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RU2018101978A - Антитела против трансферринового рецептора, обладающие индивидуализированной аффинностью - Google Patents

Антитела против трансферринового рецептора, обладающие индивидуализированной аффинностью Download PDF

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RU2018101978A
RU2018101978A RU2018101978A RU2018101978A RU2018101978A RU 2018101978 A RU2018101978 A RU 2018101978A RU 2018101978 A RU2018101978 A RU 2018101978A RU 2018101978 A RU2018101978 A RU 2018101978A RU 2018101978 A RU2018101978 A RU 2018101978A
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seq
variable domain
mutations
humanized antibody
heavy chain
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RU2018101978A
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RU2729416C2 (ru
RU2018101978A3 (ru
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Стефан ДЕНГЛЬ
Ги Жорж
Ульрих Гёпферт
Йенс Нивёнер
Тильман ШЛОТАУЭР
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Ф. Хоффманн-Ля Рош Аг
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Claims (67)

1. Гуманизированное антитело, которое специфично связывается с человеческим трансферриновым рецептором, где указанное антитело содержит:
HVR (гипервариабельная область) SEQ ID NO 66, 68 и 72 в вариабельном домене тяжелой цепи
и
HVR SEQ ID NO 75, 76 и 78 в вариабельном домене легкой цепи.
2. Гуманизированное антитело по п. 1, содержащее вариабельный домен тяжелой цепи SEQ ID NO 24 и вариабельный домен легкой цепи SEQ ID NO 37.
3. Гуманизированное антитело по п. 1 или 2, где у данного гуманизированного антитела выключена эффекторная функция.
4. Гуманизированное антитело по любому из пп. 1-3, где указанное гуманизированное антитело специфично связывается с человеческим трансферриновым рецептором и с трансферриновым рецептором яванского макака.
5. Гуманизированное антитело по любому из пп. 1-4, где указанное гуманизированное антитело представляет собой мультиспецифичное антитело, имеющее по меньшей мере одну специфичность связывания в отношении человеческого трансферринового рецептора и по меньшей мере одну специфичность связывания в отношении терапевтической мишени.
6. Гуманизированное антитело по п. 5, где указанное гуманизированное антитело содержит первый антигенсвязывающий сайт, который связывается с человеческим трансферриновым рецептором, и второй антигенсвязывающий сайт, который связывается с мозговым антигеном.
7. Гуманизированное антитело по п. 6, где мозговой антиген выбран из группы, состоящей из Абета, рецептора эпидермального фактора роста (EGFR), рецептора 2 человеческого эпидермального фактора роста (HER2), альфа-синуклеина, CD20, белка-предшественника амилоида (АРР) и глюкоцереброзидазы.
8. Гуманизированное антитело по любому из пп. 5-7, где мультиспецифичное антитело связывается с обоими:
i) человеческим трансферриновым рецептором и Абета, или
ii) человеческим трансферриновым рецептором и CD20, или
iii) человеческим трансферриновым рецептором и альфа-синуклеином, или
iv) человеческим трансферриновым рецептором и фосфо-тау, или
v) человеческим трансферриновым рецептором и глюкоцереброзидазой.
9. Гуманизированное антитело по любому из пп. 1-8, где указанное гуманизированное антитело представляет собой биспецифичное антитело, содержащее:
i) первый сайт связывания, содержащий вариабельный домен тяжелой цепи SEQ ID NO 24 и вариабельный домен легкой цепи SEQ ID NO 37,
и
ii) второй сайт связывания, выбранный из:
а) вариабельного домена тяжелой цепи SEQ ID NO 81 и вариабельного домена легкой цепи SEQ ID NO 82, или
б) вариабельного домена тяжелой цепи SEQ ID NO 83 и вариабельного домена легкой цепи SEQ ID NO 84, или
в) вариабельного домена тяжелой цепи SEQ ID NO 85 и вариабельного домена легкой цепи SEQ ID NO 86, или
г) вариабельного домена тяжелой цепи SEQ ID NO 87 и вариабельного домена легкой цепи SEQ ID NO 88, или
д) вариабельного домена тяжелой цепи SEQ ID NO 91 и вариабельного домена легкой цепи SEQ ID NO 92, или
е) вариабельного домена тяжелой цепи SEQ ID NO 89 и вариабельного домена легкой цепи SEQ ID NO 90, или
ж) вариабельного домена тяжелой цепи SEQ ID NO 93 и вариабельного домена легкой цепи SEQ ID NO 94, или
з) вариабельного домена тяжелой цепи SEQ ID NO 79 и вариабельного домена легкой цепи SEQ ID NO 80.
10. Гуманизированное антитело по любому из пп. 1-9, где указанное гуманизированное антитело представляет собой:
а) полноразмерное антитело человеческого подкласса IgG1, или
б) полноразмерное антитело человеческого подкласса IgG4, или
в) полноразмерное антитело человеческого подкласса IgG1 с мутациями L234A, L235A и P329G,
г) полноразмерное антитело человеческого подкласса IgG4 с мутациями S228P, L235E и, возможно, P329G,
д) полноразмерное антитело человеческого подкласса IgG1 с мутациями L234A, L235A и P329G в обеих тяжелых цепях, и с мутациями T366W и S354C в одной тяжелой цепи и мутациями T366S, L368A, Y407V и Y349C в соответствующей другой тяжелой цепи, или
е) полноразмерное антитело человеческого подкласса IgG4 с мутациями S228P, L235E и, возможно, P329G в обеих тяжелых цепях, и с мутациями T366W и S354C в одной тяжелой цепи и мутациями T366S, L368A, Y407V и Y349C в соответствующей другой тяжелой цепи.
11. Гуманизированное антитело по любому из пп. 1-9, где данное гуманизированное антитело содержит:
i) гомодимерную область Fc человеческого подкласса IgG1, возможно с мутациями P329G, L234A и L235A; или
ii) гомодимерную область Fc человеческого подкласса IgG4, возможно с мутациями P329G, S228P и L235E; или
iii) гетеродимерную область Fc, в которой:
а) один полипептид области Fc содержит мутацию T366W, и другой полипептид области Fc содержит мутации T366S, L368A и Y407V, или
б) один полипептид области Fc содержит мутации T366W и Y349C, и другой полипептид области Fc содержит мутации T366S, L368A, Y407V и S354C, или
в) один полипептид области Fc содержит мутации T366W и S354C, и другой полипептид области Fc содержит мутации T366S, L368A, Y407V и Y349C;
или
iv) гетеродимерную область Fc человеческого подкласса IgG4, в которой оба полипептида области Fc содержат мутации P329G, L234A и L235A, и
а) один полипептид области Fc содержит мутацию T366W, и другой полипептид области Fc содержит мутации T366S, L368A и Y407V, или
б) один полипептид области Fc содержит мутации T366W и Y349C, и другой полипептид области Fc содержит мутации T366S, L368A, Y407V и S354C, или
в) один полипептид области Fc содержит мутации T366W и S354C, и другой полипептид области Fc содержит мутации T366S, L368A, Y407V и Y349C;
или
v) гетеродимерную область Fc человеческого подкласса IgG4, в которой оба полипептида области Fc содержат мутации P329G, S228P и L235E, и
а) один полипептид области Fc содержит мутацию T366W, и другой полипептид области Fc содержит мутации T366S, L368A и Y407V, или
б) один полипептид области Fc содержит мутации T366W и Y349C, и другой полипептид области Fc содержит мутации T366S, L368A, Y407V и S354C, или
в) один полипептид области Fc содержит мутации T366W и S354C, и другой полипептид области Fc содержит мутации T366S, L368A, Y407V и Y349C.
12. Гуманизированное антитело против трансферринового рецептора, содержащее:
i) вариабельный домен тяжелой цепи, выбранный из группы, состоящей из SEQ ID NO 52, 53, 54, 55, 56, 57 и 58, и вариабельный домен легкой цепи, выбранный из группы, состоящей из SEQ ID NO 60, 61, 62 и 63,
или
и) вариабельный домен тяжелой цепи, выбранный из группы, состоящей из SEQ ID NO 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 и 25, и вариабельный домен легкой цепи, выбранный из группы, состоящей из SEQ ID NO 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46 и 47.
13. Фармацевтический препарат, содержащий гуманизированное антитело по любому из пп. 1-12, и фармацевтически приемлемый носитель.
14. Гуманизированное антитело по любому из пп. 1-12 для применения в качестве лекарственного средства.
15. Применение гуманизированного антитела по любому из пп. 1-12 в изготовлении лекарственного средства для лечения неврологического расстройства.
16. Применение по п. 15, где неврологическое расстройство выбрано из группы, состоящей из невропатического расстройства, нейродегенеративного заболевания, рака, расстройства, связанного с глазным заболеванием, эпилепсии, лизосомальной болезни накопления, амилоидоза, вирусного или микробного заболевания, ишемии, поведенческого расстройства и воспаления ЦНС (центральная нервная система).
17. Применение антитела по любому из пп. 1-12 в изготовлении лекарственного средства для транспортировки одного или более чем одного соединения через ГЭБ (гематоэнцефалический барьер).
18. Гуманизированное антитело по любому из пп. 1-12 для применения в лечении неврологического расстройства.
19. Гуманизированное антитело по п. 18, где неврологическое расстройство выбрано из группы, состоящей из невропатического расстройства, нейродегенеративного заболевания, рака, расстройства, связанного с глазным заболеванием, эпилепсии, лизосомальной болезни накопления, амилоидоза, вирусного или микробного заболевания, ишемии, поведенческого расстройства и воспаления ЦНС.
20. Применение гуманизированного антитела по любому из пп. 1-12 в изготовлении лекарственного средства.
21. Применение по п. 20, при котором лекарственное средство служит для лечения неврологического расстройства выбранного из группы, состоящей из невропатического расстройства, нейродегенеративного заболевания, рака, расстройства, связанного с глазным заболеванием, эпилепсии, лизосомальной болезни накопления, амилоидоза, вирусного или микробного заболевания, ишемии, поведенческого расстройства и воспаления ЦНС.
22. Способ лечения, включающий введение гуманизированного антитела по любому из пп. 1-12 для лечения неврологического расстройства.
23. Способ по п. 22, в котором неврологическое расстройство выбрано из группы, состоящей из невропатического расстройства, нейродегенеративного заболевания, рака, расстройства, связанного с глазным заболеванием, эпилепсии, лизосомальной болезни накопления, амилоидоза, вирусного или микробного заболевания, ишемии, поведенческого расстройства и воспаления ЦНС.
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