HRP20220070T1 - Cjepiva nukleinske kiseline - Google Patents

Cjepiva nukleinske kiseline Download PDF

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Publication number
HRP20220070T1
HRP20220070T1 HRP20220070TT HRP20220070T HRP20220070T1 HR P20220070 T1 HRP20220070 T1 HR P20220070T1 HR P20220070T T HRP20220070T T HR P20220070TT HR P20220070 T HRP20220070 T HR P20220070T HR P20220070 T1 HRP20220070 T1 HR P20220070T1
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Croatia
Prior art keywords
pseudouridine
thio
methyl
vaccine according
uridine
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HRP20220070TT
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English (en)
Inventor
Giuseppe Ciaramella
Axel Bouchon
Eric Yi-Chun Huang
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Modernatx, Inc.
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54333225&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20220070(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Modernatx, Inc. filed Critical Modernatx, Inc.
Publication of HRP20220070T1 publication Critical patent/HRP20220070T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088Compounds having three or more nucleosides or nucleotides
    • A61K31/7105Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/145Orthomyxoviridae, e.g. influenza virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/155Paramyxoviridae, e.g. parainfluenza virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Liposomes
    • A61K9/1271Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/5123Organic compounds, e.g. fats, sugars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/513Organic macromolecular compounds; Dendrimers
    • A61K9/5146Organic macromolecular compounds; Dendrimers obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyamines, polyanhydrides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/16Antivirals for RNA viruses for influenza or rhinoviruses
    • 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
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53DNA (RNA) vaccination
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55555Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/16011Orthomyxoviridae
    • C12N2760/16111Influenzavirus A, i.e. influenza A virus
    • C12N2760/16122New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/16011Orthomyxoviridae
    • C12N2760/16111Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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
    • C12N2760/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011Details
    • C12N2760/16011Orthomyxoviridae
    • C12N2760/16211Influenzavirus B, i.e. influenza B virus
    • C12N2760/16234Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • YGENERAL 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
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Claims (12)

1. Cjepivo nukleinske kiseline, koje sadrži: jedan ili više polinukleotida mRNA s otvorenim okvirom za čitanje koji kodira antigenski polipeptid, naznačeno time što jedan ili više polinukleotida mRNA sadrže najmanje jednu kemijsku modifikaciju i formulirani su u lipidnoj nanočestici s molarnim omjerom od 20-60% kationskog lipida: 5-25 % nekationskog lipida: 25-55% sterola; i 0.5-15% PEG-modificiranog lipida, pri čemu je najmanje jedna kemijska modifikacija odabrana iz skupine koju čine pseudouridin, N1-metilpseudouridin, 2-tiouridin, 4-tiouridin, 5-metilcitozin, 2-tio-1-metil-1-deaza-pseudouridin, 2-tio-1-metil-pseudouridin, 2-tio-5-aza-uridin, 2-tio-dihidropseudouridin, 2-tio-dihidrouridin, 2-tio-pseudouridin, 4-metoksi-2-tio-pseudouridin, 4-metoksi-pseudouridin, 4-tio-1-metil-pseudouridin, 4-tio-pseudouridin, 5-aza-uridin, dihidropseudouridin, 5-metoksiuridin, 2'-O-metil uridin, 1-karboksimetil-pseudouridin, 1-propinil-pseudouridin, 1-taurinometil-pseudouridin, 1-taurinometil-4-tio-pseudouridin, 3-metil-pseudouridin (m3ψ), 1-metil-1-deaza-pseudouridin, 2-metoksiuridin, 2-metoksi-4-tio-uridin, 1-metil-3-(3-amino-3-karboksipropil)pseudouridin (acp3ψ), i 2'-O-metil-pseudouridin (ψm), pri čemu je antigenski polipeptid izveden iz infektivnog agensa, pri čemu je infektivni agens soj gripe A ili gripe B ili njihove kombinacije i pri čemu je antigenski polipeptid protein hemaglutinin ili njegov fragment.
2. Cjepivo prema zahtjevu 1, naznačeno time što je kationski lipid kationski lipid koji se može ionizirati, ne-kationski lipid je neutralni lipid i sterol je kolesterol.
3. Cjepivo prema bilo kojem od zahtjeva 1-2, naznačeno time što je najmanje jedna kemijska modifikacija N1-metil pseudouridin.
4. Cjepivo prema bilo kojem od zahtjeva 1-3, naznačeno time što protein hemaglutinin sadrži a) dio glavne domene (HA1), b) dio citoplazmatske domene, i/ili c) dio transmembranske domene.
5. Cjepivo prema zahtjevu 1, naznačeno time što je infektivni agens virus odabran iz skupine koju čine H1N1, H3N2, H7N9, i H10N8.
6. Cjepivo prema bilo kojem od zahtjeva 1-2, naznačeno time što je kemijska modifikacija odabrana iz skupine koju čine pseudouridin, N1-metilpseudouridin, 2-tiuridin, 4-tiouridin, 5-metilcitozin, 2-tio-1-metil-1-deaza-pseudouridin, 2-tio-1-metil-pseudouridin, 2-tio-5-aza-uridin, 2-tio-dihidropseudouridin, 2-tio-dihidrouridin, 2-tio-pseudouridin, 4-metoksi-2-tio-pseudouridin, 4-metoksi-pseudouridin, 4-tio-1-metil-pseudouridin, 4-tio-pseudouridin, 5-aza-uridin, dihidropseudouridin, 5-metoksiuridin, i 2'-O-metil uridin.
7. Cjepivo prema bilo kojem od zahtjeva 1-6, naznačeno time što lipidna nanočestica ima: a) srednji promjer od 50-200nm, ili b) neto neutralni naboj pri neutralnom pH.
8. Cjepivo prema bilo kojem od zahtjeva 1-7, naznačeno time što polinukleotid mRNA sadrži polinukleotid koji ima najmanje 80% identiteta sekvence sa SEQ ID NOs 2459-2621.
9. Cjepivo prema bilo kojem od zahtjeva 1-7, naznačeno time što polinukleotid mRNA sadrži polinukleotid koji kodira aminokiselinsku sekvencu koja ima najmanje 90% identiteta sekvence sa SEQ ID NO 2254, 2259, ili 2624.
10. Cjepivo prema bilo kojem od zahtjeva 1-7, naznačeno time što polinukleotid mRNA sadrži polinukleotid koji kodira aminokiselinsku sekvencu od SEQ ID NO 2254, 2259, ili 2624.
11. Cjepivo prema bilo kojem od zahtjeva 1-10 za uporabu u postupku induciranja imunosnog odgovora specifičnog za antigen kod subjekta, postupak uključuje davanje cjepiva subjektu u učinkovitoj količini za proizvodnju imunosnog odgovora specifičnog za antigen.
12. Cjepivo prema bilo kojem od zahtjeva 1-10, naznačeno time što se koristi u postupku prevencije ili liječenja virusne infekcije gripe, postupak uključuje davanje cjepiva subjektu.
HRP20220070TT 2014-04-23 2015-04-23 Cjepiva nukleinske kiseline HRP20220070T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201461983250P 2014-04-23 2014-04-23
US201462088994P 2014-12-08 2014-12-08
EP15783606.5A EP3134131B1 (en) 2014-04-23 2015-04-23 Nucleic acid vaccines
PCT/US2015/027400 WO2015164674A1 (en) 2014-04-23 2015-04-23 Nucleic acid vaccines

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HRP20220070T1 true HRP20220070T1 (hr) 2022-04-01

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US (7) US10022435B2 (hr)
EP (3) EP3981437A1 (hr)
JP (2) JP6881813B2 (hr)
CN (1) CN106659803A (hr)
AU (2) AU2015249553B2 (hr)
BR (1) BR112016024644A2 (hr)
CA (2) CA2946751A1 (hr)
DK (1) DK3134131T3 (hr)
ES (1) ES2909180T3 (hr)
HR (1) HRP20220070T1 (hr)
HU (1) HUE057800T2 (hr)
LT (1) LT3134131T (hr)
PL (1) PL3134131T3 (hr)
PT (1) PT3134131T (hr)
RS (1) RS63050B1 (hr)
RU (2) RU2746406C2 (hr)
SG (2) SG10201912038TA (hr)
SI (1) SI3134131T1 (hr)
WO (1) WO2015164674A1 (hr)

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