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RU2017103162A - Онколитический вирус для экспрессии модуляторов иммунологических контрольных точек - Google Patents

Онколитический вирус для экспрессии модуляторов иммунологических контрольных точек Download PDF

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RU2017103162A
RU2017103162A RU2017103162A RU2017103162A RU2017103162A RU 2017103162 A RU2017103162 A RU 2017103162A RU 2017103162 A RU2017103162 A RU 2017103162A RU 2017103162 A RU2017103162 A RU 2017103162A RU 2017103162 A RU2017103162 A RU 2017103162A
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virus
oncolytic virus
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oncolytic
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RU2017103162A
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RU2696312C2 (ru
RU2017103162A3 (ru
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Натали СИЛЬВЕСТР
Мишель ГЕЙСТ
Карола РИТТНЕР
Жан-Батист Маршан
Кристин ТИУДЕЛЛЕ
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Трансген Са
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Claims (26)

1. Онколитический вирус, содержащий молекулу нуклеиновой кислоты, вставленную в его геном, кодирующую один или более чем один модулятор иммунологической контрольной точки.
2. Онколитический вирус по п. 1, где указанный онколитический вирус выбран из группы, состоящей из реовируса, вируса долины Сенека (SVV), вируса везикулярного стоматита (VSV), вируса ньюкаслской болезни (NDV), вируса простого герпеса (HSV), морбилливируса, ретровируса, вируса гриппа, вируса Синдбис, вируса группы оспы и аденовируса.
3. Онколитический вирус по п. 2, где указанный вирус группы оспы представляет собой вирус осповакцины и, в частности, вирус осповакцины, выбранный из группы штаммов Elstree, Wyeth, Copenhagen и Western Reserve.
4. Онколитический вирус по п. 3, где указанный онколитический вирус представляет собой вирус осповакцины, дефектный по тимидинкиназе (ТK) в результате инактивирующих мутаций в вирусном гене J2R.
5. Онколитический вирус по п. 3, где указанный вирус представляет собой вирус осповакцины, дефектный по активности рибонуклеотидредуктазы (RR) в результате инактивирующих мутаций в вирусном(ных) гене(нах) I4L и/или F4L.
6. Онколитический вирус по п. 1, где указанный онколитический вирус дополнительно содержит по меньшей мере один терапевтический ген, вставленный в вирусный геном.
7. Онколитический вирус по п. 6, где указанный терапевтический ген выбран из группы, состоящей из генов, кодирующих продукты суицидных генов, или генов, кодирующих иммуностимулирующие белки.
8. Онколитический вирус по п. 7, где указанный суицидный ген выбран из группы, состоящей из генов, кодирующих белок, имеющий активность цитозиндезаминазы (ЦДаза), активность тимидинкиназы, активность урацилфосфорибозилтрансферазы (УФРТаза), активность фосфорилазы пуриновых нуклеозидов и активность тимидилаткиназы.
9. Онколитический вирус по п. 8, где указанный продукт суицидного гена имеет ЦДазную и УФРТазную активности, и предпочтительно они выбраны из группы, состоящей из полипептидов codA::upp, FCY1::FUR1 и FCY1::FUR1 [дельта] 105 (FCU1) и FCU1-8.
10. Онколитический вирус по п. 8, где указанный онколитический вирус представляет собой вирус осповакцины, дефектный по активностям и ТK, и RR, и содержащий терапевтический суицидный ген FCU1, вставленный в его геном.
11. Онколитический вирус по п. 7, где указанный иммуностимулирующий белок представляет собой интерлейкин или колониестимулирующий фактор, с конкретным предпочтением в отношении GM-CSF (гранулоцитарно-макрофагальный колониестимулирующий фактор).
12. Онколитический вирус по п. 11, где указанный онколитический вирус представляет собой вирус осповакцины, дефектный в отношении активности ТK и содержащий терапевтический человеческий GM-CSF, вставленный в его геном.
13. Онколитический вирус по п. 1, где указанный один или более чем один модулятор иммунологической контрольной точки выбран из группы, состоящей из пептидных лигандов, растворимых доменов природных рецепторов, РНКи (интерферирующая РНК), антисмысловых молекул, антител и белковых каркасов.
14. Онколитический вирус по п. 13, где указанный один или более чем один модулятор иммунологической контрольной точки оказывает по меньшей мере частичный антагонистический эффект на активность ингибирующей(щих) иммунологической(ких) контрольной(ных) точки(чек), в частности на активности, опосредованные любым из следующих: PD-1 (белок 1 программируемой клеточной смерти), PD-L1 (лиганд 1 белка программируемой клеточной смерти), PD-L2 (лиганд 2 белка программируемой клеточной смерти), LAG3 (ген 3, активирующий лимфоциты), Tim3 (белок 3, содержащий домен муцина), BTLA (аттенюатор В- и Т-лимфоцитов) и CTLA4 (белок-4, ассоциированный с цитотоксическими Т-лимфоцитами).
15. Онколитический вирус по п. 14, где указанный один или более чем один модулятор иммунологической контрольной точки включает антитело, которое специфично связывается с человеческим PD-1 и, в частности, антитело против PD-1, выбранное из группы, состоящей из ниволумаба, пембролизумаба и пидилизумаба.
16. Онколитический вирус по п. 14, где указанный один или более чем один модулятор иммунологической контрольной точки включает антитело, которое специфично связывается с человеческим PD-L1 и, в частности, антитело против PD-L1, выбранное из группы, состоящей из MPDL3280A и BMS-936559.
17. Онколитический вирус по п. 14, где указанный один или более чем один модулятор иммунологической контрольной точки включает антитело, которое специфично связывается с человеческим CTLA-4 и, в частности, антитело против
CTLA4, выбранное из группы, состоящей из ипилимумаба, тремелимумаба и одноцепочечных антител против CTLA4.
18. Фармацевтическая композиция, содержащая эффективное количество онколитического вируса по любому из пп. 1-17 и фармацевтически приемлемый носитель.
19. Фармацевтическая композиция по п. 18, содержащая от приблизительно 107 pfu до приблизительно 5×109 pfu указанного онколитического вируса.
20. Фармацевтическая композиция по п. 18, которая приготовлена для парентерального введения.
21. Применение онколитического вируса по любому из пп. 1-17 или фармацевтической композиции по любому из пп. 18-20 для изготовления лекарства для лечения пролиферативного заболевания.
22. Применение по п. 21, где указанное пролиферативное заболевание представляет собой рак и предпочтительно рак, выбранный из группы, состоящей из меланомы, рака почки, рака предстательной железы, рака молочной железы, колоректального рака, рака легкого и рака печени.
23. Применение по п. 21, где указанный онколитический вирус вводится посредством внутривенного или внутриопухолевого пути.
24. Применение по п. 23, которое включает от 2 до 5 внутривенных или внутриопухолевых введений 108 или 109 pfu онколитического вируса осповакцины приблизительно с инервалом 1 или 2 недели.
25. Применение по п. 21, которое дополнительно включает введение пролекарства и/или вещества, эффективного в противораковой терапии.
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