HRP20150873T1 - Pripravci i postupci za lijeäśenje celijakije - Google Patents

Pripravci i postupci za lijeäśenje celijakije Download PDF

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HRP20150873T1
HRP20150873T1 HRP20150873TT HRP20150873T HRP20150873T1 HR P20150873 T1 HRP20150873 T1 HR P20150873T1 HR P20150873T T HRP20150873T T HR P20150873TT HR P20150873 T HRP20150873 T HR P20150873T HR P20150873 T1 HRP20150873 T1 HR P20150873T1
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peptide
derived
gluten
amino acid
biologically active
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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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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
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    • A61K39/4621Cellular immunotherapy characterized by the effect or the function of the cells immunosuppressive or immunotolerising
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    • A61K39/4632T-cell receptors [TCR]; antibody T-cell receptor constructs
    • AHUMAN NECESSITIES
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    • A61K39/00Medicinal preparations containing antigens or antibodies
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    • A61K39/4643Vertebrate antigens
    • A61K39/46433Antigens related to auto-immune diseases; Preparations to induce self-tolerance
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    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
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    • C12N5/0636T lymphocytes
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    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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Claims (19)

1. Pripravak naznačen time da sadrži i) prvi peptid koji sadrži sekvencu aminokiseline LQPFPQPELPYPQPQ (SEQ ID BR.: 13), njegov biološki aktivni fragment s najmanje 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegovu biološki aktivnu varijantu s najmanje 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ii) drugi peptid koji sadrži sekvencu aminokiseline QPFPQPEQPFPWQP (SEQ ID BR.: 14), njegov biološki aktivni fragment s najmanje 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegovu biološki aktivnu varijantu s najmanje 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, i iii) treći peptid koji sadrži sekvencu aminokiseline PEQPIPEQPQPYPQQ (SEQ ID BR.: 16), njegov biološki aktivni fragment s najmanje 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegovu biološki aktivnu varijantu s najmanje 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven.
2. Pripravak prema zahtjevu 1, naznačen time da (a) drugi peptid koji sadrži sekvencu aminokiseline PQQPFPQPEQPFPWQP (SEQ ID BR.: 320), njegov biološki aktivni fragment s najmanje 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegovu biološki aktivnu varijantu s najmanje 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, i/ili treći peptid koji sadrži sekvencu aminokiseline FPEQPIPEQPQPYPQQ (SEQ ID BR.: 321), njegov biološki aktivni fragment s najmanje 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegovu biološki aktivnu varijantu s najmanje 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven; (b) prvi, drugi i/ili treći peptidi sadrže N terminalnu acetil skupinu ili piroglutamatnu skupinu, i/ili C terminalnu amidnu skupinu, poželjno N terminalnu piroglutamatnu skupinu i C terminalnu amidnu skupinu; (c) prvi, drugi i/ili treći peptidi su konjugirani na spoj, pri čemu spoj je poželjno pomoćno sredstvo, ili MHC molekula ili njegov vezni fragment; (d) dva ili tri od prvog, drugog i/ili trećeg peptida, njegove biološki aktivne fragmente s ne manje od 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegove biološki aktivne varijante s ne više od 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, su na jednom polipeptidnom lancu; i/ili; (e) navedeni pripravak sadrži jedan ili više dodatnih peptida koji sadrže sekvencu aminokiseline odabranu iz skupine koja sadrži SEQ ID BR.: 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, i 210.
3. Pripravak naznačen time da sadrži jedan ili više polinukleotida koji kodiraju i) prvi peptid koji sadrži sekvencu aminokiseline LQPFPQPELPYPQPQ (SEQ ID BR.: 13), njegov biološki aktivni fragment s najmanje 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegovu biološki aktivnu varijantu s najmanje 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ii) drugi peptid koji sadrži sekvencu aminokiseline QPFPQPEQPFPWQP (SEQ ID BR.: 14), njegov biološki aktivni fragment s najmanje 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegovu biološki aktivnu varijantu s najmanje 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, i iii) treći peptid koji sadrži sekvencu aminokiseline PEQPIPEQPQPYPQQ (SEQ ID BR.: 16), njegov biološki aktivni fragment s najmanje 7 aminokiselina u duljinu i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven, ili njegovu biološki aktivnu varijantu s najmanje 3 varijacije aminokiselina u odnosu na peptid iz kojeg je dobiven i koji je sposoban generirati jednak ili veći odgovor T stanica kod subjekta osjetljivog na gluten kao peptid iz kojeg je dobiven.
4. Pripravak prema zahtjevu 3, naznačen time da dodatno sadrži jedan ili više polinukleotida koji kodiraju jedan ili više dodatnih peptida koji sadrže sekvencu aminokiseline odabranu iz skupine koja sadrži SEQ ID BR: 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, i 210.
5. Pripravak naznačen time da sadrži i) prvi peptid kao što je definirano u zahtjevu 1 ili polinukleotid koji kodira prvi peptid kao što je definirano u zahtjevu 1, ii) drugi peptid kao što je definirano u zahtjevu 1 ili polinukleotid koji kodira drugi peptid kao što je definirano u zahtjevu 1, i iii) treći peptid kao što je definirano u zahtjevu 1 ili polinukleotid koji kodira treći peptid kao što je definirano u zahtjevu 1.
6. Cjepivo naznačeno time da sadrži pripravak prema bilo kojem od zahtjeva 1 do 5, i farmaceutski prihvatljiv nosač.
7. Cjepivo prema zahtjevu 6, naznačeno time da dodatno sadrži pomoćno sredstvo.
8. Izolirana stanica za predočavanje antigena, naznačena time da sadrži peptide, polinukleotid ili polinukleotide prema bilo kojem od patentnih zahtjeva 1 do 5.
9. Izolirana stanica za predočavanje antigena prema zahtjevu 8, naznačena time da stanica za predočavanje antigena je dendritička stanica, makrofag, B-limfocit ili sinusna endotelna stanica jetre.
10. Pripravak prema bilo kojem od zahtjeva 1 do 5, cjepivo prema zahtjevu 6 ili 7, i/ili antigen koji iskazuje stanicu prema zahtjevu 8 ili 9, naznačen time da je za uporabu u: (a) postupku moduliranja odgovora T stanice na peptid glutena kod subjekta koji je osjetljiv na gluten; (b) postupku izazivanja imunološke tolerancije na peptid glutena kod subjekta koji je osjetljiv na gluten; (c) postupku liječenja celijakije kod subjekta koji je osjetljiv na gluten; ili (d) postupku modificiranja izlučivanja citokina kod subjekta koji je osjetljiv na gluten.
11. Pripravak, cjepivo i/ili stanica koja ispoljava antigen prema zahtjevu 10, za uporabu u postupku kao što je definirano u zahtjevu 10, naznačen time da je u postupku smanjeno izlučivanje interleukina-2 (IL-2), interferona gama (IFNγ) i/ili čimbenika tumorske nekroze alfa (TNFα) i/ili je povećano izlučivanje interleukina-10 (IL-10).
12. Postupak za dijagnosticiranje celijakije kod subjekta, praćenje napredovanja celijakije, ili određivanje djelotvornosti postupka kao što je definirano u zahtjevu 10 ili 11, postupak koji sadrži kontaktiranje uzorka od subjekta s pripravkom prema bilo kojem od zahtjeva 1 do 4, i/ili cjepivom prema zahtjevu 6 ili 7, te određivanje in vitro da li jedan ili više peptida vežu T stanice u uzorku, pri čemu vezanje jednog ili više peptida na T stanice ukazuje da subjekt ima celijakiju, ili je podložan celijakiji.
13. Komplet za provođenje postupka prema zahtjevu 12, naznačen time da komplet sadrži pripravak prema bilo kojem od zahtjeva 1 do 5, i/ili cjepivo prema zahtjevu 6 ili 7, te sredstva za otkrivanje vezanja jednog ili više peptida na T stanice.
14. Postupak za proizvodnju antigena koji iskazuje stanicu prema zahtjevu 8 ili 9, naznačen time da postupak sadrži i) dobivanje stanice koja ispoljava antigen, te ii) kontaktiranje stanice in vitro sa pripravkom prema bilo kojem od zahtjeva 1 do 5 i/ili cjepivom prema zahtjevu 6 ili 7.
15. Pripravak prema bilo kojem od zahtjeva 1 do 5, cjepivo prema zahtjevu 6 ili 7, i/ili antigen koji iskazuje stanicu prema zahtjevu 8 ili 9 naznačeni time da su za uporabu za dijagnozu ili liječenje.
16. Postupak za pripremanje cjepiva prema zahtjevu 6 ili 7, naznačen time da postupak sadrži kombiniranje prvog, drugog i trećeg peptida, biološki aktivnih fragmenata, ili biološki aktivnih fragmenata varijanti, s farmaceutski prihvatljivim nosačem.
17. Postupak prema zahtjevu 16, naznačen time da postupak dodatno sadrži kombiniranje jednog ili više dodatnih peptida koji sadrže sekvencu aminokiseline odabranu iz skupine koja sadrži SEQ ID BR: 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, i 210.
18. Postupak prema zahtjevu 16 ili 17, naznačen time da postupak dodatno sadrži kombiniranje pomoćnog sredstva.
19. Postupak utvrđivanja da li je drugi pripravak ili hrana u stanju izazvati celijakiju, naznačen time da postupak obuhvaća detektiranje prisutnosti pripravka prema bilo kojem od zahtjeva 1 do 5, u drugom pripravku ili hrani.
HRP20150873TT 2008-11-30 2015-08-18 Pripravci i postupci za lijeäśenje celijakije HRP20150873T1 (hr)

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US11864308P 2008-11-30 2008-11-30
PCT/AU2009/001556 WO2010060155A1 (en) 2008-11-30 2009-11-30 Compositions and methods for treatment of celiac disease
EP20090828453 EP2367561B1 (en) 2008-11-30 2009-11-30 Compositions and methods for treatment of celiac disease

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