HRP20170094T1 - Imunogeni pripravak - Google Patents

Imunogeni pripravak Download PDF

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HRP20170094T1
HRP20170094T1 HRP20170094TT HRP20170094T HRP20170094T1 HR P20170094 T1 HRP20170094 T1 HR P20170094T1 HR P20170094T T HRP20170094T T HR P20170094TT HR P20170094 T HRP20170094 T HR P20170094T HR P20170094 T1 HRP20170094 T1 HR P20170094T1
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toxin
amino acids
proximal end
polypeptide according
polypeptide
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HRP20170094TT
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Cindy Castado
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Glaxosmithkline Biologicals S.A.
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Application filed by Glaxosmithkline Biologicals S.A. filed Critical Glaxosmithkline Biologicals S.A.
Publication of HRP20170094T1 publication Critical patent/HRP20170094T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/08Clostridium, e.g. Clostridium tetani
    • AHUMAN NECESSITIES
    • 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
    • AHUMAN NECESSITIES
    • 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
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/33Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Clostridium (G)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/12Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1267Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-positive bacteria
    • C07K16/1282Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-positive bacteria from Clostridium (G)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K19/00Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/62DNA sequences coding for fusion proteins
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/70Vectors or expression systems specially adapted for E. coli
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/57Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/40Fusion polypeptide containing a tag for immunodetection, or an epitope for immunisation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/55Fusion polypeptide containing a fusion with a toxin, e.g. diphteria toxin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
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  • Medicinal Chemistry (AREA)
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  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Wood Science & Technology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Claims (40)

1. Polipeptid koji sadrži prvi fragment i drugi fragment, naznačen time što (i) prvi fragment je fragment ponavljajuće domene toksina A; (ii) drugi fragment je fragment ponavljajuće domene toksina B; (iii) prvi fragment ima prvi proksimalni kraj; (iv) drugi fragment ima drugi proksimalni kraj; i gdje prvi fragment i drugi fragment razdvaja manje od ili točno 5 aminokiselina u primarnoj strukturi, gdje polipeptid izaziva pojavu protutijela koja neutraliziraju i toksin A i toksin B, gdje je prvi proksimalni kraj unutar kratke ponavljajuće jedinice i drugi proksimalni kraj je unutar kratke ponavljajuće jedinice, gdje prvi proksimalni kraj i drugi proksimalni kraj ne prekidaju dijelove kratka ponavljajuća jedinica-duga ponavljajuća jedinica-kratka ponavljajuća jedinica.
2. Polipeptid u skladu s patentnim zahtjevom 1, naznačen time što polipeptid izaziva zaštitni imunosni odgovor kod sisavačkog domaćina protiv sojeva bakterije C. difficile.
3. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 1-2, naznačen time što prvi fragment i/ili drugi fragment sadrži manje od 25%, 20%, 18% ili 15% strukture α-uzvojnice.
4. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što prvi fragment i/ili drugi fragment sadrži više od 25%, 30%, 35%, 38% ili 40% strukture β-ploče.
5. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što prvi proksimalni kraj nije među aminokiselinama 1878-1940, 2012-2074, 2146-2208, 2258-2322, 2394-2456, 2507-2569 ili 2598-2660 toksina A.
6. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što drugi proksimalni kraj nije među aminokiselinama 1881-1942, 2012-2074, 2144-2208 ili 2278-2339 toksina B.
7. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što prvi fragment sadrži najmanje 100, 250, 400 ili 450 aminokiselina.
8. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što drugi fragment sadrži najmanje 100, 200, 300 ili 400 aminokiselina.
9. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je prvi proksimalni kraj unutar ponavljajućeg dijela VIII (aminokiseline 2645-2710) toksina A.
10. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 1-9, naznačen time što je prvi proksimalni kraj među aminokiselinama 2700-2710 ili 2680-2690 toksina A.
11. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je drugi proksimalni kraj unutar ponavljajućeg dijela I (aminokiseline 1834-1926) toksina B.
12. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je drugi proksimalni kraj među aminokiselinama 1860-1878 ili 1854-1876 toksina B.
13. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 1-10, naznačen time što je drugi proksimalni kraj unutar ponavljajućeg dijela II (aminokiseline 1927-2057) toksina B.
14. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 1-10 ili 13, naznačen time što je drugi proksimalni kraj među aminokiselinama 1960-1970, 1988-1998 ili 1867-1877 toksina B.
15. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 9, 10, 11 ili 12, naznačen time što je prvi proksimalni kraj unutar ponavljajućeg dijela VIII (aminokiseline 2645-2710) toksina A, te što je drugi proksimalni kraj unutar ponavljajućeg dijela I (aminokiseline 1834-1926) toksina B.
16. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 9, 10, 13 ili 14, naznačen time što je prvi proksimalni kraj unutar ponavljajućeg dijela VIII (aminokiseline 2645-2710) toksina A, te što je drugi proksimalni kraj unutar ponavljajućeg dijela II (aminokiseline 1927-2057) toksina B.
17. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 9, 10, 13 ili 14, naznačen time što je prvi proksimalni kraj unutar kratke ponavljajuće jedinice 3 ponavljajućeg dijela VIII toksina A (aminokiseline 2687-2710), a drugi proksimalni kraj je unutar kratke ponavljajuće jedinice 4 ponavljajućeg dijela II toksina B (aminokiseline 1988-2007).
18. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 9, 10, 13 ili 14, naznačen time što je prvi proksimalni kraj unutar kratke ponavljajuće jedinice 2 ponavljajućeg dijela VIII (aminokiseline 2665-2686) toksina A, a drugi proksimalni kraj je unutar kratke ponavljajuće jedinice 3 ponavljajućeg dijela II toksina B (aminokiseline 1968-1987).
19. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 9, 10, 11 ili 12, naznačen time što je prvi proksimalni kraj unutar kratke ponavljajuće jedinice 2 ponavljajućeg dijela VIII toksina A (aminokiseline 2665-2686), a drugi proksimalni kraj je unutar kratke ponavljajuće jedinice 3 ponavljajućeg dijela I toksina B (1877-1896).
20. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 1-8, 9, 10, 11, 12 i 15, naznačen time što je prvi proksimalni kraj unutar kratke ponavljajuće jedinice 3 ponavljajućeg dijela VIII toksina A (aminokiseline 2645-2686), a drugi proksimalni kraj je unutar kratke ponavljajuće jedinice 1 ponavljajućeg dijela I toksina B (aminokiseline 1834-1854).
21. Polipeptid u skladu s bilo kojim od patentnih zahtjeva 9, 10, 13 ili 14, naznačen time što je prvi proksimalni kraj unutar kratke ponavljajuće jedinice 3 ponavljajućeg dijela VIII toksina A (aminokiseline 2687-2710), a drugi proksimalni kraj je unutar kratke ponavljajuće jedinice 4 ponavljajućeg dijela II toksina B (aminokiseline 1988-2007).
22. Polipeptid u skladu s patentnim zahtjevom 16, naznačen time što je prvi proksimalni kraj među aminokiselinama 2700-2710 toksina A, a drugi proksimalni kraj je među aminokiselinama 1960-1970 toksina B.
23. Polipeptid of patentnih zahtjeva 16, naznačen time što je prvi proksimalni kraj među aminokiselinama 2680-2690 toksina A, a drugi proksimalni kraj je među aminokiselinama 1960-1970 toksina B.
24. Polipeptid of patentnih zahtjeva 16, naznačen time što je prvi proksimalni kraj među aminokiselinama 2700-2710 u toksinu A, a drugi proksimalni kraj je među aminokiselinama 1988-1998 toksina B.
25. Polipeptid u skladu s patentnim zahtjevom 16, naznačen time što je prvi proksimalni kraj među aminokiselinama 2680-2690, a drugi proksimalni kraj je među aminokiselinama 1860-1878.
26. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je polipeptid dio većeg fuzijskog proteina.
27. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što polipeptid sadrži imunogeni fragment od SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:7 SEQ ID NO:21, SEQ ID NO:23, SEQ ID NO:25 ili SEQ ID NO:27.
28. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što polipeptid sadrži imunogeni fragment od najmanje 500, 600, 700, 750, 800, 850 ili 900 aminokiselina sa SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:6, SEQ ID NO:7 SEQ ID NO:21, SEQ ID NO:23, SEQ ID NO:25 ili SEQ ID NO:27.
29. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što polipeptid sadrži više od 450, 475, 500, 525, 575, 600, 625, 650, 675, 700, 725, 750, 775, 800, 825 ili 850 aminokiselina iz toksina A.
30. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što polipeptid sadrži manje od 850, 825, 800, 775, 750, 725, 700, 675, 650, 625, ili 600 aminokiselina iz toksina A.
31. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što polipeptid sadrži više od 350, 375, 400, 425, 450, 475, 500 ili 525 aminokiselina iz toksina B.
32. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što polipeptid sadrži manje od 525, 500, 475, ili 450 aminokiselina iz toksina B.
33. Polinukleotid, naznačen time što kodira polipeptid u skladu s bilo kojim od patentnih zahtjeva 1-32.
34. Vektor, naznačen time što sadrži polinukleotid u skladu s patentnim zahtjevom 33, naznačen time što je povezan s inducibilnim promotorom.
35. Imunogeni pripravak, naznačen time što sadrži polipeptid u skladu s bilo kojim od patentnih zahtjeva 1-32 i farmaceutski prihvatljivu pomoćnu tvar.
36. Imunogeni pripravak u skladu s patentnim zahtjevom 35, naznačen time što dodatno sadrži adjuvans.
37. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 35-36, naznačen time što dodatno sadrži dodatne antigene.
38. Imunogeni pripravak u skladu s patentnim zahtjevom 37, naznačen time što su dodatni antigeni antigeni dobiveni iz bakterije koju se bira iz skupine koju čine S. pneumoniae, H. influenzae, N. meningitidis, E. coli, M. cattarhalis, tetanus, difterija, hripavac, S. epidermidis, enterokoki, te S. aureus.
39. Cjepivo, naznačeno time što sadrži imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 35-38.
40. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 35-38 ili cjepivo u skladu s patentnim zahtjevom 39, naznačeni time što su namijenjeni upotrebi u liječenju ili sprječavanju bolesti koju uzrokuje bakterija C. difficile.
HRP20170094TT 2011-05-27 2017-01-20 Imunogeni pripravak HRP20170094T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161490707P 2011-05-27 2011-05-27
US201161490716P 2011-05-27 2011-05-27
US201161490734P 2011-05-27 2011-05-27
EP12726374.7A EP2714911B1 (en) 2011-05-27 2012-05-25 Immunogenic composition
PCT/EP2012/059805 WO2012163817A2 (en) 2011-05-27 2012-05-25 Immunogenic composition

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HRP20170094T1 true HRP20170094T1 (hr) 2017-03-24

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HRP20231749TT HRP20231749T1 (hr) 2011-05-27 2012-05-25 Imunogeni pripravak
HRP20170094TT HRP20170094T1 (hr) 2011-05-27 2017-01-20 Imunogeni pripravak
HRP20180339TT HRP20180339T1 (hr) 2011-05-27 2018-02-23 Imunogeni pripravak
HRP20191291TT HRP20191291T1 (hr) 2011-05-27 2019-07-17 Imunogeni pripravak

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HRP20191291TT HRP20191291T1 (hr) 2011-05-27 2019-07-17 Imunogeni pripravak

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US (5) US9290565B2 (hr)
EP (6) EP3138916B1 (hr)
JP (3) JP5952390B2 (hr)
KR (1) KR102014502B1 (hr)
CN (3) CN103732750A (hr)
BR (2) BR112013030396A2 (hr)
CA (2) CA2837393A1 (hr)
CY (3) CY1118599T1 (hr)
DK (4) DK3564378T3 (hr)
EA (1) EA030898B1 (hr)
ES (4) ES2968455T3 (hr)
FI (1) FI3564378T3 (hr)
HR (4) HRP20231749T1 (hr)
HU (4) HUE037126T2 (hr)
IL (1) IL229529B2 (hr)
LT (4) LT2714910T (hr)
ME (1) ME02600B (hr)
MX (1) MX346200B (hr)
PL (4) PL2714911T3 (hr)
PT (4) PT3564378T (hr)
RS (1) RS55605B1 (hr)
SG (1) SG195037A1 (hr)
SI (4) SI2714911T1 (hr)
SM (1) SMT201700110B (hr)
WO (3) WO2012163817A2 (hr)

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BR122016023101B1 (pt) 2012-10-21 2022-03-22 Pfizer Inc Polipeptídeo, composição imunogênica que o compreende, bem como célula recombinante derivada de clostridium difficile
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WO2019243307A1 (en) 2018-06-19 2019-12-26 Glaxosmithkline Biologicals Sa Immunogenic composition
WO2023020993A1 (en) 2021-08-16 2023-02-23 Glaxosmithkline Biologicals Sa Novel methods
WO2023020992A1 (en) 2021-08-16 2023-02-23 Glaxosmithkline Biologicals Sa Novel methods
WO2023020994A1 (en) 2021-08-16 2023-02-23 Glaxosmithkline Biologicals Sa Novel methods
GB202205833D0 (en) 2022-04-21 2022-06-08 Glaxosmithkline Biologicals Sa Bacteriophage
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