HRP20140661T1 - Apoptotiäśka protutijela anti-ige koja vežu ige spojen s membranom - Google Patents
Apoptotiäśka protutijela anti-ige koja vežu ige spojen s membranom Download PDFInfo
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- HRP20140661T1 HRP20140661T1 HRP20140661AT HRP20140661T HRP20140661T1 HR P20140661 T1 HRP20140661 T1 HR P20140661T1 HR P20140661A T HRP20140661A T HR P20140661AT HR P20140661 T HRP20140661 T HR P20140661T HR P20140661 T1 HRP20140661 T1 HR P20140661T1
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- 230000001640 apoptogenic effect Effects 0.000 title claims 3
- 239000012528 membrane Substances 0.000 title 1
- 239000005557 antagonist Substances 0.000 claims 18
- 108090000765 processed proteins & peptides Proteins 0.000 claims 9
- 125000003275 alpha amino acid group Chemical group 0.000 claims 8
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 8
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- VZQHRKZCAZCACO-PYJNHQTQSA-N (2s)-2-[[(2s)-2-[2-[[(2s)-2-[[(2s)-2-amino-5-(diaminomethylideneamino)pentanoyl]amino]propanoyl]amino]prop-2-enoylamino]-3-methylbutanoyl]amino]propanoic acid Chemical compound OC(=O)[C@H](C)NC(=O)[C@H](C(C)C)NC(=O)C(=C)NC(=O)[C@H](C)NC(=O)[C@@H](N)CCCNC(N)=N VZQHRKZCAZCACO-PYJNHQTQSA-N 0.000 claims 3
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- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 claims 3
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- C07K16/4283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
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- A01K67/00—Rearing or breeding animals, not otherwise provided for; New or modified breeds of animals
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Claims (33)
1. Protutijelo anti-IgE/M1’ koje specifično veže epitop u segmentu M1’ od IgE, naznačeno time, da je definirano pomoću ostataka od 317 do 351 iz SEQ ID NO:1, te inducira apoptozu u B-stanicama koje izražavaju IgE.
2. Protutijelo prema zahtjevu 1, naznačeno time, da protutijelo ima sposobnost vezanja IgE koji je podrijetlom od čovjeka, od zamoraca rezus majmuna ili od Javanskog majmuna.
3. Protutijelo prema zahtjevu 1 ili zahtjevu 2, naznačeno time, da protutijelo specifično iscrpljuje proizvodnju B-stanica koje proizvode IgE, kada se terapeutski djelotvorna količina primjenjuje na sisavcu in vivo i po želji se smanjuje ukupni IgE-serum ili se smanuje slobodni IgE-serum; pri čemu je IgE po potrebi alergenski specifičan.
4. Protutijelo prema zahtjevu 3, naznačeno time, da je ono kimerno, humanizirano ili ljudsko.
5. Protutijelo prema jednom od prethodnih zahtjeva, naznačeno time, da se specifično veže na isti epitop koji je spojen pomoću protutijela odabranog iz skupine koju čine: 47H4 (ATTC Dep. br. PTA-8270), 7A6 (ATTC Dep. br. PTA-8268), 26A11 (ATTC Dep. br. PTA-8262), 47H4v5 koji sadrži amino kiselinsku sekvencu varijabilnog slabog lanca, prikazanu u SEQ ID NO:31 (Sl. 6C) i amino kiselinsku sekvencu varijabilnog jakog lanca, prikazanu u SEQ ID NO:41 (Sl. 6F), 7A6v1 koji sadrži amino kiselinsku sekvencu varijabilnog slabog lanca, prikazanu u SEQ ID NO:28 (Sl. 6B) i amino kiselinsku sekvencu varijabilnog jakog lanca, prikazanu u SEQ ID NO:37 (Sl. 6E), i 26A11v6 koji sadrži amino kiselinsku sekvencu varijabilnog slabog lanca, prikazanu u SEQ ID NO:24 (Sl. 6A) te amino kiselinsku sekvencu varijabilnog jakog lanca, prikazanu u SEQ ID NO:35 (Sl. 6D).
6. Protutijelo prema zahtjevu 5, naznačeno time, da epitop odgovara peptidu koji je odabran iz skupine koju čine: peptid 4 (SEQ ID NO:8), peptid 5 (SEQ ID NO:9), peptid 7 (SEQ ID NO:11) ili peptid 8 (SEQ ID NO:12), te time da po želji epitop odgovara peptidu 4 (SEQ ID NO:8).
7. Protutijelo prema jednom od prethodnih zahtjeva, naznačeno time, da se spaja sa Scatchard-afinitetom vezivanja koji odgovara onom od mišjeg anti-IgE/M1’ protutijela 47H4 (ATTC Dep. br. PTA-8270), dok je afinitet po želji od 0,30 do 0,83 nm.
8. Protutijelo prema jednom od prethodnih zahtjeva, naznačeno time, da se specifično spaja na M1’ segment od IgE sa Scatchard-afinitetom vezivanja, koji odgovara onom od humaniziranog anti-IgE/M1’ protutijela 47H4v5 koje sadrži amino kiselinsku sekvencu varijabilnog slabog lanca prikazanu u SEQ ID NO:31 (Sl. 6C) i koje sadrži amino kiselinsku sekvencu varijabilnog jakog lanca prikazanu u SEQ ID NO:41 (Sl. 6F), dok je afinitet po želji oko 1,5 nm.
9. Protutijelo prema jednom od prethodnih zahtjeva, naznačeno time, da sadrži HVRs jakog lanca i slabog lanca od protutijela ili njegovog fragmenta koje/i veže antigen, odabrane iz skupine koju čine: 26A11 prikazano u SEQ ID NO:21 (Sl. 6A) i SEQ ID NO:33 (Sl. 6D), 26A11v.1-16 prikazano u SEQ ID NO:22 do SEQ ID NO:26 (Sl. 6A) i SEQ ID NO:34 i SEQ ID NO:35 (Sl. 6D), 7A6 prikazano u SEQ ID NO:27 (Sl. 6B) i SEQ ID NO:36 (Sl. 6E), 7A6v1 prikazano u SEQ ID NO:28 (Sl. 6B) i SEQ ID NO:37 (Sl. 6E), 47H4 prikazano u SEQ ID NO:29 (Sl. 6C) i SEQ ID NO:38 (Sl. 6F), i 47H4v1-6 prikazano u SEQ ID NO:30 i SEQ ID NO:31 (Sl. 6C) i SEQ ID NO:39 do SEQ ID NO:42 (Sl. 6F), te po želji sadrži HVRs jakog i slabog lanca ili protutijelo ili njegov fragment, koje/i veže antigen od 47H4v1-6 kako je prikazano u SEQ ID NO:30 i SEQ ID NO:31 (Sl. 6C) te SEQ ID NO:39 do SEQ ID NO:42 (Sl. 6F).
10. Protutijelo prema zahtjevu 9, naznačeno time, da obuhvaća varijabilna područja jakog i slabog lanca od protutijela ili njegovog fragmenta, koje/i veže antigen, odabranih iz skupine koju čine: 26A11 prikazano u SEQ ID NO:21 (Sl. 6A) i SEQ ID NO:33 (Sl. 6D), 26A11v.1-16 prikazano u SEQ ID NO:22 do SEQ ID NO:26 (Sl. 6A) i SEQ ID NO:34 i SEQ ID NO:35 (Sl. 6D), 7A6 prikazano u SEQ ID NO:27 (Sl. 68) i SEQ ID NO:36 (Sl. 6E), 7A6v1 prikazano u SEQ ID NO:28 (Sl. 6B) i SEQ ID NO:37 (Sl. 6E), 47H4 prikazano u SEQ ID NO:29 (Sl. 6C) i SEQ ID NO:38 (Sl. 6F), i 47H4v1-6 prikazano u SEQ ID NO:30 i SEQ ID NO:31 (Sl. 6C) te SEQ ID NO:39 do SEQ ID NO:42 (Sl. 6F).
11. Protutijelo prema zahtjevu 9, naznačeno time, da je afukosilirano.
12. Peptid, naznačen time, da je peptid odabran iz skupine koju čine: peptid 4 (SEQ ID NO:8), peptid 5 (SEQ ID NO:9), peptid 7 (SEQ ID NO:11) ili peptid 8 (SEQ ID NO:12).
13. Sastav, naznačen time, da obuhvaća protutijelo prema bilo kojem zahtjevu od 1 do 11, u kombinaciji s barem jednim farmaceutski prihvatljivim nosačem.
14. Sastav prema zahtjevu 13, naznačen time, da nadalje obuhvaća jedan ili više lijekova odabranih iz skupine koju čine: protutijelo anti-IgE, antihistamin, bronhodilator, glukokortikoid, NSAID, TNF-antagonist, integrinski antagonist, imunosupresivno sredstvo, IL-4-antagonist, IL-13-antagonist, dvojni IL-4/IL-13-antagonist, DMARD, protutijelo koje se veže na površinski marker B-stanice i BAFF-antagonist.
15. Izolirana nukleinska kiselina, naznačena time, da kodira protutijelo ili njegov fragment koji veže antigen, pri čemu sadrži HVRs jakog i slabog lanca od apoptotičkog anti-IgE/M1’ protutijela ili njegovog fragmenta koji veže antigen, odabrane iz skupine koju čine: 26A11 prikazano u SEQ ID NO:21 (Sl. 6A) i SEQ ID NO:33 (Sl. 6D), 26A11 v1-16 prikazano u SEQ ID NO:22 do SEQ ID NO:26 (Sl. 6A) i SEQ ID NO:34 i SEQ ID NO:35 (Sl. 6D), 7A6 prikazano u SEQ ID NO:27 (Sl. 6B) i SEQ ID NO:36 (Sl. 6E), 7A6v1 prikazano u SEQ ID NO:28 (Sl. 6B) i SEQ ID NO:37 (Sl. 6E), 47H4 prikazano u SEQ ID NO:29 (Sl. 6C) i SEQ ID NO:38 (Sl. 6F), te 47H4v1-6 prikazano u SEQ ID NO:30 i SEQ ID NO:31 (Sl. 6C) te SEQ ID NO:39 do SEQ ID NO:42 (Sl. 6F).
16. Nukleinska kiselina prema zahtjevu 15, naznačena time, da nadalje obuhvaća nukleinsku kiselinu koja kodira varijabilna područja jakog i slabog lanca od sekvence protutijela odabrane iz skupine koju čine: 26A11 prikazano u SEQ ID NO:21 (Sl. 6A) i SEQ ID NO:33 (Sl. 6D), 26A11v1-16 prikazano u SEQ ID NO:22 do SEQ ID NO:26 (Sl. 6A) i SEQ ID NO: 34 i SEQ ID NO:35 (Sl. 6D), 7A6 prikazano u SEQ ID NO:27 (Sl. 6B) i SEQ ID NO:36 (Sl. 6E), 7A6v1 prikazano u SEQ ID NO:28 (Sl. 6B) i SEQ ID NO:37 (Sl. 6E), 47H4 prikazano u SEQ ID NO:29 (Sl. 6C) i SEQ ID NO:38 (Sl. 6F), te 47H4v1-6 prikazano u SEQ ID NO:30 i SEQ ID NO:31 (Sl. 6C) i SEQ ID NO:39 do SEQ ID NO:42 (Sl. 6F).
17. Nukleinska kiselina prema zahtjevu 16, naznačena time, da kodirano protutijelo je afukosilirano.
18. Vektor, naznačen time, da je u njemu operativno spojena nukleinska kiselina prema bilo kojem zahtjevu od 15 do 17.
19. Stanica domaćina, naznačena time, da ona sadrži vektor prema zahtjevu 18.
20. Stanica domaćina prema zahtjevu 19, naznačena time, da je od sisavca, i poželjno je iz jajnika kineskog hrčka.
21. Postupak za proizvodnju apoptotičnog anti-IgE/M1’ protutijela ili njegovog funkcionalnog fragmenta, naznačen time, da obuhvaća kultiviranje stanice domaćina prema zahtjevu 19 ili zahtjevu 20, koje se provodi u prikladnim uvjetima za ekspresiju protutijela ili fragmenta, te obnavljanje protutijela ili fragmenta.
22. Predmet proizvodnje, naznačen time, da obuhvaća sastav prema zahtjevu 13 ili zahtjevu 14 i umetak u pakiranju koji navodi upute za uporabu u liječenju poremećaja posredovanih s IgE.
23. Proizvod prema zahtjevu 22, naznačen time, da je to (i) fijala, ili (ii) pred-napunjena štrcaljka, te po želji nadalje obuhvaća injekcijsku napravu, kao što je primjerice samoinjektor.
24. Protutijelo prema bilo kojem zahtjevu od 1 do 11, naznačeno time, da se upotrebljava u postupku za specifično iscrpljivanje B-stanica koje proizvode IgE, gdje postupak obuhvaća primjenu terapeutski djelotvorne količine spomenutog anti-IgE/M1’ protutijela na sisavcu, pri čemu protutijelo po želji ima ADCC-djelotvornost.
25. Protutijelo prema bilo kojem zahtjevu od 1 do 11, naznačeno time, da se upotrebljava u postupku liječenja poremećaja posredovanog s IgE, gdje postupak obuhvaća primjenu terapeutski djelotvorne količine spomenutog anti-IgE/M1’ protutijela.
26. Protutijelo za uporabu prema zahtjevu 25, naznačeno time, da:
(i) je poremećaj, koji je posredovan s IgE, odabran iz skupine koju čine: alergijski rinitis, alergijska astma, nealergijska astma, atopički dermatitis, alergijska gastroenteropatija, anafilaksa, urtikarija, alergije na hranu, alergijska bronhopulmonarna aspergiloza, parazitne bolesti, intersticijski cistitis, hiper-IgE-sindrom, ataxia-telangiectasia, sindrom Wiskott-Aldrich, atimična limfoplazija, IgE mijelom, reakcija usatka protiv stanice domaćina i alergijska purpura, i/ili
(ii) je protutijelo za primjenu u kombinaciji s terapeutski djelotvornom količinom barem jednog lijeka odabranog iz skupine koju čine: protutijelo anti-IgE, antihistamin, bronhodilator, glukokortikoid, NSAID, dekongestant, sredstvo za obuzdavanje kašlja, analgetik, TNF-antagonist, integrinski antagonist, imunosupresivno sredstvo, IL-4-antagonist, IL-13-antagonist, dvojni IL-4/IL-13-antagonist, DMARD, protutijelo koje se veže na površinski marker B-stanice i BAFF-antagonist; i/ili
(iii) je protutijelo za primjenu u kombiniranom režimu liječenja koje obuhvaća primjenu terapeutski djelotvorne količine spomenutog anti-IgE/M1’ protutijela, prije, istovremeno ili nakon primjene poznatog postupka liječenja za alergijske poremećaje.
27. Protutijelo za uporabu prema zahtjevu 25 (iii), naznačeno time, da:
(a) poznati postupak liječenja alergijskih poremećaja obuhvaća primjenu protutijela anti-IgE, antihistamina, bronhodilatora, glukokortikoida, nesteroidnog protuupalnog lijeka, imunosupresanta, IL-4-antagonista, IL-13-antagonista, dvojnog IL-4/IL-13-antagonista, sredstva protiv zagušenja, sredstva za obuzdavanje kašlja ili analgetika; ili
(b) poznato liječenje za alergijske poremećaje obuhvaća režim liječenja alergijskom desenzibilizacijom.
28. Protutijelo za uporabu prema zahtjevima od 24 do 27, naznačeno time, da se upotrebljava u postupku za sprečavanje ili smanjivanje proizvodnje alergijski induciranog IgE.
29. Uporaba protutijela prema bilo kojem zahtjevu od 1 do 11, naznačena time, da je za proizvodnju lijeka za liječenje poremećaja posredovanog s IgE.
30. Uporaba prema zahtjevu 29, naznačena time, da:
(i) je poremećaj posredovan s IgE odabran iz skupine koju čine: alergijski rinitis, alergijska astma, nealergijska astma, atopički dermatitis, alergijska gastroenteropatija, anafilaksa, urtikarija, alergije na hranu, alergijska bronhopulmonarna aspergiloza, parazitne bolesti, intersticijski cistitis, hiper-IgE-sindrom, ataxia-telangiectasia, sindrom Wiskott-Aldrich, atimijska limfoplazija, IgE mijelom, reakcija usatka protiv stanice domaćina i alergijska purpura; i/ili
(ii) je protutijelo za primjenu u kombinaciji s terapeutski djelotvornom količinom barem jednog lijeka odabranog iz skupine koju čine: protutijelo anti-IgE, antihistamin, bronhodilator, glukokortikoid, NSAID, dekongestant, sredstvo za obuzdavanje kašlja, analgetik, TNF-antagonist, integrinski antagonist, imunosupresivno sredstvo, IL-4- antagonist, IL-13-antagonist, dvojni IL-4/IL-13-antagonist, DMARD, protutijelo koje se veže na površinski marker B-stanice i BAFF-antagonist.
31. Mišji hibridom deponiran pod ATCC dana 21. ožujka 2007, naznačen time, da je odabran iz skupine koju čine: PTA-8260, PTA-8261, PTA-8262, PTA-8263, PTA-8264, PTA-8265, PTA-8266, PTA-8267, PTA-8268, PTA-8269, PTA-8270.
32. Protutijelo, naznačeno time, da je to sekret hibridoma prema zahtjevu 31.
33. Transgenska životinja, naznačena time, da izražava humani segment M1’ od IgE, koji sadrži ostatke od 317 do 351 iz SEQ ID NO:1.
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| PCT/US2008/057819 WO2008116149A2 (en) | 2007-03-22 | 2008-03-21 | Apoptotic anti- ige antibodies binding the membrane-bound ige |
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