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RU2018102103A - Терапия и диагностика на основе белков тау-опосредуемой патологии при болезни альцгеймера - Google Patents

Терапия и диагностика на основе белков тау-опосредуемой патологии при болезни альцгеймера Download PDF

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RU2018102103A
RU2018102103A RU2018102103A RU2018102103A RU2018102103A RU 2018102103 A RU2018102103 A RU 2018102103A RU 2018102103 A RU2018102103 A RU 2018102103A RU 2018102103 A RU2018102103 A RU 2018102103A RU 2018102103 A RU2018102103 A RU 2018102103A
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peptide
immunogenic peptide
composition
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RU2018102103A
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RU2018102103A3 (ru
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Михал НОВАК
Ева КОНТСЕКОВА
Бранислав КОВАЧЕХ
Норберт ЖИЛКА
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Аксон Ньюросайенс Се
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Claims (40)

1. Иммуногенный пептид, имеющий последовательность SEQ ID NO: 108.
2. Иммуногенный пептид по п.1, также содержащий дополнительный цистеин.
3. Иммуногенный пептид по п.2, где указанный пептид имеет последовательность, представленную SEQ ID NO: 218.
4. Иммуногенный пептид по любому из пп.1-3, где указанный пептид связан с носителем путем химического сшивания.
5. Иммуногенный пептид по п.4, где носитель конъюгирован с иммуногенным пептидом посредством N-сукцинимидил-3-(2-пиридилтио)пропионата (SPDP) или сукцинимидил-4-(N-малеимидометил)циклогексан-1-карбоксилата (SMCC), или N-[?-малеимидобутирилокси]сукцинимидного сложного эфира (GMBS).
6. Иммуногенный пептид по п.4, где указанный носитель представляет собой гемоцианин лимфы улитки (KLH).
7. Композиция, содержащая (1) иммуногенный пептид по любому из пп.1-6 и (2) фармацевтически приемлемый эксципиент.
8. Композиция по п.7, дополнительно содержащая адъювант.
9. Композиция по п.8, в которой указанный адъювант представляет собой соль алюминия.
10. Композиция по любому из пп.7-9, дополнительно содержащая фармацевтически приемлемый носитель, выбранный из группы, состоящей из белков, полисахаридов, таких как хитозан, полимолочных кислот, полигликолевых кислот и сополимеров (например, функционализированной латексом сефарозы, агарозы, целлюлозы, и т.п.), полимерных аминокислот, сополимеров аминокислот и агрегатов липидов (например, масляных капель или липосом).
11. Изделие для фармацевтического или диагностического применения, содержащее упаковочный материал и контейнер, содержащий раствор или лиофилизированную форму иммуногенного пептида по любому из пп.1-6.
12. Изделие по п.11, где контейнер является компонентом устройства или системы для доставки антитела индивидууму.
13. Медицинское устройство, содержащее иммуногенный пептид по любому из пп.1-6, где устройство пригодно для контактирования или введения антитела по меньшей мере одним путем, выбранным из парентерального, подкожного, внутримышечного, внутривенного, внутрисуставного, внутрибронхиального, внутрибрюшного, внутрикапсулярного, внутрихрящевого, внутриполостного, осуществляемого внутрь брюшной полости, внутримозжечкового, интрацеребровентрикулярного, интратекального, внутритолстокишечного, интрацервикального, внутрижелудочного, внутрипеченочного, интрамиокардиального, внутрикостного, внутритазового, внутриперикардиального, внутрибрюшинного, внутриплеврального, внутрипростатического, внутрилегочного, внутриректального, внутрипочечного, интраретинального, внутрипозвоночного, интрасиновиального, внутригрудного, внутриматочного, внутрипузырного, внутриочагового, болюсного, вагинального, ректального, буккального, сублингвального, интраназального и трансдермального.
14. Способ индуцирования иммунного ответа на патологический тау у индивидуума, включающий введение иммуногенного пептида по любому из пп.1-6 или композиции по любому из пп.7-10.
15. Способ по п.14, где указанный иммунный ответ включает образование антител к пептиду по пп.1-3.
16. Способ лечения болезни Альцгеймера или родственных таупатий, включающий введение иммуногенного пептида по любому из пп.1-6 или композиции по любому из пп.7-10.
17. Способ по п.15, где указанные антитела способны:
распознавать один или несколько эпитопов, которые представляют собой или имитируют эпитопы выделенного антитела, при этом указанное выделенное антитело содержит:
вариабельную область легкой цепи антитела, содержащую:
QSLLNSRTRKNY (SEQ ID NO: 117) для CDR1;
ii. WAS (SEQ ID NO: 118) для CDR2; и
iii. KQSFYLRT (SEQ ID NO: 119) для CDR3; и
b) вариабельную область тяжелой цепи антитела, содержащую:
iv. GYIFTDYVIS (SEQ ID NO: 120) для CDR1;
v. IFPRSGST (SEQ ID NO: 121) для CDR2; и
vi. ARDYYGTSFAMDY (SEQ ID NO: 122) для CDR3.
(ii) различать патологический белок тау и нормальный белок тау; и/или
(iii) распознавать нейрофибриллярные очаги в головном мозге человека при AD и/или в моделях AD на трансгенных крысах.
18. Способ по любому из пп.16 или 17, где патологическая агрегация тау-тау ингибирована.
19. Способ по любому из пп.14-17, где указанный пептид или композицию вводят парентеральным, местным, внутрикожным, внутривенным, пероральным, подкожным, внутрибрюшинным, интраназальным или внутримышечным путем.
20. Способ по п.19, где указанный пептид или композицию вводят подкожно или внутримышечной инъекцией.
21. Способ по любому из пп.14-17 и 20, где количество вводимого пептида составляет от 1 мг до 10 мг.
22. Способ по любому из пп.14-17 и 20, где количество вводимого пептида составляет от 1 мкг до 500 мг на инъекцию.
23. Способ по любому из пп.14-17 и 20, где указанный пептид или композицию вводят с несколькими интервалами во множестве дозировок, одинаковых или различных, в течение периода по меньшей мере 6 месяцев.
24. Способ по любому из пп.14-17 и 20, дополнительно включающий стадию определения уровней костимулирующей молекулы CD28 на CD8+ T-клетках до введения указанного пептида или композиции.
25. Способ по любому из пп.14-17 и 20, где применение способно смягчить по меньшей мере один из симптомов, ассоциированных с болезнью Альцгеймера или родственной таупатией у индивидуума.
26. Способ по любому из пп.14-17 и 20, где применение способно уменьшить двигательное нарушение, улучшить двигательную функцию, уменьшить когнитивное нарушение, улучшить когнитивную функцию или осуществлять комбинацию перечисленного.
27. Способ по любому из пп.14-17 и 20, дополнительно включающий стадию оценки эффективности лечения.
28. Способ по любому из пп.14-17 и 20, где оценку эффективности лечения проводят посредством оценки уровней одной или нескольких патологических форм белка тау, выведения патологического тау из головного мозга и/или CSF; показателей когнитивной деятельности; исследований двигательной функции; исследования осуществления основных видов активности повседневной жизни (ADL); и снижения тяжести/степени нарушения силы сжатия при AD, двигательной активности и апраксии, снижения памяти, афазии, агнозии, дезориентации во времени и пространстве и депрессии.
29. Способ по любому из пп.14-17 и 20, где применение способно уменьшить по меньшей мере один симптом болезни Альцгеймера, выбранный из прогрессирующего ухудшения памяти, снижения когнитивных способностей, нарушения речи, изменениями поведения, психологическими симптомами, расстройства настроения, эмоций, аппетита, цикла сна и пробуждения, спутанности сознания, тревожного возбуждения, депрессии, нарушения двигательной функции, апраксии, миоклонуса, нарушения походки, сниженной силы мышц, экстрапирамидальных признаков, брадикинезии, ригидности, тремора в состоянии покоя, нарушения осуществления основных видов активности повседневной жизни и дезориентации.
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