DK2274335T3 - Monoklonale antistoffer i stand til at reagere med et stort antal af influenza virus A-undertyper - Google Patents

Monoklonale antistoffer i stand til at reagere med et stort antal af influenza virus A-undertyper Download PDF

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DK2274335T3
DK2274335T3 DK09722394.5T DK09722394T DK2274335T3 DK 2274335 T3 DK2274335 T3 DK 2274335T3 DK 09722394 T DK09722394 T DK 09722394T DK 2274335 T3 DK2274335 T3 DK 2274335T3
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influenza
virus
monoclonal antibody
variable domain
antibodies
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DK09722394.5T
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Roberto Burioni
Massimo Clementi
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Pomona Ricerca Srl
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    • 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
    • C07K16/1018—Orthomyxoviridae, e.g. influenza virus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6839—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting material from viruses
    • A61K47/6841—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting material from viruses the antibody targeting a RNA virus
    • 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
    • A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4208—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an idiotypic determinant on Ig
    • C07K16/4216—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an idiotypic determinant on Ig against anti-viral Ig
    • 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
    • C12N15/74—Vectors or expression systems specially adapted for prokaryotic hosts other than E. coli, e.g. Lactobacillus, Micromonospora
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • G01N33/686—Anti-idiotype
    • 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
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2469/00—Immunoassays for the detection of microorganisms

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
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  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
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  • Wood Science & Technology (AREA)
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Claims (16)

1. Humant monoklonalt antistof rettet mod influenza A virus hemagglutinin antigen, kendetegnet ved at det er i stand til at binde til og neutralisere et stort antal undertyper af influenza A virusser, hvori nævnte store antal undertyper omfatter mindst en influenza A virus undertype indeholdende hemagglutinin H1 og mindst en influenza A virus undertype indeholdende hemagglutinin H3.
2. Monoklonalt antistof ifølge krav 1, omfattende mindst en tung kæde med variabelt domæne og mindst en let kæde med variabelt domæne, hvori den tunge kæde med variabelt domæne har aminosyresekvensen SEQ ID NO:1 og den lette kæde med variabelt domæne har aminosyresekvensen SEQ ID NO:2.
3. Monoklonalt antistof ifølge krav 2, omfattende mindst en tung kæde med variabelt domæne og mindst en let kæde med variabelt domæne, hvori den tunge kæde med variabelt domæne kodes af nucleotidsekvensen SEQ ID NO:3, og den lette kæde med variabelt domæne kodes af nucleotidsekvensen SEQ ID NO:4.
4. Monoklonalt antistof ifølge krav 1, som er i stand til at binde det konformationelle hemagglutininepitop specifikt genkendt af det monoklonale antistof ifølge krav 2.
5. Monoklonalt antistof ifølge ethvert af kravene 1 til 4, valgt fra gruppen bestående af hele immunoglobuliner og immunoglobulinfragmenter omfattende mindst en tung kæde med variabelt domæne og mindst en let kæde med variabelt domæne.
6. Monoklonalt antistof ifølge krav 5, hvori nævnte immunoglobulinfragmenter vælges fra gruppen omfattende Fab fragmenter, Fab’ fragmenter, F(ab’)2 fragmenter, Fv fragmenter, enkeltkædede antistoffer (scFv).
7. Anti-idiotypt antistof der er specifikt rettet mod idiotypen af et monoklonalt antistof ifølge ethvert af kravene 1 til 6.
8. Isolerede nucleotidsekvenser SEQ ID NO:3 og SEQ ID NO:4.
9. Ekspressionsvektor omfattende nucleotidsekvenser SEQ ID NO:3 og SEQ ID NO:4.
10. Værtscelle transformeret med en ekspressionsvektor ifølge krav 9.
11. Pharmaceutisk sammensætning omfattende en effektiv mængde af mindst et antistof ifølge ethvert af kravene 1 til 7 og en pharmaceutisk acceptabel bære og/eller diluent.
12. Antistof ifølge ethvert af kravene 1 til 7, til anvendelse i en prophylaktisk eller therapeutisk behandling af en influenza A virusinfektion eller en pathologi direkte eller indirekte forårsaget af en influenza A virusinfektion.
13. Antistof til anvendelse ifølge krav 12, hvori pathologien forårsaget af en influenza A virusinfektion er influenzasyndromet.
14. Assaymetode til i en biologisk prøve fra en patient at detektere tilstedeværelsen af anti-influenzavirusantistoffer med en heteroundertype krydsneutraliserende egenskab, omfattende at kontakte den nævnte biologske prøve med et monoklonalt antistof ifølge ethvert af kravene 1 til 6 som et specifikt assayreagens.
15. Diagnostisk kit omfattende et monoklonalt antistof ifølge ethvert af kravene 1 til 6 som et specifikt reagens, nævnte kit er især designet til anvendelse i en metode til at detektere eller kvantificere anti-influenza A virus antistoffer, der har en heteroundertype krydsneutraliserende egenskab i en biologisk prøve opnået fra en patient.
16. Assaymetode til i en immuniserende- or vaccinesammensætning at detektere tilstedeværelsen af influenza A virus epitoper, der er i stand til at udskille anti-influenza A virus antistoffer, der har en heteroundertype krydsneutraliserende egenskab mod influenza A virus’en i et individ hvortil det administreres, omfattende at kontakte nævnte sammensætning med et monoklonalt antistof ifølge ethvert af kravene 1 til 6 som et specifikt assayreagens.
DK09722394.5T 2008-03-17 2009-03-16 Monoklonale antistoffer i stand til at reagere med et stort antal af influenza virus A-undertyper DK2274335T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000204A ITTO20080204A1 (it) 2008-03-17 2008-03-17 Anticorpi monoclonali atti a reagire con una pluralita di sottotipi del virus influenzale a
PCT/IB2009/051068 WO2009115972A1 (en) 2008-03-17 2009-03-16 Monoclonal antibodies capable of reacting with a plurality of influenza virus a subtypes

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US (3) US9200063B2 (da)
EP (1) EP2274335B2 (da)
JP (1) JP5542118B2 (da)
KR (1) KR101605573B1 (da)
CN (1) CN102037013B (da)
AU (1) AU2009227567B2 (da)
BR (1) BRPI0909123B8 (da)
CA (1) CA2718923C (da)
DK (1) DK2274335T3 (da)
EA (1) EA027069B1 (da)
ES (1) ES2544968T5 (da)
HU (1) HUE025329T2 (da)
IL (1) IL208210A0 (da)
IT (1) ITTO20080204A1 (da)
MX (1) MX2010010120A (da)
MY (1) MY157359A (da)
NZ (1) NZ588238A (da)
PL (1) PL2274335T3 (da)
PT (1) PT2274335E (da)
SG (1) SG188890A1 (da)
WO (1) WO2009115972A1 (da)
ZA (1) ZA201006934B (da)

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