RU2015100656A - Способ получения конъюгатов fc-фрагмента антитела, включающих по меньшей мере одну связывающую группировку, которая специфически связывается с мишенью, и их применения - Google Patents

Способ получения конъюгатов fc-фрагмента антитела, включающих по меньшей мере одну связывающую группировку, которая специфически связывается с мишенью, и их применения Download PDF

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RU2015100656A
RU2015100656A RU2015100656A RU2015100656A RU2015100656A RU 2015100656 A RU2015100656 A RU 2015100656A RU 2015100656 A RU2015100656 A RU 2015100656A RU 2015100656 A RU2015100656 A RU 2015100656A RU 2015100656 A RU2015100656 A RU 2015100656A
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Себастьян ФЕНН
Эрхард КОПЕЦКИ
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Ф. Хоффманн-Ля Рош Аг
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    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
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    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
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    • C—CHEMISTRY; METALLURGY
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    • C07K2319/90—Fusion polypeptide containing a motif for post-translational modification
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Abstract

1. Способ получения конъюгата Fc-фрагмента антитела, содержащего в качестве первого компонента рекомбинантный Fc-фрагмент антитела и в качестве второго компонента по меньшей мере одну рекомбинантную связывающую группировку, которая специфически связывается с мишенью, с применением сортазы A для ферментативной конъюгации Fc-фрагмента антитела по меньшей мере с одной связывающей группировкой, включающий следующий этап:- инкубацию i) связывающей группировки, которая специфически связывается с мишенью, содержащей аминокислотную последовательность GSLPX1TG (SEQ ID NO: 02, n=1, 2 или 3, где X1 может представлять собой любой аминокислотный остаток) в составе своих 20 C-концевых аминокислотных остатков, и ii) Fc-фрагмента антитела, содержащего по меньшей мере на одном N-конце олигоглицин G(m=2, 3, 4 или 5), с ферментом Сортазой Aс получением таким образом конъюгата Fc-фрагмента антитела.2. Способ по п. 1, отличающийся тем, что связывающая группировка, которая специфически связывается с мишенью, содержит аминокислотную последовательность GSLPX1TGGSGS (SEQ ID NO: 03, n=1, 2 или 3, где X1 может представлять собой любой аминокислотный остаток) в составе своих 20 C-концевых аминокислотных остатков.3. Способ по любому из пп. 1 и 2, отличающийся тем, что связывающая группировка, которая специфически связывается с мишенью, содержит аминокислотную последовательность X2GSLPX1TGGSGS (SEQ ID NO: 04, где X1 может представлять собой любой аминокислотный остаток) в составе своих 20 C-концевых аминокислотных остатков, где X2 может представлять собой любой аминокислотный остаток, кроме глицина.4. Способ по п. 1, отличающийся тем, что связывающая группировка, которая специфически связывается с мишенью, содержит аминокислотную последовательность GSLPX1TGGSGSX3 (SEQ ID NO: 05, n=1, 2 или 3, где X1 может

Claims (13)

1. Способ получения конъюгата Fc-фрагмента антитела, содержащего в качестве первого компонента рекомбинантный Fc-фрагмент антитела и в качестве второго компонента по меньшей мере одну рекомбинантную связывающую группировку, которая специфически связывается с мишенью, с применением сортазы A для ферментативной конъюгации Fc-фрагмента антитела по меньшей мере с одной связывающей группировкой, включающий следующий этап:
- инкубацию i) связывающей группировки, которая специфически связывается с мишенью, содержащей аминокислотную последовательность GnSLPX1TG (SEQ ID NO: 02, n=1, 2 или 3, где X1 может представлять собой любой аминокислотный остаток) в составе своих 20 C-концевых аминокислотных остатков, и ii) Fc-фрагмента антитела, содержащего по меньшей мере на одном N-конце олигоглицин Gm (m=2, 3, 4 или 5), с ферментом Сортазой A
с получением таким образом конъюгата Fc-фрагмента антитела.
2. Способ по п. 1, отличающийся тем, что связывающая группировка, которая специфически связывается с мишенью, содержит аминокислотную последовательность GnSLPX1TGGSGS (SEQ ID NO: 03, n=1, 2 или 3, где X1 может представлять собой любой аминокислотный остаток) в составе своих 20 C-концевых аминокислотных остатков.
3. Способ по любому из пп. 1 и 2, отличающийся тем, что связывающая группировка, которая специфически связывается с мишенью, содержит аминокислотную последовательность X2GSLPX1TGGSGS (SEQ ID NO: 04, где X1 может представлять собой любой аминокислотный остаток) в составе своих 20 C-концевых аминокислотных остатков, где X2 может представлять собой любой аминокислотный остаток, кроме глицина.
4. Способ по п. 1, отличающийся тем, что связывающая группировка, которая специфически связывается с мишенью, содержит аминокислотную последовательность GnSLPX1TGGSGSX3 (SEQ ID NO: 05, n=1, 2 или 3, где X1 может представлять собой любой аминокислотный остаток) в составе своих 20 C-концевых аминокислотных остатков, где X3 представляет собой аминокислотную последовательность tag.
5. Способ по п. 1, отличающийся тем, что связывающая группировка, которая специфически связывается с мишенью, выбрана из группы, состоящей из Fv, Fab, Fab′, Fab′-SH, F(ab′)2, диатела, линейного антитела, scFv, scFab и dsFv.
6. Способ по п. 1, отличающийся тем, что Fc-фрагмент антитела содержит по меньшей мере на одном из своих N-концов два остатка глицина.
7. Способ по п. 1, отличающийся тем, что Fc-фрагмент антитела содержит по меньшей мере на одном из своих N-концов аминокислотную последовательность GGCPX4C (SEQ ID NO: 07), где X4 представляет собой S или P.
8. Способ по п. 1, отличающийся тем, что Fc-фрагмент антитела содержит на обоих своих N-концах аминокислотную последовательность GGCPX4C (SEQ ID NO: 07), где X4 представляет собой S или P.
9. Конъюгат Fc-фрагмента антитела, полученный способом по любому из пп. 1-8.
10. Конъюгат Fc-фрагмента антитела, содержащий аминокислотную последовательность GnSLPX1TGG (SEQ ID NO: 09, n=1, 2 или 3, где X1 может представлять собой любой аминокислотный остаток).
11. Фармацевтическая композиция, содержащая конъюгат Fc-фрагмента антитела по пп. 9 или 10 и возможно фармацевтически приемлемый носитель.
12. Конъюгат Fc-фрагмента антитела по п. 9 или 10 для применения в качестве лекарственного средства.
13. Применение конъюгата Fc-фрагмента антитела по пп. 9 или 10 при изготовлении лекарственного средства.
RU2015100656A 2012-06-27 2013-06-25 Способ получения конъюгатов fc-фрагмента антитела, включающих по меньшей мере одну связывающую группировку, которая специфически связывается с мишенью, и их применения RU2015100656A (ru)

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PCT/EP2013/063259 WO2014001325A1 (en) 2012-06-27 2013-06-25 Method for making antibody fc-region conjugates comprising at least one binding entity that specifically binds to a target and uses thereof

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UA118028C2 (uk) 2013-04-03 2018-11-12 Рош Глікарт Аг Біспецифічне антитіло, специфічне щодо fap і dr5, антитіло, специфічне щодо dr5, і спосіб їх застосування
US9195896B2 (en) 2013-07-10 2015-11-24 Tencent Technology (Shenzhen) Company Limited Methods and systems for image recognition
JP6810687B2 (ja) 2014-10-08 2021-01-06 エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト Ｆａｐ及びｄｒ５に特異的な二重特異性抗体と化学療法剤との併用療法

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HK1208234A1 (en) 2016-02-26
EP2867254B1 (en) 2017-10-25
MX2014014804A (es) 2015-02-12
US20150232541A1 (en) 2015-08-20
CN104411718A (zh) 2015-03-11
CN104411718B (zh) 2018-04-24
CA2871882A1 (en) 2014-01-03
WO2014001325A1 (en) 2014-01-03
BR112014028368A2 (pt) 2017-11-14
KR20150030744A (ko) 2015-03-20

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