DK2829283T3 - Fremgangsmåde til behandling af kræft ved brug af immunotoxin - Google Patents

Fremgangsmåde til behandling af kræft ved brug af immunotoxin Download PDF

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DK2829283T3
DK2829283T3 DK14172801.4T DK14172801T DK2829283T3 DK 2829283 T3 DK2829283 T3 DK 2829283T3 DK 14172801 T DK14172801 T DK 14172801T DK 2829283 T3 DK2829283 T3 DK 2829283T3
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immunotoxin
cancer
antibody
tumor
treatment
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Uwe Zangenmeister-Wottke
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
    • 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
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    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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    • 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
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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
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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
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    • C07—ORGANIC CHEMISTRY
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
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    • C07—ORGANIC CHEMISTRY
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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 (16)

1. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ved indgivelse intratumoralt eller peri-tumoralt 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 hoved- og nakke-pladecellecarcinom 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 hoved- og nakke-pladecellecarcinom ifølge krav 1 eller 2, hvori antistoffet eller antistoffragmentet er Fab, Fab’, (Fab’)2, scFv eller dsFv fragment, eventuelt hvor antistoffragmentet er et scFv fragment.
4. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge krav 1, hvori antistoffet eller antistoffragmentet omfatter kortkædede-CDR'er som defineret af SEQ ID NO: 4-6 og langkædede CDR'er som defineret af SEQ ID NO: 7-9.
5. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge krav 1, hvori immunotoksinet består af aminosyresekvensen som defineret af SEQ ID NO: 2.
6. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge krav 1, hvori antistoffragmentet består af aminosyresekvensen som defineret af SEQ ID NO: 3 eller en variant deraf.
7. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge ethvert af krav 1 til 6, hvori antistoffet eller fragmentet binder til human Ep-CAM med en dissociationskonstant (Kd) på mindre end 2,0 x 10~8.
8. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge ethvert af krav 1 til 7, hvori toksinet omfatter et middel der virker til opbrydning af DNA, et middel der virker til opbrydning af tubulin, et alkyleringsmiddel, et antimitotisk middel, en topoisomerase I-hæmmer, en topoisomerase Π-hæmmer, en RNA eller DNA antimetabolit, vinblastin-sulfat eller et ribosom-inaktiverende polypeptid, eventuelt hvor toksinet er udvalgt blandt gmppen bestående af gelonin, bouganin, saporin, ricin, ricin A-kæde, bryodin, difteri og restrictocin, især hvori toksinet er Pseudomonas exotoxin A eller en variant deraf.
9. Effektiv mængde af et immunotoksin til anvendelse ved behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge ethvert af krav 1 til 8, ydereligere omfattende anvendelsen af yderligere kræftterapier til samtidig, separat eller sekventiel behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom, hvori de yderligere kræftterapier er udvalgt blandt grupperne bestående af: (A) et eller flere cytokiner herunder en lymfokin, tumornekrosefaktor, tumor-nekrosefaktorlignende cytokin, lymfotoxin, interferon, makrofaginflammato-risk protein, granulocyt-monocyt-kolonistimuleringsfaktor og interleukin og en variant deraf, herunder et farmaceutisk acceptabelt salt deraf; (B) antibiotika herunder bleomycin; nervevækstfaktor, blodpladeafledt vækstfaktor; antihistaminiske midler; eller anti-kvalme midler; (C) hormonterapier, herunder flutamid, tamoxifen, leuprolidacetat, dexame-thason, retinoid, betamethason, cortisol, cortison, prednison, dehydrotestoste-ron, glucocorticoid, mineralocorticoid, østrogen, testosteron eller progestin; (D) strålebehandling, eventuelt i kombination med cisplatin, fluorouracil, carboplatin og/eller paclitaxel; kirurgi og/eller kemoterapi; (E) genterapi; (F) en eller flere af terapeutiske midler, herunder bleomycin, carboplatin, cis- platin, cyclophosphamid, cytarabin, dacarbazin, docetaxel, fludarabin, flu-orouracil, flutamid, gemcitabin, hydroxyurea, interferon-alfa, interferon-beta, interferon-gamma, interleukin-2, methotrexat, mitomyciner, oxaliplatin, pac-litaxel, tamoxifen, vineristin, gemtuzumab, 6-mercaptopurin, 6-thioguanin, 5-fluorouracil, temozamid, hexamethylmelamin, nukleosidanaloger, camp-tothecin, topotecan, irinotecan, vincaalkyloider, antracycliner, leuprolidace-tat, rituximab, retinoin, og vinorelbine; (G) mindst en anden immunoterapi herunder rituximab, gemtuzumab og trastuzumab; eller (H) vinorelbintartrat og/eller paclitaxel.
10. Effektiv mængde af et immunotoksin til anvendelse til behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge et hvilket som helst af kravene 1 til 9, hvori immunotoksinet indgives i en dosis fra 10 til 3000 pg immunotok-sin/tumor/dag, eventuelt i en dosis fra 20 til 1240 pg immunotoxin/tumor/dag.
11. Effektiv mængde af et immunotoksin til anvendelse til behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge et hvilket som helst af kravene 1 til 10, hvori immunotoksinet indgives i 1-6 cyklusser, hvor hver cyklus omfatter en daglig dosis for 1 til 7 dage.
12. Kit til anvendelse ved behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom 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.
13. Kit til anvendelse til behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge krav 12, hvori antistoffragmentet er et Fab, Fab’, (Fab’)2, scFv eller dsFv fragment, eventuelt hvor antistoffragmentet er et scFv- ragment.
14. Kit til anvendelse til behandling eller forebyggelse af hoved- og nakke-pladecellecarcinom ifølge krav 12, hvori antistoffet eller antistoffragmentet omfatter kortkædede CDCD'er, som defineret af SEQ ID NO: 4-6 og langkædede CDR'er som defineret af SEQ ID NOS: 7-9, og hvor immunotoksinet indgives intratumoralt eller peritumoralt direkte til kræftstedet.
15. Kit til anvendelse til behandling eller forebyggelse af hoved- og nakke- pladecellecarcinom ifølge krav 12, hvori immunotoksinet består af aminosyresekven-sen som defineret af SEQ ID NO: 2, og hvor immunotoksinet indgives intratumoralt eller peritumoralt direkte til kræftstedet.
16. Kit til anvendelse til behandling eller forebyggelse af hoved- og nakke- pladecellecarcinom ifølge krav 12, hvori antistoffragmentet består af aminosyrese-kvensen som defineret af SEQ ID NO: 3 eller en variant deraf, og hvor immunotoksinet indgives intratumoralt eller peritumoralt direkte til kræftstedet.
DK14172801.4T 2003-04-30 2004-04-30 Fremgangsmåde til behandling af kræft ved brug af immunotoxin DK2829283T3 (da)

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