DK2115151T3 - Fremgangsmåder og vektorer til generering af asialylerede immunoglobuliner - Google Patents

Fremgangsmåder og vektorer til generering af asialylerede immunoglobuliner Download PDF

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DK2115151T3
DK2115151T3 DK07869893.3T DK07869893T DK2115151T3 DK 2115151 T3 DK2115151 T3 DK 2115151T3 DK 07869893 T DK07869893 T DK 07869893T DK 2115151 T3 DK2115151 T3 DK 2115151T3
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cells
antibody
cell
binding
sialic acid
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DK07869893.3T
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Michael Naso
T Shantha Raju
Bernard Scallon
Susan Tam
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Janssen Biotech Inc
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    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • 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
    • 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
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
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    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P31/04—Antibacterial agents
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • 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
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    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins
    • C12P21/005—Glycopeptides, glycoproteins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • 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
    • C07K2317/72—Increased effector function due to an Fc-modification
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01018—Exo-alpha-sialidase (3.2.1.18), i.e. trans-sialidase

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Claims (10)

1. Fremgangsmåde til tilvejebringelse af en sialidase-enzymaktivitet i en kultur, der omfatter en pattedyrcelle, der er manipuleret til at eksprimere et Fc-holdigt molekyle, hvorved polypeptidet kan udøve sialidase-enzymaktivitet på det Fc-holdige molekyles glycaner, hvilken fremgangsmåde omfatter transfektion af den genetisk manipulerede pattedyrcelle med en vektor, der koder for det katalytiske domæne af Arthrobacter ureafaciens sialidaseenzym A, hvor polypeptidet secerneres i kulturen sammen med det Fc-holdige molekyle.
2. Fremgangsmåde til kontrol af egenskaberne af et i en cellelinje eksprimeret Fc-holdigt molekyle, omfattende reduktion af sialylering af oligosacchariderne i Fc-området ved at transficere cellelinjen med en vektor, der koder for det katalytiske domæne af Arthrobacter ureafaciens sialidaseenzym A, hvor det eksprimerede Fc-holdige molekyle omfatter en reduceret mængde sialinsyrerester, hvor egenskaberne af det kontrollerede Fc-holdige molekyle er aviditet af molekylet for multiplikation af lokaliserede targetproteiner; affinitet for én eller flere af Fc-gamma-receptorerne af FcyRI, FcyRIIA og FcyRIIIA; ADCC-aktivitet; makrofag- eller monocytaktivering; og serumhalveringstid.
3. Fremgangsmåde ifølge krav 1 eller krav 2, hvorved det Fc-holdige molekyle er et antistof, og pattedyrcellelinjen er valgt fra gruppen bestående af COS-1, COS-7, HEK293, BHK21, CHO, BSC-1, Hep G2, 653, SP2/0, 293, HeLa, YB2/0 eller Y3, myelom eller lymfomceller eller ethvert derivat, enhver immortaliseret eller transformeret celle deraf.
4. Fremgangsmåde ifølge krav 3, hvorved antistoffet er et anti-TNFa-antistof, og cellelinjen er C168M.
5. Fremgangsmåde ifølge krav 2, hvorved det Fc-holdige molekyle har et for et target specifikt bindingsdomæne, hvilket target: i) er et immobiliseret target; eller ii) er eksprimeret på overfladen af en celle.
6. Ekspressionsvektor, der omfatter en nukleotidsekvens, der koder for Arthrobacter ureafaciens sialidaseenzym A, hvor vektoren er i stand til at eksprimere et polypeptid med sialidase-enzymaktivitet i en pattedyrcellekultur, der eksprimerer et Fc-holdigt molekyle.
7. Vektor ifølge krav 6, hvor pattedyrcellelinjen er valgt fra gruppen bestående af COS-1, COS-7, HEK293, BHK21, CHO, BSC-1, Hep G2, 653, SP2/0, 293, HeLa, YB2/0 eller Y3, myelom eller lymfomceller eller ethvert derivat, enhver immortaliseret eller transformeret celle deraf.
8. Vektor ifølge krav 6, hvor vektoren omfatter: i) en signalsekvens, for eksempel en signalsekvens for et humant væksthormon; ii) en promotorsekvens, for eksempel en CMV-promotorsekvens; og iii) en antibiotikaresistens, for eksempel neomycin.
9. Fremgangsmåde til fremstilling af et Fc-holdigt molekyle, omfattende fremgangsmåden ifølge et hvilket som helst af kravene 1-5.
10. Fremgangsmåde ifølge krav 9, hvorved det Fc-holdige molekyle er et antistof.
DK07869893.3T 2006-12-28 2007-12-26 Fremgangsmåder og vektorer til generering af asialylerede immunoglobuliner DK2115151T3 (da)

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US88230106P 2006-12-28 2006-12-28
PCT/US2007/088809 WO2008083150A2 (en) 2006-12-28 2007-12-26 Methods and vectors for generating asialylated immunoglobulins

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EP (1) EP2115151B1 (da)
JP (1) JP2010514448A (da)
KR (1) KR101667981B1 (da)
CN (2) CN101646775B (da)
BR (1) BRPI0720861A2 (da)
CA (1) CA2674239C (da)
DK (1) DK2115151T3 (da)
ES (1) ES2474940T3 (da)
MX (1) MX2009007139A (da)
RU (1) RU2466189C2 (da)
WO (1) WO2008083150A2 (da)

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WO2008083150A3 (en) 2009-04-30
BRPI0720861A2 (pt) 2014-02-25
US20140057319A1 (en) 2014-02-27
MX2009007139A (es) 2009-10-08
US8975040B2 (en) 2015-03-10
EP2115151A4 (en) 2011-01-26
KR101667981B1 (ko) 2016-10-20
WO2008083150A2 (en) 2008-07-10
RU2009128960A (ru) 2011-02-10
KR20090096740A (ko) 2009-09-14
JP2010514448A (ja) 2010-05-06
CA2674239A1 (en) 2008-07-10
RU2466189C2 (ru) 2012-11-10
CN101646775A (zh) 2010-02-10
ES2474940T3 (es) 2014-07-10
EP2115151A2 (en) 2009-11-11
CA2674239C (en) 2018-01-23
US8540992B2 (en) 2013-09-24
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