RU2011118879A - Включение адъюванта в иммунонанотерапевтические средства - Google Patents
Включение адъюванта в иммунонанотерапевтические средства Download PDFInfo
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Abstract
1. Композиция, содержащая: ! (1) наноноситель, включающий первую поверхность, включающую множество групп, которые связывают антигенпредставляющие клетки с высокой авидностью и низкой аффинностью; ! (2) иммуностимулирующее средство; ! (3) полипептид, поддающийся представлению посредством МНС класса I, МНС класса II или CD-1; и ! (4) фармацевтически приемлемый эксципиент. ! 2. Композиция по п.1, где иммуностимулирующее средство: (i) является связанным с иммунофункциональной поверхностью; (ii) является связанным со второй поверхностью наноносителя; или (iii) является инкапсулированным в наноносителе. ! 3. Композиция по п.1, где полипептид, поддающийся представлению посредством МНС класса I, МНС класса II или CD-1: ! (i) является связанным с иммунофункциональной поверхностью; !(ii) является связанным со второй поверхностью наноносителя; или ! (iii) является инкапсулированным в области ядра наноносителя. ! 4. Композиция по п.1, где иммунофункциональная поверхность содержит множество групп, которые присутствуют с плотностью, равной или большей, чем плотность, необходимая для получения по меньшей мере 10% от максимальной иммобилизации, наблюдаемой для моноклонального антитела (МАb) в анализе связывания антигенпредставляющих клеток (АРС), при условии, что в анализе связывания АРС половина максимальной плотности связывания для иммуностимулирующего средства по меньшей мере в два раза превышает половину максимальной плотности связывания для МАb. ! 5. Композиция по п.4, где иммуностимулирующее средство присутствует с плотностью, равной или большей, чем плотность, необходимая для получения по меньшей мере 20% от максимальной иммобилизации, наблюда�
Claims (35)
1. Композиция, содержащая:
(1) наноноситель, включающий первую поверхность, включающую множество групп, которые связывают антигенпредставляющие клетки с высокой авидностью и низкой аффинностью;
(2) иммуностимулирующее средство;
(3) полипептид, поддающийся представлению посредством МНС класса I, МНС класса II или CD-1; и
(4) фармацевтически приемлемый эксципиент.
2. Композиция по п.1, где иммуностимулирующее средство: (i) является связанным с иммунофункциональной поверхностью; (ii) является связанным со второй поверхностью наноносителя; или (iii) является инкапсулированным в наноносителе.
3. Композиция по п.1, где полипептид, поддающийся представлению посредством МНС класса I, МНС класса II или CD-1:
(i) является связанным с иммунофункциональной поверхностью;
(ii) является связанным со второй поверхностью наноносителя; или
(iii) является инкапсулированным в области ядра наноносителя.
4. Композиция по п.1, где иммунофункциональная поверхность содержит множество групп, которые присутствуют с плотностью, равной или большей, чем плотность, необходимая для получения по меньшей мере 10% от максимальной иммобилизации, наблюдаемой для моноклонального антитела (МАb) в анализе связывания антигенпредставляющих клеток (АРС), при условии, что в анализе связывания АРС половина максимальной плотности связывания для иммуностимулирующего средства по меньшей мере в два раза превышает половину максимальной плотности связывания для МАb.
5. Композиция по п.4, где иммуностимулирующее средство присутствует с плотностью, равной или большей, чем плотность, необходимая для получения по меньшей мере 20% от максимальной иммобилизации, наблюдаемой для МАb в анализе связывания АРС.
6. Композиция по п.4, где половина максимальной плотности связывания для иммуностимулирующего средства по меньшей мере в четыре раза превышает половину максимальной плотности связывания для МАb.
7. Композиция по п.4, где анализ связывания АРС включает:
(a) получение серий субстратов, обладающих покрытиями из функциональной группы при сериях плотности покрытия поверхности, где функциональная группа является способной связывать рецепторы поверхности дендритных клеток (DC) или макрофагов субкапсулярного синуса;
(b) приведение в контакт серий субстратов и суспензий отдельных клеток DC или макрофагов субкапсулярного синуса в течение предопределенного периода времени;
(c) удаление несвязавшихся АРС с серией субстратов и фиксация связавшихся АРС на сериях субстратов;
(d) количественное определения числа связавшихся АРС на единицу площади поверхности для каждого субстрата в сериях субстратов;
(e) нанесение на график результатов (d) против плотности покрытия функциональной группы;
(f) получение значения для максимальной иммобилизации посредством определения максимального числа связавшихся АРС на единицу площади поверхности для серий субстратов; и
(g) получение значения для половины максимальной плотности связывания посредством определения плотности покрытия поверхности, обеспечивающей 50% от максимума.
8. Композиция по п.4, где MAb представляет собой анти-CD1c (BDCA-I) клон AD5-8E7 или антитело крысы к CD169 мыши, клон 3D6.112, изотип IgG2a.
9. Композиция по п.1, где иммуностимулирующее средство представляет собой агонист Toll-подобного рецептора (TLR).
10. Композиция по п.1, где агонист TLR представляет собой агонист TLR-1, TLR-2, TLR-3, TLR-4, TLR-5, TLR-6, TLR-7, TLR-8, TLR-9 или TLR-10.
11. Композиция по п.1, где иммуностимулирующее средство выбрано из интерлейкина, интерферона, цитокина и адъюванта.
12. Композиция по п.1, где композиция является способной обеспечивать усиленную пролиферацию Т-клеток у пациента-человека.
13. Композиция по п.1, где композиция вызывает созревание дендритных клеток при введении пациенту-человеку.
14. Композиция по п.1, где наноносители содержат два или более различных полипептидов, поддающихся представлению МНС класса I, МНС класса II или CD-1.
15. Композиция по п.1, где композиция содержит два или более иммуностимулирующих средств.
16. Композиция по п.15, где композиция содержит два или более агонистов Toll-подобного рецептора (TLR).
17. Композиция по п.15, где композиция содержит один агонист Toll-подобного рецептора (TLR) и один не агонист TLR.
18. Композиция по п.17, где не агонист TLR представляет собой группу, индуцирующую передачу сигнала через инфламмасому, CD40 или рецептор цитокина.
19. Композиция по п.1, где полипептид, поддающийся представлению посредством МНС класса I, выбран из антигенов, SIINFEKL, GP33, Core 18-27 и MAGE.
20. Композиция по п.1, где полипептид, поддающийся представлению посредством МНС класса II, выбран из антигенов, OVA323-339, GP61, MAGE-A4 280-299, токсоида столбняка, токсоида дифтерии и пептида PADRE.
21. Композиция по п.1, где полипептид, поддающийся представлению CD-1, выбран из липидных антигенов, миколовой кислоты, сульфолипидов, липофосфогликана, диацилглицеринов, гликосфинголипидов, альфа-галактозилцерамида, изоглоботригексозилцерамида и ганглиозида GD3.
22. Композиция по п.1, дополнительно содержащая иммуномодулирующее средство, выбранное из В-клеточных антигенов, Т-клеточных антигенов, белков, пептидов, углеводов, гликопротеинов, гликопептидов, протеогликанов, инактивированных организмов и вирусов, убитых организмов и вирусов, генетически измененных организмов или вирусов, антигенов грибов, простейших, и/или паразитических организмов и экстрактов клеток.
23. Способ, включающий:
введение пациенту начальной дозы композиции по п.1; и введение пациенту первой последующей дозы композиции по п.1 в период времени после введения начальной дозы.
24. Способ по п.23, где период времени представляет собой интервал в диапазоне от 1 суток до 1 года.
25. Способ по п.23, где первая доза композиции вызывает пролиферацию Т-клеток у пациента.
26. Способ по п.23, где через одну неделю после введения начальной дозы концентрация антигенспецифических Т-клеток в крови пациента по меньшей мере в 10 превышает концентрацию Т-клеток, узнающих неродственный антиген, для которого у пациента не существует иммунологической памяти.
27. Способ по п.26, где неродственный антиген представляет собой бычий сывороточный альбумин.
28. Способ по п.23, где через одну неделю после введения первой последующей дозы концентрация антигенспецифических Т-клеток в крови пациента по меньшей мере в 10 превышает концентрацию Т-клеток, узнающих неродственный антиген, для которого у пациента не существует иммунологической памяти.
29. Способ по п.28, где неродственный антиген представляет собой бычий сывороточный альбумин.
30. Композиция, содержащая:
(1) наноноситель, имеющий по меньшей мере одну поверхность, где первая поверхность наноносителя содержит множество групп в количестве, эффективном для обеспечения гуморального ответа на группы;
(2) иммуностимулирующую группу;
(3) полипептид, поддающийся представлению посредством МНС класса I, МНС класса II или CD-1; и
(4) фармацевтически приемлемый эксципиент.
31. Композиция по п.30, где группы присутствуют в количестве, эффективном для обеспечения основанного на авидности связывания для связывания с антигенпредставляющими клетками млекопитающих.
32. Композиция по п.30, где диаметр наноносителей превышает 100 нм.
33. Композиция по п.30, где фармацевтически приемлемый эксципиент выбран из растворителей, диспергентов, разбавителей, или других жидких носителей, веществ, способствующих диспергированию или суспендированию, изотонических средств, загустителей или эмульгаторов, консервантов, твердых связующих веществ и лубрикантов.
34. Композиция по п.30, где композиция нацелена на дендритные клетки.
35. Композиция по п.30, где композиция по существу не
активирует комплемент.
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- 2009-10-09 WO PCT/US2009/060242 patent/WO2010042870A1/en active Application Filing
- 2009-10-09 CN CN200980150137.2A patent/CN102245201B/zh active Active
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- 2009-10-09 RU RU2011118879/15A patent/RU2496517C2/ru active
- 2009-10-09 CA CA2740155A patent/CA2740155C/en active Active
- 2009-10-09 BR BRPI0920284A patent/BRPI0920284A2/pt not_active Application Discontinuation
- 2009-10-09 KR KR1020117010817A patent/KR101756995B1/ko active IP Right Grant
- 2009-10-09 JP JP2011531223A patent/JP5937354B2/ja active Active
- 2009-10-09 AU AU2009303338A patent/AU2009303338B2/en active Active
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Also Published As
Publication number | Publication date |
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US9439859B2 (en) | 2016-09-13 |
JP2012505248A (ja) | 2012-03-01 |
JP2014221838A (ja) | 2014-11-27 |
US8343498B2 (en) | 2013-01-01 |
EP2344185A1 (en) | 2011-07-20 |
US9233072B2 (en) | 2016-01-12 |
KR101756995B1 (ko) | 2017-07-26 |
CN102245201B (zh) | 2016-01-20 |
CA2740155C (en) | 2020-08-25 |
US8637028B2 (en) | 2014-01-28 |
AU2009303338B2 (en) | 2013-05-30 |
KR20110091855A (ko) | 2011-08-16 |
WO2010042870A1 (en) | 2010-04-15 |
JP5937354B2 (ja) | 2016-06-22 |
MX2011003843A (es) | 2011-09-27 |
US20140127301A1 (en) | 2014-05-08 |
BRPI0920284A2 (pt) | 2016-08-02 |
US20110268805A1 (en) | 2011-11-03 |
RU2496517C2 (ru) | 2013-10-27 |
AU2009303338A1 (en) | 2010-04-15 |
CN102245201A (zh) | 2011-11-16 |
IL212240A0 (en) | 2011-06-30 |
US20130129790A1 (en) | 2013-05-23 |
CA2740155A1 (en) | 2010-04-15 |
US20100129439A1 (en) | 2010-05-27 |
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