RU2497542C2 - Нацеливание на антигенпрезентирующие клетки иммунонанотерапевтических средств - Google Patents

Нацеливание на антигенпрезентирующие клетки иммунонанотерапевтических средств Download PDF

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RU2497542C2
RU2497542C2 RU2011118878/15A RU2011118878A RU2497542C2 RU 2497542 C2 RU2497542 C2 RU 2497542C2 RU 2011118878/15 A RU2011118878/15 A RU 2011118878/15A RU 2011118878 A RU2011118878 A RU 2011118878A RU 2497542 C2 RU2497542 C2 RU 2497542C2
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composition according
antigen
molecules
binding
density
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Цзиньцзюнь ШИ
Франк АЛЕКСИС
Маттео ИАННАКОНЕ
Эллиотт Эшли МОУЗМАН
Памела БАСТО
Роберт ЛАНГЕР
Омид К. Фарокхзад
АНДРИАН Ульрих ВОН
Елена ТОНТИ
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Массачусетс Инститьют Оф Текнолоджи
Президент Энд Феллоуз Оф Гарвард Колледж
Дзе Брихэм Энд Уимен'З Хоспитал, Инк.
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Abstract

Группа изобретений относится к медицине и касается композиции для индукции иммунной системы, содержащей синтетические наноносители, обладающие по меньшей мере одной поверхностью с иммунными свойствами, образованной множеством молекул, которые обеспечивают высокую авидность и низкую аффиность связывания с антигенпрезентирующими клетками (АРС), и фармацевтически приемлемый наполнитель; способа индукции иммунной системы, включающего введение указанной композиции индивидууму. Группа изобретений обеспечивает направленную доставку к антигенпрезентирующим клеткам при введении индивидууму. 4 н. и 26 з.п. ф-лы, 18 пр., 41 ил.

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Claims (30)

1. Композиция для индукции иммунной системы, содержащая:
(1) синтетические наноносители, обладающие по меньшей мере одной поверхностью с иммунными свойствами, образованной множеством молекул, которые обеспечивают высокую авидность и низкую аффинность связывания с антиген-презентирующими клетками (АРС); и
(2) фармацевтически приемлемый наполнитель.
2. Композиция по п.1, где молекулы поверхности с иммунными свойствами присутствуют с плотностью, равной или превышающей плотность, требуемую для получения по меньшей мере 10% от максимальной иммобилизации, наблюдаемой для моноклонального антитела (MAb) в анализе связывания антиген-презентирующих клеток (АРС), предлагаемая так, что в тесте связывания АРС полумаксимальная плотность связывания для множества молекул превышает по меньшей мере в два раза полумаксимальную плотность связывания для MAb.
3. Композиция по п.2, где молекулы поверхности с иммунными свойствами присутствуют с плотностью, равной или превышающей плотность, требуемую для получения по меньшей мере 20% от максимальной иммобилизации, наблюдаемой для MAb в анализе связывания АРС.
4. Композиция по п.2, где полумаксимальная плотность связывания для множества молекул превышает по меньшей мере в четыре раза полумаксимальную плотность связывания для MAb.
5. Композиция по п.2, где анализ связывания АРС включает:
(a) получение серий субстратов, обладающих покрытиями из функциональных молекул в сериях плотностей покрытия поверхности, где функциональная молекула способна связываться с рецепторами поверхности дендритной клетки (DC) или макрофага субкапсулярного синуса;
(b) экспозицию серий субстратов с суспензиями одиночных клеток DC или макрофагов субкапсулярного синуса в течение предварительно определенного периода времени;
(c) удаление неадгезированных АРС из серий субстратов и фиксацию адгезированных АРС к сериям субстратов;
(d) определение количества адгезированных АРС на единицу площади поверхности для каждого субстрата в сериях субстратов;
(e) графическое представление результата из (d) против плотности покрытия функциональной части;
(f) получение величины максимальной иммобилизации с помощью определения максимального количества адгезированных АРС на единицу площади поверхности для серий субстратов; и
(g) получение величины полумаксимальной плотности связывания путем определения плотности покрытия поверхности, которая обеспечивает 50% от максимума.
6. Композиция по п.2, где MAb выбрано из MAb против CD1c (BDCA-1), клон AD5-8E7, и крысиного антимышиного MAb против CD 169, клон 3D6.112, изотип IgG2a.
7. Композиция по п.1, где поверхность с иммунными свойствами включает антиген В-клеток.
8. Композиция по п.1, где поверхность с иммунными свойствами включает множество различных частей.
9. Композиция по п.1, где поверхность с иммунными свойствами включает одну или более молекул, которые положительно заряжены, отрицательно заряжены или нейтральны, где одна или более молекул находятся в забуференном водном растворе при pH в диапазоне 7,2-7,4.
10. Композиция по п.1, где поверхность синтетических наноносителей дополнительно содержит высокоаффинную молекулу для направленной доставки.
11. Композиция по п.1, где синтетические наноносители дополнительно содержат одно или более иммуностимулирующее средство, иммуномодулирующее средство, антиген В-клеток и антиген Т-клеток.
12. Композиция по п.11, где иммуностимулирующее средство, антиген В-клеток или антиген Т-клеток находятся на: (i) поверхности с иммунными свойствами; (ii) второй поверхности наноносителя; или (iii) инкапсулированы в область ядра наноносителя.
13. Композиция по п.1, где диаметр наноносителей больше 100 нм.
14. Композиция по п.1, где фармацевтически приемлемый наполнитель выбран из растворителей, диспергирующих сред, разбавителей или других жидких носителей, диспергирующих или суспендирующих вспомогательных агентов, поверхностно-активных агентов, изотонических агентов, загустителей или эмульгирующих агентов, консервантов, твердых связующих агентов и смазывающих агентов.
15. Композиция по п.1, где композиция направлена на макрофаг субкапсулярного синуса.
16. Композиция по п.1, где композиция направлена на дендритную клетку.
17. Композиция по п.1, где композиция, по существу, не активирует комплемент.
18. Композиция по п.1, где поверхность с иммунными свойствами состоит, по существу, из молекул, которые не являются гидроксигруппами, активирующими комплемент.
19. Способ индукции иммунной системы, включающий введение первой дозы композиции по п.1 индивидууму.
20. Способ по п.19, дополнительно включающий введение второй дозы композиции индивидууму после интервала, варьирующего от 1 дня до 1 года.
21. Способ по п.20, где интервал варьирует от 1 дня до 1 месяца.
22. Способ по п.20, где интервал варьирует от 1 дня до 1 недели.
23. Способ повышения захвата антигена макрофагом субкапсулярного синуса, включающий введение нуждающемуся в этом индивидууму композиции, содержащей:
(1) синтетический наноноситель, включающий:
(a) по меньшей мере, одну поверхность с иммунными свойствами, которая образована множеством молекул, которые обеспечивают высокую авидность и низкую аффинность связывания с антиген-презентирующими клетками (АРС); и
(b) антиген, где антиген находится на: (i) поверхности с иммунными свойствами; (ii) второй поверхности наноносителя; или (iii) инкапсулирован в область ядра наноносителя; и
(2) фармацевтически приемлемый наполнитель.
24. Способ по п.23, где антиген конъюгирован с наноносителем с плотностью, равной или превышающей плотность, требуемую для получения по меньшей мере 10% от максимальной иммобилизации, наблюдаемой для моноклонального антитела (MAb) в тесте связывания антиген-презентирующих клеток.
25. Способ по п.23, где субкапсулярный макрофаг представляет собой CD169+макрофаг.
26. Способ по п.23, где наноноситель дополнительно включает иммуностимулирующее средство на: (i) поверхности с иммунными свойствами; (ii) второй поверхности наноносителя; или (iii) инкапсулирован в область ядра наноносителя.
27. Способ по п.23, где поверхность с иммунными свойствами состоит, по существу, из молекул, которые не являются гидроксигруппами, активирующими комплемент.
28. Композиция по п.1, где молекулы присутствуют в количестве, эффективном для обеспечения связывания на основе авидности с антиген-презентирующими клетками млекопитающих.
29. Композиция по п.1, где диаметр наноносителей больше 100 нм.
30. Способ индукции гуморального иммунного ответа, причем способ включает введение композиции по п.1.
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