RU2018104962A - Снижение системного уровня регуляторных т-клеток или их активности для лечения заболеваний и трамв цнс - Google Patents
Снижение системного уровня регуляторных т-клеток или их активности для лечения заболеваний и трамв цнс Download PDFInfo
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- RU2018104962A RU2018104962A RU2018104962A RU2018104962A RU2018104962A RU 2018104962 A RU2018104962 A RU 2018104962A RU 2018104962 A RU2018104962 A RU 2018104962A RU 2018104962 A RU2018104962 A RU 2018104962A RU 2018104962 A RU2018104962 A RU 2018104962A
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Claims (60)
1. Активный агент, который вызывает снижение уровня системной иммуносупрессии путем снятия ограничения, налагаемого на иммунную систему одной или несколькими иммунными контрольными точками, для использования при лечении заболеваний, расстройств, патологически состояний или травм центральной нервной системы (ЦНС), кроме аутоиммунного рецидивирующе-ремиттирующего рассеянного склероза (РРРС), при этом упомянутый активный агент вводится с помощью режима дозирования, включающего по меньшей мере два сеанса лечения, каждый сеанс лечения включает в себя сеанс лечения с последующим перерывом без лечения, и упомянутая иммунная контрольная точка (несколько точек) выбирается из группы, состоящей из ICOS-B7RP1, Ig-супрессора активации Т-клеток V-домена (VISTA), В7-CD28-подобной молекулы, CD40L-CD40, CD28-CD80, CD28-CD86, В7Н3, В7Н4, В7Н7, BTLA-HVEM, CD137-CD137L, OX40L, CD27-CD70, стимулятора генов интерферона (STING), ингибиторного мотива домена иммуноглобулина и иммунорецептора Т-клеток на основе тирозина (TIGIT), а также A2aR-аденозина и индоламин-2,3-диоксигеназы (IDO)-L-триптофана.
2. Активный агент по п. 1, отличающийся тем, что упомянутое снижение уровня системной иммуносупрессии связано с увеличением системного присутствия или активности IFNγ-продуцирующих лейкоцитов.
3. Активный агент по п. 1, отличающийся тем, что упомянутый активный агент приводит к снижению уровня системной иммуносупрессии и, тем самым, к увеличению системного присутствия или активности эффекторных Т-клеток.
4. Активный агент по п. 1, отличающийся тем, что упомянутый активный агент вызывает высвобождение из иммуносупрессии посредством блокады упомянутой одной или более иммунных контрольных точек.
5. Активный агент по любому из пп. 1-4, отличающийся тем, что упомянутый активный агент выбран из группы, состоящей из:
(i) антитела, такого как гуманизированное антитело; человеческого антитела; функционального фрагмента антитела; однодоменного антитела, такого как нанотело; рекомбинантного антитела; и одноцепочечного вариабельного фрагмента (ScFv);
(ii) имитатора антитела, такого как молекула аффибного антитела; аффилина; аффимера; аффитина; алфатела; антикалина; авимера; дарпина; финомера; пептида домена Куниц; и монотела;
(iii) аптамера; и
(iv) низкомолекулярного ингибитора.
6. Активный агент по любому из пп. 1-5, отличающийся тем, что упомянутый активный агент выбран из группы, состоящей из
(i) антитела, выбранного из группы, состоящей из:
(a) анти-ICOS;
(b) анти-B7RP1;
(c) анти-VISTA;
(d) анти-CD40;
(e) анти-CD40L;
(f) анти-CD80;
(g) анти-CD86;
(h) анти-B7-H3;
(i) анти-B7-H4;
(j) анти-В7-Н7;
(k) анти-BTLA;
(l) анти-HVEM;
(m) анти-CD137;
(n) анти-CD137L;
(o) анти-OX40L
(p) анти-CD-27;
(q) анти-CD70;
(r) анти-STING;
(s) анти-TIGIT; и
(t) любой комбинации (a)-(s);
(ii) любой комбинации (a)-(s) в сочетании с адъювантом;
(iii) малой молекулы, выбранной из группы, состоящей из:
(a) антагониста рецепторов аденозина А1;
(b) антагониста рецепторов аденозина А2а;
(c) антагониста рецепторов A3;
(iv) любой комбинации (iii) (а-с) и (i) (a-s);
а также
(v) любой комбинации (i)-(iv).
7. Активный агент по любому из пп. 1-6, отличающийся тем, что упомянутый сеанс лечения включает введение упомянутого активного агента упомянутому пациенту, и упомянутый сеанс лечения продолжается по меньшей мере до тех пор, пока системное присутствие или уровень лейкоцитов, продуцирующих IFNγ, не поднимется выше контрольного, при этом введение приостанавливается во время перерыва, и данный перерыв в лечении продолжается до тех пор, пока упомянутый уровень находится выше упомянутого контрольного уровня,
при этом упомянутый контрольный уровень выбирается из вариантов:
(a) уровень системного присутствия или активности IFNγ-продуцирующих лейкоцитов, измеренный в последнем образце крови, взятом у упомянутого пациента перед упомянутым введением; или
(b) уровень системного присутствия или активности лейкоцитов, продуцирующих IFNγ, характерный для группы пациентов, страдающих от болезни, расстройства, патологического состояния или травмы ЦНС.
8. Активный агент по любому из пп. 1-6, отличающийся тем, что упомянутый сеанс лечения включает введение упомянутого активного агента упомянутому пациенту, и упомянутый сеанс лечения продолжается по меньшей мере до тех пор, пока системное присутствие упомянутого активного агента не достигнет терапевтического уровня, при этом введение приостанавливается во время перерыва, и данный перерыв в лечении продолжается до тех пор, пока упомянутый уровень выше, чем примерно 95%, 90%, 80%, 70%, 60% или 50% от упомянутого терапевтического уровня.
9. Активный агент по любому из пп. 1-8, отличающийся тем, что введение препарата во время сеанса лечения выполняется однократно.
10. Активный агент по любому из пп. 1-8, отличающийся тем, что введение препарата во время сеанса лечения выполняется неоднократно.
11. Активный агент по п. 10, отличающийся тем, что неоднократное введение выполняется один раз каждые два, три, четыре, пять или шесть дней.
12. Активный агент по п. 10, отличающийся тем, что неоднократное введение выполняется еженедельно.
13. Активный агент по п. 10, отличающийся тем, что неоднократное введение выполняется каждые четыре недели.
14. Активный агент по любому из пп. 1-13, отличающийся тем, что сеанс лечения продолжается от 3 дней до четырех недель.
15. Активный агент по любому из пп. 1-14, отличающийся тем, что сеанс лечения продолжается от одной недели до шести месяцев.
16. Активный агент по любому из пп. 1-15, предназначенный для лечения заболеваний, расстройств или патологических состояний, к которым относится нейродегенеративное заболевание, выбранное из группы, включающей в себя болезнь Альцгеймера, амиотрофический боковой склероз, болезнь Паркинсона, болезнь Хантингтона, первичный прогрессирующий рассеянный склероз; вторичный прогрессирующий рассеянный склероз, кортикобазальную дегенерацию, синдром Ретта, дегенерацию сетчатки, выбранную из группы, куда входит возрастная макулярная дегенерация и пигментная дегенерация сетчатки; переднюю ишемическую оптическую невропатию; глаукому; увеит; депрессию; связанный с травмой стресс или посттравматическое стрессовое расстройство, лобно-временную деменцию, болезнь диффузных телец Леви, умеренные когнитивные нарушения, атрофию задней коры головного мозга, первичную прогрессирующую афазию, прогрессирующий надъядерный паралич и возрастную деменцию.
17. Активный агент по п. 16, отличающийся тем, что указанное нейродегенеративное заболевание, расстройство или патологическое состояние выбрано из группы, состоящей из болезни Альцгеймера, бокового амиотрофического склероза, болезни Паркинсона и болезни Хантингтона.
18. Активный агент по п. 17, для использования в лечении болезни Альцгеймера.
19. Активный агент по любому из пп. 1-15, для использования в лечении повреждений ЦНС, выбранных из группы, состоящей из травмы спинного мозга, закрытой травмы головы, тупой травмы, проникающей травмы, геморрагического инсульта, ишемического инсульта, церебральной ишемии, травмы зрительного нерва, инфаркта миокарда, отравления органофосфатом и травм, вызванных удалением опухоли.
20. Активный агент по любому из пп. 1-15, отличающийся тем, что упомянутое лечение улучшает двигательные и/или когнитивные функции ЦНС.
21. Активный агент по п. 20, предназначенный для облегчения возрастной потери когнитивных функций.
22. Активный агент по п. 21, отличающийся тем, что упомянутая возрастная потеря когнитивной функции происходит у лиц, не страдающих диагностированным заболеванием.
23. Активный агент по п. 21, используемый для уменьшения потери когнитивной функции в результате острого стресса или травматического происшествия.
24. Активный агент по п. 19, отличающийся тем, что упомянутая когнитивная функция представляет собой обучение, память или то и другое.
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| US9394365B1 (en) | 2014-03-12 | 2016-07-19 | Yeda Research And Development Co., Ltd | Reducing systemic regulatory T cell levels or activity for treatment of alzheimer's disease |
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| EP3725370A1 (en) * | 2019-04-19 | 2020-10-21 | ImmunoBrain Checkpoint, Inc. | Modified anti-pd-l1 antibodies and methods and uses for treating a neurodegenerative disease |
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