WO2008109686A3 - Non- infectious recombinant virus-like particles and their pharmaceutical applications - Google Patents

Non- infectious recombinant virus-like particles and their pharmaceutical applications Download PDF

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Publication number
WO2008109686A3
WO2008109686A3 PCT/US2008/055936 US2008055936W WO2008109686A3 WO 2008109686 A3 WO2008109686 A3 WO 2008109686A3 US 2008055936 W US2008055936 W US 2008055936W WO 2008109686 A3 WO2008109686 A3 WO 2008109686A3
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WO
WIPO (PCT)
Prior art keywords
hepatitis
virus
vlps
interferons
vlp
Prior art date
Application number
PCT/US2008/055936
Other languages
French (fr)
Other versions
WO2008109686A2 (en
WO2008109686A8 (en
Inventor
Igor Sivov
Dmitry Kulish
Original Assignee
Neurok Pharma Llc
Igor Sivov
Dmitry Kulish
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from RU2007138092/13A external-priority patent/RU2007138092A/en
Application filed by Neurok Pharma Llc, Igor Sivov, Dmitry Kulish filed Critical Neurok Pharma Llc
Publication of WO2008109686A2 publication Critical patent/WO2008109686A2/en
Publication of WO2008109686A3 publication Critical patent/WO2008109686A3/en
Publication of WO2008109686A8 publication Critical patent/WO2008109686A8/en

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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
    • A61K39/29Hepatitis 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
    • 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
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86Viral vectors
    • 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
    • A61K2039/525Virus
    • A61K2039/5256Virus expressing foreign proteins
    • 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
    • A61K2039/5258Virus-like particles
    • 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
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/24011Flaviviridae
    • C12N2770/24211Hepacivirus, e.g. hepatitis C virus, hepatitis G virus
    • C12N2770/24223Virus like particles [VLP]
    • 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
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/24011Flaviviridae
    • C12N2770/24211Hepacivirus, e.g. hepatitis C virus, hepatitis G virus
    • C12N2770/24234Use 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
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/24011Flaviviridae
    • C12N2770/24211Hepacivirus, e.g. hepatitis C virus, hepatitis G virus
    • C12N2770/24241Use of virus, viral particle or viral elements as a vector
    • C12N2770/24243Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • 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
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/32011Picornaviridae
    • C12N2770/32111Aphthovirus, e.g. footandmouth disease virus
    • C12N2770/32122New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Virology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Biophysics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The invention relates to novel virus-like particles (VLPs), including those based on Hepatitis C virus (HCV), as well as methods for their recombinant production and their use for stimulation of immunity and treatment of human and animal diseases. More specifically, the invention relates to novel synthetic constructs allowing the production of the novel recombinant non-infectious VLP ISVAC built of structural proteins of Hepatitis C virus (HCV), which VLP is efficiently produced in cultured BHK21 cells using the replication machinery of foot-and-mouth disease virus (FMDV). The pharmaceutical VLP preparations of the invention are highly efficient inducers of (i) endogenous Type I interferons (TYPE-I-IFN) such as interferon-q together with the general pool of interferons and (ii) general humoral immune response through stimulation of B cells (B-lymphocytes). VLPs of the invention are useful in treatment of human and animal diseases that can be treated by induction of interferons and/or B cell stimulation, including, e.g., hepatitis C, hepatitis B, FMD and certain malignancies, as well as asthmatic disorders, and allergies. VLPs of the invention are also useful as adjuvants that stimulate patient immune response to antigens and as viral diagnostic tools.
PCT/US2008/055936 2007-03-05 2008-03-05 Non- infectious recombinant virus-like particles and their pharmaceutical applications WO2008109686A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
RU2007108037 2007-03-05
RU2007108037 2007-03-05
RU2007138092/13A RU2007138092A (en) 2007-10-16 2007-10-16 NON-INFECTIOUS RECOMBINANT PSEUDOVIRIONES OF THE HEPATITIS VIRUS C "ISVAK" TM, THEIR APPLICATION AS A MEANS FOR TREATMENT AND PREVENTION OF DISEASES, SYSTEMS OF DELIVERY OF BIOLOGICALLY INACTIVE ANTIVASIS
RU2007138092 2007-10-16

Publications (3)

Publication Number Publication Date
WO2008109686A2 WO2008109686A2 (en) 2008-09-12
WO2008109686A3 true WO2008109686A3 (en) 2009-03-12
WO2008109686A8 WO2008109686A8 (en) 2009-07-30

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/055936 WO2008109686A2 (en) 2007-03-05 2008-03-05 Non- infectious recombinant virus-like particles and their pharmaceutical applications

Country Status (1)

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WO (1) WO2008109686A2 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120164710A1 (en) * 2009-07-03 2012-06-28 Yuan Yuan Fan Method of preparation of a biological particulate structure
CN104995299B (en) * 2012-12-11 2020-02-28 宝生物工程株式会社 Expression cassette
JP6521965B2 (en) 2014-07-10 2019-05-29 タカラバイオ株式会社 Method for producing non-enveloped virus particle
CN108367066B (en) * 2015-09-10 2023-08-11 台湾地区“中央研究院” Avian influenza vaccine compositions comprising viroids and novel adjuvants
CN111303251B (en) * 2020-02-25 2021-07-30 中国农业科学院兰州兽医研究所 Method for in-vitro assembly of foot-and-mouth disease virus-like particles and application thereof
CN117050158B (en) * 2023-10-10 2023-12-29 云南农业大学 Application of red mouth gull IFN-gamma gene and recombinant protein encoded by same

Citations (6)

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WO1998050071A1 (en) * 1997-05-01 1998-11-12 Chiron Corporation Use of virus-like particles as adjuvants
US5846795A (en) * 1985-03-07 1998-12-08 Mycogen Plant Science, Inc. RNA transformation vector
WO2004061110A1 (en) * 2003-01-05 2004-07-22 Obschestvo S Ogranichennoi Otvetstvennostiju 'genno-Inzhenernye Tekhnologii 2000' Complementation method for producing rna-containing virus-like particles of hepatotropic viruses
WO2005005614A2 (en) * 2003-07-03 2005-01-20 Pecos Labs, Inc. Combined b-cell and t-cell epitopes on vlp for improved vaccines
WO2005014110A1 (en) * 2003-07-22 2005-02-17 Cytos Biotechnology Ag Cpg-packaged liposomes
US7049428B1 (en) * 1998-03-04 2006-05-23 Washington University HCV variants

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5846795A (en) * 1985-03-07 1998-12-08 Mycogen Plant Science, Inc. RNA transformation vector
WO1998050071A1 (en) * 1997-05-01 1998-11-12 Chiron Corporation Use of virus-like particles as adjuvants
US7049428B1 (en) * 1998-03-04 2006-05-23 Washington University HCV variants
WO2004061110A1 (en) * 2003-01-05 2004-07-22 Obschestvo S Ogranichennoi Otvetstvennostiju 'genno-Inzhenernye Tekhnologii 2000' Complementation method for producing rna-containing virus-like particles of hepatotropic viruses
WO2005005614A2 (en) * 2003-07-03 2005-01-20 Pecos Labs, Inc. Combined b-cell and t-cell epitopes on vlp for improved vaccines
WO2005014110A1 (en) * 2003-07-22 2005-02-17 Cytos Biotechnology Ag Cpg-packaged liposomes

Non-Patent Citations (10)

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Title
GRGACIC ET AL: "Virus-like particles: Passport to immune recognition", METHODS : A COMPANION TO METHODS IN ENZYMOLOGY, ACADEMIC PRESS INC., NEW YORK, NY, US, vol. 40, no. 1, 1 September 2006 (2006-09-01), pages 60 - 65, XP005660384, ISSN: 1046-2023 *
GRUBMAN M J ET AL: "Foot-and-mouth disease", CLINICAL MICROBIOLOGY REVIEWS, WASHINGTON, DC, US, vol. 17, no. 2, 1 April 2004 (2004-04-01), pages 465 - 493, XP002996189, ISSN: 0893-8512 *
JEONG SOOK-HYANG ET AL: "Immunization with hepatitis C virus-like particles induces humoral and cellular immune responses in nonhuman primates", JOURNAL OF VIROLOGY, vol. 78, no. 13, July 2004 (2004-07-01), pages 6995 - 7003, XP002502301, ISSN: 0022-538X *
KUNDIG ET AL: "Der p 1 peptide on virus-like particles is safe and highly immunogenic in healthy adults", JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, MOSBY - YEARLY BOOK, INC, US, vol. 117, no. 6, 1 June 2006 (2006-06-01), pages 1470 - 1476, XP005470419, ISSN: 0091-6749 *
NDJOMOU ET AL: "Development and characterization of a recombinant cDNA-based hepatitis C virus system", BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, ACADEMIC PRESS INC. ORLANDO, FL, US, vol. 359, no. 1, 2 June 2007 (2007-06-02), pages 57 - 62, XP022103142, ISSN: 0006-291X *
PINTO LIGIA A ET AL: "CELLULAR IMMUNE RESPONSES TO HUMAN PAPILLOMAVIRUS (HPV)-16 L1 IN HEALTHY VOLUNTEERS IMMUNIZED WITH RECOMBINANT HPV-16 L1 VIRUS-LIKE PARTICLES", JOURNAL OF INFECTIOUS DISEASES, CHICAGO, IL, vol. 188, no. 2, 15 July 2003 (2003-07-15), pages 327 - 338, XP008069504, ISSN: 0022-1899 *
QIAO M ET AL: "HEPATITIS C VIRUS-LIKE PARTICLES COMBINED WITH NOVEL ADJUVANT SYSTEMS ENHANCE VIRUS-SPECIFIC IMMUNE RESPONSES", HEPATOLOGY, WILLIAMS AND WILKINS, BALTIMORE, MD, US, vol. 37, no. 1, 1 January 2003 (2003-01-01), pages 52 - 59, XP009020356, ISSN: 0270-9139 *
SAILAJA ET AL: "Human immunodeficiency virus-like particles activate multiple types of immune cells", VIROLOGY, ACADEMIC PRESS,ORLANDO, US, vol. 362, no. 2, 5 May 2007 (2007-05-05), pages 331 - 341, XP022065065, ISSN: 0042-6822 *
SANTI ET AL: "Virus-like particles production in green plants", METHODS : A COMPANION TO METHODS IN ENZYMOLOGY, ACADEMIC PRESS INC., NEW YORK, NY, US, vol. 40, no. 1, 1 September 2006 (2006-09-01), pages 66 - 76, XP005660385, ISSN: 1046-2023 *
YANG RONGEUN ET AL: "B lymphocyte activation by human papillomavirus-like particles directly induces Ig class switch recombination via TLR4-MyD88", JOURNAL OF IMMUNOLOGY, vol. 174, no. 12, June 2005 (2005-06-01), pages 7912 - 7919,7904, XP002502300, ISSN: 0022-1767 *

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WO2008109686A2 (en) 2008-09-12
WO2008109686A8 (en) 2009-07-30

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