DK2794658T3 - Bispecifikt antistofmolekyle - Google Patents

Bispecifikt antistofmolekyle Download PDF

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DK2794658T3
DK2794658T3 DK12798623.0T DK12798623T DK2794658T3 DK 2794658 T3 DK2794658 T3 DK 2794658T3 DK 12798623 T DK12798623 T DK 12798623T DK 2794658 T3 DK2794658 T3 DK 2794658T3
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Michael Durben
Ludger Grosse-Hovest
Gundram Jung
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Synimmune Gmbh
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], 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
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • C—CHEMISTRY; METALLURGY
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    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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
    • C07K16/2809—Immunoglobulins [IGs], 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 the T-cell receptor (TcR)-CD3 complex
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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
    • C07K16/2818—Immunoglobulins [IGs], 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 CD28 or CD152
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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
    • C07K16/283—Immunoglobulins [IGs], 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 Fc-receptors, e.g. CD16, CD32, CD64
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3015—Breast
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3053—Skin, nerves, brain
    • 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
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 domain
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    • C07—ORGANIC CHEMISTRY
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • 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
    • C07K2317/60—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
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/64—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components

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Claims (15)

  1. BISPECIFIKT ANTISTOFMOLEKYLE
    1. Rekombinant bispecifikt antistofmolekyle, der består af et Fab-fragment, der omfatter et første bindingssted for et første antigen, et enkeltkædet Fv-fragment, der omfatter et andet bindingssted for et andet antigen, og et immunoglobulin-CH2-domæne, hvor Fab-fragmentet yderligere omfatter hængseiregionen, hvor Fab-fragmentet og det enkeltkædede Fv-fragment er koblet via CH2-domænet, hvor mindst én aminosyrerest i CH2-domænet, der er i stand til at mediere binding til Fc-receptorer, mangler eller er muteret, og hvor yderligere aminosyreresterne i sekvenspositionerne 226 og 229 (nummerering af sekvenspositioner i henhold til EU-indekset) mangler eller er muteret, hvor den mindst ene aminosyrerest i hængselregionen eller CH2-domænet, der er i stand til at mediere binding til Fc-receptorer, der mangler eller er muteret, er udvalgt fra gruppen, der består af sekvensposition 228, 230, 231, 232, 233, 234, 235, 236, 237, 238, 265, 297, 327 og 330 (nummerering af sekvenspositioner i henhold til EU-indekset).
  2. 2. Antistofmolekyle ifølge krav 1, a) hvor enten det første bindingssted eller det andet bindingssted binder et tumorassocieret antigen; hvor (i) det tumorassocierede antigen fortrinsvis er placeret på vaskulaturen i en tumor; og/elier (ii) det tumorassocierede antigen fortrinsvis er et overfladeantigen eller et antigen i den ekstracellulære matrix; og/eller (iii) det tumorassocierede antigen fortrinsvis er udvalgt fra gruppen, der består af CD 10, CD19, CD2G, CD21, CD22, CD25, CD3Q, CD33, CD34, CD37, CD44v6, CD45, CDw52, Fms-lignende tyrosinkinase 3 (FLT-3, CD 135), c-Kit (CD! 17), CSF1 R, (CD115), CD133, PDGFR-α (CD140a), PDGFR-β (CD140b), chondroitinsulfatproteoglycan 4 (CSPG4, melanomas,socieret chondroitinsulfatproteoglycan), Muc-1, EGFR, de2-7-EGFR, EGFRvIII, folatbindingsprotein, Her2neu, Her3, PSMA, PSCA, PSA, TAG-72, HLA-DR, IGFR, CD133, 1L3R, fibroblastaktiverende protein (FAP), carboanhydrase IX (MN/CA IX), karcinoembryonalt antigen (CEA), EpCAM, CDCP1, Derlinl, Tenascin, Frizzled 1-10, de vaskulære antigener VEGFR2 (KDR/FLK1), VEGFR3 (FLT4, CD309), endoglin, CLEC14, Teml-8 og Tie2; og/eller b) hvor enten det første bindingssted eller det andet bindingssted fortrinsvis binder et T-celie- eller NK (naturlig dræber)-cellespecifikt receptormolekyle, hvor det T-celle- eller NK-cellespecifikke receptormolekyle fortrinsvis er én af CD3, T-cellereceptoren (TCR), CD28, CD16, NKG2D, 0x40, 4-1 BB, CD2, CD5 og CD95, hvor TCR fortrinsvis er TCR~(alfa/beta) eller TCR-(gamma/delta).
  3. 3, Antistofmolekyle ifølge krav 1 eller 2, hvor (i) Fab-fragmentet er koblet til CH2-domænet via CH1 - og VH-domænerne af den tunge kæde af Fab-fragmentet eller via CL- og VL-domæneme af den lette kæde af Fab-fragmentet, hvor domænerne af den tunge kæde af Fab-fragmentet eller domænerne af den lette kæde af Fab-fragmentet fortrinsvis er anbragt i N-terminalen af polypeptidkæden, hvor CH2-domænet fortrinsvis er koblet til scFv-fragmentet via det variable domæne af den lette kæde (VL-domænet) af scFv-fragmentet, der omfatter det andet bindingssted, eller via det variable domæne af den tunge kæde (VH-domænet) af scFv-fragmentet, der omfatter det andet bindingssted; eller (ii) Fab-fragmentet, der omfatter det første bindingssted for det første antigen, fortrinsvis består af VL-domænet, der er fusioneret til CH1 -domænet, og VH-domænet, der er fusioneret til CL-domænet, hvor CH1-domænet af Fab-fragmentet fortrinsvis er fusioneret til CH2-domænet, og/eller hvor VL-CH1-kæden af Fab-fragmentet fortrinsvis er anbragt i N-terminalen af polypeptidkæden,
  4. 4, Antistofmolekyle ifølge et hvilket som helst af ovennævnte krav, hvor Fab-fragmentet er koblet til CH2-domænet via CH1- og VH-domænerne af den tunge kæde af Fab-fragmentet.
  5. 5. Antistofmolekyle ifølge krav 4, hvor domænerne af den tunge kæde af Fab-fragmentet er anbragt i N-terminalen af polypeptidkæden.
  6. 6. Antistofmolekyle ifølge krav 5, hvor CH2-dornænet er koblet til scFv-fragmentet via det variable domæne af den lette kæde (VL-domænet) af scFv-fragmentet, der omfatter det andet bindingssted.
  7. 7. Antistofmolekyle ifølge krav 5, hvor CH2-dornænet er koblet til sc-Fv-fragmentet via det variable domæne af den tunge kæde (VH-domænet) af scFv-fragmentet, der omfatter det andet bindingssted.
  8. 8. Antistofmolekyle ifølge et hvilket som helst af ovennævnte krav, a) hvor Fab-fragmentet omfatter en hængselregion; og/eller b) hvor det første bindingssted binder et tumorassocieret overfladeantigen, og det andet bindingssted binder én af CD3, T-cellereceptoren (TCR), CD28, CD 16, NKG2D, 0x40, 4-1 BB, CD2, CD5 og CD95.
  9. 9. Antistofmolekyle ifølge krav 1, hvor en cystein i én eller begge af positionerne 226 og 229, der mangler eller er muleret, er erstattet af en anden aminosyre (nummerering af sekvenspositioner i henhold til EU-indekset).
  10. 10. Antistofmolekyle ifølge et hvilket som helst af ovennævnte krav, der omfatter mindst én mutation udvalgt fra gruppen, der består af en deletion af aminosyre 228, en deletion af aminosyre 229, en deletion af aminosyre 230, en deletion af aminosyre 231, en deletion af aminosyre 232, en deletion af aminosyre 233, en substitution Glu233—»Pro, en substitution Leu234—»Val, en deletion af aminosyre 234, en substitution Leu235—»Ala, en deletion af aminosyre 235, en deletion af aminosyre 236, en deletion af aminosyre 237, en deletion af aminosyre 238, en substitution Asp265—»Gly, en substitution Asn297—»Gin, en substitution Ala327—»Gin og en substitution Ala330—»Ser (nummerering af sekvenspositioner i henhold til EU-indekset).
  11. 11. Antistofmolekyle ifølge et hvilket som helst af ovennævnte krav, hvor Fab-fragmentet er koblet til CH2-domænet via et domæne af en tung kæde af Fab-fragmentet eller via et domæn e af en let kæde af Fab-fragmentet, hvor domænerne af den tunge kæde af Fab-fragmentet fortrinsvis er anbragt i N-terminalen af po lypep tidkæden.
  12. 12. Farmaceutisk sammensætning, der omfatter et antistofmolekyle ifølge et hvilket som helst af ovennævnte krav.
  13. 13. Antistofmolekyle ifølge et hvilket søm helst af kravene 1 til 11 til anvendelse til behandling af en sygdom, hvor sygdommen fortrinsvis er en proliferate sygdom, hvor den proliferative sygdom fortrinsvis er udvalgt fra gruppen, der består af hæmopoetiske maligniteter, såsom akutte og kroniske myeloide og lymfatiske leukæmier, samt lymfomer, solide tumorer, såsom tumorer i mave-tarm-kanalen, lunge, nyre prostata, bryst, hjerne, ovarie, uterus, mesenkymale tumorer og melanom.
  14. 14. Nukleinsyremolekyle, der koder for et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 11, eller en vektor, der omfatter nukleinsyremolekylet, eller en værtscelle, der omfatter nukleinsyremolekylet eller vektoren.
  15. 15. Fremgangsmåde til fremstilling af et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 11, der omfatter ekspression af en nukleinsyre, der koder for antistofmolekylet, under betingelser, der åbner mulighed for ekspression af nukleinsyren, hvor antistofmolekylet fortrinsvis udtrykkes i en værtscelle eller et cellefrit system.
DK12798623.0T 2011-12-19 2012-11-12 Bispecifikt antistofmolekyle DK2794658T3 (da)

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EA (1) EA201400709A1 (da)
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