RU2008128311A - Анти-mn антитела и способы их применения - Google Patents
Анти-mn антитела и способы их применения Download PDFInfo
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- RU2008128311A RU2008128311A RU2008128311/13A RU2008128311A RU2008128311A RU 2008128311 A RU2008128311 A RU 2008128311A RU 2008128311/13 A RU2008128311/13 A RU 2008128311/13A RU 2008128311 A RU2008128311 A RU 2008128311A RU 2008128311 A RU2008128311 A RU 2008128311A
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- antibody
- variable region
- antibody fragment
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- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims abstract 22
- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims abstract 22
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- 125000003275 alpha amino acid group Chemical group 0.000 claims abstract 10
- 239000000427 antigen Substances 0.000 claims abstract 6
- 102000036639 antigens Human genes 0.000 claims abstract 6
- 108091007433 antigens Proteins 0.000 claims abstract 6
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- 102000004169 proteins and genes Human genes 0.000 claims abstract 5
- 108090000623 proteins and genes Proteins 0.000 claims abstract 5
- 102000004196 processed proteins & peptides Human genes 0.000 claims 5
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- CILBMBUYJCWATM-PYGJLNRPSA-N vinorelbine ditartrate Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O.OC(=O)[C@H](O)[C@@H](O)C(O)=O.C1N(CC=2C3=CC=CC=C3NC=22)CC(CC)=C[C@H]1C[C@]2(C(=O)OC)C1=CC([C@]23[C@H]([C@@]([C@H](OC(C)=O)[C@]4(CC)C=CCN([C@H]34)CC2)(O)C(=O)OC)N2C)=C2C=C1OC CILBMBUYJCWATM-PYGJLNRPSA-N 0.000 claims 1
- 229940072018 zofran Drugs 0.000 claims 1
- 229940033942 zoladex Drugs 0.000 claims 1
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- 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
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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
- A61K47/6871—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 an enzyme
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract
1. Антитело или фрагмент антитела, имеющие сайт антигенного связывания, специфично направленный против MN-протеина, где сайт антигенного связывания включает, по крайней мере, одну CDR1, CDR2 или CDR3: ! (a) упомянутая CDR1 выбрана из группы, состоящей из SEQ ID NOS: 57, 58, 59, 60, 61, 62, 77, 80, 81, 86, 87, 88. 89, 98, 99, 104, 107, 108 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 57, 58, 59, 60, 61, 62, 77, 80, 81, 86, 87, 88, 89, 98, 99, 104, 107 или 108; ! (b) упомянутая CDR2 выбрана из группы, состоящей из SEQ ID NOS: 63, 64, 65, 66, 67, 68, 69, 78, 82, 83, 90, 91, 92, 93, 100, 101, 105, 109, 110 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 63, 64, 65, 66, 67, 68, 69, 78, 82, 83, 90, 91, 92, 93, 100, 101, 105, 109 или 110; ! (c) упомянутая CDR3 выбрана из группы, состоящей из SEQ ID NOS: 70, 71, 72, 73, 74, 75, 76, 79, 84, 85, 94, 95, 96, 97, 102, 103, 106, 111, 112 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 70, 71, 72, 73, 74, 75, 76, 79, 84, 85, 94, 95, 96, 97, 102, 103, 106, 111 или 112. ! 2. Антитело или фрагмент антитела по п.1, где сайт антигенного связывания включает вариабельную область CDR тяжелой цепи, выбранную из группы, состоящей из: SEQ ID NOS: 57-85 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 57-85. ! 3. Антитело или фрагмент антитела по п.1, где сайт антигенного связывания включает вариабельную область CDR легкой цепи, выбранную из группы, состоящей из: SEQ ID NOS: 86-112 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 86-112. ! 4. Антитело или фрагмент антитела по п.1, где сайт антигенного связывания включает набор CDR-последователь
Claims (17)
1. Антитело или фрагмент антитела, имеющие сайт антигенного связывания, специфично направленный против MN-протеина, где сайт антигенного связывания включает, по крайней мере, одну CDR1, CDR2 или CDR3:
(a) упомянутая CDR1 выбрана из группы, состоящей из SEQ ID NOS: 57, 58, 59, 60, 61, 62, 77, 80, 81, 86, 87, 88. 89, 98, 99, 104, 107, 108 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 57, 58, 59, 60, 61, 62, 77, 80, 81, 86, 87, 88, 89, 98, 99, 104, 107 или 108;
(b) упомянутая CDR2 выбрана из группы, состоящей из SEQ ID NOS: 63, 64, 65, 66, 67, 68, 69, 78, 82, 83, 90, 91, 92, 93, 100, 101, 105, 109, 110 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 63, 64, 65, 66, 67, 68, 69, 78, 82, 83, 90, 91, 92, 93, 100, 101, 105, 109 или 110;
(c) упомянутая CDR3 выбрана из группы, состоящей из SEQ ID NOS: 70, 71, 72, 73, 74, 75, 76, 79, 84, 85, 94, 95, 96, 97, 102, 103, 106, 111, 112 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 70, 71, 72, 73, 74, 75, 76, 79, 84, 85, 94, 95, 96, 97, 102, 103, 106, 111 или 112.
2. Антитело или фрагмент антитела по п.1, где сайт антигенного связывания включает вариабельную область CDR тяжелой цепи, выбранную из группы, состоящей из: SEQ ID NOS: 57-85 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 57-85.
3. Антитело или фрагмент антитела по п.1, где сайт антигенного связывания включает вариабельную область CDR легкой цепи, выбранную из группы, состоящей из: SEQ ID NOS: 86-112 и аминокислотной последовательности, имеющей примерно более 80% идентичности любой из последовательностей SEQ ID NOS: 86-112.
4. Антитело или фрагмент антитела по п.1, где сайт антигенного связывания включает набор CDR-последовательностей тяжелой цепи, выбранный из группы, состоящей из:
(a) [3ее9] SEQ ID NOS: 57, 63,70;
(b) [3ef2] SEQ ID NOS: 58, 64, 71;
(c) [1е4] SEQ ID NOS: 59, 65 и 72;
(d) [3a4] SEQ ID NOS: 60, 66 и 73;
(e) [3ab4] SEQ ID NOS: 61, 67 и 74;
(f) [3ah10] SEQ ID NOS: 61, 68 и 75;
(g) [3bb2] SEQ ID NOS: 62, 69 и 76;
(h) [1aa1] SEQ ID NOS: 77, 78 и 79;
(i) [5a6] SEQ ID NOS: 80, 82 и 84; и
(j) [5aa3] SEQ ID NOS: 81, 83 и 85,
и набор CDR-последовательностей легкой цепи, выбранный из группы, состоящей из:
(a) [3ее9] SEQ ID NOS: 89, 93 и 97;
(b) [3ef2] SEQ ID NOS: 107, 109 и 111;
(c) [1е4] SEQ ID NOS: 107, 109 и 111;
(d) [3a4] SEQ ID NOS: 108, 110 и 112;
(e) [3ab4] SEQ ID NOS: 87, 91 и 95;
(f) [3ah10] SEQ ID NOS: 88, 92 и 96;
(g) [3bb2] SEQ ID NOS: 98,100 и 102;
(h) [1aa1] SEQ ID NOS: 86, 90 и 94;
(i) [5a6] SEQ ID NOS: 99, 101 и 103; и
(j) [5aa3] SEQ ID NOS: 104, 105 и 106.
5. Антитело или фрагмент антитела по п.1, где антитело или фрагмент антитела связываются с MN-протеином с константой диссоциации от примерно 0,15 нМ до примерно 50 нМ.
6. Антитело или фрагмент антитела по п.1, где антитело представляет собой IgG, предпочтительно IgG1, IgG2a, IgG2b, IgG3; IgM; IgD; IgE; IgA; IgM; Fab-фрагмент; F(ab')2-фрагмент; scFv-фрагмент; Fv-фрагмент; диатело; линейное антитело; одноцепочечное антитело; биоспецифичное антитело; химерное антитело или мультиспецифичное антитело.
7. Антитело или фрагмент антитела по п.1, где антитело или фрагмент антитела являются гуманизированными.
8. Антитело или фрагмент антитела по п.1, где CDR1, CDR2 и CDR3 являются нечеловечьими.
9. Антитело или фрагмент антитела по п.1, где идентичность последовательностей составляет более примерно 85%, 90%, 95% или 99%.
10. Антитело или фрагмент антитела по п.1, где антитело или фрагмент антитела конъюгированы с цитотоксичным агентом.
11. Антитело или фрагмент антитела по любому из пп.1-10, где сайт антигенного связывания включает пару из вариабельной области тяжелой цепи и вариабельной области легкой цепи, выбранрую из группы, состоящей из:
(a) вариабельной области тяжелой цепи SEQ ID NO: 133 и вариабельной области легкой цепи SEQ ID NO: 134;
(b) вариабельной области тяжелой цепи SEQ ID NO: 135 и вариабельной области легкой цепи SEQ ID NO: 136;
(c) вариабельной области тяжелой цепи SEQ ID NO: 137 и вариабельной области легкой цепи SEQ ID NO: 138;
(d) вариабельной области тяжелой цепи SEQ ID NO: 139 и вариабельной области легкой цепи SEQ ID NO: 140;
(e) вариабельной области тяжелой цепи SEQ ID NO: 141 и вариабельной области легкой цепи SEQ ID NO: 142;
(f) вариабельной области тяжелой цепи SEQ ID NO: 143 и вариабельной области легкой цепи SEQ ID NO: 144;
(g) вариабельной области тяжелой цепи SEQ ID NO: 145 и вариабельной области легкой цепи SEQ ID NO: 146;
(h) вариабельной области тяжелой цепи SEQ ID NO: 147 и вариабельной области легкой цепи SEQ ID NO: 148;
(i) вариабельной области тяжелой цепи SEQ ID NO: 149 и вариабельной области легкой цепи SEQ ID NO: 150; и
(j) вариабельной области тяжелой цепи SEQ ID NO: 151 и вариабельной области легкой цепи SEQ ID NO: 152.
12. Антитело или фрагмент антитела по п.10, где цитотоксичный агент выбран из группы, состоящей из: монометилауристатина-Е или его функционального аналога, аплидина, азарибина, анастрозола, азацитидина, блеомицина, бортезомиба, бриостатина-1, бузульфана, калихеамицина, камптотецина, 10-гидроксикамптотецина, кармустина, целебрекса, хлорамбуцила, цисплатина, иринотекана (ССТ-1 1), SN-38, карбоплатина, кладрибина, циклофосфамида, цитарабина, дакарбазина, доцетакселя, дактиномицина, глюкуронида дауномицина, даунорубицина, дексаметазона, диэтилстилбестрола, доксорубицина, глюкуронида доксорубицина, глюкуронида эпирубицина, этинил эстрадиола, эстрамустина, этопозида, глюкуронида этопозида, фосфата этопозида, флоксуридина (FUdR), 3',5'-O-диолеоил-FUdR (FUdR-dO), флударабина, флутамида, фторурацила, флуоксиместерона, гемцитабина, капроата гидроксипрогестерона, гидроксимочевины, идарубицина, ифосфамида, L-аспарагиназы, лейковорина, ломустина, мехлорэтамина, ацетата медропрогестерона, ацетата мегестрола, мелфалана, меркаптопурина, 6-меркаптопурина, метотрексата, митоксантрона, митрамицина, митомицина, митотана, фенилбутирата, преднизона, прокарбазина, паклитакселя, пентостатина, PSI-341, семустин-стрептозоцина, тамоксифена, таксанов, таксола, пропионата тестостерона, талидомида, тиогуанина, тиотепы, тенипозида, топотекана, урациловой горчицы, велкада, винбластина, винорелбина, винкристина, рицина, абрина, рибонуклеазы, онконазы, rapLRI, ДНКазы I, стафилококкового энтеротоксина-А, антивирусного протеина фитолакки американской, гелонина, дифтерийного токсина, экзотоксина Pseudomonas, эндотоксина Pseudomonas, и их комбинаций.
13. Композиция для лечения субъекта, имеющего MN-связанный рак, где рак, по выбору, является опухолью или происходит из опухоли молочной железы, дыхательного тракта, легкого, мозга, репродуктивного органа, пищеварительного тракта, ободочной кишки, мочевого тракта, почки, пищевода, шейки матки, глаза, печени, кожи, области головы, области шеи, щитовидной железы и паращитовидной железы, при этом композиция включает антитело или фрагмент антитела по любому из пп.1-10 и противораковый агент.
14. Композиция по п.13, где противораковый агент выбран из группы, состоящей из блеомицина, доцетакселя (Taxotere), доксорубицина, эдатрексата, эрлотиниба (Tarceva), этопозида, финастерида (Proscar), флутамида (Eulexin), гемцитабина (Gemzar), генитиниба (Irresa), ацетата гозерелина (Zoladex), гранизетрона (Kytril), иматиниба (Gleevec), иринотекана (Campto/Camptosar), онданзетрона (Zofran), паклитакселя (Taxol), пегаспаргазы (Oncospar), гидрохлорида пилокарпина (Salagen), профимер-натрия (Photofrin), интерлейкина-2 (Proleukin), ритуксимаба (Rituxan), топотекана (Hycamtin), трастузумаба (Herceptin), Триапина, винкристина, тартрата винорелбина (Navelbine), ангиостатина, бевацизумаба (Avastin®), зорафениба (Nexavar®), бакулостатина, канстатина, маслина, анти-VEGF-антител или пептидов, антител к или пептидов фактора анти-плацентарного роста, анти-Flk-1-антител, анти-Flt-1-антител или пептидов, ламининовых пептидов, фибронектиновых пептидов, ингибиторов активатора плазминогена, ингибиторов тканевой металлопротеиназы, интерферонов, интерлейкина 12, IP-10, Gro-β, тромбоспондина, 2-метоксиэстрадиола, пролиферин-связанного протеина, карбоксиамидотриазола, СМ101, Маримастата, полисульфата петозана, ангиопоэтина 2, интерферона-альфа, гербимицина A, PNU145156E, 16K-пролактинового фрагмента, Линомида, талидомида, пентоксифиллина, генистеина, TNP-470, эндостатина, паклитакселя, аккутина, цидофовира, винкристина, блеомицина, AGM-1470, тромбоцитового фактора 4.
15. Фармацевтическая композиция, включающая антитело или фрагмент антитела по любому из пп.1-10 и фармацевтически приемлемый носитель.
16. Применение антитела или фрагмента антитела по любому из пп.1-10 при приготовлении медикамента для лечения и/или диагностики MN-связанного нарушения, где нарушение, по выбору, является опухолью или происходит из опухоли молочной железы, дыхательного тракта, легкого, мозга, репродуктивного органа, пищеварительного тракта, ободочной кишки, мочевого тракта, почки, пищевода, шейки матки, глаза, печени, кожи, области головы, области шеи, щитовидной железы и паращитовидной железы.
17. Анти-MN IgG-антитело, кодируемое нуклеотидной последовательностью SEQ ID NO: 153.
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