RU2017102767A - Связывающие молекулы cd37 и иммуноконъюгаты - Google Patents

Связывающие молекулы cd37 и иммуноконъюгаты Download PDF

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RU2017102767A
RU2017102767A RU2017102767A RU2017102767A RU2017102767A RU 2017102767 A RU2017102767 A RU 2017102767A RU 2017102767 A RU2017102767 A RU 2017102767A RU 2017102767 A RU2017102767 A RU 2017102767A RU 2017102767 A RU2017102767 A RU 2017102767A
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antibody
binding fragment
seq
antigen
lymphoma
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RU2017102767A
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RU2017102767A3 (ru
RU2742743C2 (ru
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Джутта Декерт
Питер ПАРК
Дэниел ТАВАРЕС
Линюнь РУИ
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Дебиофарм Интернешнл, С.А.
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Claims (50)

1. Антитело или его антиген-связывающий фрагмент, специфически связывающиеся с CD37, отличающиеся тем, что упомянутое антитело или его антигенсвязывающий фрагмент содержит вариабельную область тяжелой цепи, содержащую CDR1, CDR2 и CDR3, и вариабельную область легкой цепи, содержащую CDR1, CDR2 и CDR3, причем CDR1, CDR2 и CDR3 вариабельной области тяжелой цепи и вариабельной области легкой цепи состоят из последовательностей SEQ ID NOs: 4, 5 и 6 и SEQ ID NOs: 28, 29 и 30, соответственно.
2. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент способны индуцировать антитело-зависимую клеточно-опосредованную цитотоксичность.
3. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит аминокислотные последовательности, которые по меньшей мере на 90%, 95% или 99% идентичны полипептидным последовательностям, выбранным из группы, включающей:
(a) SEQ ID NO: 57 и SEQ ID NO: 198;
(b) SEQ ID NO: 58 и SEQ ID NO: 198;
(c) SEQ ID NO: 55 и SEQ ID NO: 72; или
(d) SEQ ID NO: 56 и SEQ ID NO: 73.
4. Антитело или его антиген-связывающий фрагмент по п. 3, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит полипептидные последовательности, выбранные из группы, включающей:
(a) SEQ ID NO: 57 и SEQ ID NO: 198;
(b) SEQ ID NO: 58 и SEQ ID NO: 198;
(c) SEQ ID NO: 55 и SEQ ID NO: 72; или
(d) SEQ ID NO: 56 и SEQ ID NO: 73.
5. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит полипептидные последовательности SEQ ID NO: 57 или SEQ ID NO: 58.
6. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит полипептидную последовательность SEQ ID NO: 198.
7. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит полипептидные последовательности, выбранные из группы, включающей:
(a) SEQ ID NO: 57 и SEQ ID NO: 198; или
(b) SEQ ID NO: 58 и SEQ ID NO: 198.
8. Антитело или его антиген-связывающий фрагмент по п. 1, представляющее собой полноразмерное антитело.
9. Антитело или его антиген-связывающий фрагмент по п. 1, представляющее собой антиген-связывающий фрагмент.
10. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что упомянутые антитело или его антиген-связывающий фрагмент гуманизированы.
11. Антитело или его антиген-связывающий фрагмент по п. 10, отличающиеся тем, что антитело представляет собой антитело с перестроенной поверхностью.
12. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент способны индуцировать апоптоз in vitro в отсутствие перекрестносшивающих агентов.
13. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что упомянутое антитело или его антигенсвязывающий фрагмент содержит Fab, Fab', F(ab')2, одноцепочечный Fv или scFv, дисульфидно-связанный Fv, интратело, IgGΔCH2, минитело, F(ab')3, тетратело, триатело, диатело, DVD-Ig, mAb2, (scFv)2 или scFv-Fc.
14. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело продуцируется гибридомой - депонентом АТСС номер РТА-10664, депонированной в АТСС 18 февраля 2010 г.
15. Изолированная клетка, продуцирующая антитело или его антиген-связывающий фрагмент по любому из п.п. 1-14.
16. Иммуноконъюгат, имеющий формулу (А) - (L) - (С), где:
(А) является антителом или его антиген-связывающим фрагментом по любому из п.п. 1-14;
(L) является линкером; и
(С) является цитотоксическим агентом;
причем упомянутый линкер (L) соединяет (А) с (С).
17. Иммуноконъюгат по п. 16, дополнительно содержащий два, три, четыре, два-шесть или три-четыре цитотоксических агента.
18. Иммуноконъюгат по п. 16, отличающийся тем, что упомянутый линкер выбран из группы, состоящей из: N-сукцинимидил 4-(2-пиридилдитио)пентаноата (SPP) или N-сукцинимидил 4-(2-пиридилдитио)-2-сульфопентаноата (sulfo-SPP); N-сукцинимидил 4-(2-пиридилдитио)бутаноата (SPDB) или N-сукцинимидил 4-(2-пиридилдитио)-2-сульфобутаноата (sulfo-SPDB); N-сукцинимидил 4-(малеимидометил)
циклогексанкарбоксилата (SMCC); N-сульфосукцинимидил 4-(малеимидометил)циклогексанкарбоксилата (sulfoSMCC); N-сукцинимидил-4-(иодацетил)-аминобензоата (SLAB); и N-сукцинимидил-[(N-малеимидопропионамидо)-тетраэтиленгликолевого] эфира (NHS-PEG4-малеимида).
19. Иммуноконъюгат по п. 16, отличающийся тем, что цитотоксический агент выбран из группы, состоящей из майтансиноида, аналога майтансиноида, доксорубицина, модифицированного доксорубицина, бензодиазепина, таксоида, СС-1065, аналога СС-1065, дуокармицина, аналога дуокармицина, калихеамицина, доластатина, аналога доластатина, ауристатина, производного томаимицина, производного лептомицина или пролекарственной формы цитотоксического агента.
20. Иммуноконъюгат по п. 19, отличающийся тем, что майтансиноид является N(2')-деацетил-N(2')-(3-меркапто-1-оксопропил)-майтансином (DM1) и N(2')-деацетил-N2-(4-меркапто-4-метил-1-оксопентил)-майтансином (DM4).
21. Иммуноконъюгат по п. 16, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит вариабельную область тяжелой цепи, имеющую последовательность SEQ ID NO: 57, и вариабельную область легкой цепи, имеющую последовательность SEQ ID NO: 198.
22. Иммуноконъюгат по п. 21, отличающийся тем, что упомянутый (L) является N-сукцинимидил-4-(малеимидометил) циклогексанкарбоксилатом; и упомянутый (С) является N(2')-деацетил-N(2')-(3-меркапто-1-оксопропил)-майтансином (DM1).
23. Иммуноконъюгат по п. 16, отличающийся тем, что антитело или его антиген-связывающий фрагмент содержит вариабельную область тяжелой цепи, имеющую последовательность SEQ ID NO: 58 и вариабельную область легкой цепи, имеющую последовательность SEQ ID NO: 198.
24. Иммуноконъюгат по п. 23, отличающийся тем, что упомянутый (L) является N-сукцинимидил 4-(малеимидометил) циклогексанкарбоксилатом (SMCC); и упомянутый (С) является N(2')-деацетил-N(2')-(3-меркапто-1-оксопропил)-майтансином (DM1).
25. Изолированный полинуклеотид, который кодирует полипептид вариабельной области тяжелой цепи антитела или его антиген-связывающего фрагмента по п. 1, представленный в SEQ ID NO: 121, 122, 123 или 124.
26. Изолированный полинуклеотид, который кодирует полипептид вариабельной области легкой цепи антитела или его антиген-связывающего фрагмента по п. 1, представленный в SEQ ID NO: 136, 137 или 138.
27. Диагностический реактив, подходящий для определения присутствия CD37, содержащий антитело или его антиген-связывающего фрагмента по любому из п.п. 1-14, которое является меченым.
28. Фармацевтическая композиция, подходящая для лечения онкологического заболевания, содержащая терапевтически эффективное количество антитела или его антиген-связывающего фрагмента по любому из п.п. 1-14 и фармацевтически приемлемый носитель.
29. Фармацевтическая композиция, подходящая для лечения онкологического заболевания, содержащая терапевтически эффективное количество иммуноконъюгата по любому из п.п. 16-24 и фармацевтически приемлемый носитель.
30. Применение антитела или его антиген-связывающего фрагмента по любому из п.п. 1-14 в изготовлении медикамента для лечения онкологического заболевания.
31. Применение иммуноконъюгата по любому из п.п. 16-24 в изготовлении медикамента для лечения онкологического заболевания.
32. Применение по п. 30, отличающееся тем, что упомянутое онкологическое заболевание представляет собой лейкемию или лимфому.
33. Применение по п. 32, отличающееся тем, что упомянутое онкологическое заболевание выбрано из группы, включающей: В-клеточные лимфомы, НХЛ, прекурсорные В-клеточные лимфобластные лейкемию/лимфому и неоплазмы зрелых В-клеток, В-клеточную хроническую лимфоцитную лейкемию (ХЛЛ)/мелкоклеточную лимфоцитарную лимфому (МЛЛ), В-клеточную пролимфоцитную лейкемию, лимфоплазмацитную лимфому, лимфому клеток мантийной зоны (ЛКМЗ), фолликулярную лимфому (ФЛ), включая высокодифференцированную, среднедифференцированную и низкодифференцированную ФЛ, кожную центрально-фолликулярную лимфому, В-клеточную лимфому маргинальной зоны, В-клеточную лимфому маргинальной зоны MALT-типа, В-клеточную лимфому маргинальной зоны узлового типа, В-клеточную лимфому маргинальной зоны селезеночного типа, волосатоклеточный лейкоз, диффузную В-крупноклеточную лимфому, лимфому Беркитта, плазмацитому, плазмаклеточную миелому, посттрансплантационное лимфопролиферативное расстройство, макроглобулинемию Вальденстрема, лейкемию, лимфому и анапластическую крупноклеточную лимфому (АККЛ).
34. Применение по п. 31, отличающееся тем, что упомянутое онкологическое заболевание представляет собой лейкемию или лимфому.
35. Применение по п. 34, отличающееся тем, что упомянутое онкологическое заболевание выбрано из группы, включающей В-клеточные лимфомы, НХЛ, прекурсорные В-клеточные лимфобластные лейкемию/лимфому и неоплазмы зрелых В-клеток, В-клеточную хроническую лимфоцитную лейкемию (ХЛЛ)/мелкоклеточную лимфоцитарную лимфому (МЛЛ), В-клеточную пролимфоцитную лейкемию, лимфоплазмацитную лимфому, лимфому клеток мантийной зоны (ЛКМЗ), фолликулярную лимфому (ФЛ), включая высокодифференцированную, среднедифференцированную и низкодифференцированную ФЛ, кожную центрально-фолликулярную лимфому, В-клеточную лимфому маргинальной зоны, В-клеточную лимфому маргинальной зоны MALT-типа, В-клеточную лимфому маргинальной зоны узлового типа, В-клеточную лимфому маргинальной зоны селезеночного типа, волосатоклеточный лейкоз, диффузную В-крупноклеточную лимфому, лимфому Беркитта, плазмацитому, плазмаклеточную миелому, посттрансплантационное лимфопролиферативное расстройство, макроглобулинемию Вальденстрема, лейкемию, лимфому и анапластическую крупноклеточную лимфому (АККЛ).
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