HRP20230017T1 - Mali liposomi za isporuku rna koja kodira imunogen - Google Patents

Mali liposomi za isporuku rna koja kodira imunogen Download PDF

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Publication number
HRP20230017T1
HRP20230017T1 HRP20230017TT HRP20230017T HRP20230017T1 HR P20230017 T1 HRP20230017 T1 HR P20230017T1 HR P20230017T T HRP20230017T T HR P20230017TT HR P20230017 T HRP20230017 T HR P20230017T HR P20230017 T1 HRP20230017 T1 HR P20230017T1
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Croatia
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liposome
rna
immunogen
vertebrate
liposome according
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HRP20230017TT
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Andrew Geall
Ayush Verma
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Glaxosmithkline Biologicals Sa
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Application filed by Glaxosmithkline Biologicals Sa filed Critical Glaxosmithkline Biologicals Sa
Publication of HRP20230017T1 publication Critical patent/HRP20230017T1/hr

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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
    • A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids
    • 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
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • 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
    • A61P33/00—Antiparasitic 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
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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
    • C12N15/87—Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation
    • C12N15/88—Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation using microencapsulation, e.g. using amphiphile liposome vesicle
    • 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
    • A61K2039/53—DNA (RNA) vaccination
    • 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
    • A61K2039/55555—Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A61K9/1277—Processes for preparing; Proliposomes
    • C—CHEMISTRY; METALLURGY
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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
    • C12N2710/16011—Herpesviridae
    • C12N2710/16111—Cytomegalovirus, e.g. human herpesvirus 5
    • C12N2710/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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    • 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
    • C12N2770/36143—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
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    • C12N2770/00011—Details
    • C12N2770/36011—Togaviridae
    • C12N2770/36111—Alphavirus, e.g. Sindbis virus, VEE, EEE, WEE, Semliki
    • C12N2770/36171—Demonstrated in vivo effect
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
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  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
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  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Virology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (12)

1. Liposom unutar kojeg je inkapsulirana RNA koja kodira imunogen od interesa, naznačen time što liposom sadrži lipid s kationskom glavnom skupinom, lipid s zwitterionskom glavnom skupinom i ima promjer u rasponu od 60-180 nm, i pri čemu je imunogen šiljasti polipeptid koronavirusa.
2. Liposom prema zahtjevu 1, naznačen time što liposom ima promjer u rasponu od 80-160 nm.
3. Liposom prema zahtjevu 1 ili 2, naznačen time što je liposom formiran iz mješavine lipida, udio tih lipida koji je kationski je između 20 do 80 mol% ukupne količine lipida, s ostatkom kolesterola i/ili DMG koji je izborno PEGiliran i/ili DSPC.
4. Liposom prema bilo kojem od zahtjeva 1 do 3, naznačen time što je RNA samo-replicirajuća RNA.
5. Liposom prema zahtjevu 4, naznačen time što samo-replicirajuća RNA molekula kodira (i) RNA-ovisnu RNA polimerazu koja može transkribirati RNA iz samo-replicirajuće RNA molekule i (ii) imunogen.
6. Liposom prema zahtjevu 5, naznačen time što molekula RNA ima dva otvorena okvira čitanja, od kojih prvi kodira alfavirusnu replikazu i drugi kodira imunogen.
7. Liposom prema bilo kojem od zahtjeva 1 do 6, naznačen time što je molekula RNA duga 9000-12000 nukleotida.
8. Farmaceutski pripravak koji sadrži liposom prema bilo kojem od zahtjeva 1 do 7.
9. Farmaceutski pripravak koji sadrži populaciju liposoma prema bilo kojem od zahtjeva 1 do 7, naznačen time što je Z-prosječni promjer liposoma u populaciji između 60 nm i uključivo 180 nm.
10. Farmaceutski pripravak prema zahtjevu 9, naznačen time što promjeri unutar populacije liposoma imaju indeks polidisperznosti <0.2.
11. Liposom prema bilo kojem od zahtjeva 1 do 7, za uporabu u postupku za podizanje zaštitnog imunološkog odgovora kod kralježnjaka, navedeni postupak sadrži korak davanja kralježnjaku učinkovite količine navedenog liposoma.
12. Farmaceutski pripravak prema bilo kojem od zahtjeva 8 do 10, za uporabu u postupku za podizanje zaštitnog imunološkog odgovora kod kralježnjaka, navedeni postupak sadrži korak davanja kralježnjaku učinkovite količine navedenog farmaceutskog pripravka.
HRP20230017TT 2010-08-31 2011-08-31 Mali liposomi za isporuku rna koja kodira imunogen HRP20230017T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US37883110P 2010-08-31 2010-08-31
EP21208092.3A EP4008357B1 (en) 2010-08-31 2011-08-31 Small liposomes for delivery of immunogen-encoding rna

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HRP20230017T1 true HRP20230017T1 (hr) 2023-02-17

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HRP20230501TT HRP20230501T1 (hr) 2010-08-31 2011-08-31 Mali liposomi za isporuku rna koja kodira imunogen
HRP20230017TT HRP20230017T1 (hr) 2010-08-31 2011-08-31 Mali liposomi za isporuku rna koja kodira imunogen
HRP20230326TT HRP20230326T1 (hr) 2010-08-31 2011-08-31 Mali liposomi za isporuku rna koja kodira imunogen
HRP20221048TT HRP20221048T1 (hr) 2010-08-31 2011-08-31 Mali liposomi za isporuku rna koja kodira imunogen

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HRP20230501TT HRP20230501T1 (hr) 2010-08-31 2011-08-31 Mali liposomi za isporuku rna koja kodira imunogen

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HRP20230326TT HRP20230326T1 (hr) 2010-08-31 2011-08-31 Mali liposomi za isporuku rna koja kodira imunogen
HRP20221048TT HRP20221048T1 (hr) 2010-08-31 2011-08-31 Mali liposomi za isporuku rna koja kodira imunogen

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Country Link
US (1) US9254265B2 (hr)
EP (6) EP4008357B1 (hr)
JP (2) JP2013538569A (hr)
CN (1) CN103179989A (hr)
AU (8) AU2011296062A1 (hr)
BR (1) BR112013004879A2 (hr)
CA (1) CA2809678A1 (hr)
DK (4) DK4008357T3 (hr)
ES (4) ES2923634T3 (hr)
FI (3) FI4008357T3 (hr)
HR (4) HRP20230501T1 (hr)
HU (4) HUE059214T2 (hr)
LT (4) LT4043040T (hr)
MX (1) MX341989B (hr)
PL (4) PL4008357T3 (hr)
PT (4) PT4066819T (hr)
RS (4) RS63404B1 (hr)
RU (1) RU2671482C2 (hr)
SI (4) SI4043040T1 (hr)
WO (1) WO2012030901A1 (hr)

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