HRP20210872T1 - Liposomni adjuvantni pripravci - Google Patents

Liposomni adjuvantni pripravci Download PDF

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Publication number
HRP20210872T1
HRP20210872T1 HRP20210872TT HRP20210872T HRP20210872T1 HR P20210872 T1 HRP20210872 T1 HR P20210872T1 HR P20210872T T HRP20210872T T HR P20210872TT HR P20210872 T HRP20210872 T HR P20210872T HR P20210872 T1 HRP20210872 T1 HR P20210872T1
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Croatia
Prior art keywords
vaccine preparation
antigens
vaccine
liposome
alkyl
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HRP20210872TT
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English (en)
Inventor
Paul Joseph Dominowski
Duncan Mwangi
Sharath K. Rai
Dennis L. Foss
Traci K. Godbee
Laurel Mary Sly
Suman MAHAN
Shaunak VORA
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Zoetis Services Llc
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Publication of HRP20210872T1 publication Critical patent/HRP20210872T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • 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
    • A61K9/1272Non-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
    • 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
    • A61K9/1273Polymersomes; Liposomes with polymerisable or polymerised bilayer-forming substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)

Claims (23)

1. Liposom koji uglavnom ne sadrži saponine, naznačen time što sadrži vanjski lipid dvosloj membrana i unutarnji odjeljak, gdje vanjska membrana sadrži: a) kvaternarni amonijev spoj, koji se sastoji od četiti alkilna lanca, od kojih su dva C10-C20 alkili, a preostala dva su C1-C4 alkili; b) sterol kojeg se bira iz skupine koju čine β-sitosterol, stigmasterol, ergosterol, ergokalciferol, te kolesterol; c) fosfolipid; i d) glikolipid formule I: [image] , gdje: R1 je vodik, ili zasićeni alkilni radikal s do 20 atoma ugljika; X je -CH2-, -O- ili -NH-; R2 je vodik, ili zasićeni ili nezasićeni alkilni radikal s do 20 atoma ugljika; R3, R4 i R5 su neovisno vodik, -SO42–, -PO42–, -COC1-10 alkil; R6 je l-alanil, l-α-aminobutil, l-arginil, l-asparginil, l-aspartil, l-cisteinil, l-glutamil, l-glicil, l-histidil, l-hidroksiprolil, l-izoleucil, l-leucil, l-lizil, l-metionil, l-ornitinil, l-fenilalanil, l-prolil, l-seril, l-treonil, l-tirozil, l-triptofanil, te l-valil ili njihovi d-izomeri.
2. Liposom u skladu s patentnim zahtjevom 1, naznačen time što navedeni liposom ne sadrži saponine.
3. Liposom u skladu s patentnim zahtjevom 1 ili 2, naznačen time što je kvaternarni amonijev spoj DDA (dimetildioktadecilamonij), sterol je kolesterol, a glikolipid je N-(2-deoksi-2-l-leucilamino-β-d-glukopiranozil)-N-oktadecildodecanoilamid, ili njegova sol.
4. Liposom u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što dodatno sadrži, u unutarnjem odjeljku, imunostimulacijski oligonukleotid kojeg se bira iz skupine koju čine imunostimulacijski ribonukleotid, oligodeoksiribonukleotid CpG, te njihovu kombinaciju.
5. Liposom u skladu s patentnim zahtjevom 4, naznačen time što navedeni imunostimulacijski oligonukleotid sadrži bilo koji od SEQ ID NO 1-14.
6. Adjuvantna formulacija, naznačena time što sadrži liposom u skladu s bilo kojim od patentnih zahtjeva 1-5.
7. Adjuvant pripravak u skladu s patentnim zahtjevom 6, naznačen time što navedena adjuvantna formulacija uglavnom ne sadrži saponine.
8. Cjepivni pripravak, naznačen time što sadrži djelotvornu količinu antigene komponente i adjuvantne formulacije u skladu s patentnim zahtjevom 6 ili patentnim zahtjevom 7.
9. Cjepivni pripravak u skladu s patentnim zahtjevom 8, naznačen time što navedeni cjepivni pripravak uglavnom ne sadrži saponine.
10. Cjepivni pripravak u skladu s patentnim zahtjevom 8 ili 9, naznačen time što se antigena komponenta nalazi u unutarnjem odjeljku.
11. Cjepivni pripravak u skladu s bilo kojim od patentnih zahtjeva 8-10, naznačen time što antigena komponenta se bira iz skupine koju čine goveđi antigeni, kozji antigeni, svinjski antigeni, antigeni peradi, konjski antigeni, pseći antigeni, konjski antigeni i mačji antigeni.
12. Cjepivni pripravak u skladu s bilo kojim od patentnih zahtjeva 8-11, naznačen time što imunostimulacijski oligonukleotid sadrži oligodeoksiribonukleotid CpG.
13. Cjepivni pripravak u skladu s patentnim zahtjevom 9, naznačen time što antigena komponenta sadrži IBR, BVDV-1, te BVDV-2, te što cjepivni pripravak uglavnom ne sadrži saponine.
14. Cjepivni pripravak namijenjen upotrebi u postupku izazivanja imunosnog odgovora protiv virusa goveđe virusne dijareje (BVDV) kod goveda, naznačen time što se sastoji u primjeni na navedenom govedu cjepivnog pripravka u skladu s patentnim zahtjevom 13.
15. Cjepivni pripravak namijenjen upotrebi in postupak u skladu s patentnim zahtjevom 14, naznačen time što je navedeni imunosni odgovor izazvan bez popratne groznice.
16. Cjepivni pripravak u skladu s patentnim zahtjevom 12, naznačen time što antigen sadrži antigen peradi.
17. Cjepivni pripravak u skladu s patentnim zahtjevom 16, naznačen time što je antigen profilin.
18. Cjepivni pripravak namijenjen upotrebi u postupku sprječavanja rasipanja oocista parazita Eimeria kod životinje tipa peradi zaražene parazitom Eimeria, naznačen time što se sastoji u primjeni na navedenoj životinji cjepivnog pripravka u skladu s patentnim zahtjevom 17 prije navedene zaraze.
19. Cjepivni pripravak u skladu s patentnim zahtjevom 11, naznačen time što antigena komponenta sadrži ssRNA virus, te što cjepivni pripravak uglavnom ne sadrži oligodeoksiribonukleotid CpG.
20. Cjepivo u skladu s patentnim zahtjevom 19, naznačen time što je ssRNA virus virus influence.
21. Cjepivo u skladu s patentnim zahtjevom 20, naznačen time što je virus influence inaktivirani virus svinjske influence (SIV).
22. Postupak priprave liposoma u skladu s patentnim zahtjevom 1, naznačen time što se postupak sastoji u: a) otapanju u organskom otapalu kvaternarnog amonijevog spoja, sterola, fosfolipida, te glikolipida formule I: [image] , gdje: R1 je vodik, ili zasićeni alkilni radikal s do 20 atoma ugljika; X je -CH2-, -O- ili -NH-; R2 je vodik, ili zasićeni ili nezasićeni alkilni radikal s do 20 atoma ugljika; R3, R4 i R5 su neovisno vodik, -SO42–, -PO42–, -COC1-10 alkil; R6 je l-alanil, l-α-aminobutil, l-arginil, l-asparginil, l-aspartil, l-cisteinil, l-glutamil, l-glicil, l-histidil, l-hidroksiprolil, l-izoleucil, l-leucil, l-lizil, l-metionil, l-ornitinil, l-fenilalanil, l-prolil, l-seril, l-treonil, l-tirozil, l-triptofanil, te l-valil ili njihovi d-izomeri; b) uklanjanju organskog otapala i stvaranje filma; c) rehidriranju filma u vodenom otapalu, čime se dobije rehidrirani pripravak; d) mikrofluidiziranju rehidriranog pripravka.
23. Postupak u skladu s patentnim zahtjevom 22, naznačen time što vodeno otapalo sadrži imunostimulacijski oligonukleotid.
HRP20210872TT 2015-07-20 2021-06-01 Liposomni adjuvantni pripravci HRP20210872T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562194355P 2015-07-20 2015-07-20
PCT/US2016/042882 WO2017015252A1 (en) 2015-07-20 2016-07-19 Liposomal adjuvant compositions
EP16745318.2A EP3325015B1 (en) 2015-07-20 2016-07-19 Liposomal adjuvant compositions

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HRP20210872T1 true HRP20210872T1 (hr) 2021-07-09

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EP (1) EP3325015B1 (hr)
JP (1) JP6975132B2 (hr)
KR (1) KR102085968B1 (hr)
CN (1) CN107847603B (hr)
AR (1) AR105393A1 (hr)
AU (1) AU2016297529B2 (hr)
BR (1) BR112018001318B1 (hr)
CA (1) CA2992892C (hr)
CL (1) CL2018000155A1 (hr)
CO (1) CO2018000496A2 (hr)
CY (1) CY1124319T1 (hr)
DK (1) DK3325015T3 (hr)
ES (1) ES2878475T3 (hr)
HK (1) HK1250338A1 (hr)
HR (1) HRP20210872T1 (hr)
HU (1) HUE054422T2 (hr)
LT (1) LT3325015T (hr)
MX (1) MX2018000879A (hr)
PH (1) PH12018500146A1 (hr)
PL (1) PL3325015T3 (hr)
PT (1) PT3325015T (hr)
RS (1) RS62015B1 (hr)
RU (1) RU2736642C2 (hr)
SI (1) SI3325015T1 (hr)
TW (1) TWI655002B (hr)
UA (1) UA125017C2 (hr)
WO (1) WO2017015252A1 (hr)
ZA (1) ZA201800285B (hr)

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TW202206098A (zh) * 2020-08-11 2022-02-16 美商碩騰服務公司 抗冠狀病毒疫苗

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Publication number Publication date
CA2992892A1 (en) 2017-01-26
TW201711675A (zh) 2017-04-01
CO2018000496A2 (es) 2018-04-19
JP2018524388A (ja) 2018-08-30
AR105393A1 (es) 2017-09-27
PH12018500146A1 (en) 2018-07-23
BR112018001318A2 (pt) 2018-09-11
SI3325015T1 (sl) 2021-08-31
RS62015B1 (sr) 2021-07-30
ES2878475T3 (es) 2021-11-18
HUE054422T2 (hu) 2021-09-28
ZA201800285B (en) 2019-07-31
UA125017C2 (uk) 2021-12-29
JP6975132B2 (ja) 2021-12-01
CA2992892C (en) 2019-12-31
WO2017015252A1 (en) 2017-01-26
DK3325015T3 (da) 2021-07-05
AU2016297529A1 (en) 2018-02-01
EP3325015A1 (en) 2018-05-30
PL3325015T3 (pl) 2021-10-25
EP3325015B1 (en) 2021-05-12
CY1124319T1 (el) 2022-07-22
KR102085968B1 (ko) 2020-03-06
CN107847603A (zh) 2018-03-27
LT3325015T (lt) 2021-08-10
RU2018102114A3 (hr) 2019-12-23
RU2736642C2 (ru) 2020-11-19
NZ739040A (en) 2021-06-25
PT3325015T (pt) 2021-07-08
KR20180025977A (ko) 2018-03-09
BR112018001318B1 (pt) 2023-11-14
TWI655002B (zh) 2019-04-01
AU2016297529B2 (en) 2021-09-09
MX2018000879A (es) 2018-05-15
CN107847603B (zh) 2021-05-11
HK1250338A1 (zh) 2018-12-14
RU2018102114A (ru) 2019-08-20
CL2018000155A1 (es) 2018-06-08

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