RU2016102116A - Конъюгаты антител с лекарственными агентами, обладающие улучшенной стабильностью, и их применение - Google Patents
Конъюгаты антител с лекарственными агентами, обладающие улучшенной стабильностью, и их применение Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- A61K47/50—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
- A61K47/51—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
- A61K47/68—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
- A61K47/6891—Pre-targeting systems involving an antibody for targeting specific cells
- A61K47/6899—Antibody-Directed Enzyme Prodrug Therapy [ADEPT]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- A61K47/50—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
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- A61K47/50—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
- A61K47/51—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
- A61K47/68—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
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- A61K47/50—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
- A61K47/51—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
- A61K47/68—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
- A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
- A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
- A61K47/6817—Toxins
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- A61K47/50—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
- A61K47/51—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
- A61K47/68—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
- 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
- A61K47/6849—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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- A—HUMAN NECESSITIES
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- A61K47/00—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
- A61K47/50—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
- A61K47/51—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
- A61K47/68—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
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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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
- C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
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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
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Claims (23)
1. Конъюгат антитела с лекарственным агентом, содержащий цитотоксическое вещество, присоединенное к N-концевому аминокислотному остатку тяжелой или легкой цепи антитела.
2. Конъюгат антитела с лекарственным агентом по п. 1, в котором цитотоксическое вещество присоединено к N-концевой α-аминогруппе тяжелой или легкой цепи антитела.
3. Конъюгат антитела с лекарственным агентом по п. 2, в котором цитотоксическое вещество присоединено к антителу реакционноспособной группой цитотоксического вещества, способной к образованию поперечной сшивки с указанной α-аминогруппой.
4. Конъюгат антитела с лекарственным агентом по п. 3, в котором реакционноспособную группу, способную к образованию поперечной сшивки с указанной α-аминогруппой, выбирают из группы, состоящей из изотиоцианатной, изоцианатной, ацилазидной, N-гидроксисукцинимидэфирной (NHS-эфирной), сульфонилхлоридной, альдегидной, глиоксальной, эпоксидной, оксирановой, карбонатной, арилгалогенидной, имидоэфирной, карбодиимидной, ангидридной и фторфенилэфирной групп.
5. Конъюгат антитела с лекарственным агентом по п. 1, в котором антитело включает полноразмерные молекулы антител или фрагменты антител, содержащие домены, связывающие антиген.
6. Конъюгат антитела с лекарственным агентом по п. 5, в котором антитело выбирают из группы, состоящей из IgG, scFv, Fv, Fab, Fab' и F(ab')2.
7. Конъюгат антитела с лекарственным агентом по п. 1, в котором цитотоксическое вещество выбирают из группы, состоящей из ингибиторов образования структуры микротрубочек, ингибиторов мейоза, ингибиторов РНК-полимеразы, ингибиторов топоизомеразы, агентов, интеркалирующих в ДНК, агентов, алкилирующих ДНК, ингибиторов функций рибосом, радиоактивных изотопов и токсинов.
8. Конъюгат антитела с лекарственным агентом по п. 7, в котором цитотоксическое вещество выбирают из группы, состоящей из мейтансиноида, ауристатина, долостатина, тубулизина, калихеамицина, пирролобензодиазепинов, доксорубицина, дуокамицина, карбоплатина (параплатина), цисплатина, циклофосфамида, ифосфамида, нидрана, азотистого иприта (мехлорэтамина-HCl), блеомицина, митомицина С, цитарабина, фторурацила, гемцитабина, триметрексата, метотрексата, этопозида, винбластина, винорелбина, алимты, алтретамина, прокарбазина, таксола, таксотера,
топотекана, иринотекана, трихотецена, СС1065, альфа-аманитина, других энединовых антибиотиков, экзотоксинов и растительных токсинов.
9. Конъюгат антитела с лекарственным агентом по п. 8, в котором ауристатин представлен монометилауристатином Е или монометилауристатином F.
10. Конъюгат антитела с лекарственным агентом по п. 1, в котором антитело специфично связывается с антигеном поверхности раковых клеток.
11. Конъюгат антитела с лекарственным агентом по п. 10, в котором антиген поверхности раковых клеток выбирают из группы, состоящей из CD19, CD20, CD30, CD33, CD37, CD22, CD56, CD70, CD74, CD138, Muc-16, мезотелина, HER2, HER3, гликопротеина NMB (GPNMB), IGF-1R, антигена созревания В-клеток (ВСМА), PSMA (мембранного антигена, характерного для предстательной железы), ЕрСАМ (молекулы адгезии эпителиальных клеток) и EGFR (рецептора фактора роста эпидермиса).
12. Конъюгат антитела с лекарственным агентом по п. 1, в котором антитело выбирают из группы, состоящей из антител против HER2, антител против CD30, антител против CD56, антител против GPNMB (гликопротеина NMB).
13. Конъюгат антитела с лекарственным агентом по п. 12, в котором антитело выбирают из группы, состоящей из трастузумаба, лорвотузумаба, брентуксимаба и глембатумумаба.
14. Конъюгат антитела с лекарственным агентом, содержащий иммуносупрессивный агент, присоединенный к N-концевому аминокислотному остатку тяжелой или легкой цепи антитела.
15. Способ получения конъюгата антитела с лекарственным агентом по любому из пп. 1-14, включающий присоединение цитотоксического вещества или иммуносупрессивного агента к N-концевой α-аминогруппе тяжелой или легкой цепи антитела путем обеспечения взаимодействия антитела с цитотоксическим веществом или иммуносупрессивным агентом, содержащим реакционноспособную группу, способную образовывать поперечную сшивку с α-аминогруппой.
16. Способ по п. 15, включающий также отделение конъюгата антитела с лекарственным агентом от прочих продуктов реакции, в том числе молекул антитела и цитотоксического или иммуносупрессивного вещества, не образовавших конъюгата.
17. Способ по п. 15, в котором реакционноспособную группу, способную образовывать поперечную сшивку с указанной α-аминогруппой, выбирают из группы, состоящей из изотиоцианатной, изоцианатной, ацилазидной, N-гидроксисукцинимидэфирной (NHS-эфирной), сульфонилхлоридной, альдегидной, глиоксальной, эпоксидной, оксирановой, карбонатной, арилгалогенидной, имидоэфирной,
карбодиимидной, ангидридной и фторфенилэфирной групп.
18. Фармацевтическая композиция для лечения ракового заболевания, содержащая конъюгат антитела с лекарственным агентом по любому из пп. 1-13.
19. Фармацевтическая композиция для лечения аутоиммунного заболевания, содержащая конъюгат антитела с лекарственным агентом по п. 14.
20. Способ лечения рака, включающий введение конъюгата антитела с лекарственным агентом по любому из пп. 1-13 индивиду, у которого подозревается наличие ракового заболевания.
21. Способ лечения аутоиммунного заболевания, включающий введение конъюгата антитела с лекарственным агентом по п. 14 индивиду, у которого подозревается наличие аутоиммунного заболевания.
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KR20130072686 | 2013-06-24 | ||
KR10-2013-0072686 | 2013-06-24 | ||
PCT/KR2014/005589 WO2014208987A1 (ko) | 2013-06-24 | 2014-06-24 | 안정성이 개선된 항체-약물 결합체 및 이의 용도 |
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RU2016102116A true RU2016102116A (ru) | 2017-07-28 |
RU2670748C2 RU2670748C2 (ru) | 2018-10-25 |
RU2670748C9 RU2670748C9 (ru) | 2018-12-13 |
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US (2) | US10071170B2 (ru) |
EP (1) | EP3015116B1 (ru) |
JP (1) | JP6208864B2 (ru) |
KR (1) | KR101641206B1 (ru) |
CN (2) | CN105377307B (ru) |
AU (1) | AU2014299561B2 (ru) |
BR (1) | BR112015032200A2 (ru) |
CA (1) | CA2916202C (ru) |
RU (1) | RU2670748C9 (ru) |
WO (1) | WO2014208987A1 (ru) |
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AU2017204139B2 (en) | 2016-06-17 | 2018-08-09 | Magenta Therapeutics, Inc. | Compositions and methods for the depletion of cells |
MA45408A (fr) | 2016-06-17 | 2019-04-24 | Magenta Therapeutics Inc | Compositions et procédés pour la déplétion des cellules cd117+ |
US10576161B2 (en) | 2017-01-20 | 2020-03-03 | Magenta Therapeutics, Inc. | Compositions and methods for the depletion of CD137+ cells |
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BR112015032200A2 (pt) | 2017-11-21 |
KR101641206B1 (ko) | 2016-07-22 |
CA2916202A1 (en) | 2014-12-31 |
EP3015116A4 (en) | 2017-03-08 |
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CN105377307A (zh) | 2016-03-02 |
CN110251683A (zh) | 2019-09-20 |
US20160136300A1 (en) | 2016-05-19 |
WO2014208987A1 (ko) | 2014-12-31 |
CA2916202C (en) | 2019-07-02 |
RU2670748C9 (ru) | 2018-12-13 |
JP2016523900A (ja) | 2016-08-12 |
JP6208864B2 (ja) | 2017-10-04 |
US10071170B2 (en) | 2018-09-11 |
RU2670748C2 (ru) | 2018-10-25 |
CN105377307B (zh) | 2019-09-24 |
US20180360986A1 (en) | 2018-12-20 |
EP3015116B1 (en) | 2020-02-26 |
KR20150000843A (ko) | 2015-01-05 |
AU2014299561A1 (en) | 2016-01-21 |
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