RU2015139969A - Комбинация вакцинации и ингибирования пути pd-1 - Google Patents

Комбинация вакцинации и ингибирования пути pd-1 Download PDF

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RU2015139969A
RU2015139969A RU2015139969A RU2015139969A RU2015139969A RU 2015139969 A RU2015139969 A RU 2015139969A RU 2015139969 A RU2015139969 A RU 2015139969A RU 2015139969 A RU2015139969 A RU 2015139969A RU 2015139969 A RU2015139969 A RU 2015139969A
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rna
combination
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vaccine
pathway inhibitor
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Мариола ФОТИН-МЛЕЧЕК
Карл-Йозеф КАЛЛЕН
Йохен ПРОБСТ
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Куревак Гмбх
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    • AHUMAN NECESSITIES
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    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
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    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/51Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/53DNA (RNA) vaccination
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
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    • A61K2039/55516Proteins; Peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Claims (34)

1. Комбинация вакцина/ингибитор, содержащая:
(I) в качестве вакцины РНК-вакцину, содержащую по меньшей мере одну РНК, которая содержит по меньшей мере одну открытую рамку считывания (ОРС), кодирующую по меньшей мере один антиген, и
(II) в качестве ингибитора композицию, содержащую ингибитор PD-1-пути.
2. Комбинация по п. 1, в которой ингибитор PD-1-пути выбран из группы, состоящей из ингибиторов, направленных против PD-1, PD-L1 или PD-L2.
3. Комбинация по п. 1 или 2, в которой ингибитор PD-1-пути выбран из группы, состоящей из антагонистического антитела или нуклеиновой кислоты, кодирующей антагонистическое антитело, siPHK, антисмысловой РНК, белка, содержащего аминокислотную последовательность, которая обладает способностью связываться с PD-1, но препятствует передаче сигнала PD-1-путем, или нуклеиновой кислоты, кодирующей указанную аминокислотную последовательность, растворимого белка или нуклеиновой кислоты, кодирующей растворимый белок, который конкурирует с PD-1 за связывание с его лигандами PD-L1 и PD-L2, и низкомолекулярного ингибитора.
4. Комбинация по п. 3, в которой ингибитор PD-1-пути представляет собой антитело или нуклеиновую кислоту, кодирующую антитело, мишенью которого является PD-1 или лиганд PD-1.
5. Комбинация по п. 4, в которой антитело, мишенью которого является PD-1, представляет собой ниволумаб (BMS-936558/MDX1106), СТ-011 или MK-3475 (SCH 900475).
6. Комбинация по п. 4, в которой антитело, мишенью которого является PD-L1, представляет собой MDX-1105/BMS-936559, MPDL3280A/RG7446 или MEDI4736.
7. Комбинация по п. 3, в которой белок, содержащий аминокислотную последовательность, которая обладает способностью связываться с PD-1, но препятствует передаче сигнала PD-1-путем, или нуклеиновую кислоту, кодирующую указанную аминокислотную последовательность, представляет собой слитый белок фрагмента PD-L1 или лиганда PD-L2.
8. Комбинация по п. 7, в которой слитый белок представляет собой слитый белок внеклеточного домена PD-L1 или PD-L2, или его фрагмента, способного связываться с PD-1.
9. Комбинация по п. 8, в которой слитый белок представляет собой слитый белок внеклеточного домена PD-L2 и Fc-области иммуноглобулина.
10. Комбинация по п. 3, в которой растворимый белок представляет собой растворимый рецептор PD-1, который конкурирует со связанным с мембраной PD-1 за связывание с PD-L1 и/или PD-L2.
11. Комбинация по одному из пп. 1, 2 и 4-10, в которой по меньшей мере одна РНК, входящая в РНК-вакцину, представляет собой выделенную РНК.
12. Комбинация по одному из пп. 1, 2 и 4-10, в которой по меньшей мере одна РНК, входящая в РНК-вакцину, представляет собой стабилизированную РНК.
13. Комбинация по одному из пп. 1, 2 и 4-10, в которой по меньшей мере одна РНК, входящая в РНК-вакцину, является по меньшей мере частично G/C-модифицированной, в которой предпочтительно содержание G/C по меньшей мере в одной открытой рамке считывания по меньшей мере одной РНК, входящей в РНК-вакцину, увеличено по сравнению с открытой рамкой считывания дикого типа.
14. Комбинация по одному из пп. 1, 2 и 4-10, в которой по меньшей мере одна РНК, входящая в РНК-вакцину, содержит область с оптимизированными кодонами, предпочтительно в которой по меньшей мере одна открытая рамка считывания по меньшей мере одной РНК, входящей в РНК-вакцину, имеет оптимизированные кодоны.
15. Комбинация по одному из пп. 1, 2 и 4-10, в которой по меньшей мере одна РНК, входящая в РНК-вакцину, представляет собой мРНК.
16. Комбинация по одному из пп. 1, 2 и 4-10, в которой по меньшей мере одна РНК, входящая в РНК-вакцину, включена в комплекс с носителем.
17. Комбинация по п. 16, в которой носитель представляет собой катионное или поликатионное соединение, или полимерный носитель, предпочтительно протамин.
18. Фармацевтическая композиция, содержащая:
(I) РНК-вакцину, содержащую по меньшей мере одну РНК, которая содержит по меньшей мере одну открытую рамку считывания, кодирующую по меньшей мере один антиген, по одному из предыдущих пунктов, и
(II) ингибитор PD-1-пути по одному из предыдущих пунктов.
19. Набор компонентов, содержащий:
(I) РНК-вакцину, содержащую по меньшей мере одну РНК, которая содержит по меньшей мере одну открытую рамку считывания, кодирующую по меньшей мере один антиген, по одному из предыдущих пунктов, и
(II) композицию, содержащую ингибитор PD-1-пути по одному из предыдущих пунктов.
20. Комбинация по одному из пп. 1, 2 и 4-10, фармацевтическая композиция по п. 18, набор компонентов по п. 19, предназначенные для медицинского применения.
21. Комбинация по одному из пп. 1, 2 и 4-10, фармацевтическая композиция по п. 18 или п. 20, набор компонентов по п. 19 или п. 20, предназначенные для применения в способе предупреждения или лечения опухолевого или ракового заболевания, или инфекционного заболевания.
22. Комбинация или набор компонентов по п. 21, где ингибитор PD-1-пути и РНК-вакцина предназначены для последовательного введения пациенту, нуждающемуся в этом.
23. Комбинация или набор компонентов по п. 21, где ингибитор PD-1-пути и РНК-вакцина предназначены для одновременного введения пациенту, нуждающемуся в этом.
24. Комбинация или набор компонентов по п. 21, где ингибитор PD-1-пути и РНК-вакцина предназначены для введения пациенту, нуждающемуся в этом, с помощью различных путей введения.
25. Применение ингибитора PD-1-пути согласно определению в любом из предыдущих пунктов, в терапии в комбинации с РНК-вакциной по одному из предыдущих пунктов.
26. Применение РНК-вакцины согласно определению в любом из предыдущих пунктов, предназначенная для применения в терапии в комбинации с ингибитором PD-1-пути по одному из предыдущих пунктов.
27. Способ лечения, включающий введение индивидууму, нуждающемуся в этом, в терапевтически эффективном количестве РНК-вакцины по одному из предыдущих пунктов в комбинации с ингибитором PD-1-пути по одному из предыдущих пунктов.
28. Способ лечения по п. 27, в котором РНК-вакцину и ингибитор PD-1-пути вводят последовательно и/или с помощью различных путей введения.
RU2015139969A 2013-02-22 2014-02-21 Комбинация противораковой рнк-вакцины и ингибитора пути pd-1 и ее применение RU2718988C2 (ru)

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