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HRP20190960T1 - Poboljšane adjuvantne formulacije koje sadrže agoniste tlr4 i postupci njihove upotrebe - Google Patents

Poboljšane adjuvantne formulacije koje sadrže agoniste tlr4 i postupci njihove upotrebe Download PDF

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Publication number
HRP20190960T1
HRP20190960T1 HRP20190960TT HRP20190960T HRP20190960T1 HR P20190960 T1 HRP20190960 T1 HR P20190960T1 HR P20190960T T HRP20190960T T HR P20190960TT HR P20190960 T HRP20190960 T HR P20190960T HR P20190960 T1 HRP20190960 T1 HR P20190960T1
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Croatia
Prior art keywords
oil
alkyl
water emulsion
following structure
pharmaceutically acceptable
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HRP20190960TT
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English (en)
Inventor
Christopher Fox
Steven G. Reed
Susan Baldwin
Thomas Vedvick
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Infectious Disease Research Institute
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Publication of HRP20190960T1 publication Critical patent/HRP20190960T1/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
    • A61K39/002—Protozoa antigens
    • A61K39/015—Hemosporidia antigens, e.g. Plasmodium antigens
    • 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
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/113—Multiple emulsions, e.g. oil-in-water-in-oil
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/12—Viral antigens
    • 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
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • 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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
    • C12N2760/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • 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
    • C12N2760/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses negative-sense
    • C12N2760/00011—Details
    • C12N2760/16011—Orthomyxoviridae
    • C12N2760/16211—Influenzavirus B, i.e. influenza B virus
    • C12N2760/16234—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Virology (AREA)
  • Biochemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Claims (15)

1. Emulzija ulja u vodi koja sadrži agonist TLR4 i metabolizirajuće ulje, naznačena time što je metabolizirajuće ulje prisutno u emulziji ulja u vodi u koncentraciji od 0,01%-1% vol./vol., te što je ravnoteža hidrofobno:lipofilno (HLB) emulzije ulja u vodi veća od 9, ili veća od 10, ili između 9 i 12, gdje se agonist TLR4 bira iz skupine koju čine monofosforilirani lipid A (MPL), 3-O-deacilirani monofosforilirani lipid A i sintetski glukopiranozilirani lipidni adjuvans (GLA).
2. Emulzija ulja u vodi u skladu s patentnim zahtjevom, naznačena time što je metabolizirajuće ulje prisutno u emulziji ulja u vodi u koncentraciji od 0,01 %-0.5% vol./vol.
3. Emulzija ulja u vodi u skladu s patentnim zahtjevom 1, naznačena time što emulzija dodatno sadrži 1,2-dimiristoil-sn-glycero-3-fosfocholine (DMPC), izborno gdje emulzija ne sadrži antioksidans.
4. Emulzija ulja u vodi u skladu s patentnim zahtjevom 1, naznačena time što agonist TLR4 sadrži sintetski GLA.
5. Emulzija ulja u vodi u skladu s patentnim zahtjevom 4, naznačena time što sintetski GLA ima sljedeću strukturu: (i) , gdje: R1, R3, R5 i R6 su C11-C20 alkil; i R2 i R4 su C12-C20 alkil; ili, gdje sintetski GLA ima sljedeću strukturu: (ii) , ili njegova farmaceutski prihvatljiva sol, gdje: R1, R3, R5 i R6 su C11-20 alkil; i R2 i R4 su C9-20 alkil; ili, gdje sintetski GLA ima sljedeću strukturu: (iii) , ili njegova farmaceutski prihvatljiva sol, gdje: R1, R3, R5 i R6 su C11-C20 alkil; i R2 i R4 su C9-C20 alkil; ili gdje sintetski GLA ima sljedeću strukturu: (iv) , ili njegova farmaceutski prihvatljiva sol.
6. Emulzija ulja u vodi u skladu s patentnim zahtjevom 5(i), naznačena time što R1, R3, R5 i R6 su C11 alkil; i R2 i R4 su C13 alkil.
7. Emulzija ulja u vodi u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačena time što emulzija dodatno sadrži surfaktant, izborno gdje je surfaktant Pluronic F68.
8. Emulzija ulja u vodi u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time što je metabolizirajuće ulje skvalen.
9. Emulzija ulja u vodi u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačena time što emulzija dodatno sadrži antioksidans, izborno gdje je antioksidans vitamin E.
10. Emulzija ulja u vodi u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačena time što emulzija dodatno sadrži najmanje jedan antigen.
11. Emulzija ulja u vodi u skladu s patentnim zahtjevom 1, naznačena time što je agonist TLR4 sintetski GLA, gdje je HLB emulzije veći od otprilike 10 i gdje emulzija dodatno sadrži DMPC u koncentraciji od otprilike 0,002%-2%.
12. Emulzija ulja u vodi u skladu s patentnim zahtjevom 11, naznačena time što sintetski GLA ima sljedeću strukturu: , gdje: R1, R3, R5 i R6 su C11-C20 alkil; i R2 i R4 su C12-C20 alkil, izborno, gdje su R1, R3, R5 i R6 C11 alkil; i R2 i R4 su C13 alkil; ili, gdje sintetski GLA ima sljedeću strukturu: , ili njegova farmaceutski prihvatljiva sol, gdje: L1, L2, L3, L4, L5 i L6 su isti ili različiti i neovisno -O-, -NH-ili -(CH2)-; L7, L8, L9 i L10 su isti ili različiti i neovisno odsutni ili -C(=O)-; Y1 je kiselinska funkcionalna skupina; Y2 i Y3 su isti ili različiti i neovisno -OH, -SH, ili kiselinska funkcionalna skupina; Y4 je -OH ili -SH; R1, R3, R5 i R6 su isti ili različiti i neovisno C8-13 alkil; i R2 i R4 su isti ili različiti i neovisno C6-11 alkil, izborno gdje su R1, R3, R5 i R6 C10 alkil; i R2 i R4 su C8 alkil; ili gdje sintetski GLA ima sljedeću strukturu: , ili njegova farmaceutski prihvatljiva sol, gdje: R1, R3, R5 i R6 su C11-20 alkil; i R2 i R4 su C9-20 alkil; ili, gdje sintetski GLA ima sljedeću strukturu: , ili njegova farmaceutski prihvatljiva sol, gdje: R1, R3, R5 i R6 su C11-C20 alkil; i R2 i R4 su C9-C20 alkil; ili, gdje sintetski GLA ima sljedeću strukturu: , ili njegova farmaceutski prihvatljiva sol.
13. Emulzija ulja u vodi u skladu s bilo kojim od patentnih zahtjeva 1-12, naznačena time što je namijenjena upotrebi u terapijskom postupku stimuliranja imunosnog odgovora kod subjekta.
14. Emulzija ulja u vodi namijenjena upotrebi u skladu s patentnim zahtjevom 13, naznačena time što je imunosni odgovor nespecifični imunosni odgovor ili imunosni odgovor specifičan za antigen.
15. Emulzija ulja u vodi namijenjena upotrebi u skladu s patentnim zahtjevom 13 ili patentnim zahtjevom 14, naznačena time što se emulziju ulja u vodi primjenjuje intradermalno.
HRP20190960TT 2012-02-07 2013-02-07 Poboljšane adjuvantne formulacije koje sadrže agoniste tlr4 i postupci njihove upotrebe HRP20190960T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261596066P 2012-02-07 2012-02-07
PCT/US2013/025204 WO2013119856A1 (en) 2012-02-07 2013-02-07 Improved adjuvant formulations comprising tlr4 agonists and methods of using the same
EP13746983.9A EP2811981B1 (en) 2012-02-07 2013-02-07 Improved adjuvant formulations comprising tlr4 agonists and methods of using the same

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HRP20190960T1 true HRP20190960T1 (hr) 2019-07-26

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US (2) US11510875B2 (hr)
EP (2) EP3563834A1 (hr)
CN (2) CN104363892A (hr)
CY (1) CY1121666T1 (hr)
DK (1) DK2811981T3 (hr)
ES (1) ES2729967T3 (hr)
HR (1) HRP20190960T1 (hr)
HU (1) HUE044841T2 (hr)
LT (1) LT2811981T (hr)
PL (1) PL2811981T3 (hr)
PT (1) PT2811981T (hr)
RS (1) RS58868B1 (hr)
SI (1) SI2811981T1 (hr)
SM (1) SMT201900324T1 (hr)
TR (1) TR201908003T4 (hr)
WO (1) WO2013119856A1 (hr)
ZA (2) ZA201405890B (hr)

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