RU2017103151A - Комбинация онколитического вируса с модуляторами иммунологических контрольных точек - Google Patents

Комбинация онколитического вируса с модуляторами иммунологических контрольных точек Download PDF

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RU2017103151A
RU2017103151A RU2017103151A RU2017103151A RU2017103151A RU 2017103151 A RU2017103151 A RU 2017103151A RU 2017103151 A RU2017103151 A RU 2017103151A RU 2017103151 A RU2017103151 A RU 2017103151A RU 2017103151 A RU2017103151 A RU 2017103151A
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Лоранс ЦИТФОГЕЛЬ
Ксавье ПРЕВИЛЛЬ
Летиция ФЕНД
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Трансген Са
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Claims (20)

1. Применение комбинации, содержащей онколитический поксвирус и один или более чем один модулятор иммунологической контрольной точки, который оказывает по меньшей мере частичный антагонистический эффект на активность ингибиторной иммунологической контрольной точки, для изготовления лекарства для лечения рака, где указанный онколитический поксвирус и один или более чем один модулятор иммунологической контрольной точки вводятся последовательно, таким образом, что первым вводится онколитический поксвирус и вторым - модулятор(ры) иммунологической контрольной точки.
2. Применение по п. 1, где указанный онколитический поксвирус представляет собой вирус осповакцины, дефектный в отношении тимидинкиназы (ТK) в результате инактивирующих мутаций в вирусном гене J2R.
3. Применение по п. 1, где указанный поксвирус представляет собой вирус осповакцины, дефектный в отношении активности рибонуклеотидредуктазы (RR) в результате инактивирующих мутаций в вирусном(ных) гене(нах) I4L и/или F4L.
4. Применение по п. 1, где указанный онколитический поксвирус дополнительно экспрессирует по меньшей мере один терапевтический ген, вставленный в вирусный геном, где указанный терапевтический ген выбран из группы, состоящей из генов, кодирующих продукты суицидных генов, и генов, кодирующих иммуностимулирующие белки.
5. Применение по п. 4, где указанный суицидный ген выбран из группы, состоящей из генов, кодирующих белок, имеющий цитозиндезаминазную (ЦДазную) активность, тимидинкиназную активность, урацилфосфорибозилтрансферазную (УФРТазную) активность, фосфорилазную активность пуриновых нуклеозидов и тимидилаткиназную активность.
6. Применение по п. 5, где указанный продукт суицидного гена имеет ЦДазную и УФРТазную активности и предпочтительно выбран из группы, состоящей из полипептидов codA::upp, FCY1::FUR1 и FCY1::FUR1[дельта]105 (FCU1) и FCUI-8.
7. Применение по п. 5, где указанный онколитический поксвирус представляет собой вирус осповакцины, дефектный по активностям и ТK, и RR, и содержащий терапевтический суицидный ген FCU1, вставленный в его геном.
8. Применение по п. 4, где указанный иммуностимулирующий белок представляет собой интерлейкин или колониестимулирующий фактор с конкретным предпочтением в отношении GM-CSF (гранулоцитарно-макрофагальный колониестимулирующий фактор).
9. Применение по п. 8, где указанный онколитический поксвирус представляет собой вирус осповакцины, дефектный в отношении активности ТК и содержащий терапевтический человеческий GM-CSF, вставленный в его геном.
10. Применение по п. 1, где композиция содержит от приблизительно 107 pfu до приблизительно 5×109 pfu указанного онколитического поксвируса.
11. Применение по любому из пп. 1-10, где указанный модулятор иммунологической(ких) контрольной(ных) точки(чек) опосредован любыми из следующих: PD-1, PD-L1, PD-L2, LAG3, Tim3, BTLA и CTLA4.
12. Применение по п. 11, 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, ланбролизумаба и пидилизумаба.
13. Применение по п. 11, 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.
14. Применение по п. 11, 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.
15. Применение по п. 1, где композиция содержит от примерно 2 мг/кг до примерно 15 мг/кг указанного одного или более чем одного модулятора иммунологической контрольной точки.
16. Применение по п. 1, где указанный(ные) модулятор(ры) иммунологической контрольной точки вводится(дятся) посредством внутривенного, внутриопухолевого или внутрибрюшинного пути, и в которой указанный онколитический поксвирус вводится внутривенным или внутриопухолевым путем.
17. Применение по п. 1, включающее от 2 до 5 внутривенных или внутриопухолевых введений 108 или 109 pfu онколитического вируса осповакцины приблизительно с 1- или 2-недельным интервалом с последующими или перемежающимися 2-5 внутривенными введениями 3-10 мг/кг одного или более чем одного антитела против иммунологической контрольной точки каждые 2 или 3 недели.
18. Применение по п. 1, где указанный рак выбран из группы, состоящей из меланомы, рака почки, рака предстательной железы, рака молочной железы, колоректального рака, рака легкого и рака печени.
19. Набор, содержащий по меньшей мере онколитический вирус, как определено по любому из пп. 2-10 и 16-17, в одном контейнере, и один или более чем одим модулятор иммунологической контрольной точки, как определено в любом из пп. 11-17, в другом контейнере.
20. Фармацевтическая композиция, содержащая эффективные количества указанного онколитического вируса и указанного одного или более чем одного модулятора иммунологической контрольной точки как определено в любом из пп. 1-18.
RU2017103151A 2014-07-16 2015-07-16 Комбинация онколитического вируса с модуляторами иммунологических контрольных точек RU2705780C2 (ru)

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