ME02600B - Imunogena kompozicija - Google Patents

Imunogena kompozicija

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Publication number
ME02600B
ME02600B MEP-2017-26A MEP201726A ME02600B ME 02600 B ME02600 B ME 02600B ME P201726 A MEP201726 A ME P201726A ME 02600 B ME02600 B ME 02600B
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ME
Montenegro
Prior art keywords
toxin
proximal end
amino acids
polypeptide according
polypeptide
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MEP-2017-26A
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German (de)
English (en)
French (fr)
Inventor
Cindy Castado
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Glaxosmithkline Biologicals Sa
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Application filed by Glaxosmithkline Biologicals Sa filed Critical Glaxosmithkline Biologicals Sa
Publication of ME02600B publication Critical patent/ME02600B/me

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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
    • 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/12Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1267Gram-positive bacteria
    • C07K16/1282Clostridium (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
    • 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)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Zoology (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (40)

  1. l. Polipeptid koji sadrži prvi fragment i drugi fragment,gde(i) prvi fragment je fragment ponavljajućeg domena toksina A;(ii) drugi fragment je fragment ponavljajućeg domena toksina B; (iii) prvi fragment ima prvi proksimalni (susedni) kraj;(iv) drugi fragment ima drugiproksimalni(susedni) kraj igde su prvi fragment i drugi fragment odvojeni sa manje od ili tačno sa S amino-kiselina u primarnoj strukturi, gde polipeptid indukuje antitela koja neutralizuju oba toksina A i B, gde je prvi proksimalni kraj u okviru kratkog ponovka, drugi proksimalni kraj je u okviru kratkog ponovka i prvi proksimalni kraj i drugi proksimalni kraj ne remete motiv ponovaka kratko dugačko-kratko.
  2. 2. Polipeptid prema zahtevu 1, gde polipeptid indukuje zaštitni imuni odgovor kod domaćina sisara protiv soja C.difficile..
  3. 3. Polipeptid prema bilo kom od zahteva 1-2, gde prvi fragment i/ili drugi fragment sadrže manje od 2S%, 20%, 18% ili lS% alfa helikoidne strukture..
  4. 4. Polipeptid prema bilo kom prethodnom zahtevu, gde prvi fragment i/ili drugi fragment sadrže više od 2S%,30%, 3S%,38% ili 40% beta nabrane strukture.
  5. 5. Polipeptid prema bilo kom prethodnom zahtevu, gde prvi proksimalni kraj nije u okviru amino-kiselina 1878-1940, 2012-2074, 2146-2208, 22S8-2322, 2394-2456, 2507-2569 ili 2598-2660 toksina A.
  6. 6 Polipeptid prema bilo kom od prethodnog zahteva, gde drugi proksimalni kraj nije u okviru amino-kiselina 1881-1942,2012-2074,2144-2208 ili 2278-2339 toksina B.
  7. 7. Polipeptid prema bilo kom prethodnom zahtevu, gde prvi fragment ima bar 100, 250, 400 ili 450 amino-kiselina.
  8. 8. Polipeptid prema bilo kom prethodnom zahtevu,gde drugi fragment ima bar 100, 200,300 ili 400 amino-kiselina.
  9. 9. Polipeptid prema bilo kom prethodnom zahtevu, gde je prvi proksimalni kraj u okviru ponavljajućeg motiva VIlI (amino-kiselina 2645-2710) toksina A.
  10. 10. Polipeptid prema bilo kom od zahteva 1-9, gde je prvi proksimalni kraj u okviru amino kiselina 2700-2710 ili 2680-2690 toksina A.
  11. 11. Polipeptid prema bilo kom prethodnom zahtevu, gde je drugi proksimalni kraj u ovkiru ponavljajućeg motiva l (amino-kiselina 1834-1926) toksina B.
  12. 12. Polipeptid prema bilo kom prethodnom zahtevu, gde je drugi proksimalni kraj u okviru amino-kiselina 1860-1878 ili 1854-1876 toksina B.
  13. 13. Polipeptid prema bilo kom od zahteva 1-10, gde je drugi proksimalni kraj u okviru ponavljajućeg motiva ll (amino-kiselina 1927-2057) toksina B.
  14. 14. Polipeptid prema bilo kom od zahteva 1-10 ili 13, gde je drugi proksimalni kraj u okviru amino-kiselina 1960-1970, 1988-1998 ili 1867-1877 toksina B.
  15. 15. Polipeptid prema bilo kom od zahteva 9, 10, llili 12, gde je prvi proksimalni kraj u okviru ponavljajućeg motiva VIII (amino-kiselina 2645-2710) toksina A i gde je drugi proksimalni kraj u okviru ponavljajućeg motiva l (amino-kiselina 1834-1926) toksina B.
  16. 16. Polipeptid prema bilo kom od zahteva 9, 10, 13 ili 14, gde je prvi proksimalni kraj u okviru ponavljajućeg motiva VIll (amino-kiselina 2645-2710) toksina A i gde je drugi proksimalni kraj u okviru ponavljajućeg motiva ll (amino-kiselina 1927-2057) toksina B.
  17. 17. Polipeptid prema bilo kom od zahteva 9, 10, 13 ili 14, gde je prvi proksimalni kraj u okviru kratkog ponovka 3 ponavljajućeg motiva VIII toksina A (amino-kiselina 2687-2710) i drugi proksimalni kraj je u okviru kratkog ponovka 4 ponavljajućeg motiva ll toksina B (amino kiselina 1988-2007).
  18. 18. Polipeptid prema bilo kom od zahteva 9, 10, 13 ili 14, gde je prvi proksimalni kraj u okviru kratkog ponovka 2 ponavljajućeg motiva VIII (amino-kiselina 2665-2686) toksina A i drugi proksimalni kraj je u okviru kratkog ponovka 3 ponavljajućeg motiva ll toksina B (amino kiselina 1968-1987).
  19. 19. Polipeptid prema bilo kom od zahteva 9,10, 11 ili 12,gde je prvi proksimalni u okviru kratkog ponovka 2 ponavljajućeg motiva VIIl toksina A (amino-kiselina 2665-2686) i drugi proksimalni kraj je u oviru kratkog ponovka 3 ponavljajućeg motiva l toksina B (1877-1896).
  20. 20. Polipeptid prema bilo kom od zahteva 1-8, 9, 10, 11, 12 i 15, gde je prvi proksimalni kraj u okviru kratkog ponovka 3 ponavljajućeg motiva VIlI toksina A (amino-kiselina 2645-2686) i drugi proksimalni kraj je u okviru kratkog ponovkal ponavljajućeg motiva l toksina B (amino kiselina 1834-1854).
  21. 21. Polipeptid prema bilo kom od zahteva 9, 10, 13 ili 14, gde je prvi proksimalni kraj u okviru kratkog ponovka 3 ponavljajućeg motiva VIlI toksina A (amino-kiseline 2687-2710) i drugi proksimalni kraj je u okviru kratkog ponovka 4 ponavljajućeg motiva ll toksina B (amino kiseline 1988-2007).
  22. 22. Polipeptid prema zahtevu 16, gde je prvi proksimalni kraj u okviru amino-kiselina 2700-2710 toksina A i drugi proksimalni kraj je u okviru amino-kiselina 1960-1970 toksina B.
  23. 23. Polipeptid prema zahtevu 16, gde je prvi proksimalni kraj u ovkiru amino-kiselina 2680-2690 toksina A i drugi proksimalni kraj je u okviru amin -kiselina 1960-1970 toksina B.
  24. 24. Polipeptid prema zahtevu 16, gde je prvi proksimalni kraj u okviru amino-kiselina 2700-2710 toksina A i drugi proksimalni kraj je u okviru amino-kiselina 1988-1998 toksina B.
  25. 25. Polipeptid prema zahtevu 16, u kome je prvi proksimalni kraj u okviru amino-kiselina 2680-2690 i drugi proksimalni kraj je u okviru amino-kiselina 1860-1878.
  26. 26. Polipeptid prema bilo kom prethodnom zahtevu gde je polipeptid deo većeg fuzionog proteina.
  27. 27. Polipeptid prema bilo kom prethodnom zahtevu, gde polipeptid sadrži imunogeni fragment SEQ ID N0:3, SEQ ID N0:4, SEQ ID N0:6, SEQ ID N0:7 SEQ ID N0:21, SEQ ID N0:23, SEQ ID N0:25 ili SEQ ID N0:27.
  28. 28. Polipeptid prema bilo kom zahtevu, gde polipeptid sadrži imunogeni fragment od bar 500, 600, 700, 750,800,850 ili 900 amino-kiselina SEQ ID N0:3,SEQ ID N0:4, SEQ ID N0:6,SEQ ID N0:7 SEQ ID N0:21, SEQ ID N0:23, SEQ ID N0:25 ili SEQ ID N0:27.
  29. 29. Polipeptid prema bilo kom prethodnom zahtevu gde polipeptid sadrži više od 450, 475, 500 ,525,575,600,625, 650,675,700, 725,750,775,800, 825 ili 850 amino-kiselina iz toksina A.
  30. 30. Polipeptid prema bilo kom prethodnom zahtevu, gde polipeptid sadrži manje od 850, 825, 800, 775,750,725,700,675,650, 625,ili 600 amino-kiselina toksina A.
  31. 31. Polipeptid prema bilo kom prethodnom zahtevu,gde polipeptid sadrži više od 350, 375,400, 425,450, 475, 500 ili 525 amino-kiselina iz toksina B.
  32. 32. Polipeptid prema bilo kom prethodnom zahtevu, gde polipeptid sadrži manje od 525, 500,475, ili 450 amino-kiselina toksina B.
  33. 33. Polinukleotid koji kodira polipeptid prema bilo kom od zahteva 1-32.
  34. 34. Vektor koji sadrži polinukleotid prema zahtevu 33 vezan za inducibilni promoter.
  35. 35. lmunogena kompozicija koja sadrži polipeptid prema bilo kom od zahteva 1-32 i farmaceutski prihvatljiv ekscipijent.
  36. 36. lmunogena kompozicija prema zahtevu 35 koja dalje sadrži pomoćno sredstvo.
  37. 37. lmunogena kompozcija prema bilo kom od zahteva 35-36 što dalje sadrži dodatne antigene.
  38. 38. lmunogena kompozicija prema zahtevu 37, što su dodatni antigeni antigeni koji potiču iz bakterija izabranih iz grupe koju čine S.pneumoniae, H.influenzae, N.meningitidis, E.coli, M.cattarhalis, tetanus,difterija,veliki kašalj,S.epidermidis, enterokoke, i S.aureus.
  39. 39. Vakcina koja sadrži imunogenu kompoziciju prema bilo kom od zahteva 35-38.
  40. 40. lmunogena kompozicija prema bilo kom od zahteva 35-38 ili vakcina prema zahtevu 39 za upotrebu u lečenju ili prevencijibolestiizazvane sa C.difficile.
MEP-2017-26A 2011-05-27 2012-05-25 Imunogena kompozicija ME02600B (me)

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
PCT/EP2012/059805 WO2012163817A2 (en) 2011-05-27 2012-05-25 Immunogenic composition
EP12726374.7A EP2714911B1 (en) 2011-05-27 2012-05-25 Immunogenic composition

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US (5) US9409974B2 (me)
EP (6) EP3327126A1 (me)
JP (3) JP2014516532A (me)
KR (1) KR102014502B1 (me)
CN (3) CN107098977A (me)
BR (2) BR112013030395B1 (me)
CA (2) CA2837395C (me)
CY (3) CY1118599T1 (me)
DK (4) DK2714911T3 (me)
EA (1) EA030898B1 (me)
ES (4) ES2968455T3 (me)
FI (1) FI3564378T3 (me)
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LT (4) LT2714910T (me)
ME (1) ME02600B (me)
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PL (4) PL2714911T3 (me)
PT (4) PT3564378T (me)
RS (1) RS55605B1 (me)
SG (1) SG195037A1 (me)
SI (4) SI3138916T1 (me)
SM (2) SMT201700110T1 (me)
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EA201391548A1 (ru) 2014-06-30
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HRP20170094T1 (hr) 2017-03-24
CN107098977A (zh) 2017-08-29
CN103732750A (zh) 2014-04-16
DK3138916T3 (da) 2019-08-26
JP5952390B2 (ja) 2016-07-13
HUE030823T2 (en) 2017-06-28
PT3564378T (pt) 2024-01-26
US20140093529A1 (en) 2014-04-03
DK3564378T5 (da) 2024-09-02
DK2714911T3 (en) 2017-02-27
EP3327126A1 (en) 2018-05-30
CA2837395A1 (en) 2012-12-06
KR20140019848A (ko) 2014-02-17
HUE064492T2 (hu) 2024-03-28
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