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RU2018113505A - IL-8-BINDING ANTIBODIES AND THEIR APPLICATIONS - Google Patents

IL-8-BINDING ANTIBODIES AND THEIR APPLICATIONS Download PDF

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RU2018113505A
RU2018113505A RU2018113505A RU2018113505A RU2018113505A RU 2018113505 A RU2018113505 A RU 2018113505A RU 2018113505 A RU2018113505 A RU 2018113505A RU 2018113505 A RU2018113505 A RU 2018113505A RU 2018113505 A RU2018113505 A RU 2018113505A
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amino acid
seq
acid sequence
antibody
region
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RU2018113505A
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RU2728430C2 (en
RU2018113505A3 (en
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Томоюки ИГАВА
Ацухико МАЭДА
Генки НАКАМУРА
Масару МУРАОКА
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Чугаи Сейяку Кабусики Кайся
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Claims (44)

1. Выделенное антитело к IL-8, связывающееся с человеческим IL-8, которое содержит по меньшей мере одну аминокислотную(ые) замену(ы) по меньшей мере в одном из участков, указанных ниже в подпунктах (а)-(е), и которое связывается с IL-8 pH-зависимым образом:1. The selected anti-IL-8 antibody that binds to human IL-8, which contains at least one amino acid (s) substitution (s) in at least one of the areas listed below in subparagraphs (a) to (e), and which binds to IL-8 in a pH dependent manner: (а) HVR-H1, содержащий аминокислотную последовательность SEQ ID NO: 67;(a) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 67; (б) HVR-H2, содержащий аминокислотную последовательность SEQ ID NO: 68;(b) an HVR-H2 containing the amino acid sequence of SEQ ID NO: 68; (в) HVR-H3, содержащий аминокислотную последовательность SEQ ID NO: 69;(c) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 69; (г) HVR-L1, содержащий аминокислотную последовательность SEQ ID NO: 70;(g) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 70; (д) HVR-L2, содержащий аминокислотную последовательность SEQ ID NO: 71; и(e) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 71; and (е) HVR-L3, содержащий аминокислотную последовательность SEQ ID NO: 72.(e) an HVR-L3 containing the amino acid sequence of SEQ ID NO: 72. 2. Антитело к IL-8 по п. 1, которое обладает особенностью, выбранной из группы, включающей2. The antibody to IL-8 according to claim 1, which has a feature selected from the group including (а) аминокислотные замены тирозина в положении 9 аминокислотной последовательности SEQ ID NO: 68, аргинина в положении 11 аминокислотной последовательности SEQ ID NO: 68 и тирозина в положении 3 аминокислотной последовательности SEQ ID NO: 69;(a) amino acid substitutions of tyrosine at position 9 of the amino acid sequence of SEQ ID NO: 68, arginine at position 11 of the amino acid sequence of SEQ ID NO: 68 and tyrosine at position 3 of the amino acid sequence of SEQ ID NO: 69; (б) аминокислотные замены тирозина в положении 9 аминокислотной последовательности SEQ ID NO: 68, аланина в положении 6 аминокислотной последовательности SEQ ID NO: 68, глицина в положении 8 аминокислотной последовательности SEQ ID NO: 68, аргинина в положении 11 аминокислотной последовательности SEQ ID NO: 68 и тирозина в положении 3 аминокислотной последовательности SEQ ID NO: 69;(b) amino acid substitutions of tyrosine at position 9 of the amino acid sequence of SEQ ID NO: 68, alanine at position 6 of the amino acid sequence of SEQ ID NO: 68, glycine at position 8 of the amino acid sequence of SEQ ID NO: 68, arginine at position 11 of the amino acid sequence of SEQ ID NO : 68 and tyrosine at position 3 of the amino acid sequence of SEQ ID NO: 69; (в) аминокислотные замены аспарагина в положении 1 аминокислотной последовательности SEQ ID NO: 71, лейцина в положении 5 аминокислотной последовательности SEQ ID NO: 71 и глутамина в положении 1 аминокислотной последовательности SEQ ID NO: 72;(c) amino acid substitutions of asparagine at position 1 of the amino acid sequence of SEQ ID NO: 71, leucine at position 5 of the amino acid sequence of SEQ ID NO: 71 and glutamine at position 1 of the amino acid sequence of SEQ ID NO: 72; (г) аминокислотные замены тирозина в положении 9 аминокислотной последовательности SEQ ID NO: 68, аргинина в положении 11 аминокислотной последовательности SEQ ID NO: 68 и тирозина в положении 3 аминокислотной последовательности SEQ ID NO: 69, аспарагина в положении 1 аминокислотной последовательности SEQ ID NO: 71, лейцина в положении 5 аминокислотной последовательности SEQ ID NO: 71 и глутамина в положении 1 аминокислотной последовательности SEQ ID NO: 72; и(d) amino acid substitutions of tyrosine at position 9 of the amino acid sequence of SEQ ID NO: 68, arginine at position 11 of the amino acid sequence of SEQ ID NO: 68 and tyrosine at position 3 of the amino acid sequence of SEQ ID NO: 69, asparagine at position 1 of the amino acid sequence of SEQ ID NO : 71, leucine at position 5 of the amino acid sequence of SEQ ID NO: 71 and glutamine at position 1 of the amino acid sequence of SEQ ID NO: 72; and (д) аминокислотные замены тирозина в положении 9 аминокислотной последовательности SEQ ID NO: 68, аланина в положении 6 аминокислотной последовательности SEQ ID NO: 68, глицина в положении 8 аминокислотной последовательности SEQ ID NO: 68, аргинина в положении 11 аминокислотной последовательности SEQ ID NO: 68, тирозина в положении 3 аминокислотной последовательности SEQ ID NO: 69, аспарагина в положении 1 аминокислотной последовательности SEQ ID NO: 71, лейцина в положении 5 аминокислотной последовательности SEQ ID NO: 71 и глутамина в положении 1 аминокислотной последовательности SEQ ID NO: 72.(e) amino acid substitutions of tyrosine at position 9 of the amino acid sequence of SEQ ID NO: 68, alanine at position 6 of the amino acid sequence of SEQ ID NO: 68, glycine at position 8 of the amino acid sequence of SEQ ID NO: 68, arginine at position 11 of the amino acid sequence of SEQ ID NO : 68, tyrosine at position 3 of the amino acid sequence of SEQ ID NO: 69, asparagine at position 1 of the amino acid sequence of SEQ ID NO: 71, leucine at position 5 of the amino acid sequence of SEQ ID NO: 71 and glutamine at position 1 of the amino acid sequence SEQ ID NO: 72. 3. Антитело к IL-8 по п. 1 или 2, которое содержит (a) HVR-H1, содержащий аминокислотную последовательность SEQ ID NO: 67, (б) HVR-H2, содержащий аминокислотную последовательность SEQ ID NO: 73 и (в) HVR-H3, содержащий аминокислотную последовательность SEQ ID NO: 74.3. The antibody to IL-8 according to claim 1 or 2, which contains (a) HVR-H1 containing the amino acid sequence of SEQ ID NO: 67, (b) HVR-H2 containing the amino acid sequence of SEQ ID NO: 73 and (c ) HVR-H3 containing the amino acid sequence of SEQ ID NO: 74. 4. Антитело к IL-8 по одному из пп. 1-3, которое содержит (a) HVR-L1, содержащий аминокислотную последовательность SEQ ID NO: 70, (б) HVR-L2, содержащий аминокислотную последовательность SEQ ID NO: 75 и (в) HVR-L3, содержащий аминокислотную последовательность SEQ ID NO: 76.4. The antibody to IL-8 according to one of paragraphs. 1-3, which contains (a) an HVR-L1 containing the amino acid sequence of SEQ ID NO: 70, (b) an HVR-L2 containing the amino acid sequence of SEQ ID NO: 75, and (c) an HVR-L3 containing the amino acid sequence of SEQ ID NO: 76. 5. Антитело к IL-8 по одному из пп. 1-4, которое содержит вариабельную область тяжелой цепи, имеющую SEQ ID NO: 78, и вариабельную область легкой цепи, имеющую SEQ ID NO: 79.5. The antibody to IL-8 according to one of paragraphs. 1-4, which contains the variable region of the heavy chain having SEQ ID NO: 78, and the variable region of the light chain having SEQ ID NO: 79. 6. Антитело к IL-8, которое содержит Fc-область, содержащую аминокислотную(ые) замену(ы) в одном или нескольких положениях, выбранных из группы, состоящей из положений 235, 236, 239, 327, 330, 331, 428, 434, 436, 438 и 440, согласно EU-нумерации.6. The antibody to IL-8, which contains the Fc region containing the amino acid (s) substitution (s) in one or more positions selected from the group consisting of positions 235, 236, 239, 327, 330, 331, 428, 434, 436, 438 and 440, according to EU numbering. 7. Антитело к IL-8 по п. 6, которое содержит Fc-область, обладающую по меньшим мере одним свойством, выбранным из свойств, указанных ниже в подпунктах (а)-(е):7. The antibody to IL-8 according to claim 6, which contains an Fc region having at least one property selected from the properties indicated below in subparagraphs (a) - (e): (а) повышенная аффинность связывания Fc-области с FcRn по сравнению с аффинностью связывания с FcRn нативной Fc-области при кислом pH;(a) increased binding affinity of the Fc region to FcRn compared to the binding affinity of FcRn of the native Fc region at acidic pH; (б) пониженная аффинность связывания Fc-области с предсуществующим (ранее присутствующим) ADA по сравнению с аффинностью связывания нативной Fc с предсуществующим ADA;(b) reduced binding affinity of the Fc region to preexisting (previously present) ADA compared to the binding affinity of native Fc to preexisting ADA; (в) удлиненное время полужизни в плазме Fc-области по сравнению с временем полужизни в плазме нативной Fc-области;(c) an extended half-life in the plasma of the Fc region compared to the half-life in the plasma of the native Fc region; (г) пониженный плазменный клиренс Fc-области по сравнению с плазменным клиренсом нативной Fc-области; и(d) a reduced plasma clearance of the Fc region compared to the plasma clearance of the native Fc region; and (д) пониженная аффинность связывания Fc-области с эффекторным рецептором по сравнению с аффинностью связывания нативной Fc-области с эффекторным рецептором; и(e) reduced binding affinity of the Fc region to the effector receptor compared to the binding affinity of the native Fc region to the effector receptor; and (е) увеличенное связывание с внеклеточным матриксом.(e) increased binding to the extracellular matrix. 8. Антитело к IL-8 по п. 6 или п. 7, которое содержит Fc-область, содержащую одну или несколько аминокислотную(ых) замену(н), выбранных из группы, состоящей из L235R, G236R, S239K, A327G, A330S, P331S, M428L, N434A, Y436T, Q438R и S440E, согласно EU-нумерации.8. The antibody to IL-8 according to claim 6 or claim 7, which contains an Fc region containing one or more amino acid (s) substitution (s) selected from the group consisting of L235R, G236R, S239K, A327G, A330S , P331S, M428L, N434A, Y436T, Q438R and S440E, according to EU numbering. 9. Антитело к IL-8 по п. 8, которое содержит Fc-область, содержащую аминокислотные замены (a) L235R, G236R, S239K, M428L, N434A, Y436T, Q438R и S440E; или (б) L235R, G236R, A327G, A330S, P331S, M428L, N434A, Y436T, Q438R и S440E, согласно EU-нумерации.9. The antibody to IL-8 according to claim 8, which contains the Fc region containing the amino acid substitutions (a) L235R, G236R, S239K, M428L, N434A, Y436T, Q438R and S440E; or (b) L235R, G236R, A327G, A330S, P331S, M428L, N434A, Y436T, Q438R and S440E according to EU numbering. 10. Антитело к IL-8 по п. 6, которое содержит тяжелую цепь, содержащую аминокислотную последовательность SEQ ID NO: 80 или SEQ ID NO: 81, и легкую цепь, содержащую аминокислотную последовательность SEQ ID NO: 82.10. The antibody to IL-8 according to claim 6, which contains a heavy chain containing the amino acid sequence of SEQ ID NO: 80 or SEQ ID NO: 81, and a light chain containing the amino acid sequence of SEQ ID NO: 82. 11. Выделенная нуклеиновая кислота, кодирующая антитело к IL-8 по одному из пп. 1-10.11. The selected nucleic acid encoding an antibody to IL-8 according to one of paragraphs. 1-10. 12. Вектор, содержащий нуклеиновую кислоту по п. 11.12. A vector containing the nucleic acid according to claim 11. 13. Клетка-хозяин, содержащая вектор по п. 12.13. A host cell containing the vector of claim 12. 14. Способ получения антитела к IL-8, который включает культивирование клетки-хозяина по п. 13.14. A method for producing an anti-IL-8 antibody, which comprises culturing a host cell according to claim 13. 15. Способ по 14, который включает также выделение антитела из культуры клетки-хозяина.15. The method according to 14, which also includes the selection of antibodies from the culture of the host cell. 16. Фармацевтическая композиция, содержащая антитело к IL-8 по одному из пп. 1-10 и фармацевтически приемлемый носитель.16. A pharmaceutical composition comprising an antibody to IL-8 according to one of claims. 1-10 and a pharmaceutically acceptable carrier. 17. Способ лечения пациента, который имеет нарушение, характеризующееся избытком IL-8, включающий введение индивидууму антитела к IL-8 по одному из пп. 1-10.17. A method of treating a patient who has a disorder characterized by an excess of IL-8, comprising administering to the individual an anti-IL-8 antibody according to one of claims. 1-10. 18. Применение антитела к IL-8 по одному из пп. 1-10 для приготовления фармацевтической композиции, предназначенной для лечения нарушения, характеризующегося избытком IL-8.18. The use of antibodies to IL-8 according to one of paragraphs. 1-10 for the preparation of a pharmaceutical composition intended for the treatment of a disorder characterized by an excess of IL-8. 19. Способ ингибирования ангиогенеза у индивидуума, где способ включает введение индивидууму антитела к IL-8 по одному из пп. 1-10.19. A method of inhibiting angiogenesis in an individual, wherein the method comprises administering to the individual an anti-IL-8 antibody according to one of claims. 1-10. 20. Применение антитела к IL-8 по одному из пп. 1-10 для приготовления фармацевтической композиции, предназначенной для ингибирования ангиогенеза.20. The use of antibodies to IL-8 according to one of paragraphs. 1-10 for the preparation of a pharmaceutical composition intended to inhibit angiogenesis. 21. Способ ингибирования облегчения миграции нейтрофилов у индивидуума, где способ включает введение индивидууму антитела к IL-8 по одному из пп. 1-10.21. A method of inhibiting the facilitation of neutrophil migration in an individual, wherein the method comprises administering to the individual an anti-IL-8 antibody according to one of claims. 1-10. 22. Применение антитела к IL-8 по одному из пп. 1-10 для приготовления фармацевтической композиции, предназначенной для ингибирования облегчения миграции нейтрофилов.22. The use of antibodies to IL-8 according to one of paragraphs. 1-10 for the preparation of a pharmaceutical composition intended to inhibit the facilitation of neutrophil migration. 23. Способ получения антитела к IL-8, которое содержит вариабельную область с pH-зависимой активностью связывания с IL-8, где способ включает:23. The method of producing antibodies to IL-8, which contains a variable region with a pH-dependent activity of binding to IL-8, where the method includes: (а) оценку связывания антитела к IL-8 с внеклеточным матриксом,(a) evaluation of the binding of antibodies to IL-8 with the extracellular matrix, (б) отбор антитела к IL-8 с сильной способностью связываться с внеклеточным матриксом,(b) selection of antibodies to IL-8 with a strong ability to bind to the extracellular matrix, (в) культивирование хозяина, который содержит вектор, содержащий нуклеиновую кислоту, которая кодирует антитело, и(c) culturing a host that contains a vector containing a nucleic acid that encodes an antibody, and (г) выделение антитела из культурального раствора.(g) the selection of antibodies from the culture solution.
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