DK2542575T3 - Ekspression af monoklonale antistoffer i tetrahymena - Google Patents

Ekspression af monoklonale antistoffer i tetrahymena Download PDF

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DK2542575T3
DK2542575T3 DK11707394.0T DK11707394T DK2542575T3 DK 2542575 T3 DK2542575 T3 DK 2542575T3 DK 11707394 T DK11707394 T DK 11707394T DK 2542575 T3 DK2542575 T3 DK 2542575T3
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antibody
ciliate
derivative
antigen
monoclonal antibody
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DK11707394.0T
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Marcus Hartmann
Jenny Apelt
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Cilian Ag
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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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2812—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD4
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • 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
    • 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
    • C12N2510/00—Genetically modified cells
    • C12N2510/02—Cells for production
    • C—CHEMISTRY; METALLURGY
    • C40—COMBINATORIAL TECHNOLOGY
    • C40B—COMBINATORIAL CHEMISTRY; LIBRARIES, e.g. CHEMICAL LIBRARIES
    • C40B40/00—Libraries per se, e.g. arrays, mixtures
    • C40B40/04—Libraries containing only organic compounds
    • C40B40/10—Libraries containing peptides or polypeptides, or derivatives thereof

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  • Immunology (AREA)
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  • Life Sciences & Earth Sciences (AREA)
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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Claims (10)

  1. EKSPRESSION AF MONOKLONALE ANTISTOFFER ITETRAHYMENA Patentkrav
    1. System til heterolog ekspression af et monoklonalt antistof (mAb) eller et antigenbindende fragment eller derivat deraf, hvilket system omfatter a) mindst én ciliat-værtscelle og b) inkorporeret i ciliat-værtscellen mindst ét heterologt nukleinsyremolekyle, der koder for det monoklonale antistof eller et antigenbindende fragment eller derivat deraf, og hvilket system yderligere omfatter en signalsekvens, der er operabelt koblet til nukleinsyremolekylet, hvor signalsekvensen forårsager sekretion af det monoklonale antistof eller fragmentet deraf, der kodes af nukleinsyremolekylet, ud i det ekstracellulære medium, hvor ciliaten er et medlem af familien Tetrahymenidae, og hvor det antigenbindende derivat er mindst én udvalgt fra gruppen, der består af • scFv eller • bi-, tri- eller højere specifikke antistofkonstruktioner.
  2. 2. System ifølge krav 1, hvor det monoklonale antistof (mAb) eller et antigenbindende fragment eller derivat deraf har en N-glycanstruktur, der er i det væsentlige fucosefri.
  3. 3. System ifølge krav 1 eller 2, hvor det monoklonale antistof (mAb) eller et antigenbindende fragment eller derivat deraf har mindst én effekt udvalgt fra gruppen, der består af • forøget antistofafhængig cellulær cytotoksicitet (ADCC), • forøget komplementafhængig cytotoksicitet (CDC), • forøget antistofafhængig apoptose, • forøget antistofafhængig opsonisering eller en forlænget halveringstid i serum.
  4. 4. System til heterolog ekspression af et monoklonalt antistof (mAb) eller et antigenbindende fragment eller derivat deraf, hvilket system omfatter en ciliat- værtscelle, der er opnået ved konjugation af mindst to ciliat-værtsceller ifølge systemet i krav 1, hvor ciliaten er et medlem af familien Tetrahymenidae.
  5. 5. Ciliat-værtscelle, der er transficeret med mindst én vektor, der omfatter mindst ét nukleinsyremolekyle, der koder for et monoklonalt antistof (mAb) eller et antigenbindende fragment eller derivat deraf ifølge krav 4, eller er opnået ved konjugation af mindst to ciliat-værtsceller ifølge systemet i krav 1, hvor ciliaten er et medlem af familien Tetrahymenidae.
  6. 6. Bibliotek, der omfatter mindst to ciliat-værtsceller ifølge krav 5 eller mindst to systemer ifølge krav 5, hvor hver værtscelle har inkorporeret mindst ét heterologt nukleinsyremolekyle, der koder for et antistof eller et antigenbindende fragment eller derivat deraf, fortrinsvis i form af en vektor, og hvor mindst to ciliater er udvalgt på en sådan måde, at de kan konjugere med hinanden, og ciliaten er et medlem af familien Tetrahymenidae.
  7. 7. Monoklonalt antistof (mAb), der dannes med et system ifølge et hvilket som helst af kravene 1-4 eller med en ciliat-værtscelle ifølge krav 5, hvor ciliaten er et medlem af familien Tetrahymenidae, hvilket antistof eller antigenbindende fragment eller derivat yderligere binder til mindst ét af målene, der er anført i tabel 1 (ADCC) eller 3 (ikke-ADCC).
  8. 8. Monoklonalt antistof ifølge krav 7, som har mindst ét træk udvalgt fra gruppen, der består af • forøget ADCC, CDC og/eller antistofafhængig apoptose, • forlænget halveringstid i serum og/eller • bi, tri- eller multispecificitet.
  9. 9. Fremgangsmåde til fremstilling af mindst ét monoklonalt antistof (mAb) eller et antigenbindende fragment eller derivat deraf i en ciliat-værtscelle, hvilken fremgangsmåde omfatter trinene a) transfektion af mindst to forskellige ciliat-værtsceller med mindst ét nukleinsyremolekyle, der koder for et antistof eller et fragment eller derivat deraf, eller fortrinsvis med mindst én vektor, der omfatter mindst ét nukleinsyremolekyle, der koder for et monoklonalt antistof (mAb) eller et antigenbindende fragment eller derivat deraf, b) konjugering af de to ciliat-værtsceller eller afkom deraf til opnåelse af mindst én ciliat-celle, der bærer mindst to forskellige nukleinsyremolekyler, der koder for mindst to forskellige antistoffer eller fragmenter eller derivater deraf, og c) dyrkning af den således dannede ciliat-celle under betingelser, der åbner mulighed for ekspression af et protein, hvor ciliaten er et medlem af familien Te tra hym enidae.
  10. 10. Monoklonalt antistof (mAb), der er dannet ved en fremgangsmåde ifølge krav 9, hvor ciliaten er et medlem af familien Tetrahymenidae, hvilket antistof eller antigenbindende fragment eller derivat yderligere binder til mindst ét af målene anført i tabel 1 (ADCC) eller 3 (ikke-ADCC).
DK11707394.0T 2010-03-05 2011-03-02 Ekspression af monoklonale antistoffer i tetrahymena DK2542575T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1003701.8A GB201003701D0 (en) 2010-03-05 2010-03-05 System for the expression of a protein
PCT/EP2011/053129 WO2011107520A1 (en) 2010-03-05 2011-03-02 Expression of monoclonal antibodies in ciliate host cells

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US (1) US9963499B2 (da)
EP (1) EP2542575B1 (da)
JP (1) JP5984680B2 (da)
KR (2) KR102035439B1 (da)
CN (1) CN102884078B (da)
BR (1) BR112012022459B1 (da)
CA (1) CA2828131C (da)
DK (1) DK2542575T3 (da)
ES (1) ES2609787T3 (da)
GB (1) GB201003701D0 (da)
PL (1) PL2542575T3 (da)
WO (1) WO2011107520A1 (da)

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KR20180037304A (ko) 2018-04-11
US9963499B2 (en) 2018-05-08
CA2828131C (en) 2019-03-26
PL2542575T3 (pl) 2017-06-30
ES2609787T3 (es) 2017-04-24
BR112012022459A2 (pt) 2020-09-01
EP2542575B1 (en) 2016-10-05
BR112012022459B1 (pt) 2023-03-07
GB201003701D0 (en) 2010-04-21
WO2011107520A1 (en) 2011-09-09
KR102035439B1 (ko) 2019-10-22
KR20120131201A (ko) 2012-12-04
US20130109593A1 (en) 2013-05-02
EP2542575A1 (en) 2013-01-09
CN102884078A (zh) 2013-01-16
JP5984680B2 (ja) 2016-09-06
CA2828131A1 (en) 2011-09-09
JP2013520976A (ja) 2013-06-10
CN102884078B (zh) 2015-06-17

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