WO2004048402B1 - A hepatitis c virus codon optimized non-structural ns3/4a fusion gene - Google Patents

A hepatitis c virus codon optimized non-structural ns3/4a fusion gene

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Publication number
WO2004048402B1
WO2004048402B1 PCT/IB2003/006361 IB0306361W WO2004048402B1 WO 2004048402 B1 WO2004048402 B1 WO 2004048402B1 IB 0306361 W IB0306361 W IB 0306361W WO 2004048402 B1 WO2004048402 B1 WO 2004048402B1
Authority
WO
WIPO (PCT)
Prior art keywords
nucleic acid
seq
peptide
ribavirin
composition
Prior art date
Application number
PCT/IB2003/006361
Other languages
French (fr)
Other versions
WO2004048402A3 (en
WO2004048402A2 (en
Inventor
Matti Sallberg
Original Assignee
Tripep Ab
Matti Sallberg
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
Application filed by Tripep Ab, Matti Sallberg filed Critical Tripep Ab
Priority to ES03782748T priority Critical patent/ES2421132T3/en
Priority to EP03782748.2A priority patent/EP1567190B1/en
Priority to KR1020057009575A priority patent/KR101144642B1/en
Priority to JP2004554859A priority patent/JP4660195B2/en
Priority to CA 2506820 priority patent/CA2506820A1/en
Priority to AU2003290385A priority patent/AU2003290385B2/en
Publication of WO2004048402A2 publication Critical patent/WO2004048402A2/en
Publication of WO2004048402A3 publication Critical patent/WO2004048402A3/en
Publication of WO2004048402B1 publication Critical patent/WO2004048402B1/en
Priority to HK06102404A priority patent/HK1081973A1/en

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    • 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
    • C07K14/08RNA viruses
    • C07K14/18Togaviridae; Flaviviridae
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    • 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
    • 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
    • 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
    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • 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
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • 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
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    • 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
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    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53DNA (RNA) vaccination
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    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
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    • A61K39/00Medicinal preparations containing antigens or antibodies
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    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/57Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
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    • C12N2730/00Reverse transcribing DNA viruses
    • C12N2730/00011Details
    • C12N2730/10011Hepadnaviridae
    • C12N2730/10111Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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    • 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
    • C12N2770/24022New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
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    • C12N2770/00011Details
    • C12N2770/24011Flaviviridae
    • C12N2770/24211Hepacivirus, e.g. hepatitis C virus, hepatitis G virus
    • C12N2770/24221Viruses as such, e.g. new isolates, mutants or their genomic sequences
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    • C12N2770/00011Details
    • C12N2770/24011Flaviviridae
    • C12N2770/24211Hepacivirus, e.g. hepatitis C virus, hepatitis G virus
    • C12N2770/24222New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
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    • 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
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    • C12N2800/00Nucleic acids vectors
    • C12N2800/22Vectors comprising a coding region that has been codon optimised for expression in a respective host
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Aspects of the present invention relate to the creation of a codon-optimized hepatitis C virus (HCV) NS3/4A gene. Embodiments include said NS3/4A gene, fragments of said gene, HCV peptides encoded by said nucleic acids, nucleic acids encoding said HCV peptides, antibodies directed to said peptides, compositions containing said nucleic acids and peptides, as well as methods of making and using the aforementioned compositions including, but not limited to, diagnostics and medicaments for the treatment and prevention of HCV infection.

Claims

AMENDED CLAIMS[received by the International Bureau on 28 July 2004 (28.07.04); original claims 1-36 replaced by new claims 1-39 (3 pages) ]WHAT IS CLAIMED IS:
1. A purified or isolated nucleic acid comprising at least 30 consecutive nucleotides of the sequence of SEQ ID NO:35 or the complement thereof.
2. The purified or isolated nucleic acid of claim 1, wherein said nucleic acid comprises the sequence of SEQ ID NO:35.
3. The purified or isolated nucleic acid of claim 1, wherein said nucleic acid consists of the sequence of SEQ ID NO:35.
4. The nucleic acid of claim 1, comprising at least 50 consecutive nucleotides.
5. The nucleic acid of claim 1, comprising at least 100 consecutive nucleotides.
6. The nucleic acid of claim 1, comprising at least 200 consecutive nucleotides.
7. The nucleic acid of claim 1, comprising at least 500 consecutive nucleotides.
8. A purified or isolated nucleic acid encoding the amino acid sequence of SEQ ID NO:36.
9. A vector comprising the nucleic acid of claim 1.
10. A cell comprising the nucleic acid of claim 1.
11. A purified or isolated peptide comprising at least 30 consecutive amino acids of the sequence of SEQ ID NO:36.
12. A purified or isolated peptide comprising the amino acid sequence of SEQ ID NO:36.
13. A purified or isolated peptide consisting of the amino acid sequence of SEQ ID NO:36.
14. The peptide of claim 12 comprising at least 35 consecutive amino acids.
15. The peptide of claim 12 comprising at least 40 consecutive amino acids.
16. The peptide of claim 12 comprising at least 45 consecutive amino acids.
17. The peptide of claim 12 comprising at least 50 consecutive amino acids.
18. A pharmaceutical composition comprising the nucleic acid of claim 1, 2, 3, 4, 5, 6, 7 or 8 and a pharmaceutically acceptable carrier.
19. The pharmaceutical composition of claim 18, further comprising an adjuvant.
20. The pharmaceutical composition of claim 19, wherein said adjuvant is ribavirin.
21. A pharmaceutical composition comprising any one of the peptides of claims 11, 12, 13, 14, 15, 16 or 17.
22. The pharmaceutical composition of claim 21, further comprising an adjuvant.
23. The pharmaceutical composition of claim 22, wherein said adjuvant is ribavirin.
24. A method of making an immunogen preparation comprising: providing ribavirin; providing the nucleic acid of SEQ TD NO:35; and
77 combining said ribavirin and said nucleic acid so as to formulate said immunogen preparation.
25. A method of making an immunogen preparation comprising: providing ribavirin; providing the peptide of SEQ ID NO:36; and combining said ribavirin and said peptide so as to formulate said immunogen preparation.
26. A method of making an immunogen preparation comprising: providing ribavirin; providing the nucleic acid of SEQ ID NO:35 or a fragment thereof at least 30 consecutive nucleotides in length; and combining said ribavirin and said nucleic acid so as to formulate said immunogen preparation.
27. A method of making an immunogen preparation comprising: providing ribavirin; providing the nucleic acid of SEQ TD NO:36 or a fragment thereof at least 10 consecutive amino acids in length; and combining said ribavirin and said nucleic acid so as to formulate said immunogen preparation.
28. An improved hepatitis C virus immunogen preparation, wherein the improvement comprises a nucleic acid comprising at least 30 consecutive nucleotides of the sequence of SEQ TD NO:35.
29. The immunogen preparation of claim 28, wherein said improvement comprises a nucleic acid consisting of the sequence of SEQ TD NO:35.
30. The immunogen preparation of claim 28, wherein said improvement comprises a nucleic acid comprising the sequence of SEQ TD NO:35.
31. Use of the nucleic acid of claim 1 to prepare an HCV antiviral composition.
78
32. Use of the peptide of claim 12 to prepare an HCV antiviral composition.
33. A composition comprising the nucleic acid of claim 1.
34. A composition comprising the nucleic acid of claim 2.
35. A composition comprising the nucleic acid of claim 3.
36. A composition comprising the nucleic acid of claim 8.
37. A composition comprising the peptide of claim 11.
38. A composition comprising the nucleic acid of claim 12.
39. A composition comprising the nucleic acid of claim 13.
79
PCT/IB2003/006361 2002-11-26 2003-11-25 A hepatitis c virus codon optimized non-structural ns3/4a fusion gene WO2004048402A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
ES03782748T ES2421132T3 (en) 2002-11-26 2003-11-25 A non-structural NS3 / 4A fusion gene optimized for hepatitis C virus codon
EP03782748.2A EP1567190B1 (en) 2002-11-26 2003-11-25 A hepatitis c virus codon optimized non-structural ns3/4a fusion gene
KR1020057009575A KR101144642B1 (en) 2002-11-26 2003-11-25 A hepatitis c virus codon optimized non-structural ns3/4a fusion gene
JP2004554859A JP4660195B2 (en) 2002-11-26 2003-11-25 Hepatitis C virus codon optimized nonstructural NS3 / 4A fusion gene
CA 2506820 CA2506820A1 (en) 2002-11-26 2003-11-25 A hepatitis c virus codon optimized non-structural ns3/4a fusion gene
AU2003290385A AU2003290385B2 (en) 2002-11-26 2003-11-25 A hepatitis C virus codon optimized non-structural NS3/4A fusion gene
HK06102404A HK1081973A1 (en) 2002-11-26 2006-02-23 A hepatitis c virus codon optimized non-structural ns3/4a fusion gene

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/307,047 2002-11-26
US10/307,047 US7022830B2 (en) 2000-08-17 2002-11-26 Hepatitis C virus codon optimized non-structural NS3/4A fusion gene

Publications (3)

Publication Number Publication Date
WO2004048402A2 WO2004048402A2 (en) 2004-06-10
WO2004048402A3 WO2004048402A3 (en) 2004-07-29
WO2004048402B1 true WO2004048402B1 (en) 2004-10-07

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US (9) US7022830B2 (en)
EP (1) EP1567190B1 (en)
JP (1) JP4660195B2 (en)
KR (1) KR101144642B1 (en)
CN (1) CN100566753C (en)
AU (1) AU2003290385B2 (en)
CA (1) CA2506820A1 (en)
ES (1) ES2421132T3 (en)
HK (1) HK1081973A1 (en)
WO (1) WO2004048402A2 (en)

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