claim 2, wherein the immunogenic cell death comprises endogenous dendritic cell activation. ### Claim 4 (depends on 2) The method of claim 2, wherein the immunogenic cell death comprises an increased expression of pre-apoptotic Damage-Associated-Molecular-Pattern (DAMP) signals comprising of calreticulin (CRT), 70 kDa heat shock protein (HSP70), 90 kDa heat shock protein (HSP90), or a combination thereof, in the cancer cells. ### Claim 5 (depends on 1) The method of claim 1, comprising administering the recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1 with a pharmaceutically acceptable carrier. ### Claim 6 (depends on 5) The method of claim 5, wherein the recombinant polypeptide with a pharmaceutically acceptable carrier comprises a NaCl concentration of 0.4M to 1.0M and a pH of 7.5 to 9.0. ### Claim 7 (depends on 1) The method of claim 1, wherein the recombinant polypeptide comprises the amino acid sequence having at least 99% sequence identity to the recombinant polypeptide of SEQ ID NO: 9. ### Claim 8 A method of enhancing or inducing the endogenous presentation of disease associated antigens on the surface of a cancer cell in a subject in need thereof, comprising administering to said subject a recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1, or a nucleic acid encoding the recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1, wherein i. the recombinant polypeptide is acidic as determined by isoelectric point (pI); ii. the pI of the recombinant polypeptide is lower than the pI of SEQ ID NO: 1; and iii. aspartic acid, glutamic acid and leucine are each independently present in an amount greater than, or equal to, the amount of any other amino acid residue present within the recombinant polypeptide sequence. ### Claim 9 (depends on 8) The method of claim 8, comprising administering the recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1 with a pharmaceutically acceptable carrier. ### Claim 10 (depends on 9) The method of claim 9, wherein the recombinant polypeptide with a pharmaceutically acceptable carrier comprises a NaCl concentration of 0.4M to 1.0M and a pH of 7.5 to 9.0. ### Claim 11 (depends on 8) The method of claim 8, wherein the recombinant polypeptide comprises the amino acid sequence having at least 99% sequence identity to the recombinant polypeptide of SEQ ID NO: 9. ### Claim 12 A method of treating, preventing or alleviating at least one of the symptoms of cancer in a subject in need thereof comprising administering to said subject a recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1, or a nucleic acid encoding the recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1, wherein i. the recombinant polypeptide is acidic as determined by isoelectric point (pI); ii. the pI of the recombinant polypeptide is lower than the pI of SEQ ID NO: 1; and iii. aspartic acid, glutamic acid and leucine are each independently present in an amount greater than, or equal to, the amount of any other amino acid residue present within the recombinant polypeptide sequence. ### Claim 13 (depends on 12) The method of claim 12, comprising administering the recombinant polypeptide comprising the amino acid sequence having at least 99% sequence identity to the polypeptide of SEQ ID NO: 1 with a pharmaceutically acceptable carrier. ### Claim 14 (depends on 13) The method of claim 13, wherein the recombinant polypeptide with a pharmaceutically acceptable carrier comprises a NaCl concentration of 0.4M to 1.0M and a pH of 7.5 to 9.0. ### Claim 15 (depends on 12) The method of claim 12, wherein the recombinant polypeptide comprises the amino acid sequence having at least 99% sequence identity to the recombinant polypeptide of SEQ ID NO: 9. ### Claim 16 (depends on 1) The method of claim 1, wherein the recombinant polypeptide comprises the amino acid sequence of SEQ ID NO: 9. ### Claim 17 (depends on 8) The method of claim 8, wherein the recombinant polypeptide comprises the amino acid sequence of SEQ ID NO: 9. ### Claim 18 (depends on 12) The method of claim 12, wherein the recombinant polypeptide comprises the amino acid sequence of SEQ ID NO: 9.