RU2010105233A - Гуманизированные антитела против cd79b и иммуноконъюгаты и способы применения - Google Patents
Гуманизированные антитела против cd79b и иммуноконъюгаты и способы применения Download PDFInfo
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Abstract
1. Антитело против CD79b, содержащее: ! (a) по меньшей мере одну последовательность HVR, выбранную из группы, состоящей из: ! (i) HVR-L1, содержащей последовательность A1-A16, где A1-A16 представляет собой KSSQSLLDSDGKTYLN (SEQ ID NO:59) ! (ii) HVR-L2, содержащей последовательность B1-B7, где B1-B7 представляет собой LVSKLDS (SEQ ID NO:60) ! (iii) HVR-L3, содержащей последовательность C1-C9, где C1-C9 представляет собой WQGTHFPYT (SEQ ID NO:61) ! (iv) HVR-H1, содержащей последовательность D1-D10, где D1-D10 представляет собой GYTFTSYWMN (SEQ ID NO:62) ! (v) HVR-H2, содержащей последовательность E1-E18, где E1-E18 представляет собой GMIDPSDSETHYNHIFKD (SEQ ID NO:63) и ! (vi) HVR-H3, содержащей последовательность F1-F6, где F1-F6 представляет собой ARNLYL (SEQ ID NO:64); и ! (b) по меньшей мере одного варианта HVR, где вариант HVR содержит модификацию по меньшей мере одного остатка последовательности, представленной в SEQ ID NO: 59, 60, 61, 62, 63 или 64. ! 2. Антитело по п.1, где C1 в варианте HVR-L3 представляет собой F. ! 3. Антитело по п.1, где C8 в варианте HVR-L3 представляет собой F. ! 4. Антитело по п.1, где антитело является гуманизированным. ! 5. Антитело по п.1, где по меньшей мере часть последовательности каркасной области представляет собой консенсусную последовательность каркасной области человека. ! 6. Антитело по п.1, где указанная модификация представляет собой замену, инсерцию или делецию. ! 7. Антитело по п.1, где вариант HVR-L3 содержит одну замену в любом из следующих положений: C1 (F) и C8 (F). ! 8. Гуманизированное антитело против CD79b, где одновалентная аффинность антитела к CD79b человека является, по существу, такой же, как и одновалентная аффиность антитела мыши, содержащего последовательность вариабельной последовательности легкой цепи и тяжелой цепи, как представлено на фигуре 7 (SEQ ID
Claims (25)
1. Антитело против CD79b, содержащее:
(a) по меньшей мере одну последовательность HVR, выбранную из группы, состоящей из:
(i) HVR-L1, содержащей последовательность A1-A16, где A1-A16 представляет собой KSSQSLLDSDGKTYLN (SEQ ID NO:59)
(ii) HVR-L2, содержащей последовательность B1-B7, где B1-B7 представляет собой LVSKLDS (SEQ ID NO:60)
(iii) HVR-L3, содержащей последовательность C1-C9, где C1-C9 представляет собой WQGTHFPYT (SEQ ID NO:61)
(iv) HVR-H1, содержащей последовательность D1-D10, где D1-D10 представляет собой GYTFTSYWMN (SEQ ID NO:62)
(v) HVR-H2, содержащей последовательность E1-E18, где E1-E18 представляет собой GMIDPSDSETHYNHIFKD (SEQ ID NO:63) и
(vi) HVR-H3, содержащей последовательность F1-F6, где F1-F6 представляет собой ARNLYL (SEQ ID NO:64); и
(b) по меньшей мере одного варианта HVR, где вариант HVR содержит модификацию по меньшей мере одного остатка последовательности, представленной в SEQ ID NO: 59, 60, 61, 62, 63 или 64.
2. Антитело по п.1, где C1 в варианте HVR-L3 представляет собой F.
3. Антитело по п.1, где C8 в варианте HVR-L3 представляет собой F.
4. Антитело по п.1, где антитело является гуманизированным.
5. Антитело по п.1, где по меньшей мере часть последовательности каркасной области представляет собой консенсусную последовательность каркасной области человека.
6. Антитело по п.1, где указанная модификация представляет собой замену, инсерцию или делецию.
7. Антитело по п.1, где вариант HVR-L3 содержит одну замену в любом из следующих положений: C1 (F) и C8 (F).
8. Гуманизированное антитело против CD79b, где одновалентная аффинность антитела к CD79b человека является, по существу, такой же, как и одновалентная аффиность антитела мыши, содержащего последовательность вариабельной последовательности легкой цепи и тяжелой цепи, как представлено на фигуре 7 (SEQ ID NO:10) и фигурах 8A-B (SEQ ID NO:14).
9. Гуманизированное антитело против CD79b, где одновалентная аффинность антитела к CD79b человека по меньшей мере в 1, 2 или 3 раза превышает одновалентную аффиность антитела мыши или химерного антитела, содержащего последовательность вариабельной области легкой цепи и тяжелой цепи, как представлено на фигуре 7 (SEQ ID NO:10) и фигурах 8A B (SEQ ID NO:14).
10. Гуманизированное антитело против CD79b, где одновалентная аффинность антитела к CD79b человека по меньшей мере в 1, 2 или 3 раза ниже одновалентной аффинности антитела мыши или химерного антитела, содержащего последовательность вариабельной области легкой цепи и тяжелой цепи, как представлено на фигуре 7 (SEQ ID NO:10) и фигурах 8A-B (SEQ ID NO:14).
11. Гуманизированное антитело против CD79b, где аффинность антитела в его двухвалентной форме к CD79b человека является, по существу, такой же, как и аффинность антитела мыши в его двухвалентной форме, и содержащее последовательность вариабельной области легкой цепи и тяжелой цепи, как представлено на фигуре 7 (SEQ ID NO:10) и фигурах 8A-B (SEQ ID NO:14).
12. Гуманизированное антитело против CD79b, где аффинность антитела в его двухвалентной форме к CD79b человека по меньшей мере в 1, 2 или 3 раза превышает аффинность антитела мыши или химерного антитела в его двухвалентной форме, и содержащее последовательность вариабельной области легкой цепи и тяжелой цепи, как представлено на фигуре 7 (SEQ ID NO:10) и фигурах 8A-B (SEQ ID NO:14).
13. Гуманизированное антитело против CD79b, где аффинность антитела в его двухвалентной форме к CD79b человека по меньшей мере в 1, 2 или 3 раза ниже, чем аффинность антитела мыши или химерного антитела в его двухвалентной форме, и содержащее последовательность вариабельной области легкой цепи и тяжелой цепи, как представлено на фигуре 7 (SEQ ID NO:10) и фигурах 8A-B (SEQ ID NO:14).
14. Гуманизированное антитело против CD79b, где аффинность антитела в его двухвалентной форме против CD79b человека составляет 2,0 нМ.
15. Гуманизированное антитело против CD79b 2F2, где гуманизированное антитело, когда оно конъюгировано с цитотоксическим средством, ингибирует рост клеток опухоли.
16. Антитело, содержащее вариабельный домен тяжелой цепи, содержащий последовательность HVR1-HC, HVR2-HC и/или HVR3-HC, представленную на фигуре 13 (SEQ ID NO:31-33).
17. Антитело по п.33 или 34, где антитело содержит последовательность CH1 и/или Fc, представленную в (SEQ ID NO:34 и/или 35).
18. Антитело, содержащее вариабельный домен легкой цепи, содержащий последовательность HVR1-LC, HVR2-LC и/или HVR3-LC, представленную на фигуре 13 (SEQ ID NO:23-25).
19. Антитело по п.36, где вариабельный домен содержит последовательность FR1-LC, FR2-LC, FR3-LC и/или FR4-LC, представленную на фигуре 13 (SEQ ID NO:19-22).
20. Полипептид, содержащий последовательность, представленную на фигуре 13 (SEQ ID NO:12).
21. Полипептид, содержащий последовательность, представленную на фигуре 13 (SEQ ID NO:16).
22. Антитело, которое связывается с CD79b, где антитело содержит вариабельный домен тяжелой цепи, обладающий по меньшей мере 90% идентичностью последовательности с аминокислотной последовательностью SEQ ID NO:16.
23. Антитело, которое связывается с CD79b, где антитело содержит вариабельный домен легкой цепи, обладающий по меньшей мере 90% идентичностью последовательности с аминокислотной последовательностью SEQ ID NO:12.
24. Антитело, которое связывается с CD79b, где антитело содержит вариабельный домен тяжелой цепи, обладающий по меньшей мере 90% идентичностью последовательности с аминокислотной последовательностью SEQ ID NO:16, и вариабельный домен легкой цепи, обладающий по меньшей мере 90% идентичностью последовательности с аминокислотной последовательностью SEQ ID NO:12.
25. Способ получения антитела против CD79b, где способ включает (a) культивирование клетки-хозяина, выбранной из группы, содержащей эукариотическую клетку и клетку CHO в условиях, пригодных для экспрессии полинуклеотида, кодирующего антитело, и (b) выделение антитела.
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PCT/US2008/070061 WO2009012256A1 (en) | 2007-07-16 | 2008-07-15 | Humanized anti-cd79b antibodies and immunoconjugates and methods of use |
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