KR100956110B1 - 최적화된 Fc 변이체 및 그의 제조 방법 - Google Patents
최적화된 Fc 변이체 및 그의 제조 방법 Download PDFInfo
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- KR100956110B1 KR100956110B1 KR1020077025218A KR20077025218A KR100956110B1 KR 100956110 B1 KR100956110 B1 KR 100956110B1 KR 1020077025218 A KR1020077025218 A KR 1020077025218A KR 20077025218 A KR20077025218 A KR 20077025218A KR 100956110 B1 KR100956110 B1 KR 100956110B1
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Abstract
Description
Claims (42)
- 모체 Fc 폴리펩타이드의 Fc 변이체를 포함하는 폴리펩타이드로서,상기 Fc 변이체는 상기 모체 Fc 폴리펩타이드의 Fc 부위에서 325 번 위치에서의 아미노산 변형을 포함하며,상기 Fc 변이체의 단백질은 상기 모체 Fc 폴리펩타이드에 비해 FcγR에 대해 변경된 결합성을 가지며,상기 위치 번호는 EU 인덱스에 따라 기재된 것을 특징으로 하는, 폴리펩타이드.
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- 제 1항에 있어서, 상기 변경된 결합성은 상기 FcγR에 대한 상기 Fc 변이체의 친화성 증가인 것을 특징으로 하는, 폴리펩타이드.
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- 제 3항에 있어서, 상기 FcγR은 FcγRI, FcγRIIa, FcγRIIb, FcγRIIc 및 FcγRIIIa로 이루어진 군으로부터 선택된 인간 Fc 리셉터인 것을 특징으로 하는, 폴리펩타이드.
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- 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 폴리펩타이드에 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 폴리펩타이드에 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 폴리펩타이드에 비해 ADCC를 향상시키는 것을 특징으로 하는, 폴리펩타이드.
- 삭제
- 삭제
- 삭제
- 제 22항에 있어서, 상기 Fc 변이체는 마우스 작용체 세포의 존재하에 상기 모체 Fc 폴리펩타이드에 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 폴리펩타이드에 비해 ADCP를 향상시키는 것을 특징으로 하는, 폴리펩타이드.
- 삭제
- 삭제
- 제 1항에 있어서, 상기 폴리펩타이드는 CD4, CD19, CD20, CD22, CD25, CD30, CD33, CD52, CD80, B7-1, B7-2, CLTA-4, BAFF-R, Her2/neu, EGFR, EpCAM, MUC1, GD3, CEA, CA125, HLA-DR, TNFα 및 VEGF로 이루어진 군으로부터 선택되는 표적 항원에 대한 특이성을 가지는 것을 특징으로 하는, 폴리펩타이드.
- 제 1항 또는 21항에 있어서, 상기 아미노산 변형은 325K, 325R, 325S, 325F, 325M, 325Y, 325W, 325P, 325G, 325A, 325D, 325E, 325H, 325I, 325L, 325Q, 325T 및 325V로 이루어진 군으로부터 선택되는 변형을 포함하며, 상기 위치 번호는 EU 인덱스에 따라 기재된 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 모체 Fc 폴리펩타이드는 상기 Fc 변이체를 포함하는 항체인 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 있어서, 상기 모체 Fc 폴리펩타이드는 상기 Fc 변이체를 포함하는 Fc 융합 단백질인 것을 특징으로 하는, 폴리펩타이드.
- 제 1항에 따른 폴리펩타이드 및 약학적으로 허용가능한 담체를 포함하는 약학적 조성물.
- 삭제
- 제 1항 또는 제33항에 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.
- 삭제
- 제 34항에 있어서, 상기 항체는 전장 항체(full length antibody) 또는 Fc 부위를 포함하는 항체 단편인 것을 특징으로 하는, 폴리펩타이드.
- 제 34항에 있어서, 상기 항체는 인간 항체인 것을 특징으로 하는, 폴리펩타이드.
- 삭제
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