RU2008126241A - Моноклональные антитела и их применения - Google Patents
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Abstract
1. Изолированное антитело, которое связывается с большей специфичностью с глобуломером белка амилоида-бета (Aβ), чем с мономером белка амилоида-бета. ! 2. Изолированное антитело по п.1, в котором указанное антитело является моноклональным. ! 3. Изолированное антитело по п.2, в котором отношение специфичности связывания с указанным глобуломером и указанным мономером составляет по меньшей мере 1,4. ! 4. Изолированное антитело по п.3, в котором указанное отношение составляет от 1,4 до 16,9. ! 5. Изолированное антитело по п.4, в котором указанный мономер белка амилоида-бета выбран из группы, состоящей из мономера Aβ(1-42) и мономера Aβ(1-40). ! 6. Изолированное антитело по п.5, в котором указанное моноклональное антитело продуцируется гибридомой, имеющей номер PTA-7238 или PTA-7407 в Американской коллекции типовых культур. ! 7. Гибридома, имеющая номер PTA-7238 в Американской коллекции типовых культур. ! 8. Моноклональное антитело (8F5), продуцируемое указанной гибридомой по п.7. ! 9. Моноклональное антитело, содержащее вариабельную тяжелую цепь, кодируемую последовательностью SEQ ID NO: 1. ! 10. Моноклональное антитело по п.9, в котором указанное антитело является человеческим или гуманизированным. ! 11. Моноклональное антитело, содержащее вариабельную легкую цепь, кодируемую последовательностью SEQ ID NO: 2. ! 12. Моноклональное антитело по п.11, в котором указанное антитело является человеческим или гуманизированным. ! 13. Моноклональное антитело по п.11, дополнительно содержащее вариабельную тяжелую цепь, кодируемую последовательностью SEQ ID NO: 1. ! 14. Моноклональное антитело по п.13, в котором указанное антитело является человеческим или гуманизированным. ! 15. Моноклонально�
Claims (56)
1. Изолированное антитело, которое связывается с большей специфичностью с глобуломером белка амилоида-бета (Aβ), чем с мономером белка амилоида-бета.
2. Изолированное антитело по п.1, в котором указанное антитело является моноклональным.
3. Изолированное антитело по п.2, в котором отношение специфичности связывания с указанным глобуломером и указанным мономером составляет по меньшей мере 1,4.
4. Изолированное антитело по п.3, в котором указанное отношение составляет от 1,4 до 16,9.
5. Изолированное антитело по п.4, в котором указанный мономер белка амилоида-бета выбран из группы, состоящей из мономера Aβ(1-42) и мономера Aβ(1-40).
6. Изолированное антитело по п.5, в котором указанное моноклональное антитело продуцируется гибридомой, имеющей номер PTA-7238 или PTA-7407 в Американской коллекции типовых культур.
7. Гибридома, имеющая номер PTA-7238 в Американской коллекции типовых культур.
8. Моноклональное антитело (8F5), продуцируемое указанной гибридомой по п.7.
9. Моноклональное антитело, содержащее вариабельную тяжелую цепь, кодируемую последовательностью SEQ ID NO: 1.
10. Моноклональное антитело по п.9, в котором указанное антитело является человеческим или гуманизированным.
11. Моноклональное антитело, содержащее вариабельную легкую цепь, кодируемую последовательностью SEQ ID NO: 2.
12. Моноклональное антитело по п.11, в котором указанное антитело является человеческим или гуманизированным.
13. Моноклональное антитело по п.11, дополнительно содержащее вариабельную тяжелую цепь, кодируемую последовательностью SEQ ID NO: 1.
14. Моноклональное антитело по п.13, в котором указанное антитело является человеческим или гуманизированным.
15. Моноклональное антитело, содержащее SEQ ID NO: 3.
16. Моноклональное антитело по п.15, в котором указанное антитело является человеческим или гуманизированным.
17. Моноклональное антитело, содержащее SEQ ID NO: 4.
18. Моноклональное антитело по п.17, в котором указанное антитело является человеческим или гуманизированным.
19. Моноклональное антитело по п.17, дополнительно содержащее SEQ ID NO: 3.
20. Моноклональное антитело по п.19, в котором указанное антитело является человеческим или гуманизированным.
21. Изолированное антитело, которое связывается с большей специфичностью с глобуломером белка амилоида-бета, чем с фибриллой белка амилоида-бета.
22. Изолированное антитело по п.22, в котором указанное антитело является моноклональным.
23. Изолированное антитело по п.23, в котором указанное моноклональное антитело продуцируется гибридомой, имеющей номер PTA-7238 или PTA-7407 в Американской коллекции типовых культур.
24. Гибридома, имеющая номер PTA-7407 в Американской коллекции типовых культур.
25. Моноклональное антитело (8C5), продуцируемое указанной гибридомой по п.24.
26. Моноклональное антитело, содержащее вариабельную тяжелую цепь, кодируемую последовательностью SEQ ID NO: 11.
27. Моноклональное антитело по п.26, в котором указанное антитело является человеческим или гуманизированным.
28. Моноклональное антитело, содержащее вариабельную легкую цепь, кодируемую последовательностью SEQ ID NO: 12.
29. Моноклональное антитело по п.28, в котором указанное антитело является человеческим или гуманизированным.
30. Моноклональное антитело по п.28, дополнительно содержащее вариабельную легкую цепь, кодируемую последовательностью SEQ ID NO: 11.
31. Моноклональное антитело по п.30, в котором указанное антитело является человеческим или гуманизированным.
32. Моноклональное антитело, содержащее SEQ ID NO: 19.
33. Моноклональное антитело по п.32, в котором указанное антитело является человеческим или гуманизированным.
34. Моноклональное антитело, содержащее SEQ ID NO: 20.
35. Моноклональное антитело по п.34, в котором указанное антитело является человеческим или гуманизированным.
36. Моноклональное антитело, содержащее вариабельную тяжелую цепь, при этом указанная вариабельная тяжелая цепь содержит по меньшей мере одну определяющую комплементарность область (CDR), выбранную из группы, состоящей из SEQ ID NO: 13, SEQ ID NO: 14 и SEQ ID NO: 15.
37. Моноклональное антитело, содержащее вариабельную легкую цепь, при этом указанная вариабельная легкая цепь содержит по меньшей мере одну CDR, выбранную из группы, состоящей из SEQ ID NO: 16, SEQ ID NO: 17 и SEQ ID NO: 18.
38. Моноклональное антитело по п.37, дополнительно содержащее вариабельную тяжелую цепь, при этом указанная вариабельная тяжелая цепь содержит по меньшей мере одну CDR, выбранную из группы, состоящей из SEQ ID NO: 13, SEQ ID NO: 14 и SEQ ID NO: 15.
39. Моноклональное антитело, содержащее вариабельную тяжелую цепь, при этом указанная вариабельная тяжелая цепь содержит по меньшей мере одну определяющую комплементарность область (CDR), выбранную из группы, состоящей из SEQ ID NO: 5, SEQ ID NO: 6 и SEQ ID NO: 7.
40. Моноклональное антитело, содержащее вариабельную легкую цепь, при этом указанная вариабельная легкая цепь содержит по меньшей мере одну CDR, выбранную из группы, состоящей из SEQ ID NO: 8, SEQ ID NO: 9 и SEQ ID NO: 10.
41. Моноклональное антитело по п.40, дополнительно содержащее вариабельную тяжелую цепь, при этом указанная вариабельная тяжелая цепь содержит по меньшей мере одну CDR, выбранную из группы, состоящей из SEQ ID NO: 5, SEQ ID NO: 6 и SEQ ID NO: 7.
42. Способ лечения или профилактики болезни Альцгеймера у пациента, нуждающегося в указанном лечении или профилактике, включающий в себя введение указанного изолированного антитела по п.1 или 6 указанному пациенту в количестве, достаточном для осуществления указанного лечения или профилактики.
43. Способ по п.42, в котором указанное изолированное антитело вводят путем, выбранным из группы, состоящей из внутримышечного введения, внутривенного введения и подкожного введения.
44. Способ диагностики болезни Альцгеймера у пациента, предположительно имеющего такое заболевание, включающий в себя стадии
a) выделения биологического образца из организма указанного пациента;
b) осуществления контакта указанного биологического образца с указанным изолированным антителом по п.1 или 6 в течение периода и в условиях, достаточных для образования комплексов антиген/антитело; и
c) выявления присутствия указанных комплексов антиген/антитело в указанном образце, при этом присутствие указанных комплексов свидетельствует о диагнозе болезни Альцгеймера у указанного пациента.
45. Способ по п.44, в котором указанный антиген является глобуломером.
46. Способ диагностики болезни Альцгеймера у пациента, предположительно имеющего такое заболевание, включающий в себя стадии
a) выделения биологического образца из организма указанного пациента;
b) осуществления контакта указанного биологического образца с антигеном в течение периода и в условиях, достаточных для образования комплексов антиген/антитело;
c) добавления конъюгата к полученным в результате комплексам антитело/антиген в течение периода и в условиях, достаточных для обеспечения связывания указанного конъюгата со связанным антителом, при этом указанный конъюгат содержит указанное изолированное антитело по п.1 или 6, связанное с генерирующим сигнал соединением, способным генерировать регистрируемый сигнал; и
d) выявления наличия антитела, которое может присутствовать в указанном биологическом образце, посредством регистрации сигнала, создаваемого указанным генерирующим сигнал соединением, при этом указанный сигнал свидетельствует о диагнозе болезни Альцгеймера у указанного пациента.
47. Способ по п.46, в котором указанный антиген является глобуломером.
48. Способ диагностики болезни Альцгеймера у пациента, предположительно имеющего болезнь Альцгеймера, включающий в себя стадии
a) выделения биологического образца из организма указанного пациента;
b) осуществления контакта указанного биологического образца с анти-антителом, где указанное анти-антитело специфично в отношении указанного антитела по п.1 или 6, в течение периода и в условиях, достаточных для обеспечения образования комплексов анти-антитело/антитело, причем указанные комплексы содержат антитело, присутствующее в указанном биологическом образце;
c) добавления конъюгата к полученным в результате комплексам анти-антитело/антитело в течение периода и в условиях, достаточных для обеспечения связывания указанного конъюгата со связанным антителом, при этом указанный конъюгат содержит антиген, который связывает генерирующее сигнал соединение, способное генерировать регистрируемый сигнал; и
d) выявления сигнала, генерируемого указанным генерирующим сигнал соединением, при этом указанный сигнал свидетельствует о диагнозе болезни Альцгеймера у указанного пациента.
49. Композиция, содержащая указанное изолированное антитело по п.1 или 6.
50. Способ профилактики или лечения болезни Альцгеймера у пациента, нуждающегося в указанной профилактике или лечении, включающий в себя стадию введения указанной композиции по п.49 указанному пациенту в количестве, достаточном для осуществления указанной профилактики или лечения.
51. Вакцина, содержащая указанное изолированное антитело по п.1 или 6 и фармацевтически приемлемый адъювант.
52. Способ профилактики или лечения болезни Альцгеймера у пациента, нуждающегося в указанной профилактике или лечении, включающий в себя стадию введения указанной вакцины по п.51 указанному пациенту в количестве, достаточном для осуществления указанной профилактики или лечения.
53. Способ идентификации соединений, подходящих для активной иммунизации пациента, у которого прогнозируется развитие болезни Альцгеймера, включающий в себя стадии
a) воздействия на одно или несколько представляющих интерес соединений указанным изолированным антителом по п.1 или 6 в течение периода и в условиях, достаточных для связывания указанного одного или нескольких соединений с указанным изолированным антителом по п.1 или 6; и
b) идентификации тех соединений, которые связываются с указанным изолированным антителом по п.1 или 6, при этом указанные идентифицированные соединения используются в активной иммунизации пациента, у которого прогнозируется развитие болезни Альцгеймера.
54. Набор, содержащий a) указанное изолированное антитело по п.1 или 6 и b) конъюгат, содержащий антитело, связанное с генерирующим сигнал соединением, при этом указанное антитело указанного конъюгата отличается от указанного изолированного антитела.
55. Набор, содержащий a) анти-антитело к указанному изолированному антителу по п.1 или 6 и b) конъюгат, содержащий антиген, связанный с генерирующим сигнал соединением.
56. Набор по п.55, в котором указанный антиген является глобуломером.
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