DK1819359T3 - Anti-integrin-immunokonjugater, fremgangsmåder til deres fremstilling og deres anvendelse - Google Patents

Anti-integrin-immunokonjugater, fremgangsmåder til deres fremstilling og deres anvendelse Download PDF

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DK1819359T3
DK1819359T3 DK05852484T DK05852484T DK1819359T3 DK 1819359 T3 DK1819359 T3 DK 1819359T3 DK 05852484 T DK05852484 T DK 05852484T DK 05852484 T DK05852484 T DK 05852484T DK 1819359 T3 DK1819359 T3 DK 1819359T3
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antibody
conjugate
cnto
human
alphav
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Qiming Chen
Mohit Trikha
Robert J Lutz
Rita M Steeves
Godfrey Amphlett
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Janssen Biotech Inc
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    • 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
    • C07K16/2839—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 integrin superfamily
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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
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    • 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
    • A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
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    • A61K47/6849—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 receptor, a cell surface antigen or a cell surface determinant
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    • C07K—PEPTIDES
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    • 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
    • C07K2317/70—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

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Claims (32)

1. Antistof-lægemiddel-konjugat omfattende: et antistof der binder til en alfaV-underenhed af en heterodimer human integrinreceptor konjugeret til et cytotoksisk middel med en IC50 på ΙΟ'9 M eller derunder, hvor antistof-lægemiddelkonjugatet udøver en cytotoksisk eller cytostatisk virkning på en alfaV-integrin-udtrykkende cancercelielinje, med formlen:
hvor antistoffet er et human alfaV integrin-underenhed specifikt antistof, hvor antistoffet er i stand ti! at blive internaliseret af cellen der udtrykker alfaV-underenhed; hvor maytansinol forestres ved C-3; Ri, R2, Xi og X2 er uafhængigt H, Me, C2H5, lineær alkyl eller alkenyl med fra 1 til 10 carbonatomer, forgrenet eller cyklisk a I kyl eller alkenyl med fra 3 til 10 carbonatomer, phenyl, substitueret phenyl, eller en heterocyklisk arylgruppe, eller en heterocycloalkylgruppe; n er 1 - 5; p er 1 - 5; og m er 1 ti! 10, og de farmaceutisk acceptable salte og estere deraf.
2. Antistof-lægemiddelkonjugat ifølge krav 1, hvor antistoffet konkurrerer om binding til humant alfaV-integrin med monoklonalt antistof CNTO 95 eller et fragment deraf.
3. Antistofkonjugat ifølge krav 1, hvor antistofmolekylet er det monoklonale antistof CNTO 95 eller et rekombinant antistof med mindst én af de komplementære bestemmende regioner (CDR'er) af CNTO 95 med aminosyresekvensen ifølge SEQ ID NO: 1-6 eller konservative substitutioner af den mindst ene CDR.
4. Antistofkonjugat ifølge krav 2, i hvilket det monoklonale antistof konkurrerer med MAb CNTO 95 der binder til levende celler der udtrykker humant aifaVbetaS-integrin.
5. Antistofkonjugat ifølge krav 1, hvor antistofmolekylet er specifikt for en epitop inde i aminosyresekvensen SEQ ID NO: 9.
6. Antistof-lægemiddelkonjugat ifølge krav 1, hvor antistoffet er et humant, humaniseret, eller kimært ancistof.
7. Konjugatet ifølge krav 1, hver gennemsnitstallet af cytotoksiske grupper bundet tii antistofmoiekylet er mellem 3 og 4-
8. Antistofkonjugat ifølge krav 1, hvor n= 2, Ri og R2 begge er methyl, Xi og X2 er H og p er 2,
9. Fremgangsmåde til fremstilling af et konjugat ifølge krav 1, omfattende trinnene: (a) indføre én eller flere frie eller beskyttede thiolgrupper i et antistofmolekyle der binder til en alfaV-underenhed af en heterodimer human integrinreceptor; (b) omsætte antistofmolekylet fra trin (a) med en forbindelse der er et cytotoksisk middel med en IC50 på 10~9 M eller derunder, hvilken forbindelse har én eller flere disulfid- eller thiolgrupper; og (c) genvinde det resulterende konjugat, hvor den toksiske forbindelse er et maytansinoid.
10. Fremgangsmåden ifølge krav 9, hvor (2-pyridyl)-3-dithiopropansyre-N-hydroxysuccinimidester (SPDP), (2-pyridyl)-4-dithiopentansyre-N-hydroxysueinimidester (SPP), eller (2-pyridyi)~4~dithiobufansyre-N-hydroxysuccinimidester (SPDB) anvendes til at indføre de frie eller beskyttede thiolgrupper i antistofmolekylet.
11. Farmaceutisk sammensætning omfattende et konjugat ifølge et hvilket som helst af kravene 1 til 8 og en farmaceutisk acceptabel bærer, diluent, eller exipiens.
12. Konjugat ifølge et hvilket som helst af kravene 1 til 8 til anvendelse i medicin, fortrinsvis til anvendelse i behandlingen af cancer,
13. Konjugatet ifølge krav 12 til anvendelse i behandlingen af brystadenocarcinom, lungeadenocarcinom, bugspytkirteladenocarcinom, tyktarmsadenocarcinom, nyrecellecarcinom, eller maveadenocarcinom.
14. Konjugatet ifølge krav 12, til anvendelse i behandlingen af hoved- og hals-skvamøs cellecarcinom, skvamøs spiserørscellecarcinom, skvamøs lunge-cellecarcinom, skvamøs hudcellecarcinom, eller skvamøs livmoderhalscellecarcinom.
15. Konjugatet ifølge krav 12 ti! anvendelse i behandling eller forebyggelse af metastatisk spredning af cancer.
16. Monoklonalt antistofkonjugat ifølge et hvilket som helst af kravene 1-8 der forebygger CNTO 95 der binder til levende celler der udtrykker humant alfaVbetaS-integrin til anvendelse i medicin, fortrinsvis til anvendelse til inhibering af væksten af cancerceller hos et pattedyr.
17. Konjugatet til anvendelse ifølge krav 16, i hvilket antistofkonjugatet skal administreres intravenøst.
18. Konjugatet til anvendelse ifølge krav 17, i hvilket antistofkonjugatet skal administreres i en mængde på fra 0,05 mg/kg til 12,0 mg/kg legemsvægt.
19. Konjugatet til anvendelse ifølge krav 16, i hvilket pattedyret er en human patient.
20. Monoklonalt antistofkonjugat ifølge et hvilket som helst af kravene 1-8, der forebygger at CNTO 95 binder til levende celler der udtrykker humant alfaVbetaS-integrin til anvendelse i inhibering af angiogenese hos et pattedyr med en angiogenese-afhængig sygdom valgt fra gruppen bestående af cancermetastaser, angiom, angioflbrom, diabetisk retinopati, præmature spædbørn retinopati, neovaskuSær glaucom, hornhindesygdom induceret ved angiogenese, involutional makula, makular-degenerering, pterygium, retinal-degenerering, retrolentale fibroplasier, granulær konjunktivitis, psoriasis, telangiectasis, pyogenisk granulom, seborrheisk dermatitis, acne og arthritis.
21. Monoklonalt antistofkonjugat ifølge et hvilket som helst af kravene 1-8, der forebygger at CNTO 95 binder til levende celler der udtrykker humant alfaVbeta3-integrin til anvendelse i bedring af en inflammatorisk sygdom hos et pattedyr, hvor den inflammatoriske sygdom er valgt fra gruppen bestående af rheumatoid arthritis, makulær-degenerering, psoriasis, diabetisk retinopati.
22. Monoklonalt antistofkonjugat ifølge et hvilket som helst af kravene 1-8, der forebygger at CNTO 95 binder til levende celler der udtrykker humant alfaVbetaS-integrin til behandling af angiogene hudlidelser valgt fra gruppen bestående af psoriasis, venøse sår, acne, rosacea, vorter, eksem, hæmangiomer, og lymphangiogenese.
23. Monoklonalt antistofkonjugat ifølge et hvilket som helst af kravene 1-8, der forebygger at CNTO 95 binder til levende celler der udtrykker humant alfaVbetaS-integrin til behandling af lidelser der involverer hornhinde- eller nethindevaskularisering.
24. Konjugat til anvendelse ifølge krav 22 eller 23, hvor antistofkonjugatet administreres i kombination med et andet terapeutisk eller profylaktisk middel eller modalitet.
25. Artikel til fremstilling omfattende konjugatsammensætningen ifølge et hvilket som helst af kravene 1-8 og en beholder, og yderligere omfattende en pakkeinformation eller label der indikerer at sammensætningen kan anvendes til at behandle en sygdom kendetegnet ved celler der udtrykker alfaV-underenheden integrin.
26. Artikel til fremstilling ifølge krav 25, hvor pakkeinformationen indikerer at sammensætningen kan anvendes til at behandle cancer,
27. Antistofkonjugat ifølge krav 1, hvor n=2, Ri og R2 begge er methyl
28. Antistofkonjugat ifølge krav 1, hvor antistoffet omfatter (i) hele den tung-kædede komplementært bestemmende region's (CDR) aminosyresekvenser af CNTO 95 som vist i SEQ ID NO: 1, 2, og 3, og (ii) alle de let-kædede CDR- aminosyresekvenser af CNTO 95 som vist i SEQ ID NO: 4, 5, og 6.
29. Antistofkonjugat ifølge krav 28, hvor mindst én af de tung-kædede variable regionsekvenser omfatter den tung-kædede variable regionsekvens af CNTO 95 som vist i SEQ ID NO: 7.
30. Antistofkonjugat ifølge krav 28, hvor mindst én af de let-kædede variable regionsekvenser omfatter den let-kædede variable regionsekvens af CNTO 95 som vist i SEQ ID NO: 8.
31. Antistofkonjugat ifølge krav 1, hvor antistoffet omfatter en tung-kæde variabel region af CNTO 95 som vist i SEQ ID NO: 7 og en I et-kæde variabel region af CNTO 95 som vist i SEQ ID NO: 8.
32. Antistofkonjugat ifølge krav 1, hvor antistoffet er monoklonalt antistof CNTO 95.
DK05852484T 2004-12-09 2005-11-30 Anti-integrin-immunokonjugater, fremgangsmåder til deres fremstilling og deres anvendelse DK1819359T3 (da)

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