RU2487712C2 - Никотиновые иммунонанотерапевтические лекарственные средства - Google Patents

Никотиновые иммунонанотерапевтические лекарственные средства Download PDF

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RU2487712C2
RU2487712C2 RU2011118880/15A RU2011118880A RU2487712C2 RU 2487712 C2 RU2487712 C2 RU 2487712C2 RU 2011118880/15 A RU2011118880/15 A RU 2011118880/15A RU 2011118880 A RU2011118880 A RU 2011118880A RU 2487712 C2 RU2487712 C2 RU 2487712C2
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composition according
nicotine
cells
nanocarriers
binding
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Маттео ИАННАКОНЕ
АНДРИАН Ульрих ВОН
Омид К. Фарокхзад
Франк АЛЕКСИС
Памела БАСТО
Цзиньцзюнь ШИ
Эллиотт Эшли МОУЗМАН
Роберт ЛАНГЕР
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

Предложена композиция для никотиновой иммунонанотерапии, содержащая синтетические наноносители, имеющие полимерную поверхность, конъюгированную со множеством никотиновых остатков, причем множество никотиновых остатков на наноносителе образуют иммуногенную поверхность, обеспечивающую низкую аффинность, высокоавидное связывание никотиновых остатков к поверхностям антигенпрезентирующей клетки (АПК) по сравнению со связыванием антитела, и фармацевтически приемлемый эксципиент. Изобретение обеспечивает наноносители, способные стимулировать иммунный ответ в Т-клетках и/или В-клетках и продуцирование антиникотин-антител, причем гуморальный и клеточный ответ может достигаться в отсутствии экзогенного адъюванта. Это обеспечивает отсутствие неспецифического ответа на воспаление, вызванного адъювантом. 16 з.п. ф-лы, 37 ил.

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Claims (17)

1. Композиция для никотиновой иммунонанотерапии, содержащая:
(1) синтетические наноносители, имеющие полимерную поверхность, конъюгированную со множеством никотиновых остатков, имеющих приведенную ниже структуру, или его метаболит,
Figure 00000403

причем никотин ковалентно связан с полимером или липидом посредством одного из R1-R7, представляющих Н, где R8 представляет собой алкильную группу; и
причем множество никотиновых остатков на наноносителе образуют иммуногенную поверхность, обеспечивающую низкую аффинность, высокоавидное связывание никотиновых остатков к поверхностям антигенпрезентирующей клетки (АПК) по сравнению со связыванием антитела;
причем наноносители необязательно содержат один или более нацеливающих агентов, распознающих мишень, ассоциированную с конкретными органом, тканью, клеткой или субклеточным местом действия, и необязательно содержат один или более иммуномодулирующих агентов, индуцирующих иммунный ответ в В-клетках или Т-клетках или стимулирующих иммунную систему таким образом, что иммунный ответ усиливается, подавляется направляется или перенаправляется; и
(2) фармацевтически приемлемый эксципиент.
2. Композиция по п.1, в которой наноносители содержат один или более нацеливающих агентов, узнающих мишень, ассоциированную с конкретными органом, тканью, клеткой или субклеточным местом действия, или один или более иммуномодулирующих агентов, индуцирующих иммунный ответ в В-клетках или Т-клетках или стимулирующих иммунную систему таким образом, что иммунный ответ усиливается, подавляется, направляется или перенаправляется, причем нацеливающие агенты или иммуностимулирующие агенты ассоциированы с поверхностью наноносителей или инкапсулированы в наноносители.
3. Композиция по п.1, где синтетические наноносители способны активировать антиген презентирующих клеток, В-клеток, CD4+ Т-клеток, NKT-клеток или любая комбинация этих типов клеток при введении человеку.
4. Композиция по п.1, где синтетические наноносители способны стимулировать продуцирование анти-никотин-IgG-антител при введении человеку.
5. Композиция по п.1, где синтетические наноносители способны индуцировать гуморальный иммунный ответ у пациента-человека.
6. Композиция по п.1, где синтетические наноносители вводят пациенту-человеку, причем эти синтетические наноносители способны переноситься через стенку субкапсулярного синуса (SCS) макрофагами SCS в организме пациента.
7. Композиция по п.2, где иммуностимулирующий агент выбран из группы, состоящей из агониста TLR, интерлейкина, интерферона, цитокина, CD40 агониста, агониста инфламмасомы и адъюванта.
8. Композиция по п.1, где синтетические наноносители содержат полимерные молекулы и где множество никотиновых остатков ковалентно присоединены к этим полимерным молекулам.
9. Композиция по п.8, где множество никотиновых остатков являются (S)-(-)-никотиновыми остатками и где синтетические наноносители содержат полимер, имеющий структуру (X)n-L1-(Y)m-L2-A, где: Х обозначает сегмент гидрофобного полимера; Y обозначает сегмент гидрофильного полимера; n и m выбраны из 0 и 1, при условии, что n и m не являются оба 0; L1 и L2 независимо выбраны из связи и линкерной группы; и А обозначает (S)-(-)-никотин.
10. Композиция по п.1, где R8 представляет собой метил.
11. Композиция по п.1, где никотин присутствует на поверхности наноносителей в плотности, равной или большей, чем плотность, необходимая для получения по меньшей мере 10% максимальной иммобилизации, наблюдаемой для моноклонального антитела (МАb) в анализе связывания антигенпрезентирующих клеток (АРС), при условии, что в анализе связывания АРС плотность полумаксимального связывания для множества остатков является по меньшей мере в два раза большей, чем плотность полумаксимального связывания для этого МАb.
12. Композиция по п.11, где никотин присутствует на поверхности наноносителей в плотности, равной или большей, чем плотность, необходимая для получения по меньшей мере 20% максимальной иммобилизации, наблюдаемой для МАb в анализе связывания АРС.
13. Композиция по п.11, где МАb является клоном AD5-8E7 анти-CD1c (BDCA-1) или клоном 3D6.112, изотипом IgG2a крысиного анти-СD169 мыши-антитела, и плотность полумаксимального связывания для никотина является по меньшей мере в четыре раза большей, чем плотность полумаксимального связывания для МАb.
14. Композиция по п.11, где анализ связывания АРС включает:
(а) получение множества субстратов, имеющих покрытия из функционального остатка при множестве плотностей покрытия поверхности, где указанный функциональный остаток способен связываться с дендритной клеткой (DC) или рецепторами поверхности макрофагов субкапсулярного синуса;
(b) приведение в контакт множества субстратов с суспензиями отдельных клеток DC или макрофагов субкапсулярного синуса в течение заранее определенного периода времени;
(c) удаление несвязавшихся АРС из множества субстратов и фиксирование связанных АРС с множеством субстратов;
(d) определение количества связанных АРС на единицу площади поверхности для каждого субстрата в множестве субстратов;
(e) построение графика зависимости результата из (d) от плотности покрытия функционального остатка;
(f) получение величины максимальной иммобилизации определением максимального количества связанных АРС на единицу площади поверхности множества субстратов; и
(g) получение величины плотности полумаксимального связывания определением плотности покрытия поверхности, которая обеспечивает 50% максимума.
15. Композиция по п.1, в которой наноноситель представляет собой самособирающийся синтетический наноноситель, образованный из амфифильных молекул, содержащий гидрофильные иммуномодулирующие или антигенные молекулы, ковалентно связанные с гидрофобным полимером.
16. Композиция по п.9, где гидрофильный полимер представляет собой полиэтиленгликоль, а гидрофобный полимер представляет собой полигликолевую кислоту, полимолочную кислоту или поли(молочную кислоту/гликолевую кислоту).
17. Композиция по п.1, где наноносители содержат полимер, причем никотин связан с полимером.
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