HRP20230177T1 - Antigeni citomegalovirusa i njihove uporabe - Google Patents

Antigeni citomegalovirusa i njihove uporabe Download PDF

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Publication number
HRP20230177T1
HRP20230177T1 HRP20230177TT HRP20230177T HRP20230177T1 HR P20230177 T1 HRP20230177 T1 HR P20230177T1 HR P20230177T T HRP20230177T T HR P20230177TT HR P20230177 T HRP20230177 T HR P20230177T HR P20230177 T1 HRP20230177 T1 HR P20230177T1
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Croatia
Prior art keywords
fragment
protein
pentamer
complex
mutation
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HRP20230177TT
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English (en)
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Andrea Carfi
Claudio CIFERRI
Yi Xing
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Glaxosmithkline Biologicals S.A.
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Publication of HRP20230177T1 publication Critical patent/HRP20230177T1/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
    • A61K39/12Viral antigens
    • A61K39/245Herpetoviridae, e.g. herpes simplex virus
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/20Antivirals for DNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/081Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from DNA viruses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/081Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from DNA viruses
    • C07K16/082Hepadnaviridae, e.g. hepatitis B virus
    • 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
    • A61K2039/525Virus
    • 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
    • A61K2039/55566Emulsions, e.g. Freund's adjuvant, MF59
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/245Herpetoviridae, e.g. herpes simplex virus
    • A61K39/25Varicella-zoster virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/42Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • 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
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/16011Herpesviridae
    • C12N2710/16111Cytomegalovirus, e.g. human herpesvirus 5
    • C12N2710/16122New 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
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/16011Herpesviridae
    • C12N2710/16111Cytomegalovirus, e.g. human herpesvirus 5
    • C12N2710/16134Use 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
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/16011Herpesviridae
    • C12N2710/16111Cytomegalovirus, e.g. human herpesvirus 5
    • C12N2710/16151Methods of production or purification of viral material
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (14)

1. Rekombinantni gL protein citomegalovirusa ili (i) njegov gH/gL dimerni fragment koji stvara kompleks, (ii) njegov gH/gL/gO trimerni fragment koji stvara kompleks ili (iii) njegov gH/gL/pUL128/pUL130/pUL131 pentamerni fragment koji stvara kompleks, naznačen time što navedeni gL protein ili fragment sadrži mutaciju na ostacima mjesta prepoznavanja proteaze 91-102 numeriranih prema SEQ ID NO: 1, pri čemu navedena mutacija smanjuje cijepanje proteaze na navedenom mjestu prepoznavanja, u usporedbi s kontrolom, gdje je navedena mutacija odabrana između: a) dodavanja F, Q, FQ ili QF između ostataka N97 i S98; b) brisanja ostatka odabranog iz skupine koju čine: A95, A96, N97, i njihova kombinacija; c) supstitucije A96 s ne-polarnim ostatkom ili s ostatkom koji sadrži veliki bočni lanac; d) supstitucije A95 s R, L, E ili N; e) supstitucije N97 s polarnim ostatkom ili ne-polarnim ostatkom; f) supstitucije S98 s aminokiselinskim ostatkom s malim bočnim lancem; g) zamjene V99 s I; h) zamjene L100 s F ili V; i) zamjene L101 s V ili I; ili njihovu kombinaciju.
2. gL protein, ili fragment, prema zahtjevu 1, naznačen time što je supstitucija A96 u c) s I, L, V ili S.
3. gL protein, ili fragment, prema bilo kojem od zahtjeva 1-2, naznačen time što je supstitucija N97 u e) s polarnim ostatkom koji sadrži mali bočni lanac.
4. gL protein, ili fragment, prema bilo kojem od zahtjeva 1-2, naznačen time što je supstitucija N97 u e) s polarnim ostatkom koji sadrži veliki bočni lanac.
5. gL protein, ili fragment, prema bilo kojem od zahtjeva 1-4, naznačen time što je supstitucija S98 u f) s G, T, V, ili I.
6. gL protein, ili fragment, prema zahtjevu 1, naznačen time što je navedena mutacija trostruka mutacija A96L/N97S/S98G.
7. gL protein, ili fragment, prema zahtjevu 1, naznačen time što je navedena mutacija trostruka mutacija A96I/N97D/S98G.
8. Proteinski kompleks citomegalovirusa sadrži rekombinantni gL protein, ili fragment, prema bilo kojem od zahtjeva 1-7.
9. Kompleks prema patentnom zahtjevu 8, naznačen time što navedeni kompleks je pentamerni kompleks koji nadalje sadrži: gH ili njegov fragment koji stvara pentamer, pUL128 ili njegov fragment koji stvara pentamer, pUL130 ili njegov fragment koji stvara pentamer, i pUL131 ili njegov fragment koji stvara pentamer.
10. Izolirana nukleinska kiselina koja sadrži polinukleotidnu sekvencu koja kodira rekombinantni gL protein citomegalovirusa, ili fragment, prema bilo kojem od zahtjeva 1-7.
11. Stanica domaćina, poželjno stanica domaćina sisavca, koja sadrži nukleinsku kiselinu prema zahtjevu 10.
12. Stanica domaćina prema zahtjevu 11, naznačena time što navedena stanica domaćin nadalje sadrži jednu ili više polinukleotidnih sekvenci koje kodiraju gH ili njegov fragment koji stvara pentamer, pUL128 ili njegov fragment koji stvara pentamer, pUL130 ili njegov fragment koji stvara pentamer, i pUL131 ili njegov fragment koji stvara pentamer.
13. Imunogeni pripravak koji sadrži rekombinantni gL protein citomegalovirusa, ili fragment, prema bilo kojem od zahtjeva 1-7, ili kompleks prema bilo kojem od zahtjeva 8-9, i izborno sadrži pomoćno sredstvo.
14. Imunogeni pripravak prema zahtjevu 13 za uporabu u induciranju imunološkog odgovora protiv citomegalovirusa.
HRP20230177TT 2015-01-22 2016-01-22 Antigeni citomegalovirusa i njihove uporabe HRP20230177T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15152221.6A EP3048114A1 (en) 2015-01-22 2015-01-22 Cytomegalovirus antigens and uses thereof
PCT/IB2016/050335 WO2016116904A1 (en) 2015-01-22 2016-01-22 Cytomegalovirus antigens and uses thereof
EP16702210.2A EP3247722B1 (en) 2015-01-22 2016-01-22 Cytomegalovirus antigens and uses thereof

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HRP20230177T1 true HRP20230177T1 (hr) 2023-04-14

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US (2) US10167321B2 (hr)
EP (3) EP3048114A1 (hr)
JP (1) JP6717836B2 (hr)
KR (1) KR20170100039A (hr)
CN (1) CN107531761B (hr)
AU (2) AU2016210548B2 (hr)
BE (1) BE1023087B1 (hr)
BR (1) BR112017015567A2 (hr)
CA (1) CA2974041C (hr)
DK (1) DK3247722T3 (hr)
EA (1) EA038250B1 (hr)
ES (1) ES2937959T3 (hr)
FI (1) FI3247722T3 (hr)
HR (1) HRP20230177T1 (hr)
HU (1) HUE061175T2 (hr)
IL (1) IL253366B (hr)
LT (1) LT3247722T (hr)
MX (1) MX2017009538A (hr)
PL (1) PL3247722T3 (hr)
PT (1) PT3247722T (hr)
SG (1) SG11201705740UA (hr)
SI (1) SI3247722T1 (hr)
WO (1) WO2016116904A1 (hr)
ZA (1) ZA201704912B (hr)

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EP3247722B1 (en) 2022-11-30
EP3048114A1 (en) 2016-07-27
CA2974041C (en) 2023-04-04
BR112017015567A2 (pt) 2018-03-13
FI3247722T3 (fi) 2023-03-17
EA201791562A1 (ru) 2018-04-30
BE1023087B1 (fr) 2016-11-18
EP3247722A1 (en) 2017-11-29
US20170369532A1 (en) 2017-12-28
HUE061175T2 (hu) 2023-05-28
SG11201705740UA (en) 2017-08-30
DK3247722T3 (da) 2023-01-30
JP2018504117A (ja) 2018-02-15
KR20170100039A (ko) 2017-09-01
US10167321B2 (en) 2019-01-01
AU2018226521A1 (en) 2018-09-27
BE1023087A1 (fr) 2016-11-18
AU2016210548B2 (en) 2018-11-08
EP4180056A1 (en) 2023-05-17
AU2016210548A1 (en) 2017-08-10
AU2018226521B2 (en) 2019-10-31
CA2974041A1 (en) 2016-07-28
CN107531761B (zh) 2022-01-14
PL3247722T3 (pl) 2023-03-20
EA038250B1 (ru) 2021-07-29
PT3247722T (pt) 2023-01-31
ES2937959T3 (es) 2023-04-03
WO2016116904A1 (en) 2016-07-28
MX2017009538A (es) 2017-11-02
SI3247722T1 (sl) 2023-04-28
IL253366A0 (en) 2017-09-28
JP6717836B2 (ja) 2020-07-08
LT3247722T (lt) 2023-02-10
ZA201704912B (en) 2018-12-19
US20190276498A1 (en) 2019-09-12
IL253366B (en) 2022-03-01
CN107531761A (zh) 2018-01-02

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