RU2017134140A - Конструкции, направленные на комплексы пептида аfp/мнс, и виды их использования - Google Patents
Конструкции, направленные на комплексы пептида аfp/мнс, и виды их использования Download PDFInfo
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- RU2017134140A RU2017134140A RU2017134140A RU2017134140A RU2017134140A RU 2017134140 A RU2017134140 A RU 2017134140A RU 2017134140 A RU2017134140 A RU 2017134140A RU 2017134140 A RU2017134140 A RU 2017134140A RU 2017134140 A RU2017134140 A RU 2017134140A
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- amc
- amino acid
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Claims (44)
1. Выделенная конструкция к AMC, содержащая фрагмент молекулы антитела, который специфически связывается с комплексом, содержащим пептид альфа-фетопротеин (AFP) и белок главного комплекса гистосовместимости (MHC) I класса (комплексом AFP/MHC I класса или AMC).
2. Выделенная конструкция к AMC по п. 1, где белок MHC I класса представляет собой подтип HLA-A*02:01 аллеля HLA-A02.
3. Выделенная конструкция к AMC по п. 1 или 2, где пептид AFP содержит аминокислотную последовательность, выбранную из группы, состоящей из SEQ ID NO: 3-13 и 16.
4. Выделенная конструкция к AMC по п. 3, где пептид AFP содержит аминокислотную последовательность FMNKFIYEI (SEQ ID NO: 4).
5. Выделенная конструкция к AMC по любому из пп. 1-4, где фрагмент молекулы антитела представляет собой полноразмерное антитело, Fab, Fab', (Fab')2, Fv или одноцепочечный Fv (scFv).
6. Выделенная конструкция к AMC по любому из пп. 1-5, где выделенная конструкция к AMC связывается с комплексом AFP/MHC I класса с Kd приблизительно от 0,1 пМ приблизительно до 500 нМ.
7. Выделенная конструкция к AMC по любому из пп. 1-6, где фрагмент молекулы антитела содержит:
i) вариабельный домен тяжелой цепи, содержащий определяющая комплементарность область тяжелой цепи (HC-CDR) 1, содержащую аминокислотную последовательность G-F/Y-S/T-F-D/S/T-D/N/S-Y/A-A/G/W (SEQ ID NO: 87) или ее вариант, содержащий приблизительно до 3 замен аминокислот, HC-CDR2, содержащую аминокислотную последовательность I/S-K/S-X-H/Y-X-G-X-T (SEQ ID NO: 88) или ее вариант, содержащий приблизительно до 3 замен аминокислот, и HC-CDR3, содержащую аминокислотную последовательность A/G-X-W/Y-Y-X-X-X-F/Y-D (SEQ ID NO: 89) или ее вариант, содержащий приблизительно до 3 замен аминокислот; и
ii) вариабельный домен легкой цепи, содержащий определяющая комплементарность область легкой цепи (LC-CDR) 1, содержащую аминокислотную последовательность S/T-G/S-D/N-I/V-A/G-A/S/V-X-H/Y (SEQ ID NO: 120) или ее вариант, содержащий приблизительно до 3 замен аминокислот, и LC-CDR3, содержащую аминокислотную последовательность Q-S/T-Y/W-D/T-S/T-A/S (SEQ ID NO: 121) или ее вариант, содержащий to 3 замены аминокислот, где X может представлять собой любую аминокислоту.
8. Выделенная конструкция к AMC по любому из пп. 1-6, где фрагмент молекулы антитела содержит:
i) вариабельный домен тяжелой цепи, содержащий HC-CDR1, содержащую аминокислотную последовательность любой из SEQ ID NO: 57-66 или ее вариант, содержащий приблизительно до 5 замен аминокислот, HC-CDR2, содержащую аминокислотную последовательность любой из SEQ ID NO: 67-76 или ее вариант, содержащий приблизительно до 5 замен аминокислот, и HC-CDR3, содержащую аминокислотную последовательность любой из SEQ ID NO: 77-86 или ее вариант, содержащий приблизительно до 5 замен аминокислот; и
ii) вариабельный домен легкой цепи, содержащий LC-CDR1, содержащую аминокислотную последовательность любой из SEQ ID NO: 90-99 или ее вариант, содержащий приблизительно до 5 замен аминокислот, LC-CDR2, содержащую аминокислотную последовательность любой из SEQ ID NO: 100-109 или ее вариант, содержащий приблизительно до 3 замен аминокислот, и LC-CDR3, содержащую аминокислотную последовательность любой из SEQ ID NO: 110-119 или ее вариант, содержащий приблизительно до 5 замен аминокислот.
9. Выделенная конструкция к AMC по п. 8, где фрагмент молекулы антитела содержит a) вариабельный домен тяжелой цепи, содержащий аминокислотную последовательность любой из SEQ ID NO: 17-26, или ее вариант, обладающий по меньшей мере приблизительно 95% идентичностью последовательности с любой из SEQ ID NO: 17-26; и b) вариабельный домен легкой цепи, содержащий аминокислотную последовательность любой из SEQ ID NO: 27-36, или ее вариант, обладающий по меньшей мере приблизительно 95% идентичностью последовательности с любой из SEQ ID NO: 27-36.
10. Выделенная конструкция к AMC по любому из пп. 1-9, где выделенная конструкция к AMC является полиспецифической.
11. Выделенная конструкция к AMC по п. 10, где выделенная конструкция к AMC представляет собой тандемное scFv, диатело (Db), одноцепочечное диатело (scDb), переориентирующееся антитело с двойной аффинностью (DART), антитело с двойным вариабельным доменом (DVD), антитело выступ во впадину (KiH), антитело "замок на причале" (DNL), химически сшитое антитело, гетеромультимерное антитело или гетероконъюгированное антитело.
12. Выделенная конструкция к AMC по п. 11, где выделенная конструкция к AMC представляет собой тандемный scFv, содержащий два scFv, связанных пептидным линкером.
13. Выделенная конструкция к AMC по любому из пп. 10-12, где выделенная конструкция к AMC дополнительно содержит второй фрагмент молекулы антитела, который специфически связывается со вторым антигеном.
14. Выделенная конструкция к AMC по п. 13, где второй антиген выбран из группы, состоящей из CD3γ, CD3δ, CD3ε, CD3ζ, CD28, OX40, GITR, CD137, CD27, CD40L и HVEM.
15. Выделенная конструкция к AMC по п. 13, где второй антиген представляет собой CD3ε, и где выделенная конструкция к AMC представляет собой тандемный scFv, содержащий scFv, специфический к комплексу AFP/MHC I класса, на N-конце и scFv, специфический к CD3ε, на C-конце.
16. Выделенная конструкция к AMC по любому из пп. 1-9, где выделенная конструкция к AMC представляет собой химерный антигенный рецептор, содержащий внеклеточный домен, содержащий фрагмент молекулы антитела, трансмембранный домен и внутриклеточный сигнальный домен, содержащий внутриклеточную сигнальную последовательность CD3ζ и внутриклеточную сигнальную последовательность CD28.
17. Выделенная конструкция к AMC по любому из пп. 1-9, где выделенная конструкция к AMC представляет собой иммуноконъюгат, содержащий фрагмент молекулы антитела и эффекторную молекулу, где эффекторная молекула представляет собой терапевтическое средство, выбранное из группы, состоящей из лекарственного средства, токсина, радиоактивного изотопа, белка, пептида и нуклеиновой кислоты.
18. Выделенная конструкция к AMC по любому из пп. 1-9, где выделенная конструкция к AMC представляет собой иммуноконъюгат, содержащий фрагмент молекулы антитела и метку.
19. Фармацевтическая композиция, содержащая выделенную конструкцию к AMC по любому из пп. 1-17.
20. Клетка-хозяин, экспрессирующая выделенную конструкцию к AMC по любому из пп. 1-18.
21. Нуклеиновая кислота, кодирующая полипептидные компоненты выделенной конструкции к AMC по любому из пп. 1-18.
22. Эффекторная клетка, экспрессирующая выделенную конструкцию к AMC по п. 16.
23. Эффекторная клетка по п. 22, где эффекторная клетка представляет собой T-клетку.
24. Способ детекции клетки, презентирующей комплекс, содержащий пептид AFP и белок MHC I класса на своей поверхности, включающий приведение клетки в контакт с выделенной конструкцией к AMC по п. 18 и детекцию наличия метки на клетке.
25. Способ лечения индивидуума, страдающего AFP-положительным заболеванием, включающий введение индивидууму
a) эффективного количества фармацевтической композиции по п. 19, или
b) эффективного количества эффекторной клетки по п. 22 или 23.
26. Способ по п. 25, где введение поводят внутривенным или внутриопухолевым путем.
27. Способ по п. 25, где введение проводят в участок инъекции, дистальный от первого участка заболевания.
28. Способ диагностики у индивидуума, страдающего AFP-положительным заболеванием, включающий:
a) введение эффективного количества выделенной конструкции к AMC по п. 18 индивидууму; и
b) определение уровня метки у индивидуума, где уровень метки выше порогового уровня указывает на то, что индивидуум страдает AFP-положительным заболеванием.
29. Способ диагностики у индивидуума, страдающего AFP-положительным заболеванием, включающий:
a) приведение образца, выделенного у индивидуума, в контакт с выделенной конструкцией к AMC по п. 18; и
b) определение числа клеток, связанных с выделенной конструкцией к AMC в образце, где величина числа клеток, связанных с выделенной конструкцией к AMC выше порогового уровня, указывает на то, что индивидуум страдает AFP-положительным заболеванием.
30. Способ по любому из пп. 25-29, где AFP-положительное заболевание представляет собой злокачественную опухоль.
31. Способ по п. 30, где злокачественная опухоль представляет собой печеночноклеточную карциному, эмбрионально-клеточная опухоль или рак молочной железы.
32. Способ по п. 31, где злокачественная опухоль представляет собой печеночноклеточную карциному.
33. Способ по п. 32, где злокачественная опухоль представляет собой метастатическую печеночноклеточную карциному.
34. Способ по любому из пп. 25-27, где AFP-положительное заболевание представляет собой печеночноклеточную карциному, и ингибируют метастазирование.
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- 2016-04-01 RU RU2017134140A patent/RU2754041C2/ru active
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- 2016-04-01 MX MX2017012352A patent/MX2017012352A/es unknown
- 2016-04-01 CN CN202210005678.3A patent/CN114456272A/zh active Pending
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2017
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2018
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2021
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