RU2015144287A - Составы конъюгата антитело против egfr-лекарственное средство - Google Patents

Составы конъюгата антитело против egfr-лекарственное средство Download PDF

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RU2015144287A
RU2015144287A RU2015144287A RU2015144287A RU2015144287A RU 2015144287 A RU2015144287 A RU 2015144287A RU 2015144287 A RU2015144287 A RU 2015144287A RU 2015144287 A RU2015144287 A RU 2015144287A RU 2015144287 A RU2015144287 A RU 2015144287A
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Маркус ЧЕПЕ
Катарина КАЛЕТА
Винеет КУМАР
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Эббви Дойчланд Гмбх Унд Ко. Кг
Эббви Инк.
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Claims (44)

1. Состав, содержащий конъюгат антитело против рецептора эпидермального фактора роста (EGFR)-лекарственное средство (ADC), сахар, гистидин и поверхностно-активное вещество, где указанный состав имеет pH приблизительно 5-7, и где указанный ADC против EGFR содержит антитело против EGFR или его антигенсвязывающую часть, конъюгированные с ауристатином.
2. Состав по п. 1, где ауристатин представляет собой монометилауристатин F (MMAF).
3. Состав по п. 2, где MMAF конъюгирован с антителом через малеимидокапроиловый линкер.
4. Состав по любому из п.п. 1-3, где поверхностно-активное вещество представляет собой полисорбат или полоксамер.
5. Состав по п. 4, где состав содержит 0,05-0,15 мг/мл полисорбата.
6. Состав по п. 4, где полисорбат представляет собой полисорбат 80.
7. Состав по любому из п.п. 1-3, где состав содержит приблизительно 1-40 мг/мл ADC против EGFR.
8. Состав по любому из п.п. 1-3, где состав содержит приблизительно 60-80 мг/мл сахара.
9. Состав по любому из п.п. 1-3, где сахар выбран из группы, состоящей из маннита, сорбита, сахарозы и трегалозы.
10. Состав по любому из п.п. 1-3, содержащий приблизительно 5-25 мМ гистидина.
11. Состав по любому из п.п. 1-3, где состав имеет pH приблизительно 5,5-6,5.
12. Состав по любому из п.п. 1-3, где состав является лиофилизированным.
13. Состав по любому из п.п. 1-3, где состав является лиофилизированным и сахар представляет собой сахарозу.
14. Состав по п. 13, где поверхностно-активное вещество представляет собой полисорбат.
15. Состав по п. 14, где полисорбат представляет собой полисорбат 80.
16. Состав по любому из п.п. 1-3, где, когда указанный состав представляет собой водный состав, содержащий приблизительно 1-100 мг/мл ADC против EGFR, приблизительно 1-10 мг/мл гистидина, приблизительно 50-90 мг/мл сахара, и приблизительно 0,01-0,2 мг/мл поверхностно-активного вещества.
17. Состав по п. 16, где сахар представляет собой сахарозу.
18. Состав по п. 16, где поверхностно-активное вещество представляет собой полисорбат 80.
19. Состав по п. 16, где состав имеет pH приблизительно 5,5-6,5.
20. Состав по п. 16, содержащий 1-150 мг/мл ADC против EGFR.
21. Состав по п. 20, содержащий 1-40 мг/мл ADC против EGFR.
22. Состав по любому из п.п. 1-3, где антитело является гуманизированным.
23. Состав по любому из п.п. 1-3, где антитело или его антигенсвязывающая часть содержат вариабельную область тяжелой цепи, содержащую аминокислотную последовательность, указанную в SEQ ID NO: 13, и вариабельную область легкой цепи, содержащую аминокислотную последовательность, указанную в SEQ ID NO: 18.
24. Состав по любому из п.п. 1-3, где указанное антитело или его антигенсвязывающая часть содержат вариабельную область тяжелой цепи, содержащую определяющие комплементарность области (CDR), содержащие аминокислотные последовательности, указанные в SEQ ID NO: 15, 16 и 17, и содержат вариабельную область легкой цепи, содержащую CDR, содержащие аминокислотные последовательности, указанные в SEQ ID NO: 20, 21 и 22.
25. Состав по любому из п.п. 1-3, где состав представляет собой лиофилизированный состав, содержащий сахарозу, полисорбат 80 и гистидин, и где антитело или его антигенсвязывающая часть содержат вариабельную область тяжелой цепи, содержащую определяющие комплементарность области (CDR), содержащие аминокислотные последовательности, указанные в SEQ ID NO: 15, 16 и 17, и содержат вариабельную область легкой цепи, содержащую CDR, содержащие аминокислотные последовательности, указанные в SEQ ID NO: 20, 21 и 22.
26. Состав по п. 25, содержащий 1-120 мг ADC против EGFR.
27. Состав по любому из п.п. 1-3, где состав содержит смесь ADC, имеющую среднее значение DAR приблизительно 3, или смесь ADC, имеющую DAR приблизительно 2-4.
28. Состав, содержащий ADC против EGFR, содержащий антитело против EGFR или его антигенсвязывающую часть, конъюгированные с монометилауристатином F (MMAF), где указанный ADC 1-MMAF содержит вариабельную область тяжелой цепи, содержащую определяющие комплементарность области (CDR), содержащие аминокислотные последовательности, указанные в SEQ ID NO: 15, 16 и 17, и содержит вариабельную область легкой цепи, содержащую CDR, содержащие аминокислотные последовательности, указанные в SEQ ID NO: 20, 21 и 22,
сахарозу,
гистидин,и
полисорбат 80,
где состав содержит смесь ADC, имеющую среднее DAR приблизительно 3, или смесь ADC, имеющую DAR приблизительно 2-4.
29. Состав по п. 28, который является лиофилизированным.
30. Состав по п. 28 или 29, где антитело против EGFR или его антигенсвязывающая часть содержат вариабельную область тяжелой цепи, содержащую аминокислотную последовательность, указанную в SEQ ID NO: 13, и вариабельную область легкой цепи, содержащую аминокислотную последовательность, указанную в SEQ ID NO: 18.
31. Состав по любому из п.п. 1-3, 28 и 29, который представляет собой фармацевтический состав.
32. Способ получения состава по любому из п.п. 1-3 или 29, причем указанный способ включает лиофилизацию водного состава, имеющего pH в диапазоне приблизительно 5-7 и содержащего 1-20 мг гистидина, приблизительно 320-410 мг сахара, приблизительно 0,1-0,9 мг поверхностно-активного вещества и приблизительно 1-150 мг ADC против EGFR.
33. Способ лечения индивидуума, включающий введение терапевтически эффективного количества состава по любому из п.п. 1-3 и 28 индивидууму, где индивидуум имеет нарушение, требующее лечения посредством ADC против EGFR.
34. Способ по п. 33, где нарушение, требующее лечения посредством ADC против EGFR, представляет собой злокачественную опухоль.
35. Способ по п. 34, где злокачественная опухоль выбрана из группы, состоящей из: глиобластомы, немелкоклеточного рака легкого, рака легкого, рака толстого кишечника, рака головы и шеи, рака молочной железы, плоскоклеточных опухолей, рака анального канала, рака кожи и рака вульвы.
36. Способ по п. 34, где злокачественная опухоль выбрана из группы, состоящей из плоскоклеточных опухолей, глиобластомы, глиомы, немелкоклеточного рака легкого (NSCLC), рака легкого, рака толстого кишечника, рака головы и шеи, рака молочной железы, рака анального канала, рак кожи и рака вульвы.
37. Способ по п. 36, где плоскоклеточная опухоль выбрана из группы, состоящей из плоскоклеточной опухоли легкого, плоскоклеточной опухоли головы и шеи и плоскоклеточной опухоли шейки матки.
38. Способ по п. 34, где злокачественная опухоль представляет собой солидную опухоль, имеющую сверхэкспрессию EGFR.
39. Способ по п. 33, где состав вводят внутривенно.
40. Набор, содержащий состав по любому из п.п. 1-3, 28 и 29.
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