RU2018139999A - Состав, содержащий агонист tlr, и способы применения - Google Patents
Состав, содержащий агонист tlr, и способы применения Download PDFInfo
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- RU2018139999A RU2018139999A RU2018139999A RU2018139999A RU2018139999A RU 2018139999 A RU2018139999 A RU 2018139999A RU 2018139999 A RU2018139999 A RU 2018139999A RU 2018139999 A RU2018139999 A RU 2018139999A RU 2018139999 A RU2018139999 A RU 2018139999A
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- agonist
- aluminum
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- antigen
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- 239000000203 mixture Substances 0.000 title claims 30
- 239000000556 agonist Substances 0.000 title claims 12
- 238000000034 method Methods 0.000 title claims 10
- 239000000427 antigen Substances 0.000 claims 15
- 102000036639 antigens Human genes 0.000 claims 15
- 108091007433 antigens Proteins 0.000 claims 15
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical class [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 claims 12
- 101000669447 Homo sapiens Toll-like receptor 4 Proteins 0.000 claims 10
- 102100039360 Toll-like receptor 4 Human genes 0.000 claims 10
- 150000002632 lipids Chemical class 0.000 claims 9
- FBFJOZZTIXSPPR-UHFFFAOYSA-N 1-(4-aminobutyl)-2-(ethoxymethyl)imidazo[4,5-c]quinolin-4-amine Chemical compound C1=CC=CC2=C(N(C(COCC)=N3)CCCCN)C3=C(N)N=C21 FBFJOZZTIXSPPR-UHFFFAOYSA-N 0.000 claims 7
- 229940124613 TLR 7/8 agonist Drugs 0.000 claims 7
- 230000028993 immune response Effects 0.000 claims 6
- 125000000217 alkyl group Chemical group 0.000 claims 5
- 239000006070 nanosuspension Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 3
- 208000004881 Amebiasis Diseases 0.000 claims 2
- 206010001980 Amoebiasis Diseases 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 101001000212 Rattus norvegicus Decorin Proteins 0.000 claims 2
- 241000700605 Viruses Species 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- 230000004913 activation Effects 0.000 claims 2
- 229940047712 aluminum hydroxyphosphate Drugs 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- FVJZSBGHRPJMMA-UHFFFAOYSA-N distearoyl phosphatidylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(COP(O)(=O)OCC(O)CO)OC(=O)CCCCCCCCCCCCCCCCC FVJZSBGHRPJMMA-UHFFFAOYSA-N 0.000 claims 2
- 125000000524 functional group Chemical group 0.000 claims 2
- 206010022000 influenza Diseases 0.000 claims 2
- 229940035032 monophosphoryl lipid a Drugs 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- 230000004936 stimulating effect Effects 0.000 claims 2
- 201000008827 tuberculosis Diseases 0.000 claims 2
- SNKAWJBJQDLSFF-NVKMUCNASA-N 1,2-dioleoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/CCCCCCCC SNKAWJBJQDLSFF-NVKMUCNASA-N 0.000 claims 1
- 102000004127 Cytokines Human genes 0.000 claims 1
- 108090000695 Cytokines Proteins 0.000 claims 1
- 206010012335 Dependence Diseases 0.000 claims 1
- 101710154606 Hemagglutinin Proteins 0.000 claims 1
- 208000005176 Hepatitis C Diseases 0.000 claims 1
- 101000669402 Homo sapiens Toll-like receptor 7 Proteins 0.000 claims 1
- 206010020751 Hypersensitivity Diseases 0.000 claims 1
- 241000124008 Mammalia Species 0.000 claims 1
- 101710093908 Outer capsid protein VP4 Proteins 0.000 claims 1
- 101710135467 Outer capsid protein sigma-1 Proteins 0.000 claims 1
- 101710176177 Protein A56 Proteins 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims 1
- 210000001744 T-lymphocyte Anatomy 0.000 claims 1
- 102100039390 Toll-like receptor 7 Human genes 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 230000007815 allergy Effects 0.000 claims 1
- RREGISFBPQOLTM-UHFFFAOYSA-N alumane;trihydrate Chemical compound O.O.O.[AlH3] RREGISFBPQOLTM-UHFFFAOYSA-N 0.000 claims 1
- WNROFYMDJYEPJX-UHFFFAOYSA-K aluminium hydroxide Chemical compound [OH-].[OH-].[OH-].[Al+3] WNROFYMDJYEPJX-UHFFFAOYSA-K 0.000 claims 1
- ILRRQNADMUWWFW-UHFFFAOYSA-K aluminium phosphate Chemical compound O1[Al]2OP1(=O)O2 ILRRQNADMUWWFW-UHFFFAOYSA-K 0.000 claims 1
- 229940009859 aluminum phosphate Drugs 0.000 claims 1
- 229940103272 aluminum potassium sulfate Drugs 0.000 claims 1
- 230000001363 autoimmune Effects 0.000 claims 1
- 239000002270 dispersing agent Substances 0.000 claims 1
- -1 galactosyl lipid Chemical class 0.000 claims 1
- 239000000185 hemagglutinin Substances 0.000 claims 1
- 208000002672 hepatitis B Diseases 0.000 claims 1
- FAHBNUUHRFUEAI-UHFFFAOYSA-M hydroxidooxidoaluminium Chemical compound O[Al]=O FAHBNUUHRFUEAI-UHFFFAOYSA-M 0.000 claims 1
- 208000037797 influenza A Diseases 0.000 claims 1
- 208000037798 influenza B Diseases 0.000 claims 1
- 208000037799 influenza C Diseases 0.000 claims 1
- 230000015788 innate immune response Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 150000003904 phospholipids Chemical class 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- GRLPQNLYRHEGIJ-UHFFFAOYSA-J potassium aluminium sulfate Chemical compound [Al+3].[K+].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O GRLPQNLYRHEGIJ-UHFFFAOYSA-J 0.000 claims 1
- 150000003242 quaternary ammonium salts Chemical class 0.000 claims 1
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Claims (47)
1. Композиция, содержащая:
(a) агонист TLR7/8;
(b) вспомогательный липид; и
(c) соль алюминия.
2. Композиция по п. 6, характеризующаяся тем, что агонист TLR7/8 адсорбирован на соли алюминия, при этом необязательно агонист TLR7/8 адсорбирован на соли алюминия при 25 процентах соли алюминия.
3. Композиция по п. 1 или 2, характеризующаяся тем, что соль алюминия выбрана из группы, состоящей из гидроксида алюминия, тригидрата алюминия, оксигидроксида алюминия, фосфата алюминия, гидроксифосфата алюминия, гидроксифосфата-сульфата алюминия и сульфата алюминия-калия, или тем, что соль алюминия включает Alhydrogel® или AdjuPhos®.
4. Композиция по любому из пп. 1-3, характеризующаяся тем, что агонист TLR7/8 включает 3М-052.
5. Композиция по любому из пп. 1-4, характеризующаяся тем, что вспомогательный липид представляет собой фосфолипид или четвертичную аммонийную соль липида; или тем, что вспомогательный липид содержит Сю-го алкильную цепь, или тем, что липид выбран из DOPC, DSPG, DSTAP и полисорбата 80.
6. Композиция по п. 1, содержащая 3М-052, Alhydrogel® и DSPG, или содержащая 3М-052, AdjuPhos® и DSTAP.
7. Композиция, содержащая:
(a) агонист TLR4;
(b) вспомогательный липид, который представляет собой DPTAP; и
(c) соль алюминия, которая представляет собой AdjuPhos®.
8. Композиция по п. 7, характеризующаяся тем, что агонист TLR4 адсорбирован на соли алюминия; при этом необязательно агонист TLR7/8 адсорбирован на соли алюминия при 25 процентах соли алюминия.
9. Композиция по п. 7 или 8, характеризующаяся тем, что агонист TLR4 включает 3D-монофосфориллипид A (MPL); или тем, что агонист TLR4 включает галактозил-липидный адъювант (GLA).
10. Композиция по п. 9, характеризующаяся тем, что агонист TLR4 включает синтетический GLA формулы (IV):
или его фармацевтически приемлемую соль, где:
L1, L2, L3, L4, L5 и L6 являются одинаковыми или различными и независимо представляют собой -О-, -NH- или -(СH2)-;
L7, L8, L8 и L10 являются одинаковыми или различными и независимо отсутствуют или представляют собой -С(=O)-;
Y1 представляет собой кислотную функциональную группу;
Y2 и Y3 являются одинаковыми или различными и независимо представляют собой -ОН, -SH или кислотную функциональную группу;
Y4 представляет собой -ОН или -SH;
R1, R3, R5 и R6 являются одинаковыми или различными и независимо представляют собой С8-13 алкил; и
R2 и R4 являются одинаковыми или различными и независимо представляют собой С6-11 алкил; или
тем, что агонист TLR4 включает синтетический GLA формулы (V):
или его фармацевтически приемлемую соль, где
R1, R3, R5 и R6 представляют собой С11-С20 алкил; и R2 и R4 представляют собой С12-С20 алкил; или тем, что
агонист TLR4 включает синтетический GLA формулы:
или его фармацевтически приемлемую соль.
11. Композиция по любому из пп. 1-10, дополнительно содержащая антиген.
12. Композиция по п. 11, характеризующаяся тем, что антиген выбран из антигена, связанного с туберкулезом, антигена, связанного с гриппом, антигена, связанного с гемагглютинином, антигена, связанного с раком, антигена, связанного с вирусом, и антигена, связанного с амебиазом; при этом необязательно антиген, связанный с туберкулезом, выбран из группы, состоящей из ID93, ID91 и БЦЖ; при этом необязательно антиген, связанный с гриппом, выбран из группы, состоящей из H5N1, гриппа А, гриппа В и гриппа С; при этом необязательно антиген, связанный с амебиазом, представляет собой LecA; при этом необязательно антиген, связанный с вирусом, выбран из группы, состоящей из гепатита В и гепатита С.
13. Композиция по любому из пп. 1-12, характеризующаяся тем, что композиция является стабильной в течение по меньшей мере примерно шести месяцев; или тем, что композиция является стабильной в течение по меньшей мере примерно одного года; или тем, что композиция является стабильной при 2-8°С в течение по меньшей мере шести месяцев; или тем, что композиция является стабильной при 2-8°С в течение по меньшей мере одного года.
14. Способ стимулирования иммунного ответа у субъекта, включающий введение композиции по любому из пп. 1-13 субъекту и стимулирование, таким образом, иммунного ответа у субъекта.
15. Способ по п. 14, характеризующийся тем, что иммунный ответ представляет собой неспецифический иммунный ответ, или тем, что иммунный ответ представляет собой антиген-специфический иммунный ответ.
16. Способ по п. 14, характеризующийся тем, что иммунный ответ включает активацию В-клеток, активацию Т-клеток, продуцирование антител или выделение цитокинов.
17. Способ по п. 14, характеризующийся тем, что композицию применяют для лечения аллергии, зависимости, рака или аутоиммунной реакции.
18. Способ по любому из пп. 14-16, характеризующийся тем, что субъект представляет собой человека или млекопитающее, отличное от человека; при этом необязательно млекопитающее, отличное от человека, представляет собой собаку, корову или лошадь.
19. Способ получения водного состава, содержащего агонист TLR7/8 или агонист TLR4 и вспомогательный липид, где композиция, содержащая агонист TLR7/8 или агонист TLR4 и вспомогательный липид, содержит частицы, имеющие размер в диапазоне от 1 нм до примерно 450 нм; характеризующийся тем, что способ включает
(a) смешивание агониста TLR7/8 или агониста TLR4 и вспомогательного липида в растворителе с получением раствора;
(b) удаление растворителя из раствора со стадии (а) с получением пленочной композиции; и
(c) регидратирование пленочной композиции со стадии (с) с получением регидратированной композиции; и
(d) воздействие на регидратированную композицию мощным источником энергии с получением наносуспензионной композиции.
20. Способ по п. 19, характеризующийся тем, что мощный источник энергии представляет собой микрофлюидизатор, экструдер, ультразвуковой диспергатор, смеситель Silverson или гомогенизатор.
21. Способ по п. 19, дополнительно включающий смешивание антигена с наносуспензионной композицией, или дополнительно включающий смешивание соли алюминия с наносуспензионной композицией, или дополнительно включающий смешивание соли алюминия и антигена с наносуспензионной композицией.
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| PT2606047T (pt) | 2010-08-17 | 2017-04-07 | 3M Innovative Properties Co | Composições, formulações e métodos de um composto lipidado modificador da resposta imunitária |
| KR20140026392A (ko) * | 2011-03-02 | 2014-03-05 | 노파르티스 아게 | 저용량의 항원 및/또는 보조제를 갖는 조합 백신 |
| BR112013032675A2 (pt) * | 2011-06-19 | 2017-08-08 | Vaxine Pty Ltd | composição adjuvante de vacina compreendendo partículas de inulina |
| US9375471B2 (en) | 2012-03-08 | 2016-06-28 | Glaxosmithkline Biologicals Sa | Adjuvanted formulations of booster vaccines |
| JP2015514696A (ja) * | 2012-03-18 | 2015-05-21 | グラクソスミスクライン バイオロジカルズ ソシエテ アノニム | ヒト・パピローマウイルスに対するワクチン接種方法 |
| EP3065829B1 (en) | 2013-11-08 | 2021-05-19 | University of Virginia Patent Foundation | Compositions and methods for treating melanoma |
| CN112521464A (zh) | 2014-03-26 | 2021-03-19 | 葛兰素史密丝克莱恩生物有限公司 | 突变型葡萄球菌抗原 |
| US10881729B2 (en) | 2014-04-18 | 2021-01-05 | Children's Medical Center Corporation | Vaccine adjuvant compositions |
| WO2016010788A1 (en) | 2014-07-15 | 2016-01-21 | The United States Of America, As Represented By The Secretary, Dept. Of Health And Human Services | Polyketal particles including a cpg oligodeoxynucleotide for the treatment of lung cancer |
| CN104800843B (zh) * | 2015-04-02 | 2017-07-04 | 中国农业科学院兰州兽医研究所 | 一种用于弓形虫感染预防的药剂及应用 |
| WO2017200852A1 (en) | 2016-05-16 | 2017-11-23 | Infectious Disease Research Institute | Formulation containing tlr agonist and methods of use |
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