DK1504035T6 - Antistoffer, der er specifikke for human CD22, og deres terapeutiske og diagnostiske anvendelser - Google Patents

Antistoffer, der er specifikke for human CD22, og deres terapeutiske og diagnostiske anvendelser Download PDF

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DK1504035T6
DK1504035T6 DK03718974.3T DK03718974T DK1504035T6 DK 1504035 T6 DK1504035 T6 DK 1504035T6 DK 03718974 T DK03718974 T DK 03718974T DK 1504035 T6 DK1504035 T6 DK 1504035T6
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Andrew George Popplewell
Simon Peter Tickle
Heather Margaret Ladyman
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Ucb Pharma Sa
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    • C07K16/2851Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
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    • C07K16/30Immunoglobulins [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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    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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    • G01N33/566Immunoassay; Biospecific binding assay; Materials therefor using specific carrier or receptor proteins as ligand binding reagents where possible specific carrier or receptor proteins are classified with their target compounds
    • G01N33/567Immunoassay; Biospecific binding assay; Materials therefor using specific carrier or receptor proteins as ligand binding reagents where possible specific carrier or receptor proteins are classified with their target compounds utilising isolate of tissue or organ as binding agent
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Claims (31)

1. Antistofmolekyle med specificitet for human CD22 omfattende en tung kæde, hvor det variable domæne omfatter SEQ ID NO: 1 for CDR-H1, sekvensen GINPGNNYATYRRKFQG af gH7 i figur 6 eller SEQ ID NO: 2 eller SEQ ID NO: 13 eller SEQ ID NO: 15 eller SEQ ID NO: 16 for CDR-H2 og SEQ ID NO:3 for CDR-H3 og en let kæde, hvor det variable domæne omfatter SEQ ID NO:4 for CDR-L1, SEQ ID NO:5 for CDR-L2 og SEQ ID NO:6 for CDR-L3.
2. Antistofmolekyle ifølge krav 1 omfattende sekvensen GINPGNNYATYRRKFQG af gH7 i figur 6 for CDR-H2.
3. Antistofmolekyle ifølge et hvilket som helst af kravene 1 til 2, som er et ved CDR-grafting fremstillet antistofmolekyle.
4. Antistofmolekyle ifølge krav 3, hvor det variable domæne omfatter humane acceptor-skeletregioner og ikke-humane donor-CDRer.
5. Antistofmolekyle ifølge krav 4, hvor de humane acceptor-skeletregioner af det variable domæne i den tunge kæde er baseret på SEQ ID NO: 21 og 22 og omfatter donorrester i positionerne 1, 28, 48, 71 og 93, nummereret ifølge Kabat, hvilke svarer til resterne henholdsvis 1,28, 48, 72 og 97 i SEQ ID NO:8.
6. Antistofmolekyle ifølge krav 5 yderligere omfattende donorrester i positionerne 67 og 69, nummereret ifølge Kabat, hvilke svarer til resterne henholdsvis 68 og 70 i SEQ ID NO:8.
7. Antistofmolekyle ifølge et hvilket som helst af kravene 4 til 6, hvor de humane acceptor-skeletregioner i det variable domæne i den lette kæde er baseret på SEQ ID NO: 17 og 18 og omfatter donorrester i positionerne 2, 4, 37, 38, 45 og 60, nummereret ifølge Kabat, hvilke svarer til resterne henholdsvis 2, 4, 42, 43, 50 og 65 i SEQ ID NO:7.
8. Antistofmolekyle ifølge krav 7 yderligere omfattende en donorrest i position 3, nummereret ifølge Kabat, hvilken svarer til resten i den position i SEQ ID NO:7.
9. Antistofmolekyle med specificitet for human CD22 omfattende en tung kæde i henhold til enten krav 5 eller krav 6, og en let kæde i henhold til enten krav 7 eller krav 8.
10. Antistofmolekyle ifølge et hvilket som helst af kravene 1 til 9, omfattende SEQ ID NO:19 (den variable region af den lette kæde 5/44-gL1) og SEQ ID NO:27 (den variable region af den tunge kæde 5/44-gH7).
11. Antistofmolekyle med specificitet for human CD22, som har en let kæde omfattende sekvensen givet i SEQ ID NO:28 og en tung kæde omfattende sekvensen givet i SEQ ID NO:30.
12. Antistofmolekyle med specificitet for human CD22, som har en let kæde bestående af sekvensen givet i SEQ ID NO:28 og en tung kæde bestående af sekvensen givet i SEQ ID NO:30.
13. Antistof ifølge krav 1, som er murint, monoklonalt anti-CD22-antistof 5/44, hvor det variable domæne af den lette kæde har sekvensen givet i SEQ ID NO: 7, og det variable domæne af den tunge kæde har sekvensen givet i SEQ ID NO: 8.
14. Antistofmolekyle ifølge krav 1, som er et kimært antistofmolekyle omfattende sekvenserne af de variable domæner af den lette og tunge kæde af det monoklonale antistof ifølge krav 18, gengivet i henholdsvis SEQ ID NO:7 og SEQ ID NO:8.
15. DNA-sekvens kodende for den tunge kæde af et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14.
16. DNA-sekvens kodende for den lette kæde af et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14.
17. DNA-sekvens kodende for den tunge kæde og den lette kæde af et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14.
18. Klonings- eller ekspressionsvektor omfattende en DNA-sekvens ifølge et hvilket som helst af kravene 15 til 17.
19. Værtscelle omfattende en klonings- eller ekspressionsvektor ifølge krav 18.
20. Antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14 eller en DNA-sekvens ifølge et hvilket som helst af kravene 15 til 17 til anvendelse i terapi.
21. Antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14 eller 20, med specificitet for human CD22, eller en DNA-sekvens ifølge et hvilket som helst af kravene 15 til 17 eller 20 til anvendelse i behandling af en patologi, der er medieret af celler, der udtrykker CD22.
22. Antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14, 20 eller 21 eller en DNA-sekvens ifølge et hvilket som helst af kravene 15 til 17, 20 eller 21 til anvendelse i behandling af maligne lymfomer.
23. Antistofmolekyle eller DNA-sekvens ifølge krav 22, hvor de maligne lymfomer er Non-Hodgkin's lymfomer.
24. Anvendelse af et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14, med specificitet for human CD22, eller anvendelse af en DNA-sekvens ifølge et hvilket som helst af kravene 15 til 17 til fremstilling af et lægemiddel til behandling af en patologi, der er medieret af celler udtrykkende CD22.
25. Anvendelse ifølge krav 24, hvor patologien er malignt lymfom.
26. Anvendelse ifølge krav 25, hvor det maligne lymfom er Non-Hodgkin's lymfom.
27. Terapeutisk eller diagnostisk sammensætning omfattende et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14 eller en DNA-sekvens ifølge et hvilket som helst af kravene 15 til 17.
28. Terapeutisk sammensætning omfattende antistofmolekylet ifølge et hvilket som helst af kravene 1 til 14, hvori antistoffet har et toxin bundet til sig ved en covalent brodannende struktur, og omfattende en farmaceutisk acceptabel excipiens, diluent eller bærer.
29. Terapeutisk eller diagnostisk sammensætning ifølge krav 27 yderligere omfattende anti-T celle-, anti-IFNy- eller anti-LPS-antistoffer eller non-antistof-ingredienser, såsom xanthiner.
30. Fremgangsmåde til fremstilling af et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14 omfattende dyrkning af en værtscelle ifølge krav 19 under betingelser, der er egnede til at føre til ekspression af protein fra DNA kodende for antistofmolekylet, og isolering af antistofmolekylet.
31. Fremgangsmåde til fremstilling af en terapeutisk eller diagnostisk sammensætning ifølge et hvilket som helst af kravene 27 eller 29, omfattende at blande et antistofmolekyle ifølge et hvilket som helst af kravene 1 til 14 sammen med en farmaceutisk acceptabel excipiens, diluent eller bærer.
DK03718974.3T 2002-05-02 2003-05-02 Antistoffer, der er specifikke for human CD22, og deres terapeutiske og diagnostiske anvendelser DK1504035T6 (da)

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GBGB0210121.0A GB0210121D0 (en) 2002-05-02 2002-05-02 Biological products
PCT/GB2003/001934 WO2003093320A2 (en) 2002-05-02 2003-05-02 Antibodies specific for human cd22 and their therapeuatic and digagnostic uses

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