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RU2014138474A - Новые модуляторы и способы применения - Google Patents

Новые модуляторы и способы применения Download PDF

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Publication number
RU2014138474A
RU2014138474A RU2014138474A RU2014138474A RU2014138474A RU 2014138474 A RU2014138474 A RU 2014138474A RU 2014138474 A RU2014138474 A RU 2014138474A RU 2014138474 A RU2014138474 A RU 2014138474A RU 2014138474 A RU2014138474 A RU 2014138474A
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RU
Russia
Prior art keywords
antibody
dll3
cancer
modulator
complementarity determining
Prior art date
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RU2014138474A
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English (en)
Inventor
Роберт А. СТАЛЛ
Лаура СОНДЕРС
Скотт Дж. ДИЛЛА
Орит ФУРД
Дэвид ЛИУ
Майкл Торгов
Хой ШАО
Original Assignee
СтемСентРкс, Инк.
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47790544&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=RU2014138474(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by СтемСентРкс, Инк. filed Critical СтемСентРкс, Инк.
Publication of RU2014138474A publication Critical patent/RU2014138474A/ru

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • 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
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
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    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
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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

1. Выделенный модулятор DLL3.2. Выделенный модулятор DLL3 по п. 1, где модулятор DLL3 включает антитело или его иммунореактивный фрагмент.3. Выделенный модулятор DLL3 по п. 2, где антитело или его иммунореактивный фрагмент включает моноклональное антитело.4. Выделенный модулятор DLL3 по п. 3, где моноклональное антитело выбрано из группы, состоящей из химерных антител, гуманизированных антител и человеческих антител.5. Выделенный модулятор DLL3 по п. 3, где указанное моноклональное антитело или его иммунореактивный фрагмент связывается с N-концевым доменом или доменом DSL белка DLL3.6. Выделенный модулятор на основе антитела к DLL3 по п. 2, где указанное антитело или его иммунореактивный фрагмент содержит вариабельную область легкой цепи с тремя определяющими комплементарность областями и вариабельную область тяжелой цепи с тремя определяющими комплементарность областями, где определяющие комплементарность области тяжелой и легкой цепи включают по меньшей мере одну определяющую комплементарность область, приведенную на ФИГ. 11А или ФИГ. 11В.7. Выделенный модулятор на основе антитела к DLL3 по п. 2, который конкурирует за связывание с белком DLL3 с эталонным антителом, выбранным из группы, состоящей из SC16.3, SC16.4, SC16.5, SC16.7, SC16.8, SC16.10, SC16.11, SC16.13, SC16.15, SC16.18, SC16.19, SC16.20, SC16.21, SC16.22, SC16.23, SC16.25, SC16.26, SC16.29, SC16.30, SC16.31, SC16.34, SC16.35, SC16.36, SC16.38, SC16.39, SC16.41, SC16.42, SC16.45, SC16.47, SC16.49, SC16.50, SC16.52, SC16.55, SC16.56, SC16.57, SC16.58, SC16.61, SC16.62, SC16.63, SC16.65, SC16.67, SC16.68, SC16.72, SC16.73, SC16.78, SC16.79, SC16.80, SC16.81, SC16.84, SC16.88, SC16.101, SC16.103, SC16.104, SC16.105, SC16.106, SC16.107, SC16.108, SC16.109, SC16.110, SC16.111, SC16.113, SC16.114, SC16.115, SC16.116, SC16.117, SC16.118, SC16.120, SC16.121, SC16.122, SC16.123, SC16.124, SC16.125, SC16.126, SC16.129, SC16.130, SC16.131, SC16.132, SC16.133, SC16.134, SC16.135, SC16.136, SC16.137, SC16.138, SC16.139, SC16.140, SC16.141, SC16.142, SC16.143, SC16.144, SC16.147, SC16.148, SC16.149 и SC16.150, где связывание модулятора на основе антитела к DLL3 с белком DLL3 ингибируется по меньшей мере на 30%.8. Выделенный модулятор DLL3 по п. 2, где указанное антитело включает интернализирующее антитело.9. Выделенный модулятор DLL3 по любому из пп. 2-7, где указанное антитело дополнительно содержит цитотоксическое средство.10. Выделенный модулятор DLL3 по п. 8, где указанное антитело до

Claims (25)

1. Выделенный модулятор DLL3.
2. Выделенный модулятор DLL3 по п. 1, где модулятор DLL3 включает антитело или его иммунореактивный фрагмент.
3. Выделенный модулятор DLL3 по п. 2, где антитело или его иммунореактивный фрагмент включает моноклональное антитело.
4. Выделенный модулятор DLL3 по п. 3, где моноклональное антитело выбрано из группы, состоящей из химерных антител, гуманизированных антител и человеческих антител.
5. Выделенный модулятор DLL3 по п. 3, где указанное моноклональное антитело или его иммунореактивный фрагмент связывается с N-концевым доменом или доменом DSL белка DLL3.
6. Выделенный модулятор на основе антитела к DLL3 по п. 2, где указанное антитело или его иммунореактивный фрагмент содержит вариабельную область легкой цепи с тремя определяющими комплементарность областями и вариабельную область тяжелой цепи с тремя определяющими комплементарность областями, где определяющие комплементарность области тяжелой и легкой цепи включают по меньшей мере одну определяющую комплементарность область, приведенную на ФИГ. 11А или ФИГ. 11В.
7. Выделенный модулятор на основе антитела к DLL3 по п. 2, который конкурирует за связывание с белком DLL3 с эталонным антителом, выбранным из группы, состоящей из SC16.3, SC16.4, SC16.5, SC16.7, SC16.8, SC16.10, SC16.11, SC16.13, SC16.15, SC16.18, SC16.19, SC16.20, SC16.21, SC16.22, SC16.23, SC16.25, SC16.26, SC16.29, SC16.30, SC16.31, SC16.34, SC16.35, SC16.36, SC16.38, SC16.39, SC16.41, SC16.42, SC16.45, SC16.47, SC16.49, SC16.50, SC16.52, SC16.55, SC16.56, SC16.57, SC16.58, SC16.61, SC16.62, SC16.63, SC16.65, SC16.67, SC16.68, SC16.72, SC16.73, SC16.78, SC16.79, SC16.80, SC16.81, SC16.84, SC16.88, SC16.101, SC16.103, SC16.104, SC16.105, SC16.106, SC16.107, SC16.108, SC16.109, SC16.110, SC16.111, SC16.113, SC16.114, SC16.115, SC16.116, SC16.117, SC16.118, SC16.120, SC16.121, SC16.122, SC16.123, SC16.124, SC16.125, SC16.126, SC16.129, SC16.130, SC16.131, SC16.132, SC16.133, SC16.134, SC16.135, SC16.136, SC16.137, SC16.138, SC16.139, SC16.140, SC16.141, SC16.142, SC16.143, SC16.144, SC16.147, SC16.148, SC16.149 и SC16.150, где связывание модулятора на основе антитела к DLL3 с белком DLL3 ингибируется по меньшей мере на 30%.
8. Выделенный модулятор DLL3 по п. 2, где указанное антитело включает интернализирующее антитело.
9. Выделенный модулятор DLL3 по любому из пп. 2-7, где указанное антитело дополнительно содержит цитотоксическое средство.
10. Выделенный модулятор DLL3 по п. 8, где указанное антитело дополнительно содержит цитотоксическое средство.
11. Нуклеиновая кислота, кодирующая аминокислотную последовательность вариабельной области тяжелой цепи или аминокислотную последовательность вариабельной области легкой цепи антитела или его иммунореактивного фрагмента по пп. 1-7.
12. Клетка-хозяин, содержащая нуклеиновую кислоту по п. 10.
13. Конъюгат антитела и лекарственного средства формулы:
M-[L-D]n, или его фармацевтически приемлемая соль, где
a) М включает модулятор DLL3;
b) L включает необязательный линкер;
c) D представляет собой антипролиферативное средство; и
d) n составляет целое число от приблизительно 1 до приблизительно 20.
14. Конъюгат антитела и лекарственного средства по п. 13, где указанный модулятор DLL3 включает антитело или его иммунореактивный фрагмент, и указанное антитело или его иммунореактивный фрагмент содержит вариабельную область легкой цепи с тремя определяющими комплементарность областями и вариабельную область тяжелой цепи с тремя определяющими комплементарность областями, причем определяющие комплементарность области тяжелой и легкой цепи включают по меньшей мере одну определяющую комплементарность область, приведенную на ФИГ. 11А или ФИГ. 11В.
15. Конъюгат антитела и лекарственного средства по п. 13, где указанный модулятор DLL3 включает интернализирующее антитело.
16. Конъюгат антитела и лекарственного средства по п. 14, где указанный модулятор DLL3 включает интернализирующее антитело.
17. Выделенный модулятор DLL3 по любому из пп. 1-7 для применения в медицине.
18. Выделенный модулятор DLL3 по любому из пп. 1-7 для лечения рака у пациента, где рак выбран из группы, состоящей из рака надпочечника, рака мочевого пузыря, рака шейки матки, рака эндометрия, рака почки, рака печени, рака легкого, рака яичника, рака ободочной и прямой кишки, рака поджелудочной железы, рака предстательной железы и рака молочной железы.
19. Конъюгат антитела и лекарственного средства по любому из пп. 13-16 для применения в медицине.
20. Конъюгат антитела и лекарственного средства по любому и из пп. 13-16 для лечения рака у пациента, где рак выбран из группы, состоящей из рака надпочечника, рака мочевого пузыря, рака шейки матки, рака эндометрия, рака почки, рака печени, рака легкого, рака яичника, рака ободочной и прямой кишки, рака поджелудочной железы, рака предстательной железы и рака молочной железы.
21. Применение модулятора DLL3 для производства лекарственного препарата для лечения мелкоклеточного рака легкого у субъекта, нуждающегося в этом.
22. Применение по п. 21, где указанный модулятор DLL3 включает моноклональное антитело.
23. Применение по п. 21, где указанный модулятор DLL3 связывается с N-концевым доменом или доменом DSL белка DLL3.
24. Применение по п. 22, где указанный модулятор DLL3 связывается с N-концевым доменом или доменом DSL белка DLL3.
25. Применение по любому из пп. 21-24, где указанный модулятор DLL3 содержит цитотоксическое средство.
RU2014138474A 2012-02-24 2013-02-22 Новые модуляторы и способы применения RU2014138474A (ru)

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