RU2010136029A - Композиция, содержащая антитело, которое связывается с доменом ii her2, и его кислые варианты - Google Patents
Композиция, содержащая антитело, которое связывается с доменом ii her2, и его кислые варианты Download PDFInfo
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Abstract
1. Композиция, содержащая HER2-антитело главного типа, которое связывается с доменом II HER2, и его кислые варианты, где кислые варианты включают гликозилированный вариант, вариант с восстановленной дисульфидной связью или невосстанавливаемый вариант. ! 2. Композиция по п.1, где композиция содержит гликозилированный вариант. ! 3. Композиция по п.1, где композиция содержит вариант с восстановленной дисульфидной связью. ! 4. Композиция по п.1, где композиция содержит невосстанавливаемый вариант. ! 5. Композиция по п.1, где кислые варианты включают гликозилированный вариант, дезаминированный вариант, вариант с восстановленной дисульфидной связью, сиалилированный вариант и невосстанавливаемый вариант. ! 6. Композиция по п.1, где количество кислых вариантов составляет менее чем примерно 25%. ! 7. Композиция по п.1, где HER2-антитело главного типа и кислые варианты являются интактными антителами. ! 8. Композиция по п.1, где HER2-антитело главного типа содержит аминокислотные последовательности вариабельной области легкой цепи и вариабельной области тяжелой цепи SEQ ID NO: 3 и 4 соответственно. ! 9. Композиция по п.8, где HER2-антитело главного типа содержит аминокислотные последовательности легкой цепи и тяжелой цепи SEQ ID NO: 15 и 16 соответственно. ! 10. Композиция по любому из предшествующих пунктов, содержащая вариант с удлинением в виде аминоконцевого лидера антитела главного типа. ! 11. Композиция по п.10, где удлинение в виде аминоконцевого лидера содержит VHS-. ! 12. Композиция по п.11, где удлинение в виде аминоконцевого лидера состоит из VHS-. ! 13. Композиция по п.1, содержащая HER2-антитело главного типа с вариантом аминокислотной последовательности, вы
Claims (27)
1. Композиция, содержащая HER2-антитело главного типа, которое связывается с доменом II HER2, и его кислые варианты, где кислые варианты включают гликозилированный вариант, вариант с восстановленной дисульфидной связью или невосстанавливаемый вариант.
2. Композиция по п.1, где композиция содержит гликозилированный вариант.
3. Композиция по п.1, где композиция содержит вариант с восстановленной дисульфидной связью.
4. Композиция по п.1, где композиция содержит невосстанавливаемый вариант.
5. Композиция по п.1, где кислые варианты включают гликозилированный вариант, дезаминированный вариант, вариант с восстановленной дисульфидной связью, сиалилированный вариант и невосстанавливаемый вариант.
6. Композиция по п.1, где количество кислых вариантов составляет менее чем примерно 25%.
7. Композиция по п.1, где HER2-антитело главного типа и кислые варианты являются интактными антителами.
8. Композиция по п.1, где HER2-антитело главного типа содержит аминокислотные последовательности вариабельной области легкой цепи и вариабельной области тяжелой цепи SEQ ID NO: 3 и 4 соответственно.
9. Композиция по п.8, где HER2-антитело главного типа содержит аминокислотные последовательности легкой цепи и тяжелой цепи SEQ ID NO: 15 и 16 соответственно.
10. Композиция по любому из предшествующих пунктов, содержащая вариант с удлинением в виде аминоконцевого лидера антитела главного типа.
11. Композиция по п.10, где удлинение в виде аминоконцевого лидера содержит VHS-.
12. Композиция по п.11, где удлинение в виде аминоконцевого лидера состоит из VHS-.
13. Композиция по п.1, содержащая HER2-антитело главного типа с вариантом аминокислотной последовательности, выбранное из группы, состоящей из антитела, содержащего C-концевой остаток лизина на одной или двух тяжелых цепях, и антитело с одним или несколькими окисленными остатками метионина.
14. Фармацевтический препарат, содержащий композицию по любому из пп.1-13, в фармацевтически приемлемом носителе.
15. Фармацевтический препарат по п.14, являющийся стерильным.
16. Композиция, содержащая HER2-антитело главного типа, содержащее последовательности вариабельной области легкой цепи и вариабельной области тяжелой цепи SEQ ID NO: 3 и 4 соответственно, и кислые варианты антитела главного типа, при этом кислые варианты включают гликозилированный вариант, дезаминированный вариант, вариант с восстановленной дисульфидной связью, сиалилированный вариант и невосстанавливаемый вариант.
17. Фармацевтический препарат, содержащий композицию по п.16 в фармацевтически приемлемом носителе.
18. Способ лечения HER2-позитивной злокачественной опухоли у пациента, включающий введение фармацевтического препарата по п.17 пациенту в количестве, эффективном для лечения злокачественной опухоли.
19. Способ по п.18, в котором злокачественная опухоль выбрана из группы, состоящей из рака молочной железы, рака яичника, рака легкого и рака прямой и ободочной кишки.
20. Способ по п.18, в котором антитело главного типа и кислые варианты имеют по существу одну и ту же фармакокинетику.
21. Способ получения фармацевтической композиции, включающий: (1) получение композиции, содержащей HER2-антитело главного типа, которое связывается с доменом II HER2, и его кислые варианты, включая гликозилированный вариант, вариант с восстановленной дисульфидной связью или невосстанавливаемый вариант, и (2) оценку кислых вариантов в композиции и подтверждение того, что их количество составляет менее чем примерно 25%.
22. Способ по п.21, в котором стадия (2) включает оценку кислых вариантов способом, выбранным из группы, состоящей из ионообменной хроматографии, при которой композицию обрабатывают сиалидазой, капиллярного электрофореза в восстанавливающих условиях с использованием додецилсульфата натрия (CE-SDS), CE-SDS в не восстанавливающих условиях, хроматографии с использованием бороната и картирования пептидов.
23. Способ по п.21, в котором стадия (2) включает оценку кислых вариантов ионообменной хроматографией.
24. Способ по п.23, который включает катионообменную хроматографию с использованием катионообменника с карбоксилатной функциональной группой.
25. Способ по п.24, в котором условия хроматографии включают: буфер A 20 мМ бистрис, pH 6,0; буфер B 20 мМ бистрис, 200 мМ NaCl, pH 6,0; и градиент 0,5% буфер B с расходом 1,0 мл/мин.
26. Способ по п.21, включающий объединение композиции после стадии (2) с фармацевтически приемлемым носителем.
27. Способ по п.21, в котором композиция, оцениваемая на стадии (2), находится в фармацевтически приемлемом носителе.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US2482508P | 2008-01-30 | 2008-01-30 | |
| US61/024,825 | 2008-01-30 | ||
| PCT/US2009/032220 WO2009099829A1 (en) | 2008-01-30 | 2009-01-28 | Composition comprising antibody that binds to domain ii of her2 and acidic variants thereof |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2015101975/10A Division RU2015101975A (ru) | 2008-01-30 | 2009-01-28 | Композиция, содержащая антитело, которое связывается с доменом ii her2, и его кислые варианты |
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| Publication Number | Publication Date |
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| RU2010136029A true RU2010136029A (ru) | 2012-03-10 |
| RU2543664C2 RU2543664C2 (ru) | 2015-03-10 |
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| Application Number | Title | Priority Date | Filing Date |
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| RU2015101975/10A RU2015101975A (ru) | 2008-01-30 | 2009-01-28 | Композиция, содержащая антитело, которое связывается с доменом ii her2, и его кислые варианты |
| RU2010136029/10A RU2543664C2 (ru) | 2008-01-30 | 2009-01-28 | Композиция, содержащая антитело, которое связывается с доменом ii her2, и его кислые варианты |
| RU2019134204A RU2019134204A (ru) | 2008-01-30 | 2019-10-25 | Композиция, содержащая антитело, которое связывается с доменом ii her2, и его кислые варианты |
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| RU2015101975/10A RU2015101975A (ru) | 2008-01-30 | 2009-01-28 | Композиция, содержащая антитело, которое связывается с доменом ii her2, и его кислые варианты |
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| RU2019134204A RU2019134204A (ru) | 2008-01-30 | 2019-10-25 | Композиция, содержащая антитело, которое связывается с доменом ii her2, и его кислые варианты |
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| CL (1) | CL2009000178A1 (ru) |
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Families Citing this family (73)
| Publication number | Priority date | Publication date | Assignee | Title |
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| KR20150140417A (ko) * | 2004-07-22 | 2015-12-15 | 제넨테크, 인크. | Ｈｅｒ２ 항체 조성물 |
| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| UA95902C2 (ru) * | 2005-02-23 | 2011-09-26 | Дженентек, Инк. | Способ увеличения времени развития заболевания или выживаемости у раковых пациентов |
| NZ578824A (en) | 2007-03-02 | 2012-03-30 | Genentech Inc | Predicting response to a her dimerisation inhibitor based on low her3 expression |
| TWI472339B (zh) | 2008-01-30 | 2015-02-11 | Genentech Inc | 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物 |
| BRPI0812682A2 (pt) | 2008-06-16 | 2010-06-22 | Genentech Inc | tratamento de cáncer de mama metastático |
| ES2594893T3 (es) * | 2009-12-16 | 2016-12-23 | Abbvie Biotherapeutics Inc. | Anticuerpos anti HER2 y sus usos |
| SG10201407983VA (en) | 2009-12-18 | 2015-01-29 | Csl Ltd | Method of purifying polypeptides |
| US8609095B2 (en) * | 2010-03-04 | 2013-12-17 | Symphogen A/S | Anti-HER2 antibodies and compositions |
| JP6082344B2 (ja) | 2010-05-27 | 2017-02-15 | ゲンマブ エー／エス | Ｈｅｒ２エピトープに対するモノクローナル抗体 |
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