RU2445319C2 - Моноклональные антитела к клаудину-18 для лечения рака - Google Patents

Моноклональные антитела к клаудину-18 для лечения рака Download PDF

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RU2445319C2
RU2445319C2 RU2008125324/10A RU2008125324A RU2445319C2 RU 2445319 C2 RU2445319 C2 RU 2445319C2 RU 2008125324/10 A RU2008125324/10 A RU 2008125324/10A RU 2008125324 A RU2008125324 A RU 2008125324A RU 2445319 C2 RU2445319 C2 RU 2445319C2
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Russia
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antibody according
hybridoma
dsm
cancer
accession number
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RU2008125324/10A
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English (en)
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RU2008125324A (ru
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Угур САХИН (DE)
Угур САХИН
Эзлем ТЮРЕЧИ (DE)
Эзлем ТЮРЕЧИ
Дирк УЗЕНЕР (DE)
Дирк УЗЕНЕР
Штефан ФРИЦ (DE)
Штефан ФРИЦ
Криштоф УХЕРЕК (DE)
Криштоф УХЕРЕК
Гунда БРАНДЕНБУРГ (DE)
Гунда БРАНДЕНБУРГ
Гаральд-Герхард ГЕППЕРТ (DE)
Гаральд-Герхард ГЕППЕРТ
Аня Кристина ШРЁДЕР (DE)
Аня Кристина ШРЁДЕР
Филипп ТИЛЬ (DE)
Филипп ТИЛЬ
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Ганимед Фармасьютикалз Аг
Йоханнес Гутенберг-Университет Майнц, Фертретен Дурх Ден Президентен
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C—CHEMISTRY; METALLURGY
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    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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Abstract

Настоящее изобретение относится к иммунологии. Предложены варианты антител специфичных к клаудину 18А2, полученных иммунизацией соответствующей аминокислотной последовательностью, или нуклеиновой кислотой, или клеткой-хозяином, экспрессирующей указанный пептид. Антитела обладают способностью опосредовать уничтожение раковых клеток, экспрессирующих клаудин 18А2. Раскрыты варианты гибридом, продуцирующих антитела. Описан конъюгат и фармацевтическая композиция на основе антител или конъюгата для уничтожения и/или ингибирования раковой клетки, экспрессирующей клаудин 18А2. Раскрыты варианты способа ингибирования роста и/или уничтожения раковой клетки, а также лечения или профилактики заболевания или нарушения с вовлечением раковых клеток, экспрессирующих клаудин 18А2 с использованием антител, конъюгата и фармацевтической композиции по изобретению. Использование изобретения может найти дальнейшее применение в медицине для лечения раковых клеток, экспрессирующих клаудин 18А2. 19 н. и 20 з.п. ф-лы, 33 ил. 5 табл., 10 пр.

Description

Текст описания приведен в факсимильном виде.
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Claims (39)

1. Антитело, обладающее способностью к связыванию с клаудином 18А2 (CLD18A2) и получаемое способом, включающим стадию иммунизации животного пептидом, имеющим аминокислотную последовательность SEQ ID NO: 16, или нуклеиновой кислотой, или клеткой-хозяином, экспрессирующей указанный пептид, причем антитело обладает способностью опосредовать уничтожение раковых клеток, экспрессирующих CLD18A2, in vivo, причем указанное уничтожение индуцируется с помощью связывания указанного антитела с CLD18A2, экспрессируемым указанными клетками.
2. Антитело по п.1, которое связывается с CLD18A1 и CLD18A2.
3. Антитело по п.1, которое связывается с CLD18A2, но не с CLD18A1.
4. Антитело по п.1, где раковые клетки выбирают из группы, состоящей из онкогенных клеток рака желудка, пищевода, поджелудочной железы и легких.
5. Антитело по любому из пп.1-3, которое опосредует указанное уничтожение клеток путем индукции лизиса, опосредованного зависимой от комплемента цитотоксичностью (CDC), лизиса, опосредованного зависимой от антител клеточной цитотоксичностью (ADCC), апоптоза, гомотипической адгезии и/или фагоцитоза.
6. Антитело по любому из пп.1-3, которое опосредует указанное уничтожение клеток путем индукции лизиса, опосредованного CDC, и/или лизиса, опосредованного ADCC.
7. Антитело по любому из пп.1-3, которое не индуцирует лизис, опосредованный CDC, указанных клеток.
8. Антитело по п.5, где лизис, опосредованный ADCC, происходит в присутствии эффекторных клеток, выбранных из группы, состоящей из моноцитов, мононуклеарных клеток, естественных клеток-киллеров (NK-клеток) и полиморфно-ядерных клеток (PMN).
9. Антитело по п.5, где указанный фагоцитоз происходит с помощью макрофагов.
10. Антитело по любому из пп.1-3, которое представляет собой моноклональное, химерное или гуманизированное антитело или фрагмент антитела.
11. Антитело по любому из пп.1-3, выбранное из группы, состоящей из антитела IgG1, IgG2, предпочтительно IgG2a и IgG2b, IgG3, IgG4, IgM, IgA1, IgA2, секреторных IgA, IgD и IgE.
12. Антитело по п.2 или 3, где CLD18A2 имеет аминокислотную последовательность в соответствии с SEQ ID NO: 2.
13. Антитело по п.2 или 3, где CLD18A1 имеет аминокислотную последовательность в соответствии с SEQ ID NO: 8.
14. Антитело по любому из пп.1-3, которое связывается с нативными эпитопами CLD18A2, присутствующими на поверхности живых клеток.
15. Антитело по любому из пп.1-3, которое специфично к раковым клеткам, предпочтительно к клеткам рака желудка.
16. Антитело по любому из пп.1-3, где указанный CLD18A2 экспрессируется на поверхности указанных клеток.
17. Антитело по п.1, полученное с помощью клона, депонированного под номером доступа DSM ACC2737, DSM ACC2738, DSM ACC2739, DSM АСС2740, DSM ACC2741, DSM ACC2742, DSM ACC2743, DSM ACC2745, DSM ACC2746, DSM ACC2747, DSM ACC2748, DSM ACC2808, DSM ACC2809 или DSM ACC2810, или его химерная или гуманизированная форма.
18. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2737.
19. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2738.
20. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2739.
21. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2740.
22. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2741.
23. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2742.
24. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2743.
25. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2745.
26. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2746.
27. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2747.
28. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2748.
29. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2808.
30. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2809.
31. Гибридома, способная продуцировать антитело по любому из пп.1-17, причем гибридома депонирована под номером доступа DSM ACC2810.
32. Конъюгат, включающий антитело по любому из пп.1-17, конъюгированное с терапевтическим средством, причем конъюгат предназначен для ингибирования роста и/или уничтожения раковой клетки, экспрессирующей CLD18A2.
33. Конъюгат по п.32, где терапевтическое средство представляет собой токсин, радиоизотоп, лекарственное средство или цитотоксическое средство.
34. Фармацевтическая композиция, включающая эффективное количество антитела по любому из пп.1-17 и/или конъюгата по п.32 или 33 и фармацевтически приемлемый носитель, причем фармацевтическая композиция предназначена для ингибирования роста и/или уничтожения раковой клетки, экспрессирующей CLD18A2.
35. Способ ингибирования роста и/или уничтожения раковой клетки, экспрессирующей CLD18A2, включающий контактирование клетки с эффективным количеством антитела по любому из пп.1-17 и/или конъюгата по п.32 или 33.
36. Способ лечения, или профилактики заболевания, или нарушения с вовлечением раковых клеток, экспрессирующих CLD18A2, включающий введение субъекту антитела по любому из пп.1-17, конъюгата по п.32 или 33 или фармацевтической композиции по п.34.
37. Способ по п.36, где заболевание или нарушение представляет собой связанное с опухолью заболевание.
38. Способ по п.37, где связанное с опухолью заболевание выбрано из группы, состоящей из рака желудка, рака пищевода, рака поджелудочной железы, рака легких, рака яичников, колоректального рака, рака печени, рака головы и шеи и рака желчного пузыря.
39. Способ по любому из пп.35-38, где указанный CLD18A2 экспрессируется на поверхности указанных клеток.
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