DK2382990T3 - Fremgangsmåder til behandling af kræft ved anvendelse af et immunotoksin - Google Patents

Fremgangsmåder til behandling af kræft ved anvendelse af et immunotoksin Download PDF

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DK2382990T3
DK2382990T3 DK10011667.2T DK10011667T DK2382990T3 DK 2382990 T3 DK2382990 T3 DK 2382990T3 DK 10011667 T DK10011667 T DK 10011667T DK 2382990 T3 DK2382990 T3 DK 2382990T3
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immunotoxin
antibody
cancer
treatment
tumor
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Uwe Zangenmeister-Wittke
Paolo Claudio Di
Dominique Christine Tschudi
Nicholas Ronald Glover
Dimitri Peter Fitsialos
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Univ Zuerich
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    • C07—ORGANIC CHEMISTRY
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    • 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
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6817—Toxins
    • A61K47/6829—Bacterial toxins, e.g. diphteria toxins or Pseudomonas exotoxin A
    • 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
    • A61K47/6851—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 a determinant of a tumour cell
    • A61K47/6861—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 a determinant of a tumour cell the tumour determinant being from kidney or bladder cancer cell
    • A—HUMAN NECESSITIES
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    • A61K47/6851—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 a determinant of a tumour cell
    • A61K47/6865—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 a determinant of a tumour cell the tumour determinant being from skin, nerves or brain cancer cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
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    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/34—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Corynebacterium (G)
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • C—CHEMISTRY; METALLURGY
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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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    • C07K2317/00—Immunoglobulins specific features
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
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    • C07—ORGANIC CHEMISTRY
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    • 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
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    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
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    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

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Claims (15)

1. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ved indgivelse intratumoralt, intravesikulært eller peritu-moralt direkte til kræftstedet, og hvori immunotoksinet omfatter: (a) et antistof eller antistoffragment, som binder til Ep-CAM på den tilknyttede kræftcelle; (b) et toksin, som er cytotoksisk for kræftcellen.
2. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ifølge krav 1, hvori antistoffet eller antistoffragmentet er murint, humaniseret eller et kimærisk antistof eller antistoffragment.
3. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ifølge krav 1 eller 2, hvori antistoffet eller antistoffragmentet er et humaniseret antistof eller antistoffragment.
4. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ifølge krav 3, hvori antistoffet eller antistoffragmentet omfatter komplementaritetsbestemmende region (CDR)-sekvenser som vist i SEQ ID NO:4-9.
5. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ifølge ethvert af krav 1 til 4, hvori antistoffragmentet er et Fab; Fab', (Fab')2, scFv eller dsFv fragment, hvori antistoffragmentet valgfrit er et scFv fragment; hvori antistoffragmentet valgfrit har sekvensen vist i SEQ ID NO:3 eller en variant deraf, eller hvori antistoffet eller fragmentet binder til human Ep-CAM med en dissocieringskonstant (KD) mindre end 2,0 x 10 8.
6. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ifølge ethvert af krav 1 til 5, hvori immunotoksinet har sekvensen vist i SEQ ID NO:2 eller en variant deraf.
7. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ifølge to ethvert af krav 1 til 5, hvori toksinet omfatter en antimetabolit, et middel til opbrydning af DNA, et middel til opbrydning af tubulin, et alkyleringsmiddel, et antimitotisk middel, en topoisomerase l-hæmmer, en topoisomerase Il-hæmmer, en RNA eller DNA antimetabolit, eller vinblastinsulfat eller hvori toksinet er et ribosom-inaktiverende polypeptid; hvori toksinet valgfrit er fra gruppen bestående af gelonin, bouganin, saporin, ricin, ricin A-kæde, bryo-din, difteri og restrictocin, eller hvori toksinet er Pseudomonas exotoksin A eller en variant deraf.
8. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller fore byggelse af blærekræft ifølge ethvert af krav 1 til 5, yderligere omfattende anvendelse af en eller flere kræftterapier til samtidig, separat eller sekventiel behandling eller forebyggelse af blærekræft, hvori kræftterapien omfatter et alkyle-ringsmiddel, et antimitotisk middel, en cytokin, en nervevækstfaktor, en blodpla-deafledt vækstfaktor, hormonterapi, midler, der øger eksprimering af Ep-CAM, stråling, operation, genterapi, vincaalkyloid, et anthracyklin, et antibiotika, et antihistaminmiddel og/eller et middel mod kvalme; hvori kræftterapien valgfrit omfatter Bacillus og Guerin (BCG), bleomycin, carboplatin, cisplatin, docetaxel, flurouracil, cyclofosfamid, cytarabin, irinotecan, gemcitabin, hydroxyurea, interferon, lymfokin, tumornekrosefaktorer, tumornekrosefaktorlignende cytokin, lymfo-toksin, makrofaginflammatorisk protein, granulocyt-monocyt- kolonistimuleringsfaktor, interleukin, methotrexat, mitomycin, oxaliplatin, pacli-taxel, gemtuzumab, rituximab, alemtuzumab, trastuzutmaban, flutamid, tamoxifen, leuprolidacetat, dexamethason, retinoid, betamethason, kortisol, kortison, prednison, dehydrotestosteron, glucocorticoid, mineralocorticoid, østrogen, testosteron, progestin, vinorelbintartrat, 6-mercaptopurin, 6-thioguanin, 5-fluorouracil, fludarabin, dacarbazin, temozoamid, hexametylmelamin, nukleosidanalogier, camptothecin, topotecan eller vineristin.
9. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ifølge ethvert af krav 1 til 8, hvori immunotoksinet gives i en dosis fra ca. 10 til ca. 3000 pg immunotoksin/tumor/dag eller i en dosis fra ca. 20 til ca. 1240 pg immunotoksin/tumor/dag.
10. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af blærekræft ifølge krav 9, hvori immunotoksinet gives i en cyklus bestående af en daglig dosis i 1 til 7 dage; hvori medikamentet eller immunotoksinet valgfrit gives i 1-6 cyklusser.
11. Kit til anvendelse ved behandling eller forebyggelse af blærekræft omfattende en effektiv mængde af et immunotoksin omfattende (a) et antistof eller antistoffragment, som binder til Ep-CAM på den tilknyttede kræftcelle; (b) et toksin, som er cytotoksisk for kræftcellen.
12. Kit til anvendelse ved behandling eller forebyggelse af blærekræft ifølge krav 11, hvori antistoffet eller antistoffragmentet er murint, humaniseret eller kimæ-risk.
13. Kit til anvendelse ved behandling eller forebyggelse af blærekræft ifølge krav 11 eller 12, hvori liganden er et humaniseret antistof eller antistoffragment omfatter komplementaritetsbestemmende region (CDR)-sekvenser vist i SEQ ID NO:4-9.
14. Kit til anvendelse ved behandling eller forebyggelse af blærekræft ifølge ethvert af krav 11 til 13, hvori antistoffragmentet er et Fab; Fab', (Fab')2, scFv eller dsFv fragment, hvori antistoffragmentet valgfrit er et scFv fragment; hvori antistoffragmentet valgfrit har sekvensen vist i SEQ ID NO:3 eller en variant deraf, eller hvori antistoffet eller fragmentet binder til human Ep-CAM med en dissocie-ringskonstant (KD) mindre end 2,0 x 10'8.
15. Kit til anvendelse ved behandling eller forebyggelse af blærekræft ifølge ethvert af krav 11 til 14, hvori immunotoksinet har sekvensen vist i SEQ ID NO:2 eller en variant deraf.
DK10011667.2T 2003-04-30 2004-04-30 Fremgangsmåder til behandling af kræft ved anvendelse af et immunotoksin DK2382990T3 (da)

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