# US 10,245,320 B2 · Immunomodulatory pharmaceutical compositions 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 10,245,320 B2 - Document ID: US10245320B2 - Status: Granted - Kind: B2 - Application number: 15/719,821 - Filed: 2017-09-29 - Published: 2018-10-25 - Granted: 2019-04-02 - Earliest claimed: 2016-09-30 - Assignees: Enzo Biochem, Inc. - Applicants: Enzo Biochem, Inc. - Inventors: Ante Tocilj; Jack Coleman; Elazar Rabbani; James J. Donegan - Web page: https://patentgrep.com/patent/US10245320B2 ## CPC - A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants - A61K 39/0008: {Antigens related to auto-immune diseases; Preparations to induce self-tolerance} - A61K 39/0011: {Cancer antigens} - A61K 39/12: Viral antigens - A61K 2039/55516: {Proteins; Peptides} - A61K 2039/55588: {Adjuvants of undefined constitution} - C12N 2730/10134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - 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) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract Provided are immunomodulatory pharmaceutical compositions that include alpha-synuclein, and at least one preselected antigen, such as at least one preselected peptide antigen or immunogen. Also provided are methods for modulating immune activity toward at least one preselected antigen in an at least substantially antigen-specific manner that includes administering such a composition to a human patient or a non-human mammalian subject. ## Claims ### Claim 1 An immunomodulatory pharmaceutical composition comprising: (a) at least substantially pure alpha-synuclein protein; and (b) at least one preselected antigen or immunogen, which is not a human or non-human mammalian alpha-synuclein protein or a fragment thereof. ### Claim 2 (depends on 1) The immunomodulatory pharmaceutical composition of claim 1, further comprising at least partially purified human or non-human mammalian HLA protein or fragments thereof, wherein the at least one preselected antigen or immunogen does not comprise human or non-human mammalian HLA protein or fragments thereof. ### Claim 3 (depends on 1) The immunomodulatory pharmaceutical composition of claim 1, wherein the at least one preselected antigen or immunogen comprises a synthetic peptide. ### Claim 4 (depends on 1) The immunomodulatory pharmaceutical composition of claim 1, wherein the at least one preselected antigen or immunogen comprises an at least substantially purified protein. ### Claim 5 (depends on 4) The immunomodulatory pharmaceutical composition of claim 4, wherein the at least substantially purified protein is a recombinant protein. ### Claim 6 (depends on 1) The immunomodulatory pharmaceutical composition of claim 1, consisting essentially of: (a) at least substantially pure alpha-synuclein protein; and (b) at least one preselected antigen or immunogen, which is not a human or non-human mammalian alpha-synuclein protein or a fragment thereof. ### Claim 7 (depends on 6) The immunomodulatory pharmaceutical composition of claim 6, wherein the at least one preselected antigen or immunogen comprises a synthetic peptide. ### Claim 8 (depends on 6) The immunomodulatory pharmaceutical composition of claim 6, wherein the at least one preselected antigen or immunogen comprises an at least substantially purified protein. ### Claim 9 (depends on 8) The immunomodulatory pharmaceutical composition of claim 8, wherein the at least substantially purified protein is a recombinant protein. ### Claim 10 (depends on 1) The immunomodulatory pharmaceutical composition of claim 1, wherein the at least one preselected antigen or immunogen comprises a self-antigen of a human or non-human mammal. ### Claim 11 (depends on 9) The immunomodulatory pharmaceutical composition of claim 9, wherein the self-antigen is associated with an autoimmune disease. ### Claim 12 (depends on 1) The immunomodulatory pharmaceutical composition of claim 1, wherein the at least one preselected antigen or immunogen comprises a cancer-associated antigen or an antigen preferentially expressed on cancer cells versus normal cells of a human or non-human mammal. ### Claim 13 (depends on 1) The composition of claim 1, further comprising at least one pharmaceutically acceptable excipient. ### Claim 14 (depends on 1) The composition of claim 1, wherein the at least one preselected antigen or immunogen does not comprise human or non-human mammalian HLA protein or fragments thereof. ### Claim 15 (depends on 6) The composition of claim 6, wherein the at least one preselected antigen or immunogen does not comprise human or non-human mammalian HLA protein or fragments thereof. ### Claim 16 (depends on 1) A method for modulating the immune response in a mammal to at least one preselected antigen comprising administering to a human or non-human mammal the immunomodulatory pharmaceutical composition of claim 1. ### Claim 17 (depends on 6) A method for modulating the immune response in a mammal to at least one preselected antigen comprising administering to a human or non-human mammal the immunomodulatory pharmaceutical composition of claim 6. ### Claim 18 A method for manufacturing an immunomodulatory pharmaceutical composition comprising the steps of: providing at least substantially purified human or non-human mammalian alpha-synuclein protein; providing at least one preselected antigen or immunogen, which is not a human or non-human mammalian alpha-synuclein protein or a fragment thereof; and mixing the at least substantially purified mammalian alpha-synuclein protein and the at least one preselected antigen or immunogen. ### Claim 19 (depends on 18) The method of claim 18, wherein the at least one preselected antigen or immunogen comprises a synthetic peptide. ### Claim 20 (depends on 18) The method of claim 18, wherein the at least one preselected antigen or immunogen comprises an at least substantially purified protein. ### Claim 21 (depends on 20) The method of claim 20, wherein the at least substantially purified protein is a recombinant protein. ### Claim 22 (depends on 18) The method of claim 18, wherein the at least substantially purified human or non-human mammalian alpha-synuclein protein comprises recombinant alpha-synuclein protein. ### Claim 23 (depends on 22) The method of claim 22, wherein the at least one preselected antigen or immunogen comprises a synthetic peptide. ### Claim 24 (depends on 22) The method of claim 22, wherein the at least one preselected antigen or immunogen comprises an at least substantially purified protein. ### Claim 25 (depends on 24) The method of claim 24, wherein the at least substantially purified protein is a recombinant protein. ### Claim 26 (depends on 18) The method of claim 18, further comprising the step of: providing at least partially purified human or non-human mammalian HLA protein, wherein said mixing step further comprises mixing the provided at least substantially pure alpha-synuclein protein, the at least one preselected antigen or immunogen, and the at least partially purified human or non-human mammalian HLA protein, and wherein the at least one preselected antigen or immunogen is not a human or non-human mammalian HLA protein or fragment thereof.