DK2591114T3 - Immunisering af store pattedyr med lave doser af RNA - Google Patents

Immunisering af store pattedyr med lave doser af RNA Download PDF

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DK2591114T3
DK2591114T3 DK11736497.6T DK11736497T DK2591114T3 DK 2591114 T3 DK2591114 T3 DK 2591114T3 DK 11736497 T DK11736497 T DK 11736497T DK 2591114 T3 DK2591114 T3 DK 2591114T3
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rna
virus
liposomes
immunogen
use according
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DK11736497.6T
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Andrew Geall
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Glaxosmithkline Biologicals Sa
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    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/117—Nucleic acids having immunomodulatory properties, e.g. containing CpG-motifs
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    • A61K39/155—Paramyxoviridae, e.g. parainfluenza virus
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    • A61K48/0025—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition wherein the non-active part clearly interacts with the delivered nucleic acid
    • A61K48/0041—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition wherein the non-active part clearly interacts with the delivered nucleic acid the non-active part being polymeric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
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    • 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
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    • A61P33/00—Antiparasitic agents
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
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    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86—Viral vectors
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
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    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511—Organic adjuvants
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
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    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
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    • C12N2760/00011—Details
    • C12N2760/18011—Paramyxoviridae
    • C12N2760/18511—Pneumovirus, e.g. human respiratory syncytial virus
    • C12N2760/18534—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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    • C12N2770/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011—Details
    • C12N2770/36011—Togaviridae
    • C12N2770/36111—Alphavirus, e.g. Sindbis virus, VEE, EEE, WEE, Semliki
    • C12N2770/36141—Use of virus, viral particle or viral elements as a vector
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    • C12N2820/00—Vectors comprising a special origin of replication system
    • C12N2820/60—Vectors comprising a special origin of replication system from viruses

Claims (13)

1. immunogen-kodende, selvreplikerende RNA til anvendelse i en profylaktisk eller terapeutisk fremgangsmåde til at øge et immunrespons i et stort pattedyr ved ikke-viral fremføring af RNA'et, omfattende: (i) at indgive til pattedyret en dosis af mellem 2pg og lOOpg af det immunogen-kodende RNA, hvor det store pattedyr er et menneske, hest, kvæg, eller gris og RNA'et indgives i kombination med et fremføringssystem omfattende: (i) liposomer; (ii) ikke-toksiske og bionedbrydelige polymermi kroparti kier; og/eller (iii) en kationisk submikrometer-olie-i-vand-emulsion.
2. RNA til anvendelse ifølge krav 1, hvor RNA'et indgives til skeletmuskelvæv.
3. RNA til anvendelse ifølge et hvilket som helst foregående krav, hvor RNA'et indgives ved injektion.
4. RNA til anvendelse ifølge krav 3, hvor injektion er via en nål.
5. RNA til anvendelse ifølge et hvilket som helst foregående krav, hvor RNA'et er +-strenget.
6. RNA til anvendelse ifølge et hvilket som helst foregående krav, hvor RNA'et er en alfavirus-baseret RNA-replikon.
7. RNA til anvendelse ifølge et hvilket som helst foregående krav, hvor RNA-molekylet koder for (i) en RNA-afhængig RNA-polymerase, som kan transskribere RNA fra det selvreplikerende RNA-molekyle og (ii) et immunogen.
8. RNA til anvendelse ifølge krav 7, hvor polymerasen er en alfavirus-replikase.
9. RNA til anvendelse ifølge krav 8, hvor RNA-molekylet ikke koder for alfavirus-strukturproteiner.
10. RNA til anvendelse ifølge et hvilket som helst foregående krav, hvor RNA'et koder for et immunogen, som kan frembringe et immunrespons mod et bakterie, en virus, en svamp eller en parasit.
11. RNA til anvendelse ifølge krav 10, hvor immunogenet kan frembringe et immunrespons in vivo mod (a) respiratorisk syncytialvirus (RSV), såsom RSV-glycoprotein F; (b) orthomyxovirus, såsom influenza A-, B- og C-virus; eller (c) herpesvirus, såsom herpes simplex-viruser (HSV), varicella zoster-virus (VZV), Epstein-barr-virus (EBV), cytomegalovirus (CMV), human herpesvirus 6 (HHV6), human herpesvirus 7 (HHV7), og human herpesvirus 8 (HHV8).
12. RNA til anvendelse ifølge et hvilket som helst foregående krav, hvor det store pattedyr er et menneske.
13. Farmaceutisk sammensætning til anvendelse i en fremgangsmåde til immunisering af et menneske, en hest, et kvæg, eller en gris mod en sygdom, omfattende (a) mellem 2 pg og lOOpg af immunogen-kodende, selvreplikerende RNA til non-viral fremføring per dosisenhed og (b) et fremføringssystem omfattende: (i) liposomer; (ii) ikke-toksiske og bionedbrydelige polymermikropartikler; og/eller (iii) en kationisk submikrome-ter-olie-i-vand-emulsion.
DK11736497.6T 2010-07-06 2011-07-06 Immunisering af store pattedyr med lave doser af RNA DK2591114T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US36179410P 2010-07-06 2010-07-06
PCT/US2011/043096 WO2012006369A2 (en) 2010-07-06 2011-07-06 Immunisation of large mammals with low doses of rna

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DK2591114T3 true DK2591114T3 (da) 2016-08-29

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US (9) US10487332B2 (da)
EP (1) EP2591114B1 (da)
JP (1) JP5940064B2 (da)
CA (2) CA2804492A1 (da)
CY (1) CY1117819T1 (da)
DK (1) DK2591114T3 (da)
ES (1) ES2586580T3 (da)
HR (1) HRP20160805T1 (da)
HU (1) HUE029284T2 (da)
PL (1) PL2591114T3 (da)
PT (1) PT2591114T (da)
SI (1) SI2591114T1 (da)
WO (1) WO2012006369A2 (da)

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