DK2595662T3 - Anti-CD19-antistof med ADCC- og CDC-funktioner og forbedret glykosyleringsprofil - Google Patents

Anti-CD19-antistof med ADCC- og CDC-funktioner og forbedret glykosyleringsprofil Download PDF

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DK2595662T3
DK2595662T3 DK11732491.3T DK11732491T DK2595662T3 DK 2595662 T3 DK2595662 T3 DK 2595662T3 DK 11732491 T DK11732491 T DK 11732491T DK 2595662 T3 DK2595662 T3 DK 2595662T3
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antibody
substituted
leu
cells
seq
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Claudine Vermot-Desroches
Boris Sébastien Vuillermoz
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Int Drug Development Biotech
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    • 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
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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    • 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
    • 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
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K39/00—Medicinal preparations containing antigens or antibodies
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    • A61K2039/507—Comprising a combination of two or more separate antibodies
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    • 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
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    • 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
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    • 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
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
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    • 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
    • C07K2317/77—Internalization into the cell

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Claims (14)

1. Anti-CD19-antistof, der er modificeret til at omfatte en variant af human IgG 1 Fc-region, i hvilken enten: Phe243 er substitueret med Leu, Arg292 er substitueret med Pro, Tyr300 er substitueret med Leu, Val305 er substitueret med Leu, Lys326 er substitueret med Ala, og Pro396 er substitueret med Leu, eller hvor Phe243 er substitueret med Leu, Arg292 er substitueret med Pro, Tyr300 er substitueret med Leu, Val305 er substitueret med Leu, Lys326 er substitueret med Ala, Pro396 er substitueret med Leu, og Glu333 er substitueret med Ala, hvor nummereringen af aminosyreresterne i Fc-regionen er Kabat-nummere-ringen, og hvor antistoffet har ADCC- og CDC-aktivitet.
2. Antistof ifølge krav 1, hvor antistoffet er blevet produceret i vildtype-gnaver-celler.
3. Antistof ifølge krav 1, hvor antistoffet er blevet produceret i vildtype-CHO-celler.
4. Antistof ifølge et hvilket som helst af de foregående krav, som har en eller to Fc, der ikke bærer nogen (GlcNAc)2(Fuc)i + (Man)3(GlcNAc)2-glycan, eller ikke nogen (Gal)i(GlcNAc)2(Fuc)i + (Man)3(GlcNAc)2-glycan
5. Antistof ifølge et hvilket som helst af de foregående krav, omfattende en eller to Fc, der bærer en (Man)s(GlcNAc)2-glycan, eller en eller to af følgende glycaner: - (Gal)i(GlcNAc)2(Fuc)i(NeuAc)i + (Man)3(GlcNAc)2 - (Gal)2(GlcNAc)2(Fuc)i(NeuAc)i + (Man)3(GlcNAc)2
6. Antistof ifølge et hvilket som helst af de foregående krav, hvor antistoffet omfatter CDR'erne af antistofferne mR005-1 eller mR005-2, hvis VH- og VL-aminosyresekvenser er vist i følgende tabel:
7. Antistof ifølge et hvilket som helst af kravene 1 til 6, hvor antistoffet omfatter et VH-domæne omfattende sekvensen SEQ ID NO: 29 og et VL-domæne omfattende sekvensen SEQ ID NO: 31; eller et VH-domæne omfattende sekvensen SEQ ID NO: 33 og et VL-domæne omfattende sekvensen SEQ ID NO: 35.
8. Antistof ifølge et hvilket som helst af kravene 1 til 7, hvor antistoffet er et kimær antistof eller et humaniseret antistof.
9. Farmaceutisk sammensætning omfattende et antistof ifølge et hvilket som helst af de foregående krav og en fysiologisk acceptabel vehikel eller exci-piens.
10. Sammensætning ifølge krav 9, yderligere omfattende et antistof, der er rettet mod et tumoralt antigen, der er forskelligt fra CD19.
11. Sammensætning ifølge krav 9 eller 10, til anvendelse i en fremgangsmåde til behandling af en cancer eller en autoimmun sygdom.
12. Sammensætning ifølge krav 10, til anvendelse ved behandling af en cancer hos CD20-antistofbehandlede patienter, der er refraktære eller har tilbagefald.
13. Ekspressionsvektor omfattende en nukleinsyresekvens, der koder for en en VH-kæde af antistof indeholdende VH-CDR'erne af antistofferne mR005-1 eller mR005-2, hvis VH-nukleinsyresekvenser er præsenteret i SEQ ID NO: 30 eller SEQ ID NO: 34, eller nukleinsyresekvens SEQ ID NO: 30 eller SEQ ID NO: 34, hvor nukleinsyresekvensen for VH også koder for en variant af human IgG 1 Fc-region, i hvilken Phe243 er substitueret med Leu, Arg292 er substitueret med Pro, Tyr300 er substitueret med Leu, Val305 er substitueret med Leu eller Ile, Lys326 er substitueret med Ala, og Pro396 er substitueret med Leu, eller Phe243 er substitueret med Leu, Arg292 er substitueret med Pro, Tyr300
er substitueret med Leu, Val305 er substitueret med Leu eller Ile, Lys326 er substitueret med Ala, Pro396 er substitueret med Leu, og Glu333 er substitueret med Ala, eller også koder for Fc-regionen SEQ ID NO: 1 eller 3.
14. Værtscelle indeholdende en vektor ifølge krav 13 og en ekspressionsvektor omfattende en nukleinsyresekvens, der koder for en VL-kæde af antistof indeholdende VL-CDR'erne af antistofferne mR005-1 eller mR005-2, hvis VL-nukleinsyresekvens er præsenteret i SEQ ID NO: 32 eller SEQ ID NO: 36, eller nukleinsyresekvens SEQ ID NO: 32 eller SEQ ID NO: 36, og en human Kappa-region, hvilken værtscelle er en vildtype-CHO-celle.
DK11732491.3T 2010-07-19 2011-07-18 Anti-CD19-antistof med ADCC- og CDC-funktioner og forbedret glykosyleringsprofil DK2595662T3 (da)

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US36554810P 2010-07-19 2010-07-19
EP10305796A EP2409712A1 (en) 2010-07-19 2010-07-19 Anti-CD19 antibody having ADCC and CDC functions and improved glycosylation profile
PCT/EP2011/062271 WO2012010562A1 (en) 2010-07-19 2011-07-18 Anti-cd19 antibody having adcc and cdc functions and improved glycosylation profile

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US (2) USRE49192E1 (da)
EP (3) EP2409712A1 (da)
JP (2) JP6092102B2 (da)
CN (2) CN103221068B (da)
CA (1) CA2805994C (da)
DK (1) DK2595662T3 (da)
ES (1) ES2700294T3 (da)
IN (1) IN2013CN01338A (da)
PL (1) PL2595662T3 (da)
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CA2805994C (en) 2020-05-12
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