RU2019125161A - НУКЛЕИНОВЫЕ КИСЛОТЫ, КОДИРУЮЩИЕ АНТИТЕЛА ПРОТИВ СИАЛИРОВАННОГО АНТИГЕНА ЛЬЮИСАа ЧЕЛОВЕКА - Google Patents
НУКЛЕИНОВЫЕ КИСЛОТЫ, КОДИРУЮЩИЕ АНТИТЕЛА ПРОТИВ СИАЛИРОВАННОГО АНТИГЕНА ЛЬЮИСАа ЧЕЛОВЕКА Download PDFInfo
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Claims (42)
1. Выделенный полинуклеотид, кодирующий полипептид, содержащий вариабельной домен тяжелой цепи (VH) антитела, которое связывается с сиалированным антигеном Льюисаа,
где указанный вариабельный домен тяжелой цепи (VH) содержит CDR1, CDR2 и CDR3, выбранные из группы, состоящей из
(а) CDR1, CDR2 и CDR3 с SEQ ID NO: 2, состоящей из аминокислотных остатков 55-62, 70-77 и 116-131,
(b) CDR1, CDR2 и CDR3 с SEQ ID NO: 6, состоящей из аминокислотных остатков 45-52, 70-77 и 116-131,
(c) CDR1, CDR2 и CDR3 с SEQ ID NO: 10, состоящей из аминокислотных остатков 45-52, 70-77 и 116-131,
(d) CDR1, CDR2 и CDR3 с SEQ ID NO: 14, состоящей из аминокислотных остатков 45-52, 70-77 и 116-134.
2. Выделенный полинуклеотид, кодирующий полипептид, содержащий вариабельной домен легкой цепи (VL) антитела, которое связывается с сиалированным антигеном Льюисаа,
где указанный вариабельный домен легкой цепи (VL) содержит CDR1, CDR2 и CDR3, выбранные из группы, состоящей из
(а) CDR1, CDR2 и CDR3 с SEQ ID NO: 4, состоящей из аминокислотных остатков 45-52, 70-72 и 109-120,
(b) CDR1, CDR2 и CDR3 с SEQ ID NO: 8, состоящей из аминокислотных остатков 45-52, 70-72 и 109-119,
(c) CDR1, CDR2 и CDR3 с SEQ ID NO: 12, состоящей из аминокислотных остатков 45-52, 70-72 и 109-120,
(d) CDR1, CDR2 и CDR3 с SEQ ID NO: 16, состоящей из аминокислотных остатков 49-53, 72-74 и 111-120.
3. Выделенный полипептид, содержащий антиген-связывающий сайт антитела, которое связывается с сиалированным антигеном Льюисаа,
где указанный антиген-связывающий сайт содержит вариабельный домен тяжелой цепи (VH) и вариабельный домен легкой цепи (VL),
где указанный домен VH и указанный домен VL соответствено содержит CDR1, CDR2 и CDR3, выбранные из группы, состоящей из
(а) CDR1, CDR2 и CDR3 с SEQ ID NO: 2, состоящей из аминокислотных остатков 55-62, 70-77 и 116-131,
(b) CDR1, CDR2 и CDR3 с SEQ ID NO: 6, состоящей из аминокислотных остатков 45-52, 70-77 и 116-131,
(c) CDR1, CDR2 и CDR3 с SEQ ID NO: 10, состоящей из аминокислотных остатков 45-52, 70-77 и 116-131,
(d) CDR1, CDR2 и CDR3 с SEQ ID NO: 14, состоящей из аминокислотных остатков 45-52, 70-77 и 116-134,
(e) CDR1, CDR2 и CDR3 с SEQ ID NO: 4, состоящей из аминокислотных остатков 45-52, 70-72 и 109-120,
(f) CDR1, CDR2 и CDR3 с SEQ ID NO: 8, состоящей из аминокислотных остатков 45-52, 70-72 и 109-119,
(g) CDR1, CDR2 и CDR3 с SEQ ID NO: 12, состоящей из аминокислотных остатков 45-52, 70-72 и 109-120,
(h) CDR1, CDR2 и CDR3 с SEQ ID NO: 16, состоящей из аминокислотных остатков 49-53, 72-74 и 111-120.
4. Полипептид по п.3, где указанный полипептид выбран из группы, состоящей из антитела, Fab, Fab', F(ab')2, scFV, диатела, триатела и минитела.
5. Полипептид по п.3 или 4, где антитело является человеческим.
6. Полипептид по п.4 или 5, где полипептид является диателом.
7. Полипептид по п.6, где указанное диатело содержит аминокислотную последовательность SEQ ID NO: 18 или 20.
8. Полипептид по любому из пп.3-5, где указанное антитело представляет собой моноклональное антитело.
9. Полипептид по любому из пп.3-5 и 8, где указанное антитело представляет собой изотип IgG или IgМ.
10. Полипептид по п.9, где указанное IgG антитело относится к подклассу IgG1.
11. Конъюгат, который связывается с сиалированным антигеном Льюисаа, содержащий полипептид по любому из пп.3-10 конъюгированный или рекомбинатно связанный с диагностическим средством, агентом для детекции или терапевтическим средством.
12. Конъюгат по п.11, где указанный агент для детекции представляет собой радиоактивное или флуоресцентное вещество.
13. Конъюгат по п.12, где радиоактивное вещество представляет собой цирконий (89Zr), йод (131I, 125I, 124I, 123I и 121I), углерод (14C и 11C), сера (35S), тритий (3H), индий (115In, 113In, 112In и 111In), технеций (99Tc), талий (201Ti), галий (68Ga и 67Ga), палладий (103Pd), молибден (99Mo), ксенон (133Xe), фтор (18F), 15O, 13N, 64Cu, 94mTc, 153Sm, 177Lu, 159Gd, 149Pm, 140La, 175Yb, 166Ho, 86Y, 90Y, 47Sc, 186Re, 188Re, 142Pr, 105Rh, 97Ru, 68Ge, 57Co, 65Zn, 85Sr, 32P, 153Gd, 169Yb, 51Cr, 54Mn, 75Se, 113Sn и 117Sn, или
где флуоресцентное вещество выбрано из группы, состоящей из умбеллиферона, флуоресцеина, флуоресцеина изотиоцианата, родамина, флуоресцеина дихлортриазиниламина, дансилхлорида или фикоэритрина.
14. Конъюгат по п.13, где терапевтическое средство представляет собой радиоактивный метал или молекулу ауристатина.
15. Конъюгат по п.14, где указанный радиоактивный металл представляет собой альфа-излучатель или указанная молекула ауристатина выбрана из группы, состоящей из ауристатина РНЕ, бриостатина 1, соластатина 10, монометилауристатина E (ММАЕ) и монометилауристатина F (MMAF).
16. Фармацевтическая композиция для лечения заболевания, содержащая эффективное количество полипептида по любому из пп.3-10 и фармацевтически приемлемый носитель, где указанное заболевание представляет собой злокачественное новообразование или опухолевое образование с клетками, экспрессирующими сиалированный антиген Льюисаа.
17. Способ лечения или профилактики заболевания, включающий введение терапевтически эффективного количества фармацевтической композиции по п.16 пациенту, где указанным заболеванием является злокачественное или опухолевое образование с клетками, экспрессирующими сиалированный антиген Льюисаа.
18. Способ по п.17, где указанное злокачественное или опухолевое образование выбрано из группы, состоящей из опухоли желудочно-кишечного тракта, рака толстой кишки, колоректальной аденокарциномы, метастатического рака толстой кишки, колоректального рака, рака поджелудочной железы, аденокарциномы поджелудочной железы, рака протоков поджелудочной железы, мелкоклеточного рака легких, аденокарциномы мочевого пузыря, перстневидноклеточного рака яичников, рака яичников, метастатического рака, аденокарциномы желудка, аденокарциномы пищевода, аденокарциномы горла, аденокарциномы мочеполового тракта и аденокарциномы молочной железы.
19. Способ по п.17 или 18, где указанный способ дополнительно включает одновременное или последовательное введение второго терапевтического средства.
20. Способ по п.19, где указанное второе терапевтическое средство представляет собой химиотерапевтическое средство или иммунотерапевтическое средство.
21. Способ детекции опухоли у пациента, включающий введение эффективного количества конъюгата по любому из пп.11-15 пациенту.
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| US201361870137P | 2013-08-26 | 2013-08-26 | |
| US61/870,137 | 2013-08-26 |
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| RU2016111015A Division RU2699289C2 (ru) | 2013-08-26 | 2014-08-26 | НУКЛЕИНОВЫЕ КИСЛОТЫ, КОДИРУЮЩИЕ АНТИТЕЛА ПРОТИВ СИАЛИРОВАННОГО АНТИГЕНА ЛЬЮИСАа ЧЕЛОВЕКА |
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