DK2416798T3 - Papillomavirus-lignende partikler (vlp) som bredspektrede vacciner mod humant papillomavirus (hpv) - Google Patents

Papillomavirus-lignende partikler (vlp) som bredspektrede vacciner mod humant papillomavirus (hpv) Download PDF

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DK2416798T3
DK2416798T3 DK10762572.5T DK10762572T DK2416798T3 DK 2416798 T3 DK2416798 T3 DK 2416798T3 DK 10762572 T DK10762572 T DK 10762572T DK 2416798 T3 DK2416798 T3 DK 2416798T3
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vlp
protein
hpv
seq
hpv16
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DK10762572.5T
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Richard B S Roden
Reinhard Kirnbauer
Christina Schellenbacher
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Univ Johns Hopkins
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • A61K39/12—Viral antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • 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
    • C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • 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
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5258—Virus-like particles
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55566—Emulsions, e.g. Freund's adjuvant, MF59
    • 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
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55572—Lipopolysaccharides; Lipid A; Monophosphoryl lipid A
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/40—Fusion polypeptide containing a tag for immunodetection, or an epitope for immunisation
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/20011—Papillomaviridae
    • C12N2710/20023—Virus like particles [VLP]
    • 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
    • C12N2710/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011—Details
    • C12N2710/20011—Papillomaviridae
    • C12N2710/20034—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

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  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (18)

1. Sammensætning af viruslignende partikler (VLP), der er samlet fra et kimært polypeptid, som omfatter et papillomavirus(PV)-L1-protein, i hvilket der indsættes et overflade-eksponeret peptid, der består af følgende sekvens fra et papillomavirus-L2-protein: a) QLYKTCKQAGTCPPDIIPKV (SEQ ID NO: 9) eller b) QLYKTCKQAGTCPPDIIPKVEG (SEQ ID NO: 56) eller c) LYKTCKQAGTCPPDIIPKVEG (SEQ ID NO: 57), hvor L2-peptidet indsættes i DE-loopet af L1 -proteinet.
2. VLP ifølge krav 1, hvor L1-proteinet stammer fra HPV16, og L2-peptidet indsættes mellem aminosyrerne 136 og 137 i DE-loopet af L1-proteinet (SEQ ID NO: 85); eller L1-proteinet stammer fra BPV1, og L2-peptidet indsættes mellem aminosyrerne 133 og 134 i DE-loopet af L1-proteinet (SEQ ID NO: 83).
3. VLP-sammensætningen ifølge krav 1, hvor L1- og L2-proteinerne stammer fra et humant papillomavirus (HPV), eller hvor L1-proteinet stammer fra et BPV, eller hvor L1-proteinet og/eller L2-proteinet stammer fra et PV, der er forskelligt fra et HPV.
4. VLP-sammensætningen ifølge krav 1, hvor L1-proteinet er en variant, således at L1-proteinet kan tolerere indsættelsen af et egnet L2-peptid uden at miste sin antigenicitet og kan samle sig i et VLP eller i mindst en capsomer.
5. VLP-sammensætning ifølge krav 1 eller krav 4, hvilken sammensætning er en immunogen sammensætning, som fortrinsvis er immunogen mod mucosale højrisiko eller lavrisiko, kutane lavrisiko og/eller kutane beta-typer af papillomavira, eller som er immunogen mod tre eller flere af de følgende papillomavira: de mucosale højrisiko-typer HPV 16,18, 31,33, 45, 52, 58, 68 eller 76; de mucosale lavrisiko-typer HPV 6, 11; HPV-typerne 13, 32; de kutane lavrisiko-typer HPV 1,2, 3, 4, 7, 10, 27, 57; og/eller beta-typerne HPV 5, 8, 9, 12, 14, 15, 38.
6. VLP-sammensætningen ifølge krav 1, der yderligere omfatter en adjuvans.
7. Vaccine, der omfatter en VLP-sammensætning ifølge krav 1 og et adjuvans, hvilken vaccine fortrinsvis er effektiv mod humane papillomavira eller effektiv mod mucosale højrisiko, lavrisiko, kutane typer og/eller beta-typer af papillomavira.
8. Vaccinen ifølge krav 7, hvor sammensætningen er formuleret til administration ved indånding, indtagelse, i en viral eller bakteriel vektor, eller som en bestanddel af et seksuelt smøremiddel, eller hvor sammensætningen er i en formulering til intramuskulær (i.m.) injektion eller subkutan administration.
9. Vaccinen ifølge krav 7, hvor sammensætningen er i en lyofiliseret eller pulveriseret form.
10. Kimært polypeptid, der omfatter et papillomavirus(PV)-L1 -protein, i hvilket der indsættes et overflade-eksponeret peptid, der består afen af følgende sekvenser fra et papillomavirus-L2-protein: a) QLYKTCKQAGTCPPDIIPKV (SEQ ID NO: 9) eller b) QLYKTCKQAGTCPPDIIPKVEG (SEQ ID NO: 56) eller c) LYKTCKQAGTCPPDIIPKVEG (SEQ ID NO: 57) hvor L2-peptidet indsættes i DE-loopet af L1-proteinet.
11. Nucleinsyre, der koder for det kimære polypeptid ifølge krav 10.
12. Ekspressionsvektor, der omfatter nucleinsyren ifølge krav 11, som er operativt forbundet med en ekspressionsstyringssekvens.
13. Værtscelle, der omfatter et kimært polypeptid ifølge krav 10, en nucleinsyre ifølge krav 11 eller en ekspressionsvektor ifølge krav 12.
14. Fremgangsmåde til fremstilling af en VLP- eller en capsomer sammensætning, der omfatter at inkubere et kimært polypeptid ifølge krav 10 under egnede betingelser for at samle sig selv.
15. VLP-sammensætningen ifølge krav 1 til anvendelse ved immunisering eller vaccination af et individ mod en PV eller til anvendelse til at fremkalde et immunrespons mod HPV i et individ, fortrinsvis hvor immunresponset er et humoralt immunrespons, er et cellulært immunrespons, er antigenspecifik eller er medfødt eller er til anvendelse ved behandling afen PV-infektion i et individ, der har en PV-infektion eller i fare for at blive udsat for PV, eller til anvendelse til forebyggelse af cervikal-, anogenital-, oropharyngeal cancer eller et forstadium til cancer, fortrinsvis til anvendelse til forebyggelse af cervikal cancer.
16. Kit, der omfatter en VLP-sammensætning ifølge krav 1.
17. Capsomer sammensætning, der er samlet fra et kimært polypeptid, der omfatter et papillomavirus(PV)-L1-protein, i hvilket der indsættes et overflade-eksponeret peptid, som består afen af følgende sekvenser fra et papillomavirus-L2-protein: a) QLYKTCKQAGTCPPDIIPKV (SEQ ID NO: 9) eller b) QLYKTCKQAGTCPPDIIPKVEG (SEQ ID NO: 56) eller c) LYKTCKQAGTCPPDIIPKVEG (SEQ ID NO: 57) hvor L2-peptidet indsættes i DE-loopet af L1 -proteinet.
18. VLP-sammensætningen ifølge krav 1 til anvendelse ved fremkaldelse afen immunologisk reaktion mod et hud-type HPV i et individ.
DK10762572.5T 2009-04-10 2010-04-12 Papillomavirus-lignende partikler (vlp) som bredspektrede vacciner mod humant papillomavirus (hpv) DK2416798T3 (da)

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PCT/US2010/030757 WO2010118424A2 (en) 2009-04-10 2010-04-12 Papillomavirus-like particles (vlp) as broad spectrum human papillomavirus (hpv) vaccines

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WO2010118424A3 (en) 2011-05-26
HK1242997A1 (zh) 2018-07-06
US20120093821A1 (en) 2012-04-19
US10046026B2 (en) 2018-08-14
EP2416798A2 (en) 2012-02-15
BRPI1013895A2 (pt) 2016-09-20
EP2416798A4 (en) 2013-01-09
WO2010118424A2 (en) 2010-10-14
ES2653251T3 (es) 2018-02-06
US20160200774A1 (en) 2016-07-14
BRPI1013895B1 (pt) 2021-08-03
CN107080833A (zh) 2017-08-22
CN102458440A (zh) 2012-05-16
US9149503B2 (en) 2015-10-06
EP2416798B1 (en) 2017-09-20

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