HRP20200382T1 - Humanizirana ili kimerna protutijela cd3 - Google Patents
Humanizirana ili kimerna protutijela cd3 Download PDFInfo
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- HRP20200382T1 HRP20200382T1 HRP20200382TT HRP20200382T HRP20200382T1 HR P20200382 T1 HRP20200382 T1 HR P20200382T1 HR P20200382T T HRP20200382T T HR P20200382TT HR P20200382 T HRP20200382 T HR P20200382T HR P20200382 T1 HRP20200382 T1 HR P20200382T1
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- antibody according
- heavy chain
- antibody
- bispecific antibody
- region
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- 150000001413 amino acids Chemical class 0.000 claims 6
- 150000007523 nucleic acids Chemical class 0.000 claims 5
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 4
- 239000013604 expression vector Substances 0.000 claims 4
- 239000000825 pharmaceutical preparation Substances 0.000 claims 4
- 238000002360 preparation method Methods 0.000 claims 4
- 239000000427 antigen Substances 0.000 claims 2
- 102000036639 antigens Human genes 0.000 claims 2
- 108091007433 antigens Proteins 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 208000023275 Autoimmune disease Diseases 0.000 claims 1
- 208000035473 Communicable disease Diseases 0.000 claims 1
- 102000006496 Immunoglobulin Heavy Chains Human genes 0.000 claims 1
- 108010019476 Immunoglobulin Heavy Chains Proteins 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000001963 growth medium Substances 0.000 claims 1
- 208000015181 infectious disease Diseases 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000000813 microbial effect Effects 0.000 claims 1
- 108020004707 nucleic acids Proteins 0.000 claims 1
- 102000039446 nucleic acids Human genes 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
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- C—CHEMISTRY; METALLURGY
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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
- C07K16/2803—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 immunoglobulin superfamily
- C07K16/2809—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 immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
- C07K16/1036—Retroviridae, e.g. leukemia viruses
- C07K16/1045—Lentiviridae, e.g. HIV, FIV, SIV
- C07K16/1063—Lentiviridae, e.g. HIV, FIV, SIV env, e.g. gp41, gp110/120, gp160, V3, PND, CD4 binding site
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- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
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- 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
- C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
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- C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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- 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
- G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
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- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
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- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6872—Intracellular protein regulatory factors and their receptors, e.g. including ion channels
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- 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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- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
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Claims (25)
1. Humanizirano protutijelo koja se veže na ljudski CD3, naznačeno time, da navedeno protutijelo obuhvaća područje vezanja koje sadrži varijabilno područje teškog lanca (VH) od SEQ ID br. 6 i varijabilno područje lakog lanca (VL) od SEQ ID br. 10.
2. Protutijelo prema patentnom zahtjevu 1, naznačeno time, da to protutijelo je protutijelo pune duljine.
3. Protutijelo prema patentnom zahtjevu 1 ili 2, naznačeno time, da Fc područje obuhvaća teške lance jednog izotipa koji je odabran iz skupine koju čine IgG1, IgG2, IgG3 i IgG4.
4. Protutijelo prema bilo kojem od prethodnih patentnih zahtjeva, naznačeno time, da navedeno protutijelo obuhvaća Fc područje koje sadrži prvi i drugi imunoglobulinski teški lanac, pri čemu su u navedenom prvom i drugom teškom lancu, aminokiseline na pozicijama koje odgovaraju pozicijama L234, L235 i D265 u ljudskom IgG1 teškom lancu, F, E odnosno A, dok su aminokiseline na pozicijama koje odgovaraju za N297 i P331 u ljudskom IgG1 teškom lancu, N odnosno P, gdje su aminokiselinske pozicije numerirane u skladu s EU sustavom numeriranja.
5. Protutijelo prema patentnom zahtjevu 4, naznačeno time, da ono obuhvaća konstantna područja teškog lanca od SEQ ID br. 16.
6. Protutijelo prema patentnom zahtjevu 4, naznačeno time, da ono obuhvaća konstantna područja teškog lanca od SEQ ID br. 25.
7. Protutijelo prema patentnom zahtjevu 4, naznačeno time, da ono obuhvaća konstantna područja teškog lanca od SEQ ID br. 26.
8. Bispecifično protutijelo, naznačeno time, da ono obuhvaća prvo područje vezanja protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 3, i drugo područje vezanja koje se veže na neki drugi cilj različit nego od navedenog prvog područja vezanja.
9. Bispecifično protutijelo prema patentnom zahtjevu 8, naznačeno time, da navedeno protutijelo obuhvaća prvi i drugi teški lanac.
10. Bispecifično protutijelo prema patentnom zahtjevu 9, naznačeno time, da navedeno bispecifično protutijelo obuhvaća Fc područje koje je modificirano u skladu s bilo kojim od patentnih zahtjeva 4 do 7.
11. Bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 8 do 10, naznačeno time, da svaki od navedenih prvog i drugog teškog lanca, obuhvaća najmanje jedno zglobno područje, naime područje CH2 i CH3, pri čemu je u navedenom prvom teškom lancu, najmanje jedna od aminokiselina, na pozicijama koje odgovaraju pozicijama odabranima iz skupine koju čine T366, L368, K370, D399, F405, Y407 i K409 u ljudskom IgG1 teškom lancu, supstituirana, i u navedenom drugom teškom lancu je najmanje jedna od aminokiselina, na pozicijama koje odgovaraju pozicijama odabranima iz skupine koju čine T366, L368, K370, D399, F405, Y407 i K409 u ljudskom IgG1 teškom lancu, supstituirana, te time, da navedeni prvi i navedeni drugi teški lanac, nisu pritom supstituirani na istim pozicijama.
12. Bispecifično protutijelo prema patentnom zahtjevu 11, naznačeno time, da aminokiselina na poziciji koja odgovara za F405 u ljudskom IgG1 teškom lancu, predstavlja L u navedenom prvom teškom lancu, i aminokiselina na poziciji koja odgovara za K409 u ljudskom IgG1 teškom lancu, predstavlja R u navedenom drugom teškom lancu, ili je obrnuto.
13. Bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 9 do 12, naznačeno time, da je navedeno prvo područje vezanja u skladu s patentnim zahtjevom 1, i navedeno drugo područje vezanja se veže na cilj koji je različit nego od navedenog prvog područja vezanja.
14. Konstrukt nukleinske kiseline, naznačen time, da kodira varijabilno područje teškog lanca (VH) od SEQ ID br. 6 i varijabilno područje lakog lanca (VL) od SEQ ID br. 10.
15. Vektor ekspresije, naznačen time, da on obuhvaća sljedeće:
(i) sekvencu nukleinske kiseline koja kodira sekvencu teškog lanca od humaniziranog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 13; i
(ii) sekvencu nukleinske kiseline koja kodira sekvencu lakog lanca od humaniziranog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 13.
16. Stanica domaćina, naznačena time, da ona obuhvaća vektor ekspresije prema patentnom zahtjevu 15, ili jedan vektor ekspresije koji sadrži sekvencu nukleinske kiseline koja kodira sekvencu teškog lanca od humaniziranog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 13 i jedan vektor ekspresije koji sadrži sekvencu nukleinske kiseline koja kodira sekvencu lakog lanca od humaniziranog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 13.
17. Stanica domaćina prema patentnom zahtjevu 16, naznačena time, da je navedena stanica domaćina rekombinantna eukariotska, rekombinantna prokariotska, ili rekombinantna mikrobna stanica domaćina.
18. Pripravak, naznačen time, da obuhvaća protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 7, ili bispecifično protutijelo u skladu s bilo kojim od patentnih zahtjeva 8 do 13.
19. Farmaceutski pripravak, naznačen time, da obuhvaća protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 7, ili bispecifično protutijelo u skladu s bilo kojim od patentnih zahtjeva 8 do 13 i jedan farmaceutski prihvatljiv nosač.
20. Protutijelo prema bilo kojem od patentnih zahtjeva 1 do 7, navedeno bispecifično protutijelo u skladu s bilo kojim od patentnih zahtjeva 8 do 13, navedeni pripravak u skladu s patentnim zahtjevom 18, ili navedeni farmaceutski pripravak u skladu s patentnim zahtjevom 19, naznačeni time, da se upotrebljavaju kao lijek.
21. Protutijelo prema bilo kojem od patentnih zahtjeva 1 do 7, navedeno bispecifično protutijelo u skladu s bilo kojim od patentnih zahtjeva 8 do 13, navedeni pripravak u skladu s patentnim zahtjevom 18, ili navedeni farmaceutski pripravak u skladu s patentnim zahtjevom 19, naznačeni time, da se upotrebljavaju u liječenju bolesti.
22. Protutijelo, bispecifično protutijelo, pripravak ili farmaceutski pripravak, za uporabu u skladu s patentnim zahtjevom 21, naznačeni time, da se kod bolesti radi o raku, infektivnoj bolesti ili autoimunoj bolesti.
23. Postupak za proizvodnju protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 7, ili bispecifičnog protutijela u skladu s bilo kojim od patentnih zahtjeva 8 do 13, naznačen time, da obuhvaća sljedeće korake:
a) kultiviranje stanice domaćina u skladu s patentnim zahtjevom 16 ili 17; i
b) pročišćavanje navedenog protutijela iz medija za uzgoj.
24. Postupak za otkrivanje prisutnosti antigena CD3, ili stanice koja eksprimira CD3, u jednom uzorku, naznačen time, da obuhvaća sljedeće korake:
a) dovođenje uzorka u doticaj s protutijelom u skladu s bilo kojim od patentnih zahtjeva 1 do 7, ili s bispecifičnim protutijelom u skladu s bilo kojim od patentnih zahtjeva 8 do 13, pod uvjetima koji dopuštaju stvaranje kompleksa između navedenog protutijela ili navedenog bispecifičnog protutijela i CD3; i
b) analiziranje stanja o tome da li se je kopleks ostvario.
25. Komplet za otkrivanje prisutnosti antigena CD3, ili stanice koja eksprimira CD3, u jednom uzorku, naznačen time, da obuhvaća sljedeće:
i) protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 7, ili bispecifično protutijelo u skladu s bilo kojim od patentnih zahtjeva 8 do 13; i
ii) upute za uporabu navedenog kompleta.
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PCT/EP2013/064330 WO2014006217A1 (en) | 2012-07-06 | 2013-07-05 | Dimeric protein with triple mutations |
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PCT/EP2014/050340 WO2014108483A1 (en) | 2013-01-10 | 2014-01-09 | Inert format |
EP14737200.7A EP3016681B1 (en) | 2013-07-05 | 2014-07-04 | Humanized or chimeric cd3 antibodies |
PCT/EP2014/064326 WO2015001085A1 (en) | 2013-07-05 | 2014-07-04 | Humanized or chimeric cd3 antibodies |
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