KR20070116176A - 최적화된 Fc 변이체 및 그의 제조 방법 - Google Patents
최적화된 Fc 변이체 및 그의 제조 방법 Download PDFInfo
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Abstract
Description
위치 | 고려되는 아미노산 | 천연형 | 바닥상태 | 바닥상태 주변 서열 |
Claims (42)
- 모체 Fc 폴리펩티드의 Fc 변이체를 포함하는 폴리펩타이드로서,상기 Fc 변이체는 상기 모체 Fc 폴리펩티드의 Fc 부위에서 적어도 하나의 아미노산 변형을 포함하며,상기 변형은 228, 230, 231, 232, 240, 244, 245, 247, 262, 263, 266, 271, 273, 275, 281, 284, 291, 299, 302, 304, 313, 323, 325, 328, 332 및 336으로 이루어진 군으로부터 선택된 위치에서 이루어지며,상기 Fc 변이체의 단백질은 상기 모체 Fc 폴리펩티드에 비해 FcγR에 대해 변경된 결합성을 가지며,상기 위치 번호는 EU 인덱스에 따라 기재된 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 Fc 변이체는 230, 240, 244, 245, 247, 262, 263, 266, 273, 275, 299, 302, 313, 323, 325, 328 및 332로 이루어진 군으로부터 선택된 적어도 하나의 치환을 포함하는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 변경된 결합성은 상기 FcγR에 대한 상기 Fc 변이체의 친화성 증가인 것을 특징으로 하는, 폴리펩타이드.
- 제 3항에 있어서, 상기 Fc 변이체는 마우스 FcγR에 대해 더 높은 친화성으로 결합하는 것을 특징으로 하는, 폴리펩타이드.
- 제 3항에 있어서, 상기 FcγR은 FcγRI, FcγRIIa, FcγRIIb, FcγRIIc 및 FcγRIIIa로 이루어진 군으로부터 선택된 인간 Fc 리셉터인 것을 특징으로 하는, 폴리펩타이드.
- 제 3항에 있어서, 상기 Fc 변이체는 인간 FcγRI 및 FcγRIIIa에 대해 더 높은 친화성으로 결합하며, FcγRIIa, FcγRIIb 및 FcγRIIc로 이루어진 군으로부터 선택된 인간 리셉터에 대해 비변이된 친화성을 나타내는 것을 특징으로 하는, 폴리펩타이드.
- 제 6항에 있어서, 상기 Fc 변이체는 FcγRIIa, FcγRIIb 및 FcγRIIc에 대해 비변이된 친화성을 가지는 것을 특징으로 하는, 폴리펩타이드.
- 제 3항에 있어서, 상기 하나 이상의 인간 FcγRII 결합시의 친화성 증가는 인간 FcγRI 또는 FcγRIIIa 결합시의 친화성 증가에 비해 더 높은 것을 특징으로 하는, 폴리펩타이드.
- 제 3항에 있어서, 상기 친화성 증가는 FcγRIIa, FcγRIIb 및 FcγRIIc에 대 한 결합에 대해 동일한 것을 특징으로 하는, 폴리펩타이드.
- 제 3항에 있어서, 상기 FcγRIIc 결합시의 친화성 증가는 FcγRIIb 결합시의 친화성 증가에 비해 더 높은 것을 특징으로 하는, 폴리펩타이드.
- 제 3항에 있어서, 상기 Fc 변이체는 인간 FcγRIIa에 대해 더 높은 친화성으로 결합하며, FcγRI, FcγRIIb, FcγRIIc 및 FcγRIIIa로 이루어진 군으로부터 선택된 인간 리셉터에 대해 비변이된 친화성을 나타내는 것을 특징으로 하는, 폴리펩타이드.
- 제 11항에 있어서, 상기 Fc 변이체는 FcγRI, FcγRIIb, FcγRIIc 및 FcγRIIIa에 대해 비변이된 친화성을 가지는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항 내지 12항중 어느 한항에 있어서, 상기 Fc 변이체는 FcRn에 대해 더 높은 친화성으로 결합하는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항 내지 12항중 어느 한항에 있어서, 상기 Fc 변이체는 FcRn에 대해 비변이된 친화성으로 결합하는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항 내지 12항중 어느 한항에 있어서, 상기 Fc 변이체는 FcRN에 대해 감 소된 친화성으로 결합하는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항 내지 12항중 어느 한항에 있어서, 상기 Fc 변이체는 C1q에 대해 더 높은 친화성으로 결합하거나 또는 CDC를 증강시키는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항 내지 12항중 어느 한항에 있어서, 상기 Fc 변이체는 C1q에 대해 비변이된 친화성으로 결합하거나 또는 CDC를 증강시키는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 Fc 변이체는 조작된 당형태(engineered glycoform)를 추가적으로 포함하는 것을 특징으로 하는, 폴리펩타이드.
- 제 18항에 있어서, 상기 조작된 당형태는 모체 Fc 폴리펩티드에 비해 푸코실화(fucosylation) 또는 양분성(bisecting) 올리고당을 변경된 수준으로 포함하는 것을 특징으로 하는, 폴리펩타이드.
- 제 18항에 있어서, 상기 조작된 당형태는 작용체(effector) 기능을 향상시키는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 Fc 변이체는 모체 Fc 폴리펩티드에 비해 작용체의 기능을 조절하는 것을 특징으로 하는, 폴리펩타이드.
- 제 21항에 있어서, 상기 작용체의 기능은 ADCC인 것을 특징으로 하는, 폴리펩타이드.
- 제 22항에 있어서, 상기 Fc 변이체는 인간의 작용체 세포의 존재하에 상기 모체 Fc 폴리펩티드에 비해 ADCC를 향상시키는 것을 특징으로 하는, 폴리펩타이드.
- 제 22항에 있어서, 상기 ADCC 향상은 상기 Fc 변이체의 EC50이 상기 모체 Fc 폴리펩티드의 EC50 보다 약 5배 높은, 효과 증진인 것을 특징으로 하는, 폴리펩타이드.
- 제 23항에 있어서, 상기 ADCC 향상은 상기 Fc 변이체의 EC50이 상기 모체 Fc 폴리펩티드의 EC50 보다 약 5배 내지 1000배 높은, 효과 증진인 것을 특징으로 하는, 폴리펩타이드.
- 제 23항에 있어서, 상기 ADCC 향상은 최대 ADCC가 상기 모체 Fc 폴리펩티드에 비해 약 2배 높은, 효능 증진인 것을 특징으로 하는, 폴리펩타이드.
- 제 26항에 있어서, 상기 Fc 변이체는 마우스 작용체 세포의 존재하에 상기 모체 Fc 폴리펩티드에 비해 ADCC를 향상시키는 것을 특징으로 하는, 폴리펩타이드.
- 제 21항에 있어서, 상기 작용체의 기능은 ADCP인 것을 특징으로 하는, 폴리펩타이드.
- 제 28항에 있어서, 상기 Fc 변이체는 상기 모체 Fc 폴리펩티드에 비해 ADCP를 향상시키는 것을 특징으로 하는, 폴리펩타이드.
- 제 25항 또는 29항에 있어서, CDC는 영향을 받지 않는 것을 특징으로 하는, 폴리펩타이드.
- 제 25항 또는 29항에 있어서, CDC는 제거된 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 폴리펩티드는 CD4, CD19, CD20, CD22, CD25, CD30, CD33, CD52, CD80, B7-1, B7-2, CLTA-4, BAFF-R, Her2/neu, EGFR, EpCAM, MUC1, GD3, CEA, CA 125, HLA-DR, TNFα 및 VEGF로 이루어진 군으로부터 선택되는 표적 항원에 대한 특이성을 가지는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항 또는 21항에 있어서, 228E, 228K, 228Y, 228G, 230E, 230Y, 230G, 231E, 231K, 231Y, 231P, 231G, 232E, 232K, 232Y, 232G, 262E, 262F, 271D, 271E, 271N, 271Q, 271K, 271R, 271S, 271T, 271H, 271A, 271V, 271L, 271I, 271F, 271M, 271Y, 271W, 271G, 275L, 281D, 281K, 281Y, 281P, 284E, 284N, 284T, 284L, 284Y, 291D, 291E, 291Q, 291T, 291H, 291I, 291G, 299D, 299E, 299N, 299Q, 299K, 299R, 299L, 299F, 299M, 299Y, 299W, 299P, 299G, 304D, 304N, 304T, 304H, 304L, 325K, 325R, 325S, 325F, 325M, 325Y, 325W, 325P, 325G, 328D, 328Q, 328K, 328R, 328S, 328T, 328V, 328I, 328Y, 328W, 328P, 328G, 332K, 332R, 332S, 332V, 332L, 332F, 332M, 332W, 332P, 332G, 336E, 336K, 336Y, 230A, 240A, 240I, 240M, 240T, 244H, 245A, 247G, 247V, 262A, 262E, 262I, 262T, 263A, 263I, 263M, 263T, 266A, 266I, 266M, 266T, 273I, 275W, 299A, 299E, 299F, 299H, 299I, 299L, 299S, 299V, 302I, 313F, 323I, 325A, 325D, 325E, 325H, 325I, 325L, 325Q, 325T, 325V, 328A, 328D, 328E, 328F, 328H, 328I, 328M, 328N, 328Q, 328T, 328V, 332A, 332D, 332E, 332H, 332N, 332Q, 332T 및 332Y로 이루어진 군으로부터 선택되는 변형을 포함하는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 모체 Fc 폴리펩티드는 상기 Fc 변이체를 포함하는 항체인 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 모체 Fc 변이체는 상기 Fc 변이체를 포함하는 Fc 융 합 단백질인 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 기재된 폴리펩타이드 및 약학적으로 허용가능한 담체를 포함하는 약학적 조성물.
- 제 1항 또는 33항에 있어서, A330L/I332E, D265F/N297E/I332E, D265Y/N297D/I332E, D265Y/N297D/T299L/I332E, F241E/F243Q/V262T/V264E, F241E/F243Q/V262T/V264E/I332E, F241E/F243R/V262E/V264R, F241E/F243R/V262E/V264R/I332E, F241E/F243Y/V262T/V264R, F241E/F243Y/V262T/V264R/I332E, F241L/F243L/V262I/V264I, F241L/V262I, F241R/F243Q/V262T/V264R, F241R/F243Q/V262T/V264R/I332E, F241W/F243W/V262A/V264A, F241Y/F243Y/V262T/V264T, F241Y/F243Y/V262T/V264T/N297D/I332E, F243L/V262I/V264W, F243L/V264I, L328D/I332E, L328E/I332E, L328H/I332E, L328I/I332E, L328M/I332E, L328N/I332E, L328Q/I332E, L328T/I332E, L328V/I332E, N297D/A330Y/I332E, N297D/I332E, N297D/I332E/S239D/A330L, N297D/S298A/A330Y/I332E, N297D/T299E/I332E, N297D/T299F/I332E, N297D/T299H/I332E, N297D/T299I/I332E, N297D/T299L/I332E, N297D/T299V/I332E, N297E/I332E, N297S/I332E, P230A/E233D/I332E, P244H/P245A/P247V, S239D/A330L/I332E, S239D/A330Y/I332E, S239D/A330Y/I332E/K326E, S239D/A330Y/I332E/K326T, S239D/A330Y/I332E/L234I, S239D/A330Y/I332E/L235D, S239D/A330Y/I332E/V240I, S239D/A330Y/I332E/V264T, S239D/A330Y/I332E/V266I, S239D/D265F/N297D/I332E, S239D/D265H/N297D/I332E, S239D/D265I/N297D/I332E, S239D/D265L/N297D/I332E, S239D/D265T/N297D/I332E, S239D/D265V/N297D/I332E, S239D/D265Y/N297D/I332E, S239D/I332D, S239D/I332E, S239D/I332E/A330I, S239D/I332N, S239D/I332Q, S239D/N297D/I332E, S239D/N297D/I332E/A330Y, S239D/N297D/I332E/A330Y/F241S/F243H/V262T/V264T, S239D/N297D/I332E/K326E, S239D/N297D/I332E/L235D, S239D/S298A/I332E, S239D/V264I/A330L/I332E, S239D/V264I/I332E, S239D/V264I/S298A/I332E, S239E/D265N, S239E/D265Q, S239E/I332D, S239E/I332E, S239E/I332N, S239E/I332Q, S239E/N297D/I332E, S239E/V264I/A330Y/I332E, S239E/V264I/I332E, S239E/V264I/S298A/A330Y/I332E, S239N/A330L/I332E, S239N/A330Y/I332E, S239N/I332D, S239N/I332E, S239N/I332N, S239N/I332Q, S239N/S298A/I332E, S239Q/I332D, S239Q/I332E, S239Q/I332N, S239Q/I332Q, S239Q/V264I/I332E, S298A/I332E, V264E/N297D/I332E, V264I/A330L/I332E, V264I/A330Y/I332E,V264I/I332E, V264I/S298A/I332E, Y296D/N297D/I332E, Y296E/N297D/I332E, Y296H/N297D/I332E, Y296N/N297D/I332E, Y296Q/N297D/I332E 및 Y296T/N297D/I332E로 이루어진 군으로부터 선택된 적어도 하나의 변형을 포함하는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항, 33항 또는 37항에 있어서, 227E, 227K, 227Y, 227G, 233N, 233Q, 233K, 233R, 233S, 233T, 233H, 233A, 233V, 233L, 233I, 233F, 233M, 233Y, 233W, 233G, 234K, 234R, 234S, 234A, 234M, 234W, 234P, 234G, 235E, 235K, 235R, 235A, 235M, 235W, 235P, 235G, 236D, 236E, 236N, 236Q, 236K, 236R, 236S, 236T, 236H, 236A, 236V, 236L, 236I, 236F, 236M, 236Y, 236W, 236P, 237D, 237E, 237N, 237Q, 237K, 237R, 237S, 237T, 237H, 237V, 237L, 237I, 237F, 237M, 237Y, 237W, 237P, 238D, 238E, 238N, 238Q, 238K, 238R, 238S, 238T, 238H, 238V, 238L, 238I, 238F, 238M, 238Y, 238W, 238G, 239Q, 239K, 239R, 239V, 239L, 239I, 239M, 239W, 239P, 239G, 241D, 241E, 241Y, 243E, 246D, 246E, 246H, 246Y, 249Q, 249H, 249Y, 255E, 255Y, 258S, 258H, 258Y, 260D, 260E, 260H, 260Y, 264D, 264E, 264N, 264Q, 264K, 264R, 264S, 264H, 264W, 264P, 264G, 265Q, 265K, 265R, 265S, 265T, 265H, 265V, 265L, 265I, 265F, 265M, 265Y, 265W, 265P, 267E, 267Q, 267K, 267R, 267V, 267L, 267I, 267F, 267M, 267Y, 267W, 267P, 268D, 268E, 268Q, 268K, 268R, 268T, 268V, 268L, 268I, 268F, 268M, 268W, 268P, 268G, 269K, 269S, 269V, 269I, 269M, 269W, 269P, 269G, 270R, 270S, 270L, 270I, 270F, 270M, 270Y, 270W, 270P, 270G, 272D, 272R, 272T, 272H, 272V, 272L, 272F, 272M, 272W, 272P, 272G, 274D, 274N, 274S, 274H, 274V, 274I, 274F, 274M, 274W, 274P, 274G, 276D, 276T, 276H, 276V, 276I, 276F, 276M, 276W, 276P, 276G, 278D, 278N, 278Q, 278R, 278S, 278H, 278V, 278L, 278I, 278M, 278P, 278G, 280K, 280L, 280W, 280P, 280G, 282E, 282K, 282Y, 282P, 282G, 283K, 283H, 283L, 283Y, 283P, 283G, 285D, 285E, 285Q, 285K, 285Y, 285W, 286E, 286Y, 286P, 286G, 288D, 288E, 288Y, 290D, 290N, 290H, 290L, 290W, 292D, 292E, 292T, 292Y, 293N, 293R, 293S, 293T, 293H, 293V, 293L, 293I, 293F, 293M, 293Y, 293W, 293P, 293G, 294K, 294R, 294S, 294T, 294H, 294V, 294L, 294I, 294F, 294M, 294Y, 294W, 294P, 294G, 295D, 295E, 295N, 295R, 295S, 295T, 295H, 295V, 295I, 295F, 295M, 295Y, 295W, 295P, 295G, 296K, 296R, 296A, 296V, 296M, 296G, 297Q, 297K, 297R, 297T, 297H, 297V, 297L, 297I, 297F, 297M, 297Y, 297W, 297P, 297G, 298D, 298E, 298Q, 298K, 298R, 298I, 298F, 298M, 298Y, 298W, 300D, 300E, 300N, 300Q, 300K, 300R, 300S, 300T, 300H, 300A, 300V, 300M, 300W, 300P, 300G, 301D, 301E, 301H, 301Y, 303D, 303E, 303Y, 305E, 305T, 305Y, 317E, 317Q, 318Q, 318H, 318L, 318Y, 320N, 320S, 320H, 320V, 320L, 320F, 320Y, 320W, 320P, 320G, 322D, 322S, 322V, 322I, 322F, 322Y, 322W, 322P, 322G, 324H, 324F, 324M, 324W, 324P, 324G, 326P, 327E, 327K, 327R, 327H, 327V, 327I, 327F, 327M, 327Y, 327W, 327P, 329D, 329E, 329N, 329Q, 329K, 329R, 329S, 329T, 329H, 329V, 329L, 329I, 329M, 329Y, 329W, 329G, 330E, 330N, 330T, 330P, 330G, 331D, 331Q, 331R, 331T, 331L, 331I, 331F, 331M, 331Y, 331W, 333L, 333F, 333M, 333P, 334P, 335N, 335S, 335H, 335V, 335L, 335I, 335F, 335M, 335W, 335P, 335G, 337E, 337N, 337H, 233D, 234D, 234E, 234F, 234H, 234I, 234N, 234Q, 234T, 234V, 234Y, 235D, 235F, 235H, 235I, 235N, 235Q, 235S, 235T, 235V, 235Y, 239D, 239E, 239F, 239H, 239N, 239Q, 239T, 239Y, 241E, 241L, 241R, 241S, 241W, 241Y, 243H, 243L, 243Q, 243R, 243W, 243Y, 264A, 264E, 264F, 264I, 264L, 264M, 264R, 264T, 264W, 264Y, 265F, 265G, 265H, 265I, 265L, 265N, 265Q, 265T, 265V, 265Y, 267D, 267H, 267L, 267N, 267Q, 267T, 269F, 269H, 269L, 269N, 269R, 269T, 269Y, 270H, 270Q, 270T, 272I, 272K, 272S, 272Y, 274E, 274L, 274R, 274T, 274Y, 276E, 276L, 276R, 276S, 276Y, 278E, 278K, 278T, 278W, 283R, 296D, 296E, 296H, 296I, 296L, 296N, 296Q, 296S, 296T, 297D, 297E, 297S, 298A, 298H, 298N, 298T, 318R, 320D, 320I, 320T, 322H, 322T, 324D, 324I, 324L, 324R, 324T, 324V, 324Y, 326E, 326I, 326L, 326T, 327D, 327L, 327N, 327S, 327T, 329F, 330F, 330H, 330I, 330L, 330M, 330R, 330S, 330V, 330W, 330Y, 331H, 331V, 333A, 333H, 333I, 333T, 333Y, 334A, 334F, 334I, 334T, 335D, 335R 및 335Y로 이루어진 군으로부터 선택된 적어도 하나의 변형을 추가적으로 포함하는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 Fc 변이체는 241W/243W, 267Q/327S, 243L/264I, 234I/235D, 264E/297D/332E, 239E/265N, 239E/265Q, 239E/265G, 267L/327S 및 240I/266I로 이루어진 군으로부터 선택된 한가지 세트의 변형을 추가적으로 포함하는 것을 특징으로 하는, 폴리펩타이드.
- 제 34항에 있어서, 상기 항체는 전장 항체(full length antibody)인 것을 특징으로 하는, 폴리펩타이드.
- 제 34항에 있어서, 상기 항체는 인간 항체인 것을 특징으로 하는, 폴리펩타이드.
- 제 34항에 있어서, 상기 항체는 항체 단편인 것을 특징으로 하는, 폴리펩타이드.
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
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US46760603P | 2003-05-02 | 2003-05-02 | |
US60/467,606 | 2003-05-02 | ||
US47783903P | 2003-06-12 | 2003-06-12 | |
US60/477,839 | 2003-06-12 | ||
US10/672,280 US20040132101A1 (en) | 2002-09-27 | 2003-09-26 | Optimized Fc variants and methods for their generation |
US10/672,280 | 2003-09-26 |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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KR20180058860A (ko) * | 2009-12-21 | 2018-06-01 | 리제너론 파마슈티칼스 인코포레이티드 | 인간화된 FcγR 마우스 |
KR20190045404A (ko) * | 2009-12-21 | 2019-05-02 | 리제너론 파마슈티칼스 인코포레이티드 | 인간화된 FcγR 마우스 |
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