DK2977053T3 - Sammensætninger og fremgangsmåder til behandling af cøliaki - Google Patents

Sammensætninger og fremgangsmåder til behandling af cøliaki Download PDF

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DK2977053T3
DK2977053T3 DK15168279.6T DK15168279T DK2977053T3 DK 2977053 T3 DK2977053 T3 DK 2977053T3 DK 15168279 T DK15168279 T DK 15168279T DK 2977053 T3 DK2977053 T3 DK 2977053T3
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gin
seq
peptide
pro
peptides
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Robert Paul Anderson
Jessica Anne Stewart
James Anthony Dromey
Jason Allan Tye-Din
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Immusant Inc
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/415—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from plants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/46—Cellular immunotherapy
    • A61K39/461—Cellular immunotherapy characterised by the cell type used
    • A61K39/4611—T-cells, e.g. tumor infiltrating lymphocytes [TIL], lymphokine-activated killer cells [LAK] or regulatory T cells [Treg]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/46—Cellular immunotherapy
    • A61K39/462—Cellular immunotherapy characterized by the effect or the function of the cells
    • A61K39/4621—Cellular immunotherapy characterized by the effect or the function of the cells immunosuppressive or immunotolerising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/46—Cellular immunotherapy
    • A61K39/463—Cellular immunotherapy characterised by recombinant expression
    • A61K39/4632—T-cell receptors [TCR]; antibody T-cell receptor constructs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/46—Cellular immunotherapy
    • A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
    • A61K39/4643—Vertebrate antigens
    • A61K39/46433—Antigens related to auto-immune diseases; Preparations to induce self-tolerance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0634—Cells from the blood or the immune system
    • C12N5/0636—T lymphocytes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/24—Immunology or allergic disorders

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Claims (16)

1. Sammensætning, der omfatter: i) et første peptid, der omfatter aminosyresekvensen PFPQPELPY (SEQ ID NO: 3) eller aminosyresekvensen PQPELPYPQ (SEQ ID NO: 4), ii) et andet peptid, der omfatter aminosyresekvensen PFPQPEQPF (SEQ ID NO: 10) eller aminosyresekvensen PQPEQPFPW (SEQ ID NO: 15) og iii) et tredje peptid, der omfatter aminosyresekvensen PIPEQPQPY (SEQ ID NO: 17) eller aminosyresekvensen EQPIPEQPQ (SEQ ID NO: 18) eller aminosyresekvensen QQPIPEQPQ (SEQ ID NO: 19).
2. Sammensætning ifølge krav 1, hvor (a) det andet peptid omfatter aminosyresekvensen PQQPFPQPEQPFPWQP (SEQ ID NO: 320), og/eller det tredje peptid omfatter aminosyresekvensen FPEQPIPEQPQPYPQQ (SEQ ID NO: 321); (b) det første, andet og/eller tredje peptid omfatter en N- terminal acetylgruppe eller pyroglutamatgruppe og/eller en C-terminal amidgruppe, fortrinsvis en N-terminal pyroglutamatgruppe og en C-terminal amidgruppe; (c) det første, andet og/eller tredje peptid er konjugeret til en forbindelse, hvor forbindelsen fortrinsvis er et adjuvans eller et MHC (major histocompatibility)-molekyle eller et bindingsfragment deraf; (d) to eller tre af det første, andet og tredje peptid er på en enkelt polypeptidkæde; og/eller; (e) sammensætningen omfatter et eller flere yderligere peptides, der omfatter en aminosyresekvens valgt fra gruppen, der består af SEQ ID NO: 47, 48, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 75, 76, 77, 78, 79, 80, 81, 89, 90, 91, 92, 95, 102, 103, 104, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 136, 169, 170, 171, 172, 173, 174, 177, 178, 179, 180, 183, 184, 187, 188, 189, 190, 191, 192, 209 og 210.
3. Sammensætning ifølge et hvilket som helst af kravene 1 til 2, hvor hver af det første, andet og tredje peptid uafhængigt er mellem 7 og 50 aminosyrer langt, eller hvor hver af det første, andet og tredje peptid er 20 eller færre aminosyrer langt.
4. Sammensætning ifølge krav 1, der omfatter: i) et første peptid, der består af aminosyresekvensen LQPFPQPELPYPQPQ (SEQ ID NO: 13) og en N-terminal og/eller C-terminal modifikation, fortrinsvis hvor det første peptid består af aminosyresekvensen pyroELQPFPQPELPYPQPQ-amid (SEQ ID NO: 228); ii) et andet peptid, der består af aminosyresekvensen QPFPQPEQPFPWQP (SEQ ID NO: 14) og en N-terminal og/eller C-terminal modifikation, fortrinsvis hvor det andet peptid består af aminosyresekvensen pyroEQPFPQPEQPFPWQP-amid (SEQ ID NO: 229); og iii) et tredje peptid, der består af aminosyresekvensen PEQPIPEQPQPYPQQ (SEQ ID NO: 16) og en N-terminal og/eller C-terminal modifikation, fortrinsvis hvor det tredje peptid består af aminosyresekvensen pyroEPEQPIPEQPQPYPQQ-amid (SEQ ID NO: 230) .
5. Sammensætning, der omfatter et eller flere polynukleotider, der koder for i) et første peptid, der omfatter aminosyresekvensen PFPQPELPY (SEQ ID NO: 3) eller aminosyresekvensen PQPELPYPQ (SEQ ID NO: 4), ii) et andet peptid, der omfatter aminosyresekvensen PFPQPEQPF (SEQ ID NO: 10) eller aminosyresekvensen PQPEQPFPW (SEQ ID NO: 15), og iii) et tredje peptid, der omfatter aminosyresekvensen PIPEQPQPY (SEQ ID NO: 17) eller aminosyresekvensen EQPIPEQPQ (SEQ ID NO: 18) eller aminosyresekvensen QQPIPEQPQ (SEQ ID NO: 19).
6. Sammensætning ifølge krav 5, der yderligere omfatter et eller flere polynukleotider, der koder for et eller flere yderligere peptider, der omfatter en aminosyresekvens valgt fra gruppen, der består af SEQ ID NO: 47, 48, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 75, 76, 77, 78, 79, 80, 81, 89, 90, 91, 92, 95, 102, 103, 104, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 136, 169, 170, 171, 172, 173, 174, 177, 178, 179, 180, 183, 184, 187, 188, 189, 190, 191, 192, 209 og 210.
7. Vaccine, der omfatter sammensætningen ifølge et hvilket som helst af kravene 1 til 6 og et farmaceutisk acceptabelt bæremateriale.
8. Vaccine ifølge krav 7, der yderligere omfatter et adj uvans.
9. Kit, der omfatter sammensætningen ifølge et hvilket som helst af kravene 1 til 5 og et middel til påvisning af binding af et eller flere peptider til T-celler.
10. Isoleret antigenpræsenterende celle, der omfatter peptiderne, polynukleotidet eller polynukleotiderne ifølge et hvilket som helst af kravene 1 til 6.
11. Sammensætning ifølge et hvilket som helst af kravene 1 til 6, vaccine ifølge et hvilket som helst af kravene 7 til 8, kit ifølge krav 9 og/eller antigenpræsenterende celle ifølge krav 10 til anvendelse til diagnosticering eller terapi.
12. Sammensætning ifølge et hvilket som helst af kravene 1 til 6, vaccine ifølge et hvilket som helst af kravene 7 til 8 og/eller antigenpræsenterende celle ifølge krav 10 til anvendelse til: (a) modulering af en T-cellerespons på et glutenpeptid hos en person, der er overfølsom over for gluten; (b) inducering af immuntolerans over for et glutenpeptid hos en person, der er overfølsom over for gluten; (c) behandling af cøliaki hos en person, der er overfølsom over for gluten; eller (d) modificering af cytokinsekretion hos en person, der er overfølsom over for gluten.
13. Fremgangsmåde til diagnosticering af cøliaki hos en person, overvågning af progression af cøliaki eller bestemmelse af effekten af en sammensætning, en vaccine og/eller en antigenpræsenterende celle til anvendelse ifølge krav 12, hvilken fremgangsmåde omfatter etablering af kontakt mellem en prøve fra personen og sammensætningen ifølge et hvilket som helst af kravene 1 til 6 og/eller vaccinen ifølge et hvilket som helst af kravene 7 til 8 og bestemmelse in vitro af, om et eller flere af peptiderne binder T-celler i prøven, hvor binding af et eller flere peptider til T-celler indikerer, at personen har eller er disponeret for cøliaki.
14. Fremgangsmåde til fremstilling af vaccinen ifølge krav 7 eller 8, hvilken fremgangsmåde omfatter kombinering af det første, andet og tredje peptid med et farmaceutisk acceptabelt bæremateriale.
15. Fremgangsmåde til bestemmelse af, om en anden sammensætning eller en fødevare er i stand til at forårsage cøliaki, hvilken fremgangsmåde omfatter påvisning af tilstedeværelse af sammensætningen ifølge et hvilket som helst af kravene 1 til 5 i den anden sammensætning eller fødevaren.
16. Sammensætning, vaccine og/eller antigenpræsenterende celle ifølge krav 12 til anvendelse ifølge krav 12, hvor sekretion af interleukin-2 (IL—2), interferon-gamma (IFNy) og/eller tumornekrosefaktor-alfa (TNFa) reduceres, og/eller sekretion af interleukin-10 (IL-10) forøges.
DK15168279.6T 2008-11-30 2009-11-30 Sammensætninger og fremgangsmåder til behandling af cøliaki DK2977053T3 (da)

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EP (3) EP2977053B1 (da)
JP (2) JP5851243B2 (da)
CN (2) CN102438643B (da)
AU (1) AU2009321481B2 (da)
BR (1) BRPI0922122A2 (da)
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