RU2011116931A - КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ КОМПЛЕКСНУЮ (и)РНК И СВОБОДНУЮ иРНК ДЛЯ ОСУЩЕСТВЛЕНИЯ ИЛИ ПОВЫШЕНИЯ ИММУНОСТИМУЛИРУЮЩЕГО ОТВЕТА У МЛЕКОПИТАЮЩИХ, И ЕЕ ПРИМЕНЕНИЯ - Google Patents
КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ КОМПЛЕКСНУЮ (и)РНК И СВОБОДНУЮ иРНК ДЛЯ ОСУЩЕСТВЛЕНИЯ ИЛИ ПОВЫШЕНИЯ ИММУНОСТИМУЛИРУЮЩЕГО ОТВЕТА У МЛЕКОПИТАЮЩИХ, И ЕЕ ПРИМЕНЕНИЯ Download PDFInfo
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
1. Иммуностимулирующая композиция, включающая ! а) адъювантный компонент, включающий или состоящий по меньшей мере из одной (и)РНК, объединенный с катионным или поликатионным соединением, и ! б) по меньшей мере одну свободную иРНК, кодирующую по меньшей мере один терапевтически активный белок, антиген и/или антитело, ! причем иммуностимулирующая композиция способна индуцировать или усиливать врожденный и необязательно адаптивный иммунный ответ у млекопитающего. ! 2. Иммуностимулирующая композиция по п.1, в которой по меньшей мере одна (и)РНК адъювантного компонента, выбрана из короткого олигонуклеотида РНК, кодирующей РНК, включая иРНК, иммуностимулирующей РНК, миРНК, антисмысловой РНК или РНК-переключателей, рибозимов или аптамеров. ! 3. Иммуностимулирующая композиция по п.1 или 2, в которой по меньшей мере одной (и)РНК адъювантного компонента является иРНК. ! 4. Иммуностимулирующая композиция по одному из п.1 или 2, в которой по меньшей мере одна свободная иРНК и по меньшей мере одна (и)РНК адъювантного компонента идентичны друг другу. ! 5. Иммуностимулирующая композиция по одному из п.1 или 2, в которой по меньшей мере одна свободная иРНК и по меньшей мере одна (и)РНК адъювантного компонента различны. ! 6. Иммуностимулирующая композиция по одному из п.1 или 2, в которой N/P соотношение и(РНК) к катионному или поликатионному соединению в адъювантном компоненте находится в диапазоне примерно 0,1-10, включая диапазон примерно 0,3-4, примерно 0,5-2, примерно 0,7-2 и примерно 0,7-1,5. ! 7. Иммуностимулирующая композиция по одному из п.1 или 2, в которой мольное соотношение (и)РНК адъювантного компонента по меньшей мере к одной свободной иРНК в�
Claims (17)
1. Иммуностимулирующая композиция, включающая
а) адъювантный компонент, включающий или состоящий по меньшей мере из одной (и)РНК, объединенный с катионным или поликатионным соединением, и
б) по меньшей мере одну свободную иРНК, кодирующую по меньшей мере один терапевтически активный белок, антиген и/или антитело,
причем иммуностимулирующая композиция способна индуцировать или усиливать врожденный и необязательно адаптивный иммунный ответ у млекопитающего.
2. Иммуностимулирующая композиция по п.1, в которой по меньшей мере одна (и)РНК адъювантного компонента, выбрана из короткого олигонуклеотида РНК, кодирующей РНК, включая иРНК, иммуностимулирующей РНК, миРНК, антисмысловой РНК или РНК-переключателей, рибозимов или аптамеров.
3. Иммуностимулирующая композиция по п.1 или 2, в которой по меньшей мере одной (и)РНК адъювантного компонента является иРНК.
4. Иммуностимулирующая композиция по одному из п.1 или 2, в которой по меньшей мере одна свободная иРНК и по меньшей мере одна (и)РНК адъювантного компонента идентичны друг другу.
5. Иммуностимулирующая композиция по одному из п.1 или 2, в которой по меньшей мере одна свободная иРНК и по меньшей мере одна (и)РНК адъювантного компонента различны.
6. Иммуностимулирующая композиция по одному из п.1 или 2, в которой N/P соотношение и(РНК) к катионному или поликатионному соединению в адъювантном компоненте находится в диапазоне примерно 0,1-10, включая диапазон примерно 0,3-4, примерно 0,5-2, примерно 0,7-2 и примерно 0,7-1,5.
7. Иммуностимулирующая композиция по одному из п.1 или 2, в которой мольное соотношение (и)РНК адъювантного компонента по меньшей мере к одной свободной иРНК второго компонента б) может быть выбрано из мольного соотношения примерно от 0,001:1 до примерно 1:0,001, включая соотношение примерно 1:1.
8. Иммуностимулирующая композиция по одному из п.1 или 2, в которой по меньшей мере одна свободная иРНК и/или по меньшей мере одна (и)РНК адъювантного компонента являются GC-стабилизированными.
9. Иммуностимулирующая композиция по п.8, в которой содержание G/C кодирующей области GC-стабилизированной РНК повышено по сравнению с содержанием G/C кодирующей области нативной РНК, кодируемая аминокислотная последовательность GC-стабилизированной модифицированной (и)РНК не изменена по сравнению с кодируемой аминокислотной последовательностью нативной модифицированной (и)РНК.
10. Иммуностимулирующая композиция по одному из п.1 или 2, в которой катионное или поликатионное соединение выбрано из протамина, нуклеолина, спермина или спермидина, поли-L-лизина, основных полипептидов, полиаргинина, проникающих в клетки пептидов, химерных проникающих в клетки пептидов, включая транспортан, или MPG пептидов, ВИЧ-связывающих пептидов, Tat, ВИЧ-1 Tat (ВИЧ), Tat-производных пептидов, олигоаргининов, представителей семейства пенетратина, включая пенетратин, пептидов, производных от белка антеннапедия (из Drosophila antennapedia), pAntp, pIsl, пептидов СРР, проникающих в клетки и являющихся антимикробными производными, включая буфорин-2, Вас715-24, SynB, SynB(1), pVEC, hCT-производных пептидов, SAP, MAP, KALA, PpTG20, обогащенных пролином пептидов, L-олигомеров, обогащенных аргинином пептидов, кальцитониновых пептидов, FGF, лактоферрина, поли-L-лизина, полиаргинина, гистонов, пептидов, являющихся производными или аналогами VP22, из HSV, VP22 (Herpes simplex), MAP, KALA или протеин-трансдуцирующих доменов PTD, РрТ620, из обогащенных пролином пептидов, обогащенных аргинином пептидов, обогащенных лизином пептидов, Рер-1, кальцитонинового пептида (пептидов), или из белков или пептидов, имеющих следующую общую формулу: (Arg)l;(Lys)m;(His)n;(Orn)o;(Xaa)x, где l+m+n+o+х=8-15, и l, m, n или о независимо друг от друга могут быть любыми числами, выбранными из 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 или 15, при условии, что общее содержание Arg, Lys, His и Orn составляет по меньшей мере 50% от всех аминокислот в олигопептиде; и Хаа может быть какой-либо аминокислотой, выбранной из нативных (естественного происхождения) или ненативных аминокислот, за исключением Arg, Lys, His или Orn; и х может быть каким-либо числом, выбранным из 0, 1, 2, 3, 4, 5, 6, 7 или 8, при условии, что общее содержание Хаа не превышает 50% от всех аминокислот в олигопептиде,
или из олигоаргининов, включающих Arg7, Arg8, Arg9, Arg7, H3R9, R9H3, H3R9H3, YSSR9SSY, (RKH)4, Y(RKH)2R,
или из катионных полисахаридов, включая хитозан, полибрен, катионные полимеры, полиэтиленимин (ПЭИ), катионные липиды, DOTMA: [1-(2,3-диолеилокси)пропил)]-N,N,N-триметиламмоний хлорид, DMRIE, ди-С14-амидин, DOTIM, SAINT, DC-Chol, BGTC, СТАР, DOPC, DODAP, ДОФЭ (диолеилфосфатидилэтаноламин), DOSPA, DODAB, DOIC, DMEPC, DOGS (диоктадесиламидоглицилспермин), DIMRI: димиристооксипропилдиметилгидроксиэтиламмоний бромид, DOTAP: диолеоилокси-3-(триметиламмоний)пропан, DC-6-14: O,O-дитетрадеканоил-N-(α-триметиламмониоацетил)диэтаноламинохлорид, CLIP1: рац-[(2,3-диоктадецилоксипропил)(2-гидроксиэтил)]-диметиламмонийхлорид, CLIP6: рац-[2(2,3-дигексадецилоксипропил-оксиметилокси)этил]триметиламмоний, CLIP9: рац-[2(2,3-дигексадецилоксипропил-оксисукцинилокси)этил]триметиламмоний, олигофектамин,
или из катионных или поликатионных полимеров, включая модифицированные полиаминокислоты, включая β-аминокислотные полимеры или инвертированные полиамиды, модифицированные полиэтилены, включая ПВП поли(N-этил-4-винилпиридиний бромид), модифицированные акрилаты, включая пДМАЭМА (поли(диметиламиноэтилметилакрилат)), модифицированные амидоамины, включая пАМАМ (поли(амидоамин)), модифицированный полибетааминновый эфир (ПБАЭ), включая модифицированные по диаминному концу сополимеры 1,4 бутандиолдиакрилата и 5-амино-1-пентанола, дендримеры, включая полипропиламинные дендримеры или основанные на пАМАМ дендримеры, полиимин (полиимины), включая ПЭИ: поли(этиленимин), поли(пропиленимин), полиаллиламин, полимеры, основанные на каркасе молекулы сахара, включая полимеры на основе циклодекстрина, полимеры на основе декстрана, хитозана, полимеры, основанные на каркасе молекулы силана, например, сополимеры PMOXA-PDMS, блокполимеры, состоящие из комбинации одного или более катионных блоков (выбранного катионного полимера, указанного выше) и из одного или более гидрофильных или гидрофобных блоков(включая полиэтиленгликоль).
11. Иммуностимулирующая композиция по одному из п.1 или 2, в которой по меньшей мере одна свободная иРНК кодирует антиген, выбранный из опухолевых антигенов, включая 5Т4, 707-АР, 9D7, AFP, AlbZIP HPG1, альфа5бета1-интегрин, альфа5бета6-интегрин, альфа-метилацил-коэнзим А рацемазу, ART-4, B7H4, BAGE-1, BCL-2, BING-4, СА 15-3/СА 27-29, СА 19-9, СА 72-4, СА125, калретикулин, CAMEL, CASP-8, катепсин В, катепсин L, CD19, CD20, CD22, CD25, CD30, CD33, CD4, CD52, CD55, CD56, CD80, CEA, CLCA2, CML28, коактозин-подобный белок, коллаген XXIII, COX-2, CT-9/BRD6, Cten, циклин В1, циклин D1, cyp-B, CYPB1, DAM-10/MAGE-B1, DAM-6/MAGE-B2, EGFR/Her1, EMMPRIN, EpCam, EphA2, EphA3, ErbB3, EZH2, FGF-5, FN, Fra-1, G250/CAIX, GAGE-1, GAGE-2, GAGE-3, GAGE-4, GAGE-5, GAGE-6, GAGE-7b, GAGE-8, GDEP, GnT-V, gp100, GPC3, HAGE, HAST-2, гепсин, Her2/neu/ErbB2, HERV-K-MEL, HNE, гомеобокс NKX 3.1, HOM-TES-14/SCP-1, HOM-TES-85, HPV-E6, HPV-E7, HST-2, hTERT, iCE, IGF-1R, Il-13Ra2, Il-2R, Il-5, незрелый рецептор ламинина, калликреин 2, калликреин 4, Ki67, KIAA0205, KK-LC-1, KM-HN-1, LAGE-1, ливин, MAGE-A1, MAGE-A10, MAGE-A12, MAGE-A2, MAGE-A3, MAGE-A4, MAGE-A6, MAGE-A9, MAGE-B1, MAGE-B10, MAGE-B16, MAGE-B17, MAGE-B2, MAGE-B3, MAGE-B4, MAGE-B5, MAGE-B6, MAGE-C1, MAGE-C2, MAGE-C3, MAGE-D1, MAGE-D2, MAGE-D4, MAGE-E1, MAGE-E2, MAGE-F1, MAGE-H1, MAGEL2, маммаглобин A, MART-1/Melan-A, MART-2, матриксный белок 22, MC1R, M-CSF, мезотелин, MG50/PXDN, MMP 11, MN/CA IX-антиген, MRP-3, MUC1, MUC2, NA88-A, N-ацетилглюкозаминилтрансфераза-V, Neo-PAP, NGEP, NMP22, NPM/ALK, NSE, NY-ESO-1, NY-ESO-B, OA1, OFA-iLRP, OGT, OS-9, остеокальцин, остеопонтин, p15, p15, p190 minor bcr-abl, p53, PAGE-4, PAI-1, PAI-2, PAP, PART-1, PATE, PDEF, Pim-1-киназа, Pin1, POTE, PRAME, простеин, протеиназа-3, PSA, PSCA, PSGR, PSM, PSMA, RAGE-1, RHAMM/CD168, RU1, RU2, S-100, SAGE, SART-1, SART-2, SART-3, SCC, Sp17, SSX-1, SSX-2/HOM-MEL-40, SSX-4, STAMP-1, STEAP, сурвивин, сурвивин-2В, ТА-90, TAG-72, TARP, TGFb, TGFbRII, TGM-4, TRAG-3, TRG, TRP-1, TRP-2/6b, TRP-2/INT2, Trp-p8, тирозиназа, UPA, VEGF, VEGFR-2/FLK-1, WT1; или выбранный из мутантных антигенов, экспрессируемых при раковых заболеваниях, включая альфа-актинин-4/m, ARTC1/m, bcr/abl, бета-катенин/m, BRCA1/m, BRCA2/m, CASP-5/m, CASP-8/m, CDC27/m, CDK4/m, CDKN2A/m, CML66, COA-1/m, DEK-CAN, EFTUD2/m, ELF2/m, ETV6-AML1, FN1/m, GPNMB/m, HLA-A*0201-R170I, HLA-A11/m, HLA-A2/m, HSP70-2M, KIAA0205/m, K-Ras/m, LDLR-FUT, MART2/m, ME1/m, MUM-1/m, MUM-2/m, MUM-3/m, миозин класса I/m, neo-PAP/m, NFYC/m, N-Ras/m, OGT/m, OS-9/m, p53/m, Pml/RARa, PRDX5/m, PTPRK/m, RBAF600/m, SIRT2/m, SYT-SSX-1, SYT-SSX-2, TEL-AML1, TGFbRII, TPI/m.
12. Иммуностимулирующая композиция по одному из п.1 или 2, в которой по меньшей мере одна свободная иРНК кодирует:
а) по меньшей мере один, два, три или четыре (разных) антигена из следующей группы антигенов:
PSA (Prostate-Specific Antigen - простатический специфический антиген)=KLK3 (калликреин-3),
PSMA (Prostate-Specific Membrane Antigen - простатический специфический мембранный антиген),
PSCA (Prostate Stem Cell Antigen - антиген стволовых клеток простаты),
STEAP (шестой трансмембранный эпителиальный антиген простаты),
или
б) по меньшей мере один, два, три, четыре, пять, шесть, семь, восемь, девять, десять, одиннадцать или двенадцать (разных) антигенов из следующих групп антигенов:
hTERT,
pWT1,
MAGE-A2,
5Т4,
MAGE-A3,
MUC1,
Her-2/neu,
NY-ESO-1,
CEA,
сурвивин,
MAGE-C1 и/или
MAGE-C2,
причем возможна какая-либо комбинация этих антигенов.
13. Фармацевтическая композиция, представляющая иммуностимулирующую композицию по одному из пп.1-12 необязательно фармацевтически приемлемый носитель, адъювант и/или растворитель.
14. Фармацевтическая композиция по п.13, причем фармацевтическая композиция является вакциной.
15. Способ получения иммуностимулирующей композиции по одному из пп.1-12, включающий следующие стадии:
а) получения адъювантного компонента, включающего или состоящего по меньшей мере из одной (и)РНК, объединенной в комплекс с катионным или поликатионным соединением, путем смешивания в определенном соотношении по меньшей мере одной (и)РНК и катионного или поликатионного соединения, описанного в одном из из пп.1-12; и
б) получения патентоспособной иммуностимулирующей композиции путем добавления в определенном соотношении по меньшей мере одной свободной иРНК, описанной в одном из пп.1-12, к адъювантному компоненту, полученному на стадии а), причем по меньшей мере одна свободная иРНК кодирует по меньшей мере один белок терапевтического действия, антиген и/или антитело по одному из пп.1-12.
16. Применение иммуностимулирующей композиции по одному из пп.1-15, или адъювантного компонента, включающего или состоящего по меньшей мере из одной (и)РНК, объединенной в комплекс с катионным или поликатионным соединением, и по меньшей мере одной свободной иРНК, кодирующей по меньшей мере один белок терапевтического действия, антиген и/или антитело по одному из пп.1-12, для получения фармацевтической композиции для профилактики, лечения и/или облегчения какого-либо заболевания или расстройства, выбранного из раковых или опухолевых заболеваний, аутоиммунных заболеваний, инфекционных заболеваний, включая вирусные, бактериальные или протозойные заболевания, или аллергию, или аллергические заболевания.
17. Набор, включающий иммуностимулирующую композицию по одному из пп.1-12 и/или фармацевтическую композицию по одному из пп.13-14 и необязательно технические инструкции с информацией по введению и дозированию иммуностимулирующей композиции и/или фармацевтической композиции.
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PCT/EP2008/008304 WO2010037408A1 (en) | 2008-09-30 | 2008-09-30 | Composition comprising a complexed (m)rna and a naked mrna for providing or enhancing an immunostimulatory response in a mammal and uses thereof |
PCT/EP2009/007032 WO2010037539A1 (en) | 2008-09-30 | 2009-09-30 | Composition comprising a complexed (m)rna and a naked mrna for providing or enhancing an immunostimulatory response in a mammal and uses thereof |
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