RU2010121898A - Fc-ВАРИАНТЫ С ИЗМЕНЕННЫМ СВЯЗЫВАНИЕМ С FcRn - Google Patents

Fc-ВАРИАНТЫ С ИЗМЕНЕННЫМ СВЯЗЫВАНИЕМ С FcRn Download PDF

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RU2010121898A
RU2010121898A RU2010121898/10A RU2010121898A RU2010121898A RU 2010121898 A RU2010121898 A RU 2010121898A RU 2010121898/10 A RU2010121898/10 A RU 2010121898/10A RU 2010121898 A RU2010121898 A RU 2010121898A RU 2010121898 A RU2010121898 A RU 2010121898A
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immunoadhesin
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Аарон ЧЕМБЕРЛЕН (US)
Аарон ЧЕМБЕРЛЕН
Бассил ДАХЬЯТ (US)
Бассил ДАХЬЯТ
Джон Рудольф ДЕЗЬЯРЛЕЙС (US)
Джон Рудольф ДЕЗЬЯРЛЕЙС
Шер Бахадур КАРКИ (US)
Шер Бахадур КАРКИ
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Ксенкор, Инк. (Us)
Ксенкор, Инк.
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Abstract

1. Антитело или иммуноадгезин исходного полипептида Fc, причем указанное антитело или иммуноадгезин содержит по меньшей мере одну модификацию в области Fc, причем указанное антитело или иммуноадгезин демонстрирует измененное связывание с FcRn по сравнению с указанным исходным антителом или иммуноадгезином, причем указанная модификация выбрана из группы, состоящей из 259I, 307S, 319F, 319L и 434М, где нумерация приведена согласно индексу EU по Kabat et al. ! 2. Антитело или иммуноадгезин по п.1, в котором указанная область Fc дополнительно содержит, по меньшей мере, одну дополнительную модификацию, выбранную из группы, состоящей из 246Н, 246S, 247D, 247Т, 248Н, 248Р, 248Q, 248R, 248Y, 249Т, 249W, 250Е, 250I, 250Q, 250V, 251 D, 251 E, 251 H, 251I, 251 К, 251 М, 251 N, 251T, 251V, 251Y, 252Q, 252Y, 253L, 253T, 253V, 254H, 254L, 254N, 254T, 254V, Λ254N, 255E, 255F, 255H, 255K, 255S, 255V, 256E, 256V, 257A, 257C, 257D, 257E, 257F, 257G, 257H, 257I, 257K, 257L, 257M, 257N, 257Q, 257R, 257S, 257T, 257V, 257W, 257Y, 258R, 258V, 279A, 279D, 279C, 279F, 279G, 279H, 279I, 279K, 279M, 279N, 279P, 279Q, 279Q, 279R, 279S, 279T, 279W, 279Y, 280H, Λ281A, Λ281 D, Λ281 S, Λ281T, 282D, 282F, 282H, 282I, 282T, 283F, 283I, 283L, 283Y, 284H, 284K, 284P, 284Q, 284R, 284S, 284Y, 285S, 285V, 286D, 286#, 286L, 287H, 287S, 287V, 287Y, 288H, 288Q, 288S, 305H, 305T, 306F, 306H, 306I, 306N, 306T, 306V, 306Y, 307D, 307P, 307Q, 307S, 307V, 307Y, 308C, 308D, 308E, 308F, 308G, 308H, 308I, 308K, 308L, 308M, 308N, 308Q, 308P, 308R, 308S, 308W, 308Y, 309F, 309H, 309N, 309Q, 309V, 309Y, 310K, 310N, 310T, 31 1 L, 311 P, 311T, 311V, 311W, 312H, 313Y, 315E, 315G, 315H, 315Q, 315S, 315T, 317H, 317S, 339P, 340P, 341 S, 374H, 374S, 376H, 376L, 378H, 378N, 380A, 380T, 380Y, 382H, 383H, 383K, 383Q, 384E, 384G, 384H, 385A, 385C, 385F, 385H, 385I, 385K, 385L, 385M, 385N, 385P, 385Q, 385S, 385T, 385V, 385W, 385Y, 386E, 386K, 387#, 387A, 387H, 387K, 387Q, 389E, 389H, 426E, 426H, 426L, 426N, 426R, 426V, 426Y, 427I, 428F, 428L, 429D, 429F, 429K, 429N, 429Q, 429S, 429T, 429Y, 430D, 430H, 430K, 430L, 430Q, 430Y, 431G, 431 H, 4311, 431 P, 431 P, 431 S, 432F, 432H, 432N, 432S, 432V, 433E, 433P, 433S, 434A, 434F, 434H, 434L, 434М, 434Q, 434S, 434Y, 435N, 436E, 436F, 436L, 436V, 436W, 437E, 437V, 438H и 438К, где Λ означает инсерцию после указанного положения, а # означает делецию в указанном положении. ! 3. Антитело �

Claims (20)

1. Антитело или иммуноадгезин исходного полипептида Fc, причем указанное антитело или иммуноадгезин содержит по меньшей мере одну модификацию в области Fc, причем указанное антитело или иммуноадгезин демонстрирует измененное связывание с FcRn по сравнению с указанным исходным антителом или иммуноадгезином, причем указанная модификация выбрана из группы, состоящей из 259I, 307S, 319F, 319L и 434М, где нумерация приведена согласно индексу EU по Kabat et al.
2. Антитело или иммуноадгезин по п.1, в котором указанная область Fc дополнительно содержит, по меньшей мере, одну дополнительную модификацию, выбранную из группы, состоящей из 246Н, 246S, 247D, 247Т, 248Н, 248Р, 248Q, 248R, 248Y, 249Т, 249W, 250Е, 250I, 250Q, 250V, 251 D, 251 E, 251 H, 251I, 251 К, 251 М, 251 N, 251T, 251V, 251Y, 252Q, 252Y, 253L, 253T, 253V, 254H, 254L, 254N, 254T, 254V, Λ254N, 255E, 255F, 255H, 255K, 255S, 255V, 256E, 256V, 257A, 257C, 257D, 257E, 257F, 257G, 257H, 257I, 257K, 257L, 257M, 257N, 257Q, 257R, 257S, 257T, 257V, 257W, 257Y, 258R, 258V, 279A, 279D, 279C, 279F, 279G, 279H, 279I, 279K, 279M, 279N, 279P, 279Q, 279Q, 279R, 279S, 279T, 279W, 279Y, 280H, Λ281A, Λ281 D, Λ281 S, Λ281T, 282D, 282F, 282H, 282I, 282T, 283F, 283I, 283L, 283Y, 284H, 284K, 284P, 284Q, 284R, 284S, 284Y, 285S, 285V, 286D, 286#, 286L, 287H, 287S, 287V, 287Y, 288H, 288Q, 288S, 305H, 305T, 306F, 306H, 306I, 306N, 306T, 306V, 306Y, 307D, 307P, 307Q, 307S, 307V, 307Y, 308C, 308D, 308E, 308F, 308G, 308H, 308I, 308K, 308L, 308M, 308N, 308Q, 308P, 308R, 308S, 308W, 308Y, 309F, 309H, 309N, 309Q, 309V, 309Y, 310K, 310N, 310T, 31 1 L, 311 P, 311T, 311V, 311W, 312H, 313Y, 315E, 315G, 315H, 315Q, 315S, 315T, 317H, 317S, 339P, 340P, 341 S, 374H, 374S, 376H, 376L, 378H, 378N, 380A, 380T, 380Y, 382H, 383H, 383K, 383Q, 384E, 384G, 384H, 385A, 385C, 385F, 385H, 385I, 385K, 385L, 385M, 385N, 385P, 385Q, 385S, 385T, 385V, 385W, 385Y, 386E, 386K, 387#, 387A, 387H, 387K, 387Q, 389E, 389H, 426E, 426H, 426L, 426N, 426R, 426V, 426Y, 427I, 428F, 428L, 429D, 429F, 429K, 429N, 429Q, 429S, 429T, 429Y, 430D, 430H, 430K, 430L, 430Q, 430Y, 431G, 431 H, 4311, 431 P, 431 P, 431 S, 432F, 432H, 432N, 432S, 432V, 433E, 433P, 433S, 434A, 434F, 434H, 434L, 434М, 434Q, 434S, 434Y, 435N, 436E, 436F, 436L, 436V, 436W, 437E, 437V, 438H и 438К, где Λ означает инсерцию после указанного положения, а # означает делецию в указанном положении.
3. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из:
250Q/252Y, 250Q/256E, 250Q/286D, 250Q/308F, 250Q/308Y, 250Q/311A, 250Q/31 1V, 250Q/380A, 250Q/428L, 250Q/428F, 250Q/434H, 250Q/434F, 250Q/434Y, 250Q/434A, 250Q/434M, 250Q/434S, 250E/252Y, 250Е/256Е, 250E/286D, 250E/308F, 250E/308Y, 250Е/311А, 250E/311V, 250Е/380А, 250E/428L, 250E/428F, 250Е/434Н, 250E/434F, 250E/434Y, 250Е/434А, 250Е/434М и 250E/434S.
4. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из: 252Y/250Q, 252Y/250E, 252Y/256E, 252Y/286D, 252Y/308F, 252Y/308Y, 252Y/311A, 252Y/311V, 252Y/380A, 252Y/428L, 252Y/428F, 252Y/434H, 252Y/434F, 252Y/434Y, 252Y/434A, 252Y/434M и 252Y/434S.
5. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из: 256E/250Q, 256Е/250Е, 256E/252Y, 256E/286D, 256E/308F, 256E/308Y, 256Е/31 1А, 256E/311V, 256Е/380А, 256E/428L, 256E/428F, 256Е/434Н, 256E/434F, 256E/434Y, 256Е/434А, 256Е/434М и 256E/434S.
6. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из: 286D/250Q, 286D/250E, 286D/252Y, 286D/256E, 286D/308F, 286D/308Y, 286D/311A, 286D/311V, 286D/380A, 286D/428L, 286D/428F, 286D/434H, 286D/434F, 286D/434Y, 286D/434A, 286D/434M и 286D/434S.
7. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из: 308F/250Q, 308F/250E, 308F/252Y, 308F/256E, 308F/286D, 308F/31 1А, 308F/311V, 308F/380A, 308F/428L, 308F/428F, 308F/434H, 308F/434F, 308F/434Y, 308F/434A, 308F/434M, 308F/434S, 308Y/250Q, 308Y/250E, 308Y/252Y, 308Y/256E, 308Y/286D, 308Y/311A, 308Y/311V, 308Y/380A, 308Y/428L, 308Y/428F, 308Y/434H, 308Y/434F, 308Y/434Y, 308Y/434A, 308Y/434M и 308Y/434S.
8. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из: 311A/250Q, 311А/250Е, 311A/252Y, 311А/256Е, 311A/286D, 311A/308F, 311A/308Y, 311А/380А, 311A/428L, 311A/428F, 311А/434Н, 311A/434F, 311A/434Y, 311А/434А, 311А/434М, 311A/434S, 311V/250Q, 31 1V/250E, 311V/252Y, 311V/256E, 311V/286D, 311V/308F, 311V/308Y, 311V/380A, 31 1V/428L, 311V/428F, 311V/434H, 311V/434F, 311V/434Y, 311V/434A, 311V/434M и 311V/434S.
9. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из: 380A/250Q, 380А/250Е, 380A/252Y, 380А/256Е, 380A/286D, 380A/308F, 380A/308Y, 380А/311А, 380A/311V, 380A/428L, 380A/428F, 380А/434Н, 380A/434F, 380A/434Y, 380А/434А, 380А7434М и 380A/434S.
10. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из: 428L/250Q, 428L/250E, 428L/252Y, 428L/256E, 428L/286D, 428L/308F, 428L/308Y, 428L/311A, 428L/311V, 428L/380A, 428L/434H, 428L/434F, 428L/434Y, 428L/434A, 428L/434M, 428L/434S, 428F/250Q, 428F/250E, 428F/252Y, 428F/256E, 428F/286D, 428F/308F, 428F/308Y, 428F/311A, 428F/311V, 428F/380A, 428F/434H, 428F/434F, 428F/434Y, 428F/434A, 428F/434M и 428F/434S.
11. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит по меньшей мере две модификации, выбранные из группы, состоящей из: 434H/250Q, 434Н/250Е, 434H/252Y, 434Н/256Е, 434H/286D, 434H/308F, 434H/308Y, 434Н/311А, 434H/311V, 434Н/380А, 434H/428L, 34H/428F434F/250Q, 434F/250E, 434F/252Y, 434F/256E, 434F/286D, 434F/308F, 434F/308Y, 434F/311A, 434F/311V, 434F/380A, 434F/428L, 434F/428F, 434Y/250Q, 434Y/250E, 434Y/252Y, 434Y/256E, 434Y/286D, 434Y/308F, 434Y/308Y, 434Y/311A, 434Y/311V, 434Y/380A, 434Y/428L, 434Y/428F, 434A/250Q, 434А/250Е, 434A/252Y, 434А/256Е, 434A/286D, 434A/308F, 434A/308Y, 434А/311А, 434A/311V, 434А/380А, 434A/428L, 434A/428F, 434M/250Q, 434М/250Е, 434M/252Y, 434М/256Е, 434M/286D, 434M/308F, 434M/308Y, 434М/311А, 434M/311V, 434М/380А, 434M/428L, 434M/428F434S/250Q, 434S/250E, 434S/252Y, 434S/256E, 434S/286D, 434S/308F, 434S/308Y, 434S/311A, 434S/311V, 434S/380A, 434S/428L и 434S/428F.
12. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит модификации, выбранные из группы, состоящей из: 319L, 307Q, 259I, 252Y, 259I/434S, 428L/434S, 308F/434S, 252Y/254T/256E/434S, 252Y/254T/256E/308F, 252Y/254T/256E/428L, 308F/428L/434S, 259I/308F/434S, 307Q/308F/434S, 250I/308F/434S, 308F/319L/434S, 259I/308F/428L, 259I/307Q/308F, 250I/259I/308F, 259I/308F/319L, 307Q/308F/309Y, 307Q/308F/319L и 250Q/308F/428L.
13. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит модификации, выбранные из группы, состоящей из: 250I, 250V, 252Q, 252Y, 254Т, 256V, 2591, 307Р, 307Q, 307S, 308F, 309N, 309Y, 311P, 319F, 319L, 428L и 434S.
14. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит модификации, выбранные из группы, состоящей из: 250V/308F, 250I/308F, 254T/308F, 256V/308F, 259I/308F, 307P/208F, 307Q/308F, 307S/308F, 308F/309Y, 308F/309Y, V308F/311P, 308F/319L, 308F/319F, 308F/428L, 252Q/308F, M252Y/S254T/T256E, 259I/434S, 428L/434S, 308F/434S, 308F/428L/434S, 259I/308F/434S, 307Q/308F/434S, 250I/308F/434S, 308F/319L/434S, 259I/308F/428L, 259I/307Q/308F, 250I/259I/308F, 259I/308F/319L, 307Q/308F/309Y, 307Q/308F/319L и 250Q/308F/428L.
15. Способ лечения пациента, нуждающегося в таком лечении, включающий введение эффективного количества антитела или иммуноадгезина по п.1 или 2.
16. Способ увеличения времени полужизни антитела или иммуноадгезина, включающий модификацию антитела или иммуноадгезина по п.1 или 2.
17. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит 259I.
18. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит 319L.
19. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит 307S.
20. Антитело или иммуноадгезин по п.1 или 2, в котором указанная область Fc содержит модификацию, выбранную из группы, состоящей из: 252Y, 254Т, 256Е, 2591, 307Q, 308F, 311V, 380А, 428L, 434А и 434S.
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