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RU2008152431A - Антитела и иммуноконъюгаты и их применения - Google Patents

Антитела и иммуноконъюгаты и их применения Download PDF

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RU2008152431A
RU2008152431A RU2008152431/10A RU2008152431A RU2008152431A RU 2008152431 A RU2008152431 A RU 2008152431A RU 2008152431/10 A RU2008152431/10 A RU 2008152431/10A RU 2008152431 A RU2008152431 A RU 2008152431A RU 2008152431 A RU2008152431 A RU 2008152431A
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antibody
hvr
seq
amino acid
acid sequence
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RU2008152431/10A
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RU2436796C2 (ru
RU2436796C9 (ru
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Аллен Дж. Мл. ЭБЕНС (US)
Аллен Дж. мл. ЭБЕНС
Алан М. ГРЭЙ (US)
Алан М. ГРЭЙ
Вэй-Чин ЛЯН (US)
Вэй-Чин ЛЯН
Янь У (US)
Янь У
Шан-Фань ЮЙ (US)
Шан-Фань ЮЙ
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Дженентек, Инк. (Us)
Дженентек, Инк.
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    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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Abstract

1. Антитело, связывающееся с CD22, содержащее (a) HVR-L1, содержащую аминокислотную последовательность, выбранную из SEQ ID NO:9, 10, 19-23, 32 и 33, и (b) по меньшей мере, одну, две, три, четыре или пять HVR, выбранных из ! (1) HVR-H1, содержащей аминокислотную последовательность SEQ ID NO:2; ! (2) HVR-H2, содержащей аминокислотную последовательность SEQ ID NO:4; ! (3) HVR-H3, содержащей аминокислотную последовательность SEQ ID NO:6; ! (4) HVR-L2, содержащей аминокислотную последовательность SEQ ID NO:12; и ! (5) HVR-L3, содержащей аминокислотную последовательность SEQ ID NO:14. ! 2. Антитело, связывающееся с CD22, содержащее вариабельный домен тяжелой цепи, который по меньшей мере на 90% идентичен последовательности с аминокислотной последовательностью SEQ ID NO:16. ! 3. Антитело, содержащее одну, две, три, четыре, пять или шесть из HVR из антитела, получаемого посредством гибридомы АТСС с инвентарным номером PTA-7620 (5E8.1.8). ! 4. Полинуклеотид, кодирующий антитело по п.1. ! 5. Полинуклеотид, кодирующий антитело по п.2. ! 6. Вектор, содержащий полинуклеотид по п.4. ! 7. Вектор, содержащий полинуклеотид по п.5. ! 8. Клетка-хозяин, содержащая вектор по п.6. ! 9. Клетка-хозяин, содержащая вектор по п.7. ! 10. Способ получения антитела к CD22, вкючающей a) культивирование клетки-хозяина по п.6 в условиях, подходящих для экспрессии полинуклеотида, кодирующего антитело, и b) выделение антитела. ! 11. Способ получения антитела к CD22, включающий a) культивирование клетки-хозяина по п.7 в условиях, подходящих для экспрессии полинуклеотида, кодирующего антитело, и b) выделение антитела. ! 12. Способ определения присутствия CD22 в биологическом образце, где способ включает приведение биологического образца в контакт с антителом по п.1 в услови�

Claims (31)

1. Антитело, связывающееся с CD22, содержащее (a) HVR-L1, содержащую аминокислотную последовательность, выбранную из SEQ ID NO:9, 10, 19-23, 32 и 33, и (b) по меньшей мере, одну, две, три, четыре или пять HVR, выбранных из
(1) HVR-H1, содержащей аминокислотную последовательность SEQ ID NO:2;
(2) HVR-H2, содержащей аминокислотную последовательность SEQ ID NO:4;
(3) HVR-H3, содержащей аминокислотную последовательность SEQ ID NO:6;
(4) HVR-L2, содержащей аминокислотную последовательность SEQ ID NO:12; и
(5) HVR-L3, содержащей аминокислотную последовательность SEQ ID NO:14.
2. Антитело, связывающееся с CD22, содержащее вариабельный домен тяжелой цепи, который по меньшей мере на 90% идентичен последовательности с аминокислотной последовательностью SEQ ID NO:16.
3. Антитело, содержащее одну, две, три, четыре, пять или шесть из HVR из антитела, получаемого посредством гибридомы АТСС с инвентарным номером PTA-7620 (5E8.1.8).
4. Полинуклеотид, кодирующий антитело по п.1.
5. Полинуклеотид, кодирующий антитело по п.2.
6. Вектор, содержащий полинуклеотид по п.4.
7. Вектор, содержащий полинуклеотид по п.5.
8. Клетка-хозяин, содержащая вектор по п.6.
9. Клетка-хозяин, содержащая вектор по п.7.
10. Способ получения антитела к CD22, вкючающей a) культивирование клетки-хозяина по п.6 в условиях, подходящих для экспрессии полинуклеотида, кодирующего антитело, и b) выделение антитела.
11. Способ получения антитела к CD22, включающий a) культивирование клетки-хозяина по п.7 в условиях, подходящих для экспрессии полинуклеотида, кодирующего антитело, и b) выделение антитела.
12. Способ определения присутствия CD22 в биологическом образце, где способ включает приведение биологического образца в контакт с антителом по п.1 в условиях, допускающих связывание антитела к CD22, и определение того, формируется ли комплекс между антителом и CD22.
13. Способ определения присутствия CD22 в биологическом образце, где способ включает приведение биологического образца в контакт с антителом по п.2 в условиях, допускающих связывание антитела к CD22, и определение того, формируется ли комплекс между антителом и CD22.
14. Иммуноконъюгат, содержащий антитело по п.1, ковалентно связанное с цитотоксическим средством.
15. Иммуноконъюгат, содержащий антитело по п.1, ковалентно связанное с цитотоксическим средством.
16. Фармацевтическая композиция, содержащая иммуноконъюгат по п.14 и фармацевтически приемлемый носитель.
17. Способ лечения B-клеточного пролиферативного нарушения, включающий введение индивидууму эффективного количества фармацевтической композиции по п.16.
18. Фармацевтическая композиция, содержащая иммуноконъюгат по п.15 и фармацевтически приемлемый носитель.
19. Способ лечения B-клеточного пролиферативного нарушения, включающий введение индивидууму эффективного количества фармацевтической композиции по п.18.
20. Фармацевтическая композиция, содержащая иммуноконъюгат по п.14 или 15 и фармацевтически приемлемый носитель.
21. Способ лечения B-клеточного пролиферативного нарушения, включающий введение индивидууму эффективного количества фармацевтической композиции по п.20.
22. Способ ингибирования B-клеточной пролиферации, включающий воздействие на клетки иммуноконъюгата по п.14 в условиях, позволяющих связывание иммуноконъюгата с CD22.
23. Способ определения наличия белка CD22 в образце, предположительно содержащем указанный белок, где указанный способ включает воздействие на указанный образец антитела по п.1 и определение связывания указанного антитела с указанным белком CD22 в указанном образце, где связывание антитела с указанным белком указывает на присутствие указанного белка в указанном образце.
24. Фармацевтический препарат, содержащий антитело к CD22 по п.1 и фармацевтически приемлемый разбавитель, носитель или эксципиент.
25. Соединение конъюгата антитело-лекарственное средство, выбранное из структур:
Figure 00000001
Figure 00000002
где Val представляет собой валин; Cit представляет собой цитруллин; p представляет собой 1, 2, 3 или 4; и Ab представляет собой антитело к CD22 по п.1.
26. Анализ для детекции B-клеток, включающий
(a) воздействие на клетки соединения конъюгата антитело-лекарственное средство по п.23 и
(b) определение степени связывания соединения конъюгата антитело-лекарственное средство с клетками.
27. Способ ингибирования клеточной пролиферации, включающий обработку злокачественных B-клеток млекопитающих в среде для культивирования клеток с соединением конъюгата антитело-лекарственное средство по п.1, в результате чего пролиферация злокачественных B-клеток ингибируется.
28. Фармацевтический препарат, содержащий конъюгат антитело-лекарственное средство по п.1 и фармацевтически приемлемый разбавитель, носитель или эксципиент.
29. Способ лечения злокачественной опухоли, включающий введение пациенту фармацевтического препарата по п.28.
30. Промышленное изделие, содержащее
фармацевтический препарат по п.26;
контейнер и
вкладыш в упаковку или ярлык, указывающий, что соединение можно использовать для лечения злокачественной опухоли, характеризующейся сверхэкспрессией полипептида CD22.
31. Способ получения соединения конъюгата антитело-лекарственное средство, содержащего антитело к CD22 (Ab) по п.1 и ауристатин или молекулу майтанзиноидного лекарственного средства (D), где антитело через одну или несколько полученных в результате конструирования аминокислот цистеина посредством линкерной группы (L) связано с D; где соединение имеет формулу I:
Ab-(L-D) p I
где p представляет собой 1, 2, 3 или 4; где способ включает в себя стадии
(a) реакции, полученной в результате конструирования группы цистеина антитела с линкерным реагентом с образованием промежуточного продукта антитело-линкер Ab-L; и
(b) реакции Ab-L с активированной молекулой лекарственного средства D; в результате чего образуется конъюгат антитело-лекарственное средство;
или где способ включает стадии
(c) реакции нуклеофильной группы молекулы лекарственного средства с линкерным реагентом с образованием промежуточного соединения лекарственное средство-линкер D-L; и
(d) реакции D-L с полученной в результате конструирования группой цистеина антитела; в результате чего образуется конъюгат антитело-лекарственное средство.
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IL195101A0 (en) 2011-08-01
CN103030696B (zh) 2016-09-28
PT2446904E (pt) 2015-09-02
CA2652945C (en) 2015-06-02
US8524865B2 (en) 2013-09-03
HK1165438A1 (en) 2012-10-05
CA2652945A1 (en) 2007-12-06
CY1116622T1 (el) 2017-03-15
SI2446904T1 (sl) 2015-08-31
RS53168B (sr) 2014-06-30
SG172656A1 (en) 2011-07-28

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