WO2010039154A1 - Hepatitis c antibodies and uses thereof - Google Patents

Hepatitis c antibodies and uses thereof Download PDF

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Publication number
WO2010039154A1
WO2010039154A1 PCT/US2008/078884 US2008078884W WO2010039154A1 WO 2010039154 A1 WO2010039154 A1 WO 2010039154A1 US 2008078884 W US2008078884 W US 2008078884W WO 2010039154 A1 WO2010039154 A1 WO 2010039154A1
Authority
WO
WIPO (PCT)
Prior art keywords
hcv
antibody
antibodies
cbh
binding
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2008/078884
Other languages
English (en)
French (fr)
Inventor
Steven Foung
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Leland Stanford Junior University
Original Assignee
Leland Stanford Junior University
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 to EA201170353A priority Critical patent/EA201170353A1/ru
Priority to CA2738644A priority patent/CA2738644A1/en
Priority to JP2011530033A priority patent/JP2012504602A/ja
Priority to AU2008362482A priority patent/AU2008362482A1/en
Priority to KR1020117008883A priority patent/KR20110061624A/ko
Priority to MX2011003613A priority patent/MX2011003613A/es
Priority to PCT/US2008/078884 priority patent/WO2010039154A1/en
Priority to EP08824626A priority patent/EP2331573A4/en
Application filed by Leland Stanford Junior University filed Critical Leland Stanford Junior University
Priority to BRPI0823197-4A priority patent/BRPI0823197A2/pt
Priority to US13/122,598 priority patent/US8858947B2/en
Priority to CN2008801313970A priority patent/CN102197050A/zh
Publication of WO2010039154A1 publication Critical patent/WO2010039154A1/en
Priority to IL212040A priority patent/IL212040A0/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
    • C07K16/1081—Togaviridae, e.g. flavivirus, rubella virus, hog cholera virus
    • C07K16/109—Hepatitis C virus; Hepatitis G virus
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/42—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum viral
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Definitions

  • polymeric molecules are considered to be "homologous" to one another if their sequences are at least 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 99% similar.
  • HCV nomenclature typically utilizes an Arabic numeral ⁇ e.g., "1,” “2,” “3,” “4,” etc.) that represents HCV genotype and a lowercase letter ⁇ e.g., "a,” “b,” etc.) that represents HCV subtype.
  • HCV antibodies may be useful for treatment of patients with strains of HCV that are identical to the strain of HCV to which the antibodies were raised. In some embodiments, HCV antibodies may be useful for treatment of patients with strains of HCV that are different from the strain of HCV to which the antibodies were raised. Both individual HCV antibodies and a cocktail of several HCV antibodies recognizing several epitopes may be employed. [0068] In some embodiments, HCV antibodies may interfere with E2-associated viral infection by mechanisms other than preventing direct interaction with CD81.
  • Labels may include enzymes, chelating groups, ligands for binding to ligand binding proteins, e.g., biotin/streptavidin, digoxigenin/antidigoxigenin, etc., green fluorescent protein, and the like.
  • the biotinylation sequence of E. coli biotin carboxylase carrier protein (BCCP) can be used for in vivo biotinylation of proteins expressed in E. coli or introduced in a lysate of E. coli.
  • a sequence of six histidines or a sequence of alternating histidines and aspartic acids that are suitable for allowing binding of the antibody to a column containing immobilized divalent cations can be used.
  • Modified antibodies can be produced by mutagenesis followed by in vitro selection for a desirable property, such as increased affinity to a target antigen or broader or narrower specificity.
  • Antibodies can also be modified by a toxin or other bioactive molecule.
  • An assay for antibodies binding to HCV E2 is described by Rosa et al. (1996, Proc. Natl. Acad. Sci., USA, 93:1759-1763; incorporated herein by reference).
  • Peptides or other small molecules may have specific affinity for a monoclonal antibody and may be competitive with an epitope of a conformationally intact E2 protein.
  • peptides or other small molecules may have specific affinity for a monoclonal antibody and may be competitive with an epitope of E2 complexed with El .
  • Such peptides may be used as vaccines, in diagnostic assays, for immunization for the production of antibodies to a specific HCV epitope, in competitive assays for defining genotype and/or subtype, and the like.
  • the "level of HCV virions circulating in a subject” refers to an absolute number of virions circulating in a subject. In some embodiments, the "level of HCV virions circulating in a subject” refers to the number of virions per unit volume (e.g., milliter, liter, etc.) of the subject's blood. In some embodiments, the "level of HCV virions circulating in a subject” refers to viral load and/or HCV RNA levels.
  • treatment regimens are particularly tailored for the individual being treated. Briefly, a patient to be treated is provided, and a sample of serum is taken from the patient. The serum sample is then analyzed for the presence of particular antibodies, to give but a few examples, neutralizing antibodies, antibodies that bind to a particular region or epitope of a protein of HCV, etc. Any method known in the art, including but not limited to those described in this application, may be used to determine the presence of the antibodies to be detected (e.g., ELISA, competition assay, virus neutralization-of-binding assay, etc.). Based on the level of antibodies in the patient's serum, treatment can be designed for the patient.
  • hybridoma cell lines that secrete anti-HCV E2 antibodies have been deposited in the American Type Culture Collection (ATCC).
  • ATCC American Type Culture Collection
  • hybridoma cell lines that secrete human monoclonal anitbody HC-I has been deposited under Accession number PTA-9416
  • human monoclonal antibody HC-3 secreted by the hybridoma cell line has been deposited in the ATCC under Accession number PTA-9417
  • human monoclonal antibody HC-11 secreted by the hybridoma cell line has been deposited in the ATCC under Accession number PTA-9418
  • human monoclonal antibody CBH-23 secreted by the hybridoma cell line has been deposited in the ATCC under Accession number PTA-9419.
  • Ballistic powder/particle delivery devices which use compressed gas to accelerate vaccine in powder form through the outer layers of the skin to the dermis are suitable.
  • conventional syringes may be used in the classical mantoux method of intradermal administration.
  • FITC-conjugated goat anti-human IgG, Fc ⁇ fragment specific and R-phycoerythrin-conjugated F(ab')2 fragment goat anti-mouse IgG were obtained from Jackson Immuno Research (West Grove, PA).
  • Alkaline phosphatase conjugated goat anti-human IgG (H+L) and alkaline phosphatase conjugated goat anti-mouse IgG (H+L) were purchased from Promega (Madison, WI).
  • Galanthus nivalis lectin (GNA) and/?-nitrophenyl phosphate disodium hexa-hydrate (phosphatase substrate) were purchased from Sigma (St. Louis, MO).
  • V L and V H domains of HC-I, HC-3, HC-11 and CBH-23 were amplified by RT-PCR from total cellular RNA isolated from the corresponding hybridoma cells (the RNeasy mini kit, Qiagen, Valencia, CA) using 5' family-specific V leader primers and 3' J region primers, as described previously (Campbell et al, 1992, MoI Immunol, 29:193-203; and Chan et al, 2001, Blood, 97:1023-26; both of which are incorporated herein by reference).

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Virology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Communicable Diseases (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Zoology (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Plant Pathology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physics & Mathematics (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
PCT/US2008/078884 2008-10-05 2008-10-05 Hepatitis c antibodies and uses thereof Ceased WO2010039154A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
PCT/US2008/078884 WO2010039154A1 (en) 2008-10-05 2008-10-05 Hepatitis c antibodies and uses thereof
JP2011530033A JP2012504602A (ja) 2008-10-05 2008-10-05 Ｃ型肝炎抗体およびその使用
AU2008362482A AU2008362482A1 (en) 2008-10-05 2008-10-05 Hepatitis C antibodies and uses thereof
KR1020117008883A KR20110061624A (ko) 2008-10-05 2008-10-05 Ｃ형 간염 항체 및 이의 용도
MX2011003613A MX2011003613A (es) 2008-10-05 2008-10-05 Anticuerpos de hepatitis c y sus usos.
EP08824626A EP2331573A4 (en) 2008-10-05 2008-10-05 ANTIBODIES AGAINST HEPATITIS C AND USES THEREOF
BRPI0823197-4A BRPI0823197A2 (pt) 2008-10-05 2008-10-05 Anticorpos contra hepatite c e aplicações dos mesmos
EA201170353A EA201170353A1 (ru) 2008-10-05 2008-10-05 Антитела против гепатита с и их применение
CA2738644A CA2738644A1 (en) 2008-10-05 2008-10-05 Hepatitis c antibodies and uses thereof
US13/122,598 US8858947B2 (en) 2008-10-05 2008-10-05 Hepatitis C antibodies and uses thereof
CN2008801313970A CN102197050A (zh) 2008-10-05 2008-10-05 丙型肝炎抗体和其用途
IL212040A IL212040A0 (en) 2008-10-05 2011-03-31 Hepatitis c antibodies and uses thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2008/078884 WO2010039154A1 (en) 2008-10-05 2008-10-05 Hepatitis c antibodies and uses thereof

Publications (1)

Publication Number Publication Date
WO2010039154A1 true WO2010039154A1 (en) 2010-04-08

Family

ID=42073762

Family Applications (1)

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PCT/US2008/078884 Ceased WO2010039154A1 (en) 2008-10-05 2008-10-05 Hepatitis c antibodies and uses thereof

Country Status (12)

Country Link
US (1) US8858947B2 (enExample)
EP (1) EP2331573A4 (enExample)
JP (1) JP2012504602A (enExample)
KR (1) KR20110061624A (enExample)
CN (1) CN102197050A (enExample)
AU (1) AU2008362482A1 (enExample)
BR (1) BRPI0823197A2 (enExample)
CA (1) CA2738644A1 (enExample)
EA (1) EA201170353A1 (enExample)
IL (1) IL212040A0 (enExample)
MX (1) MX2011003613A (enExample)
WO (1) WO2010039154A1 (enExample)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012107589A1 (en) * 2011-02-11 2012-08-16 INSERM (Institut National de la Santé et de la Recherche Médicale) Methods and pharmaceutical compositions for the treatment and prevention of hcv infections
WO2012151263A3 (en) * 2011-05-02 2013-01-17 The Johns Hopkins University A synthetic hepatitis c genome and methods of making and use
EP2495256A4 (en) * 2009-10-30 2013-09-25 Toray Industries ANTIBODIES HAVING INHIBITION ACTIVITY OF HEPATITIS C VIRUS (HCV) INFECTION AND USE THEREOF
WO2017206621A1 (en) * 2016-06-01 2017-12-07 Suzhou Galaxy Biopharma, Co., Ltd. Neutralizing human monoclonal antibody 8d6 against hcv infection
EP4095156A1 (en) * 2021-05-28 2022-11-30 Universität zu Köln Neutralizing antibodies against hepatitis c virus

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6297560B2 (ja) 2012-08-07 2018-03-20 マサチューセッツ インスティテュート オブ テクノロジー 抗デングウイルス抗体およびその使用
CN103172705B (zh) * 2013-02-27 2014-08-20 北京大学人民医院 丙型肝炎病毒b细胞表位肽puhi16及其应用
CN103113458B (zh) * 2013-02-27 2014-08-20 北京大学人民医院 丙型肝炎病毒b细胞表位肽puhi34及其应用
RU2539770C1 (ru) 2013-12-27 2015-01-27 Татьяна Николаевна Власик Способ нейтрализации вируса гепатита с, полностью человеческое моноклональное антитело против вируса гепатита с (варианты), композиция полностью человеческих моноклональных антител против вируса гепатита с и гибридная мышь/человек клеточная линия - продуцент полностью человеческих моноклональных антител против вируса гепатита с (варианты)
CN106413749B (zh) 2014-02-11 2022-04-05 麻省理工学院 新颖全谱抗登革抗体
JPWO2015133467A1 (ja) * 2014-03-06 2017-04-06 株式会社シノテスト Ｃ型肝炎ウイルスのワクチン及び診断に用いるためのＨＢｃ／ＨＣＶ Ｅ２ペプチドキメラタンパク質
CN104327170A (zh) * 2014-05-16 2015-02-04 中国疾病预防控制中心病毒病预防控制所 丙型肝炎病毒(hcv)细胞进入抑制肽zte1序列及应用
GB201415714D0 (en) * 2014-09-05 2014-10-22 Medical Res Council Antibodies and antigen binding fragments thereof
CN105254756B (zh) * 2015-11-27 2018-09-07 武汉大学 一种针对丙型肝炎病毒包膜蛋白e2的单克隆抗体及应用
WO2017162678A1 (en) * 2016-03-22 2017-09-28 INSERM (Institut National de la Santé et de la Recherche Médicale) Humanized anti-claudin-1 antibodies and uses thereof

Citations (2)

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Publication number Priority date Publication date Assignee Title
US20060104980A1 (en) * 1998-11-05 2006-05-18 Foung Steven K H Prevention and treatment of HCV infection employing antibodies directed against conformational epitopes
US20060257852A1 (en) * 2003-04-10 2006-11-16 Chiron Corporation Severe acute respiratory syndrome coronavirus

Family Cites Families (1)

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EP1127170A4 (en) * 1998-11-05 2005-04-27 Univ Leland Stanford Junior HUMAN MONOCLONAL ANTIBODIES OF THE HEPATITIS C VIRUS (HCV) PAN

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060104980A1 (en) * 1998-11-05 2006-05-18 Foung Steven K H Prevention and treatment of HCV infection employing antibodies directed against conformational epitopes
US20060257852A1 (en) * 2003-04-10 2006-11-16 Chiron Corporation Severe acute respiratory syndrome coronavirus

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
KECK ET AL.: "Analysis of a highly flexible conformational immunogenic domain A in hepatitis C virus E2", J. VIROLOGY, vol. 79, no. 21, November 2005 (2005-11-01), pages 13199 - 13208, XP002588599 *
See also references of EP2331573A4 *

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2495256A4 (en) * 2009-10-30 2013-09-25 Toray Industries ANTIBODIES HAVING INHIBITION ACTIVITY OF HEPATITIS C VIRUS (HCV) INFECTION AND USE THEREOF
US8592559B2 (en) 2009-10-30 2013-11-26 Toray Industries, Inc. Antibody having activity of inhibiting hepatitis C virus (HCV) infection and use thereof
JP5756757B2 (ja) * 2009-10-30 2015-07-29 東レ株式会社 Ｃ型肝炎ウイルス（ｈｃｖ）に対して感染阻害活性を有する抗体及びその用途
WO2012107589A1 (en) * 2011-02-11 2012-08-16 INSERM (Institut National de la Santé et de la Recherche Médicale) Methods and pharmaceutical compositions for the treatment and prevention of hcv infections
WO2012151263A3 (en) * 2011-05-02 2013-01-17 The Johns Hopkins University A synthetic hepatitis c genome and methods of making and use
US9512183B2 (en) 2011-05-02 2016-12-06 The Johns Hopkins University Synthetic hepatitis C genome and methods of making and use
US10188726B2 (en) 2011-05-02 2019-01-29 The Johns Hopkins University Synthetic hepatitis C polypeptide and methods of making and using same
WO2017206621A1 (en) * 2016-06-01 2017-12-07 Suzhou Galaxy Biopharma, Co., Ltd. Neutralizing human monoclonal antibody 8d6 against hcv infection
US10888615B2 (en) 2016-06-01 2021-01-12 Suzhou Galaxy Biopharma, Co., Ltd. Neutralizing human monoclonal antibody 8D6 against HCV infection
EP4095156A1 (en) * 2021-05-28 2022-11-30 Universität zu Köln Neutralizing antibodies against hepatitis c virus

Also Published As

Publication number Publication date
AU2008362482A1 (en) 2010-04-08
US8858947B2 (en) 2014-10-14
BRPI0823197A2 (pt) 2015-06-23
EP2331573A1 (en) 2011-06-15
CA2738644A1 (en) 2010-05-08
MX2011003613A (es) 2011-08-03
JP2012504602A (ja) 2012-02-23
EA201170353A1 (ru) 2011-12-30
KR20110061624A (ko) 2011-06-09
CN102197050A (zh) 2011-09-21
EP2331573A4 (en) 2012-09-05
IL212040A0 (en) 2011-06-30
US20120039846A1 (en) 2012-02-16

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