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NZ781654B2 - Vaccines against hepatitis b virus - Google Patents
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NZ781654B2 - Vaccines against hepatitis b virus - Google Patents

Vaccines against hepatitis b virus

Info

Publication number
NZ781654B2
NZ781654B2 NZ781654A NZ78165416A NZ781654B2 NZ 781654 B2 NZ781654 B2 NZ 781654B2 NZ 781654 A NZ781654 A NZ 781654A NZ 78165416 A NZ78165416 A NZ 78165416A NZ 781654 B2 NZ781654 B2 NZ 781654B2
Authority
NZ
New Zealand
Prior art keywords
arenavirus
hbv
viral vector
segment
protein
Prior art date
Application number
NZ781654A
Other versions
NZ781654A (en
Inventor
Strasser Vera Baumgartl
Katherine Cohen
Thomas Monath
Original Assignee
Hookipa Biotech Gmbh
Filing date
Publication date
Application filed by Hookipa Biotech Gmbh filed Critical Hookipa Biotech Gmbh
Publication of NZ781654A publication Critical patent/NZ781654A/en
Publication of NZ781654B2 publication Critical patent/NZ781654B2/en

Links

Classifications

    • 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
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/525—Virus
    • A61K2039/5256—Virus expressing foreign proteins
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • 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
    • A61K2039/70—Multivalent vaccine
    • 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
    • A61K39/12—Viral antigens
    • A61K39/29—Hepatitis virus
    • A61K39/292—Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86—Viral vectors
    • 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
    • C12N2730/00—Reverse transcribing DNA viruses
    • C12N2730/00011—Details
    • C12N2730/10011—Hepadnaviridae
    • C12N2730/10111—Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10134—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
    • C12N2760/10011—Arenaviridae
    • C12N2760/10022—New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
    • 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
    • C12N2760/10011—Arenaviridae
    • C12N2760/10034—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
    • C12N2760/10011—Arenaviridae
    • C12N2760/10041—Use of virus, viral particle or viral elements as a vector
    • C12N2760/10043—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector

Abstract

The present application provides immunotherapies for Hepatitis B virus infections. Provided herein are genetically modified arenaviral vectors suitable as vaccines for prevention and treatment of Hepatitis B virus infections. Also provided herein are pharmaceutical compositions and methods for the treatment of Hepatitis B virus infections. Specifically, provided herein are pharmaceutical compositions, vaccines, and methods of treating Hepatitis B virus infection.

Claims (22)

WHAT WE CLAIM IS:
1. An infectious replication-competent tri-segmented arenavirus viral vector comprising one L segment and two S segments, wherein the two S segments are a first S segment and a second S segment, wherein: a. the first S segment is an S segment wherein an open reading frame (ORF) encoding a first HBV antigen or an antigenic fragment thereof is under the control of an arenavirus 5’ UTR and an ORF encoding the arenaviral glycoprotein (GP) is under the l of an arenavirus 3’ UTR; b. the second S segment is an S segment wherein an ORF encoding a second HBV antigen or an antigenic fragment thereof is under the control of an irus 5’ UTR and an ORF encoding the arenaviral nucleoprotein (NP) is under the control of an arenavirus 3’ UTR; and c. the L segment is an L segment wherein an ORF encoding the arenaviral matrix protein Z (Z protein) is under the control of an arenavirus 5’ UTR and an ORF encoding the arenaviral RNA-dependent RNA polymerase L (L protein) is under the control of an arenavirus 3’ UTR; and wherein: a. the first HBV antigen is a HBV pre-S2/S protein or an antigenic fragment thereof, a HBV HBc protein or an antigenic fragment f, or a fusion protein of the HBV HBs and HBc proteins ; and / or b. the second HBV antigen is a HBV pre-S2/S protein or an antigenic nt f, a HBV HBc protein or an antigenic fragment thereof, or a fusion protein of the HBV HBs and HBc proteins.
2. The irus viral vector of claim 1, n the first HBV antigen is different from the second HBV n.
3. The arenavirus viral vector of claim 1 , wherein the first HBV antigen and the second HBV antigen are the same HBV antigen.
4. The arenavirus viral vector of claim 1, wherein the pre-S2/S n or the nic fragment thereof comprises an amino acid sequence that is 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identical to the amino acid sequence encoded by the nucleotide sequence of SEQ ID NO: 1.
5. The arenavirus viral vector of claim 1, wherein the HBc protein or the nic fragment thereof comprises an amino acid sequence that is 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% cal to the amino acid sequence encoded by the nucleotide sequence of SEQ ID NO: 2.
6. The arenavirus viral vector of claim 1, wherein fusion of HBV HBs and HBc ns or antigenic nts thereof comprise an amino acid sequence that is 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% identical to the amino acid sequence encoded by the nucleotide sequence of SEQ ID NO: 3.
7. The arenavirus viral vector of claim 1 or 2, wherein expression of the first and second HBV antigens or nts thereof produces an antigenic protein complex that elicits higher titers of neutralizing antibodies than expression of the protein complex components individually.
8. The arenavirus viral vector of any one of claims 1 to 7, wherein the arenavirus is lymphocytic choriomeningitis virus, wherein optionally the lymphocytic choriomeningitis virus is the lymphocytic choriomeningitis virus Clone 13 strain or the lymphocytic choriomeningitis virus MP strain.
9. The arenavirus viral vector of any one of claims 1 to 7, wherein the arenavirus is Junin virus or Pichinde virus.
10. The arenavirus viral vector of claim 1 to 8, wherein the viral vector comprises a genomic segment, n the genomic segment comprises a nucleotide sequence that a. is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, at least 99%, or 100% identical to the sequence of nucleotide 1639 to 3315 of SEQ ID NO: 11 or 1640 to 3316 of SEQ ID NO: 12; or b. encodes an expression product whose amino acid sequence is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, at least 99%, or 100% identical to the amino acid sequence encoded by nucleotide 1639 to 3315 of SEQ ID NO: 11 or 1640 to 3316 of SEQ ID NO: 12.
11. The arenavirus viral vector of any one of claims 1 to 10, wherein administration of the arenavirus viral vector to a t induces a long-lasting immune response for a m of at least 4 weeks against the first and/or second HBV antigen or an nic nt thereof.
12. A pharmaceutical composition, immunogenic ition, or vaccine comprising the arenavirus viral vector of any one of claims 1 to 11 and a pharmaceutically acceptable carrier.
13. Use of the arenavirus viral vector of any one of claims 1 to 11 or the pharmaceutical composition, immunogenic ition, or vaccine of claim 12 in the manufacture of a medicament for treating or preventing HBV infection, manifestations of HBV such as acute hepatitis B, chronic HBV infection, cirrhosis and hepatocellular carcinoma (HCC) or symptoms of HBV infection in a t.
14. Use of the arenavirus viral vector of any one of claims 1 to 11 or a pharmaceutical composition, immunogenic composition, or e of claim 12 in the manufacture of a medicament for treating or preventing liver cancer caused by an HBV infection in a patient.
15. A method for ting an infectious, replication-competent arenavirus viral vector comprising: a. transfecting into a host cell the cDNAs of: i. a first S segment, wherein an ORF encoding a first HBV antigen or an antigenic fragment thereof is under the control of an arenavirus 5’ UTR and an ORF encoding GP is under the control of an arenavirus 3’ UTR; ii. a second S segment, wherein an ORF ng a second HBV antigen or antigenic fragment thereof is under the control of an arenavirus 5’ UTR and an ORF encoding NP is under the control of an arenavirus 3’ UTR; and iii. an L segment, wherein an ORF encoding Z protein is under the control of an arenavirus 5’ UTR and an ORF encoding L protein is under the control of an arenavirus 3’ UTR; b. transfecting into a host cell plasmids expressing the arenavirus' minimal transacting factors NP and L protein; c. maintaining the host cell under conditions suitable for virus formation; and d. harvesting the infectious, replication-competent arenavirus particle, wherein said method is not conducted within a human.
16. The ceutical composition, immunogenic composition, or vaccine of claim 12, n the composition is suitable for intramuscular or intravenous administration.
17. A set of nucleic acids comprising: (a) a first nucleic acid comprising the cDNA of the first S segment of claim 1; (b) a second nucleic acid comprising the cDNA of the second S segment of claim 1; and (c) a third nucleic acid comprising the cDNA of the L segment of claim 1.
18. A viral vector according to claim 1, substantially as herein bed or exemplified.
19. A pharmaceutical composition according to claim 12, substantially as herein bed or exemplified.
20. A use according to claim 13, substantially as herein described or exemplified.
21. A use according to claim 14, substantially as herein described or exemplified.
22. A method according to claim 15, substantially as herein described or exemplified. > wt LCMV B —GFPnat 5*UTR C r3LCMV—GFP3”
NZ781654A 2016-11-03 Vaccines against hepatitis b virus NZ781654B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562250639P 2015-11-04 2015-11-04
NZ741950A NZ741950B2 (en) 2016-11-03 Vaccines against hepatitis b virus

Publications (2)

Publication Number Publication Date
NZ781654A NZ781654A (en) 2025-06-27
NZ781654B2 true NZ781654B2 (en) 2025-09-30

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