RU2020143675A - Конструкции, имеющие sirp-альфа домен или его вариант - Google Patents

Конструкции, имеющие sirp-альфа домен или его вариант Download PDF

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RU2020143675A
RU2020143675A RU2020143675A RU2020143675A RU2020143675A RU 2020143675 A RU2020143675 A RU 2020143675A RU 2020143675 A RU2020143675 A RU 2020143675A RU 2020143675 A RU2020143675 A RU 2020143675A RU 2020143675 A RU2020143675 A RU 2020143675A
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polypeptide
cancer
mutations
antibodies
variant
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RU2020143675A
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RU2020143675A3 (ru
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Хауме Понз
Лаура Деминг
Кори Гудман
Банг Джанет СИМ
Стивен Эллиот КАУДЕР
Хун ВАНЬ
Трэйси Чиа-Чиэнь КО
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ЭйЭлЭкс Онколоджи Инк.
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Publication of RU2020143675A publication Critical patent/RU2020143675A/ru
Publication of RU2020143675A3 publication Critical patent/RU2020143675A3/ru

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Claims (68)

1. Полипептид, содержащий:
(а) CD47-связывающий полипептид и
(b) вариант Fc, причем вариант Fc выбран из:
(i) области Fc IgG1 человека, содержащей мутации L234A, L235A, G237A и N297A;
(ii) области Fc IgG2 человека, содержащей мутации A330S, P331S и N297A; или
(iii) области Fc IgG4 человека, содержащей мутации S228P, E233P, F234V, L235A, delG236 и N297A,
причем нумерация соответствует индексу EU.
2. Полипептид по п.1, в котором вариант Fc представляет собой область Fc IgG1 человека, содержащую мутации L234A, L235A, G237A и N297A.
3. Полипептид по п.1, в котором вариант Fc представляет собой область Fc IgG2 человека, содержащую мутации A330S, P331S и N297A.
4. Полипептид по п.1, в котором вариант Fc представляет собой область Fc IgG4 человека, содержащую мутации S228P, E233P, F234V, L235A, delG236 и N297A.
5. Полипептид по п.1, в котором вариант Fc связывается с рецептором Fcγ с KD более примерно 5×10-6 М.
6. Полипептид по п.1, причем полипептид не вызывает острой анемии у грызунов и приматов, отличных от человека.
7. Полипептид по п.1, причем полипептид не вызывает острой анемии у человека.
8. Полипептид по п.1, причем CD47-связывающий полипептид представляет собой полипептид сигнального регуляторного белка α (SIRP-α) или его фрагмент, который способен связываться с CD47.
9. Полипептид по п.8, причем полипептид SIRP-α содержит вариант D1 SIRP-α, содержащий аминокислотную последовательность
EEELQX1IQPDKSVLVAAGETATLRCTX2TSLX3PVGPIQWFRGAGPGRX4LIYNQX5EGX6 FPRVTTVSDX7TKRNNMDFSIRIGX8ITPADAGTYYCX9KFRKGSPDDVEFKSGAGTELS VRAKPS (SEQ ID NO: 51), где X1 представляет собой V или I; X2 представляет собой A или I; X3 представляет собой I или F; X4 представляет собой E или V; X5 представляет собой K или R; X6 представляет собой H или P; X7 представляет собой L или T; X8 представляет собой аминокислоту, отличную от N, и X9 представляет собой V или I.
10. Полипептид по п.9, причем полипептид SIRP-α содержит вариант D1 SIRP-α, где X1 представляет собой V или I; X2 представляет собой A или I; X3 представляет собой I или F; X4 представляет собой E; X5 представляет собой K или R; X6 представляет собой H или P; X7 представляет собой L или T; X8 не является N; и X9 представляет собой V.
11. Полипептид по п.8, причем полипептид SIRP-α или его фрагмент связывается с CD47 с KD примерно 10 нМ или менее.
12. Способ лечения индивидуума, имеющего заболевание или расстройство, включающий введение индивидууму полипептида, содержащего:
(а) CD47-связывающий полипептид; и
(b) вариант Fc, причем вариант Fc выбирают из:
(i) области Fc IgG1 человека, содержащей мутации L234A, L235A, G237A и N297A;
(ii) области Fc IgG2 человека, содержащей мутации A330S, P331S и N297A;
(iii) области Fc IgG4 человека, содержащей мутации S228P, E233P, F234V, L235A, delG236 и N297A,
причем нумерация соответствует индексу EU.
13. Способ по п.12, в котором заболевание или расстройство представляет собой рак, аутоиммунное заболевание или воспалительное заболевание.
14. Способ по п.12, в котором заболевание или расстройство представляет собой рак, причем рак выбирают из рака солидной опухоли, гематологического рака, острого миелоидного лейкоза, хронического лимфоцитарного лейкоза, хронического миелоидного лейкоза, острого лимфобластного лейкоза, неходжкинской лимфомы, лимфома Ходжкина, множественной миеломы, рака мочевого пузыря, рака поджелудочной железы, рака шейки матки, рака эндометрия, рака легкого, рака бронхов, рака печени, рака яичника, рака толстой и прямой кишки, рака желудка, рака желудочно-кишечного тракта, рака желчного пузыря, желудочно-кишечной стромальной опухоли, рака щитовидной железы, рака головы и шеи, рака ротоглотки, рака пищевода, меланомы, немеланомного рака кожи, карциномы из клеток Меркеля, вирус-индуцированного рака, нейробластомы, рака молочной железы, рака предстательной железы, рака почки, почечно-клеточного рака, рака почечной лоханки, лейкоза, лимфомы, саркомы, глиомы, опухоли головного мозга и карциномы.
15. Способ по п.12, в котором заболевание или расстройтсво представляет собой аутоиммунное заболевание или воспалительное заболевание, причем аутоиммунное заболевание или воспалительное заболевание выбирают из рассеянного склероза, ревматоидного артрита, спондилоартропатии, системной красной волчанки, опосредованного антителами воспалительного или аутоиммунного заболевания, заболевания трансплантат против хозяина, сепсиса, диабетов, псориаза, атеросклероза, синдрома Шегрена, прогрессирующего системного склероза, склеродермии, острого коронарного синдрома, ишемической реперфузии, болезни Крона, эндометриоза, гломерулонефрита, миастении гравис, идиопатического легочного фиброза, астмы, острого респираторного дистресс-синдрома (ARDS), васкулита и воспалительного аутоиммунного миозита.
16. Способ по п.12, в котором CD47-связывающий полипептид содержит последовательность согласно любой из SEQ ID NO: 78-85.
17. Способ по п.16, дополнительно включающий введение по меньшей мере одного дополнительного агента.
18. Способ по п.17, в котором по меньшей мере один дополнительный агент представляет собой антитело, опухолеассоциированный антиген или терапевтическое средство, отличное от антитела.
19. Способ по п.16, в котором вводят по меньшей мере два дополнительных агента.
20. Способ по п.19, в котором по меньшей мере два дополнительных агента включают два антитела.
21. Способ по п.19, в котором по меньшей мере два дополнительных агента включают антитело и опухолеассоциированный антиген.
22. Способ по п.18, в котором указанное антитело представляет собой изотип антитела IgG1 человека, изотип антитела IgG2 человека или изотип антитела IgG4 человека.
23. Способ по п.18, в котором антитело выбирают из антитела против HER2, антитела против CD20, антитела против CD19, антитела против CS1, антитела против CD38, антитела против EGFR, антитела против OX40, антитела против PD-1, антитела против PD-L1, антитела против RANKL, антитела против CD274, антитела против CTLA-4, антитела против CD137, антитела против 4-1BB, антитела против B7-H3, антитела против FZD7, антитела против CD27, антитела против CCR4, антитела против CSF1R, антитела против CSF, антитела против CD30, антитела против BAFF, антитела против VEGF или антитела против VEGFR2.
24. Способ по п.17, в котором по меньшей мере один дополнительный агент представляет собой опухолеассоциированный антиген, причем опухолеассоциированный антиген, вызывает иммунный ответ.
25. Способ по п.17, в котором по меньшей мере один дополнительный агент представляет собой антитело, причем антитело нацелено на комплекс HLA/пептид или MHC/пептид.
26. Способ по п.25, в котором антитело нацелено на комплекс HLA/пептид или MHC/пептид, содержащий NY-ESO-1/LAGE1, SSX-2, семейство MAGE (MAGE-A3), gp100/pmel17, Melan-A/MART-1, gp75/TRP1, тирозиназу, TRP2, CEA, PSA, TAG-72, незрелый рецептор ламинина, MOK/RAGE-1, WT-1, Her2/neu, EphA3, SAP-1, BING-4, Ep- CAM, MUC1, PRAME, сурвивин, Mesothelin, BRCA1/2, CDK4, CML66, MART-2, p53, Ras, β-катенин, TGF-βRII, HPV E6 или E7.
27. Способ по п.25, в котором антитело представляет собой ESK1, RL1B, Pr20 или 3.2G1.
28. Нуклеиновая кислота, кодирующая полипептид, содержащий
(а) CD47-связывающий полипептид; и
(b) вариант Fc, причем вариант Fc выбран из:
(i) области Fc IgG1 человека, содержащей мутации L234A, L235A, G237A и N297A;
(ii) области Fc IgG2 человека, содержащей мутации A330S, P331S и N297A;
(iii) области Fc IgG4 человека, содержащей мутации S228P, E233P, F234V, L235A, delG236 и N297A,
причем нумерация соответствует индексу EU.
29. Вектор, содержащий нуклеиновую кислоту по п.28.
30. Клетка-хозяин, содержащая нуклеиновую кислоту по п.28.
31. Способ получения полипептида, включающий культивирование клетки-хозяина по п.30 в условиях, подходящих для экспрессии полипептида, и выделение полипептида.
32. Фармацевтическая композиция, содержащая:
(I) полипептид, содержащий:
(а) CD47-связывающий полипептид; и
(b) вариант Fc, причем вариант Fc выбран из:
(i) области Fc IgG1 человека, содержащей мутации L234A, L235A, G237A и N297A;
(ii) области Fc IgG2 человека, содержащей мутации A330S, P331S и N297A;
(iii) области Fc IgG4 человека, содержащей мутации S228P, E233P, F234V, L235A, delG236 и N297A,
причем нумерация соответствует индексу EU; и
(II) фармацевтически приемлемый носитель.
33. Димер, содержащий полипептид, содержащий:
(а) CD47-связывающий полипептид; и
(b) вариант Fc, причем вариант Fc выбран из:
(i) области Fc IgG1 человека, содержащей мутации L234A, L235A, G237A и N297A;
(ii) области Fc IgG2 человека, содержащей мутации A330S, P331S и N297A;
(iii) области Fc IgG4 человека, содержащей мутации S228P, E233P, F234V, L235A, delG236 и N297A,
причем нумерация соответствует индексу EU.
34. Димер по п.33, причем димер представляет собой гетеродимер.
35. Димер по п.33, причем димер представляет собой гомодимер.
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