RU2014120536A - Белки специфического связывания и их применения - Google Patents
Белки специфического связывания и их применения Download PDFInfo
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- RU2014120536A RU2014120536A RU2014120536/10A RU2014120536A RU2014120536A RU 2014120536 A RU2014120536 A RU 2014120536A RU 2014120536/10 A RU2014120536/10 A RU 2014120536/10A RU 2014120536 A RU2014120536 A RU 2014120536A RU 2014120536 A RU2014120536 A RU 2014120536A
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- 102000014914 Carrier Proteins Human genes 0.000 title 1
- 108091008324 binding proteins Proteins 0.000 title 1
- 230000009870 specific binding Effects 0.000 title 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims abstract 36
- 102000052116 epidermal growth factor receptor activity proteins Human genes 0.000 claims abstract 10
- 108700015053 epidermal growth factor receptor activity proteins Proteins 0.000 claims abstract 10
- 206010028980 Neoplasm Diseases 0.000 claims abstract 9
- YOHYSYJDKVYCJI-UHFFFAOYSA-N n-[3-[[6-[3-(trifluoromethyl)anilino]pyrimidin-4-yl]amino]phenyl]cyclopropanecarboxamide Chemical compound FC(F)(F)C1=CC=CC(NC=2N=CN=C(NC=3C=C(NC(=O)C4CC4)C=CC=3)C=2)=C1 YOHYSYJDKVYCJI-UHFFFAOYSA-N 0.000 claims abstract 8
- 101150039808 Egfr gene Proteins 0.000 claims abstract 4
- 108700021358 erbB-1 Genes Proteins 0.000 claims abstract 4
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims abstract 2
- 108010075254 C-Peptide Proteins 0.000 claims abstract 2
- 101000851181 Homo sapiens Epidermal growth factor receptor Proteins 0.000 claims abstract 2
- 230000003321 amplification Effects 0.000 claims abstract 2
- 102000045108 human EGFR Human genes 0.000 claims abstract 2
- 238000003199 nucleic acid amplification method Methods 0.000 claims abstract 2
- 102000005962 receptors Human genes 0.000 claims abstract 2
- 108020003175 receptors Proteins 0.000 claims abstract 2
- 229920001184 polypeptide Polymers 0.000 claims 8
- 108090000765 processed proteins & peptides Proteins 0.000 claims 8
- 102000004196 processed proteins & peptides Human genes 0.000 claims 8
- 102000039446 nucleic acids Human genes 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 150000007523 nucleic acids Chemical class 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 239000003153 chemical reaction reagent Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 230000002285 radioactive effect Effects 0.000 claims 1
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Abstract
1. Выделенное антитело, способное к связыванию с EGFR на поверхности опухолей, имеющих амплификации гена EGFR, при этом клетки указанных опухолей имеют множество копий гена EGFR, и на поверхности опухолей, экспрессирующих усеченный вариант рецептора de2-7 EGFR, причем указанное антитело не связывается с соединительным пептидом de2-7 EGFR, состоящим из аминокислотной последовательности SEQ ID NO: 13, причем указанное антитело связывается с эпитопом внутри последовательности из остатков 287-302 (SEQ ID NO: 14) EGFR дикого типа человека, и причем указанное антитело не включает последовательность вариабельной области тяжелой цепи, соответствующую аминокислотной последовательности, представленной в SEQ ID NO: 2, и не включает последовательность вариабельной области легкой цепи, соответствующую аминокислотной последовательности, представленной в SEQ ID NO: 4.2. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, при этом тяжелая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 42, а легкая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 47.3. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, при этом тяжелая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 129, а легкая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 134.4. Выделенное антитело по п. 1, которое включает тяжелуюцепь и легкую цепь, при этом тяжелая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 22, а легкая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 27.5. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую ц�
Claims (25)
1. Выделенное антитело, способное к связыванию с EGFR на поверхности опухолей, имеющих амплификации гена EGFR, при этом клетки указанных опухолей имеют множество копий гена EGFR, и на поверхности опухолей, экспрессирующих усеченный вариант рецептора de2-7 EGFR, причем указанное антитело не связывается с соединительным пептидом de2-7 EGFR, состоящим из аминокислотной последовательности SEQ ID NO: 13, причем указанное антитело связывается с эпитопом внутри последовательности из остатков 287-302 (SEQ ID NO: 14) EGFR дикого типа человека, и причем указанное антитело не включает последовательность вариабельной области тяжелой цепи, соответствующую аминокислотной последовательности, представленной в SEQ ID NO: 2, и не включает последовательность вариабельной области легкой цепи, соответствующую аминокислотной последовательности, представленной в SEQ ID NO: 4.
2. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, при этом тяжелая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 42, а легкая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 47.
3. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, при этом тяжелая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 129, а легкая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 134.
4. Выделенное антитело по п. 1, которое включает тяжелую
цепь и легкую цепь, при этом тяжелая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 22, а легкая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 27.
5. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, при этом тяжелая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 32, а легкая цепь имеет аминокислотную последовательность, представленную в SEQ ID NO: 37.
6. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, где вариабельная область тяжелой цепи включает участки связывающего полипептид домена, имеющие аминокислотные последовательности, в высокой степени гомологичные аминокислотным последовательностям, представленным в SEQ ID NO: 44, 45 и 46.
7. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, где вариабельная область легкой цепи включает участки связывающего полипептид домена, имеющие аминокислотные последовательности, в высокой степени гомологичные аминокислотным последовательностям, представленным в SEQ ID NO: 49, 50 и 51.
8. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, где вариабельная область тяжелой цепи включает участки связывающего полипептид домена, имеющие аминокислотные последовательности, в высокой степени гомологичные аминокислотным последовательностям, представленным в SEQ ID NO: 130, 131 и 132.
9. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, где вариабельная область легкой цепи включает участки связывающего полипептид домена, имеющие аминокислотные последовательности, в высокой степени гомологичные аминокислотным последовательностям, представленным в SEQ ID NO: 135, 136 и 137.
10. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, где вариабельная область тяжелой цепи включает участки связывающего полипептид домена, имеющие аминокислотные последовательности, в высокой степени гомологичные аминокислотным последовательностям, представленным в SEQ ID NO: 23, 24 и 25.
11. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, где вариабельная область легкой цепи включает участки связывающего полипептид домена, имеющие аминокислотные последовательности, в высокой степени гомологичные аминокислотным последовательностям, представленным в SEQ ID NO: 28, 29 и 30.
12. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, где вариабельная область тяжелой цепи включает участки связывающего полипептид домена, имеющие аминокислотные последовательности, в высокой степени гомологичные аминокислотным последовательностям, представленным в SEQ ID NO: 33, 34 и 35.
13. Выделенное антитело по п. 1, которое включает тяжелую цепь и легкую цепь, где вариабельная область легкой цепи включает участки связывающего полипептид домена, имеющие
аминокислотные последовательности, в высокой степени гомологичные аминокислотным последовательностям, представленным в SEQ ID NO: 38, 39 и 40.
14. Выделенное антитело по п. 1, которое является формой антитела F(ab')2, scFv-фрагментом, диателом, триателом или тетрателом.
15. Выделенное антитело по п. 1, дополнительно включающее обнаруживаемую или функциональную метку.
16. Выделенное антитело по п. 15, в случае которого указанной обнаруживаемой или функциональной меткой является ковалентно присоединенное лекарственное средство.
17. Выделенное антитело по п. 15, в случае которого указанной меткой является радиоактивная метка.
18. Выделенное антитело по п. 1, которое является ПЭГилированным.
19. Выделенная нуклеиновая кислота, которая включает последовательность, кодирующую выделенное антитело по п. 1.
20. Способ получения выделенного антитела по п. 1, включающий экспрессию нуклеиновой кислоты в условиях, которые приводят к экспрессии указанного антитела, и извлечение указанного антитела.
21. Способ лечения опухоли у являющегося человеком пациента, который включает введение указанному пациенту эффективного количества выделенного антитела по п. 1.
22. Набор для диагностирования опухоли, в которой EGFR аберрантно экспрессирован или в которой EGFR экспрессирован в форме усеченного белка, включающий выделенное антитело по п. 1.
23. Набор для диагностирования опухоли, в которой EGFR аберрантно экспрессирован или в которой EGFR экспрессирован в форме усеченного белка, по п. 22, который дополнительно включает реагенты и/или инструкции в отношении использования.
24. Фармацевтическая композиция, включающая выделенное антитело по п. 1.
25. Фармацевтическая композиция по п. 24, которая, кроме того, включает фармацевтически приемлемый наполнитель, носитель или разбавитель.
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