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 PDFInfo
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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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- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
- C07K16/461—Igs containing Ig-regions, -domains or -residues form different species
- C07K16/464—Igs containing CDR-residues from one specie grafted between FR-residues from another
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- 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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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
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- A—HUMAN NECESSITIES
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- 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
- C07K16/2803—Immunoglobulins [IG], 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
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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
- C07K16/2851—Immunoglobulins [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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- C07K16/00—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
- C07K16/3061—Blood cells
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- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/566—Immunoassay; 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
- G01N33/567—Immunoassay; 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
- A61K2039/507—Comprising a combination of two or more separate antibodies
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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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
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- 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
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- 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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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/567—Framework region [FR]
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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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
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- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
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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.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DK1504035T3 DK1504035T3 (da) | 2010-06-07 |
| DK1504035T6 true DK1504035T6 (da) | 2018-03-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK03718974.3T DK1504035T6 (da) | 2002-05-02 | 2003-05-02 | Antistoffer, der er specifikke for human CD22, og deres terapeutiske og diagnostiske anvendelser |
Country Status (34)
| Country | Link |
|---|---|
| US (8) | US7355011B2 (da) |
| EP (1) | EP1504035B9 (da) |
| JP (3) | JP4486494B2 (da) |
| KR (3) | KR101156796B1 (da) |
| CN (3) | CN100384878C (da) |
| AT (1) | ATE462729T3 (da) |
| AU (1) | AU2003223007C1 (da) |
| BE (1) | BE2017C068I2 (da) |
| CA (1) | CA2484420C (da) |
| CO (1) | CO5631451A2 (da) |
| CY (3) | CY1110134T1 (da) |
| DE (1) | DE60331910D1 (da) |
| DK (1) | DK1504035T6 (da) |
| EC (1) | ECSP045470A (da) |
| ES (1) | ES2341708T7 (da) |
| FR (1) | FR17C1062I2 (da) |
| GB (1) | GB0210121D0 (da) |
| HU (2) | HUS1700056I1 (da) |
| IL (1) | IL164923A (da) |
| LT (2) | LTC1504035I2 (da) |
| LU (2) | LUC00057I2 (da) |
| MX (1) | MXPA04010787A (da) |
| NL (1) | NL300920I2 (da) |
| NO (3) | NO336201B3 (da) |
| NZ (1) | NZ536757A (da) |
| PL (1) | PL218433B1 (da) |
| PT (1) | PT1504035E (da) |
| RU (1) | RU2342401C2 (da) |
| SG (1) | SG161744A1 (da) |
| SI (1) | SI1504035T1 (da) |
| TW (1) | TWI324161B (da) |
| UA (1) | UA92580C2 (da) |
| WO (1) | WO2003093320A2 (da) |
| ZA (1) | ZA200408851B (da) |
Families Citing this family (49)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7355012B2 (en) | 2001-09-26 | 2008-04-08 | United States Of America As Represented By The Secretary Of The Department Of Health And Human Services | Mutated anti-CD22 antibodies with increased affinity to CD22-expressing leukemia cells |
| US20110045005A1 (en) | 2001-10-19 | 2011-02-24 | Craig Crowley | Compositions and methods for the treatment of tumor of hematopoietic origin |
| WO2003072736A2 (en) | 2002-02-21 | 2003-09-04 | Duke University | Reagents and treatment methods for autoimmune diseases |
| SG187991A1 (en) | 2002-05-02 | 2013-03-28 | Wyeth Corp | Calicheamicin derivative-carrier conjugates |
| GB0210121D0 (en) * | 2002-05-02 | 2002-06-12 | Celltech R&D Ltd | Biological products |
| GB0312481D0 (en) | 2003-05-30 | 2003-07-09 | Celltech R&D Ltd | Antibodies |
| TW200630106A (en) * | 2004-10-08 | 2006-09-01 | Wyeth Corp | Immunotherapy of autoimmune disorders |
| BRPI0611901A2 (pt) | 2005-06-14 | 2012-08-28 | Amgen, Inc | composição, liofilizado, kit, e, processo para preparar uma composição |
| MY149159A (en) | 2005-11-15 | 2013-07-31 | Hoffmann La Roche | Method for treating joint damage |
| EP1999148B8 (en) * | 2006-03-06 | 2014-03-05 | Medlmmune, LLC | Humanized anti-cd22 antibodies and their use in treatment of oncology, transplantation and autoimmune disease |
| JP2009532336A (ja) * | 2006-03-06 | 2009-09-10 | メディミューン,エルエルシー | ヒト化抗cd22抗体、並びに腫瘍、移植及び自己免疫疾患の治療におけるこれらの使用 |
| EP2032606B1 (en) * | 2006-05-30 | 2013-11-27 | Genentech, Inc. | Antibodies and immunoconjugates and uses therefor |
| US8481683B2 (en) | 2006-12-01 | 2013-07-09 | Medarex, Inc. | Human antibodies that bind CD22 and uses thereof |
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