RU2017102767A - Связывающие молекулы cd37 и иммуноконъюгаты - Google Patents
Связывающие молекулы cd37 и иммуноконъюгаты Download PDFInfo
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- RU2017102767A RU2017102767A RU2017102767A RU2017102767A RU2017102767A RU 2017102767 A RU2017102767 A RU 2017102767A RU 2017102767 A RU2017102767 A RU 2017102767A RU 2017102767 A RU2017102767 A RU 2017102767A RU 2017102767 A RU2017102767 A RU 2017102767A
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- antibody
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- lymphoma
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- 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
- C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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- A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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- A61K47/6849—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
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- A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
- A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
- A61K47/6867—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell the tumour determinant being from a cell of a blood cancer
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- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/566—Immunoassay; Biospecific binding assay; Materials therefor using specific carrier or receptor proteins as ligand binding reagents where possible specific carrier or receptor proteins are classified with their target compounds
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Claims (50)
1. Антитело или его антиген-связывающий фрагмент, специфически связывающиеся с CD37, отличающиеся тем, что упомянутое антитело или его антигенсвязывающий фрагмент содержит вариабельную область тяжелой цепи, содержащую CDR1, CDR2 и CDR3, и вариабельную область легкой цепи, содержащую CDR1, CDR2 и CDR3, причем CDR1, CDR2 и CDR3 вариабельной области тяжелой цепи и вариабельной области легкой цепи состоят из последовательностей SEQ ID NOs: 4, 5 и 6 и SEQ ID NOs: 28, 29 и 30, соответственно.
2. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент способны индуцировать антитело-зависимую клеточно-опосредованную цитотоксичность.
3. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит аминокислотные последовательности, которые по меньшей мере на 90%, 95% или 99% идентичны полипептидным последовательностям, выбранным из группы, включающей:
(a) SEQ ID NO: 57 и SEQ ID NO: 198;
(b) SEQ ID NO: 58 и SEQ ID NO: 198;
(c) SEQ ID NO: 55 и SEQ ID NO: 72; или
(d) SEQ ID NO: 56 и SEQ ID NO: 73.
4. Антитело или его антиген-связывающий фрагмент по п. 3, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит полипептидные последовательности, выбранные из группы, включающей:
(a) SEQ ID NO: 57 и SEQ ID NO: 198;
(b) SEQ ID NO: 58 и SEQ ID NO: 198;
(c) SEQ ID NO: 55 и SEQ ID NO: 72; или
(d) SEQ ID NO: 56 и SEQ ID NO: 73.
5. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит полипептидные последовательности SEQ ID NO: 57 или SEQ ID NO: 58.
6. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит полипептидную последовательность SEQ ID NO: 198.
7. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит полипептидные последовательности, выбранные из группы, включающей:
(a) SEQ ID NO: 57 и SEQ ID NO: 198; или
(b) SEQ ID NO: 58 и SEQ ID NO: 198.
8. Антитело или его антиген-связывающий фрагмент по п. 1, представляющее собой полноразмерное антитело.
9. Антитело или его антиген-связывающий фрагмент по п. 1, представляющее собой антиген-связывающий фрагмент.
10. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что упомянутые антитело или его антиген-связывающий фрагмент гуманизированы.
11. Антитело или его антиген-связывающий фрагмент по п. 10, отличающиеся тем, что антитело представляет собой антитело с перестроенной поверхностью.
12. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело или его антиген-связывающий фрагмент способны индуцировать апоптоз in vitro в отсутствие перекрестносшивающих агентов.
13. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что упомянутое антитело или его антигенсвязывающий фрагмент содержит Fab, Fab', F(ab')2, одноцепочечный Fv или scFv, дисульфидно-связанный Fv, интратело, IgGΔCH2, минитело, F(ab')3, тетратело, триатело, диатело, DVD-Ig, mAb2, (scFv)2 или scFv-Fc.
14. Антитело или его антиген-связывающий фрагмент по п. 1, отличающиеся тем, что антитело продуцируется гибридомой - депонентом АТСС номер РТА-10664, депонированной в АТСС 18 февраля 2010 г.
15. Изолированная клетка, продуцирующая антитело или его антиген-связывающий фрагмент по любому из п.п. 1-14.
16. Иммуноконъюгат, имеющий формулу (А) - (L) - (С), где:
(А) является антителом или его антиген-связывающим фрагментом по любому из п.п. 1-14;
(L) является линкером; и
(С) является цитотоксическим агентом;
причем упомянутый линкер (L) соединяет (А) с (С).
17. Иммуноконъюгат по п. 16, дополнительно содержащий два, три, четыре, два-шесть или три-четыре цитотоксических агента.
18. Иммуноконъюгат по п. 16, отличающийся тем, что упомянутый линкер выбран из группы, состоящей из: N-сукцинимидил 4-(2-пиридилдитио)пентаноата (SPP) или N-сукцинимидил 4-(2-пиридилдитио)-2-сульфопентаноата (sulfo-SPP); N-сукцинимидил 4-(2-пиридилдитио)бутаноата (SPDB) или N-сукцинимидил 4-(2-пиридилдитио)-2-сульфобутаноата (sulfo-SPDB); N-сукцинимидил 4-(малеимидометил)
циклогексанкарбоксилата (SMCC); N-сульфосукцинимидил 4-(малеимидометил)циклогексанкарбоксилата (sulfoSMCC); N-сукцинимидил-4-(иодацетил)-аминобензоата (SLAB); и N-сукцинимидил-[(N-малеимидопропионамидо)-тетраэтиленгликолевого] эфира (NHS-PEG4-малеимида).
19. Иммуноконъюгат по п. 16, отличающийся тем, что цитотоксический агент выбран из группы, состоящей из майтансиноида, аналога майтансиноида, доксорубицина, модифицированного доксорубицина, бензодиазепина, таксоида, СС-1065, аналога СС-1065, дуокармицина, аналога дуокармицина, калихеамицина, доластатина, аналога доластатина, ауристатина, производного томаимицина, производного лептомицина или пролекарственной формы цитотоксического агента.
20. Иммуноконъюгат по п. 19, отличающийся тем, что майтансиноид является N(2')-деацетил-N(2')-(3-меркапто-1-оксопропил)-майтансином (DM1) и N(2')-деацетил-N2-(4-меркапто-4-метил-1-оксопентил)-майтансином (DM4).
21. Иммуноконъюгат по п. 16, отличающиеся тем, что антитело или его антиген-связывающий фрагмент содержит вариабельную область тяжелой цепи, имеющую последовательность SEQ ID NO: 57, и вариабельную область легкой цепи, имеющую последовательность SEQ ID NO: 198.
22. Иммуноконъюгат по п. 21, отличающийся тем, что упомянутый (L) является N-сукцинимидил-4-(малеимидометил) циклогексанкарбоксилатом; и упомянутый (С) является N(2')-деацетил-N(2')-(3-меркапто-1-оксопропил)-майтансином (DM1).
23. Иммуноконъюгат по п. 16, отличающийся тем, что антитело или его антиген-связывающий фрагмент содержит вариабельную область тяжелой цепи, имеющую последовательность SEQ ID NO: 58 и вариабельную область легкой цепи, имеющую последовательность SEQ ID NO: 198.
24. Иммуноконъюгат по п. 23, отличающийся тем, что упомянутый (L) является N-сукцинимидил 4-(малеимидометил) циклогексанкарбоксилатом (SMCC); и упомянутый (С) является N(2')-деацетил-N(2')-(3-меркапто-1-оксопропил)-майтансином (DM1).
25. Изолированный полинуклеотид, который кодирует полипептид вариабельной области тяжелой цепи антитела или его антиген-связывающего фрагмента по п. 1, представленный в SEQ ID NO: 121, 122, 123 или 124.
26. Изолированный полинуклеотид, который кодирует полипептид вариабельной области легкой цепи антитела или его антиген-связывающего фрагмента по п. 1, представленный в SEQ ID NO: 136, 137 или 138.
27. Диагностический реактив, подходящий для определения присутствия CD37, содержащий антитело или его антиген-связывающего фрагмента по любому из п.п. 1-14, которое является меченым.
28. Фармацевтическая композиция, подходящая для лечения онкологического заболевания, содержащая терапевтически эффективное количество антитела или его антиген-связывающего фрагмента по любому из п.п. 1-14 и фармацевтически приемлемый носитель.
29. Фармацевтическая композиция, подходящая для лечения онкологического заболевания, содержащая терапевтически эффективное количество иммуноконъюгата по любому из п.п. 16-24 и фармацевтически приемлемый носитель.
30. Применение антитела или его антиген-связывающего фрагмента по любому из п.п. 1-14 в изготовлении медикамента для лечения онкологического заболевания.
31. Применение иммуноконъюгата по любому из п.п. 16-24 в изготовлении медикамента для лечения онкологического заболевания.
32. Применение по п. 30, отличающееся тем, что упомянутое онкологическое заболевание представляет собой лейкемию или лимфому.
33. Применение по п. 32, отличающееся тем, что упомянутое онкологическое заболевание выбрано из группы, включающей: В-клеточные лимфомы, НХЛ, прекурсорные В-клеточные лимфобластные лейкемию/лимфому и неоплазмы зрелых В-клеток, В-клеточную хроническую лимфоцитную лейкемию (ХЛЛ)/мелкоклеточную лимфоцитарную лимфому (МЛЛ), В-клеточную пролимфоцитную лейкемию, лимфоплазмацитную лимфому, лимфому клеток мантийной зоны (ЛКМЗ), фолликулярную лимфому (ФЛ), включая высокодифференцированную, среднедифференцированную и низкодифференцированную ФЛ, кожную центрально-фолликулярную лимфому, В-клеточную лимфому маргинальной зоны, В-клеточную лимфому маргинальной зоны MALT-типа, В-клеточную лимфому маргинальной зоны узлового типа, В-клеточную лимфому маргинальной зоны селезеночного типа, волосатоклеточный лейкоз, диффузную В-крупноклеточную лимфому, лимфому Беркитта, плазмацитому, плазмаклеточную миелому, посттрансплантационное лимфопролиферативное расстройство, макроглобулинемию Вальденстрема, лейкемию, лимфому и анапластическую крупноклеточную лимфому (АККЛ).
34. Применение по п. 31, отличающееся тем, что упомянутое онкологическое заболевание представляет собой лейкемию или лимфому.
35. Применение по п. 34, отличающееся тем, что упомянутое онкологическое заболевание выбрано из группы, включающей В-клеточные лимфомы, НХЛ, прекурсорные В-клеточные лимфобластные лейкемию/лимфому и неоплазмы зрелых В-клеток, В-клеточную хроническую лимфоцитную лейкемию (ХЛЛ)/мелкоклеточную лимфоцитарную лимфому (МЛЛ), В-клеточную пролимфоцитную лейкемию, лимфоплазмацитную лимфому, лимфому клеток мантийной зоны (ЛКМЗ), фолликулярную лимфому (ФЛ), включая высокодифференцированную, среднедифференцированную и низкодифференцированную ФЛ, кожную центрально-фолликулярную лимфому, В-клеточную лимфому маргинальной зоны, В-клеточную лимфому маргинальной зоны MALT-типа, В-клеточную лимфому маргинальной зоны узлового типа, В-клеточную лимфому маргинальной зоны селезеночного типа, волосатоклеточный лейкоз, диффузную В-крупноклеточную лимфому, лимфому Беркитта, плазмацитому, плазмаклеточную миелому, посттрансплантационное лимфопролиферативное расстройство, макроглобулинемию Вальденстрема, лейкемию, лимфому и анапластическую крупноклеточную лимфому (АККЛ).
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