KR20080090565A - Cd20에 대한 인간 모노클로날 항체 - Google Patents
Cd20에 대한 인간 모노클로날 항체 Download PDFInfo
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Abstract
Description
세포주 | 기원 | 수득원 |
Daudi | 네그로이드 (Negroid) 버킷 림프종 | ECACC (85011437) |
ARH-77 | IgG 혈장 세포 백혈병 | DSMZ (ACC 512) |
DOHH | 난치성 면역아세포 B 세포 림프종 | DSMZ (ACC 47) |
Raji | 네그로이드 버킷 림프종 | ECACC (85011429) |
SU-DHL-4 | B-NHL, 미만성 조직구 림프종 | DSMZ (ACC 495) |
Ramos-EHRB | 버킷 림프종 | ECACC (85030804) |
Tanoue | 인간 B-세포 백혈병 | DSMZ (ACC 399) |
발현 | CD20 | CD55 | CD59 |
ARH-77 | ++ | ++++ | ++ |
Raji | + | ++ | +++ |
DOHH | ++ | +++ | ++ |
SU-DHL-4 | +++ | + | ++ |
Daudi | ++ | + | + |
Claims (53)
- 가변 영역에 서열 번호 9 및 서열 번호 11 각각의 뉴클레오티드 서열, 또는 이들에 의해 코딩된 아미노산 서열의 보존적 서열 변형체를 코딩하는 뉴클레오티드 서열을 포함하는 인간 중쇄 및 인간 카파 경쇄 핵산에 의해 코딩되는, 인간 CD20에 결합하는 단리된 인간 모노클로날 항체.
- 서열 번호 10 및 서열 번호 12 각각의 아미노산 서열, 또는 이들의 보존적 서열 변형체를 포함하는 인간 중쇄 및 인간 카파 경쇄 가변 영역을 갖는, 인간 CD20에 결합하는 단리된 인간 모노클로날 항체.
- (i) 서열 번호 25, 26, 27, 28, 29 및 30; 및(ii) 인간 CD20에 결합할 수 있는 능력을 보유하는 상기 (i)에 열거된 서열의 보존적 서열 변형체로 이루어진 군으로부터 선택된 6개의 CDR 서열을 포함하는, 인간 CD20에 결합하는 단리된 인간 모노클로날 항체.
- 제1항 내지 제3항 중 어느 한 항에 있어서, CD20 상의 에피토프로서 위치 170에 알라닌 아미노산 잔기 또는 위치 172에 프롤린 아미노산 잔기를 포함하지 않거나 필요로 하지 않는 에피토프에 결합하는 항체.
- 제1항 내지 제3항 중 어느 한 항에 있어서, 인간 CD20과 적어도 동일한 친화도로 돌연변이 AxP (위치 170의 알라닌이 세린으로 돌연변이되고, 위치 172의 프롤린이 세린으로 돌연변이됨)에 결합하는 항체.
- 제1항 내지 제3항 중 어느 한 항에 있어서,(i) 인간 CD20의 작은 제1 세포외 루프의 에피토프에 결합하고;(ii) CD20 상의 불연속 에피토프에 결합하고;(iii) CD20의 작은 제1 세포외 루프의 일부 및 제2 세포외 루프의 일부를 포함하는 CD20 상의 불연속 에피토프에 결합하고;(iv) CD20의 작은 제1 세포외 루프의 잔기 AGIYAP 및 제2 세포외 루프의 잔기 MESLNFIRAHTPYI를 갖는 CD20 상의 불연속 에피토프에 결합하는,특징들 중 하나 이상을 갖는 항체.
- 제1항 내지 제3항 중 어느 한 항에 있어서, 온전한 IgG1 항체, 온전한 IgG2 항체, 온전한 IgG3 항체, 온전한 IgG4 항체, 온전한 IgM 항체, 온전한 IgA1 항체, 온전한 IgA2 항체, 온전한 분비성 IgA 항체, 온전한 IgD 항체, 및 온전한 IgE 항체로 이루어진 군으로부터 선택되는 온전한 항체로서, 진핵 세포 내에서 글리코실화된 것인 항체.
- 제1항 내지 제3항 중 어느 한 항에 있어서, 항체 단편 또는 단일 사슬 항체인 항체.
- 제1항 내지 제3항 중 어느 한 항에 있어서,(i) 면역글로불린 힌지 영역 폴리펩티드에 융합된, 제1항 내지 제3항 중 어느 한 항에 정의된 중쇄 가변 영역 또는 경쇄 가변 영역 형태의 결합 도메인 폴리펩티드,(ii) 힌지 영역에 융합된 면역글로불린 중쇄 CH2 불변 영역, 및(iii) CH2 불변 영역에 융합된 면역글로불린 중쇄 CH3 불변 영역을 포함하는, 결합-도메인 면역글로불린 융합 단백질인 항체.
- 제1항 내지 제3항 중 어느 한 항의 인간 모노클로날 항체를 생산하는 하이브리도마.
- 제1항 내지 제3항 중 어느 한 항의 인간 모노클로날 항체를 생산하는, 인간 중쇄 및 인간 경쇄를 코딩하는 핵산을 포함하는 트랜스펙토마.
- 제1항 내지 제3항 중 어느 한 항의 인간 모노클로날 항체를 생산하는 진핵 또는 원핵 숙주 세포.
- 제1항 내지 제3항 중 어느 한 항의 인간 모노클로날 항체를 생산하는 트랜스제닉 비인간 동물 또는 식물.
- 인간 중쇄 트랜스진 및 인간 경쇄 트랜스진을 포함하는 게놈을 갖는 트랜스제닉 비인간 동물을 인간 CD20, 또는 인간 CD20를 발현하는 세포로 면역화하여 동물의 B 세포에 의해 항체가 생산되도록 하는 단계;동물의 B 세포를 단리하는 단계;상기 B 세포를 골수종 세포와 융합하여, 인간 CD20에 대해 특이적인 인간 모노클로날 항체를 분비하는 불멸의 하이브리도마 세포를 형성하는 단계; 및상기 하이브리도마, 또는 이 하이브리도마로부터 유래한 트랜스펙토마의 배양 상청액으로부터 CD20에 대해 특이적인 인간 모노클로날 항체를 단리하는 단계를 포함하는, 제1항 내지 제3항 중 어느 한 항에 따른 인간 CD20에 결합하는 인간 모노클로날 항체의 제조 방법.
- 제14항에 있어서, 면역화를 인간 CD20으로 트랜스펙션된 세포로 수행하는 것인 방법.
- 제1항 내지 제3항 중 어느 한 항에 있어서, 방사성 동위원소를 결합시키기 위한 킬레이터 링커를 추가로 포함하는 항체.
- 세포독성제, 방사성 동위원소 또는 약물에 연결된, 제1항 내지 제3항 중 어느 한 항에 따른 항체를 포함하는 면역콘쥬게이트.
- 제1항 내지 제3항 중 어느 한 항에 따른 항체, 및 인간 이펙터 세포에 대한 결합 특이적 부위를 포함하는 이중특이적 분자.
- 제1항 내지 제3항 중 어느 한 항에 따른 항체, 및 CD3와 같은 T 세포 수용체에 대한 결합 특이적 부위 또는 인간 Fc 수용체에 대한 결합 특이적 부위를 포함하는 이중특이적 분자.
- 항체와 CD20 간에 복합체를 형성하게 하는 조건하에서 시료를 제1항 내지 제3항 중 어느 한 항의 항체와 접촉시키는 단계; 및복합체 형성을 검출하는 단계를 포함하는, 시료에서 CD20 항원, 또는 CD20을 발현하는 세포의 존재를 검출하는 시험관내 방법.
- 제1항 내지 제3항 중 어느 한 항의 항체를 포함하는 시료에서 CD20 항원, 또는 CD20을 발현하는 세포의 존재를 검출하기 위한 키트.
- 제1항 내지 제3항 중 어느 한 항에 따른 인간 항체의 경쇄, 중쇄, 또는 경쇄 와 중쇄 모두의 가변 영역을 코딩하는 뉴클레오티드 서열을 포함하는 발현 벡터.
- 제1항 내지 제3항 중 어느 한 항에 따른 인간 항체의 경쇄, 중쇄, 또는 경쇄와 중쇄 모두의 가변 영역을 코딩하는 뉴클레오티드 서열, 및 상기 인간 항체의 경쇄, 중쇄, 또는 경쇄와 중쇄 모두의 불변 영역을 코딩하는 뉴클레오티드 서열을 포함하는 발현 벡터.
- 서열 번호 9의 뉴클레오티드 서열을 포함하는 중쇄 가변 영역을 코딩하는 뉴클레오티드 서열 및 서열 번호 11의 뉴클레오티드 서열을 포함하는 경쇄 가변 영역을 코딩하는 뉴클레오티드 서열, 또는 이들에 의해 코딩되는 아미노산 서열의 보존적 서열 변형체를 코딩하는 뉴클레오티드 서열을 포함하는 발현 벡터.
- 서열 번호 10의 아미노산 서열을 포함하는 중쇄 가변 영역 및 서열 번호 12의 아미노산 서열을 포함하는 경쇄 가변 영역, 또는 이들의 보존적 서열 변형체를 코딩하는 뉴클레오티드 서열을 포함하는 발현 벡터.
- 제1항 내지 제3항 중 어느 한 항의 항체에 결합하는 항-이디오타입 항체.
- 11B8에 결합하는 항-이디오타입 항체.
- 제26항의 항체를 사용하여 시료에서 CD20에 대한 인간 모노클로날 항체의 수준을 검출하는 방법.
- 제1항 내지 제3항 중 어느 한 항에 따른 인간 항체, 또는 제24항 또는 제25항에 따른 발현 벡터를 질환의 치료 또는 예방에 효과적인 양으로 포함하는, B 세포 림프종을 치료 또는 예방하기 위한 제약 조성물.
- 제17항의 면역콘쥬게이트를 질환의 치료 또는 예방에 효과적인 양으로 포함하는, B 세포 림프종을 치료 또는 예방하기 위한 제약 조성물.
- 제18항의 이중특이적 분자를 질환의 치료 또는 예방에 효과적인 양으로 포함하는, B 세포 림프종을 치료 또는 예방하기 위한 제약 조성물.
- 제29항에 있어서, 질환이 B 세포 비-호지킨 림프종인 제약 조성물.
- 제29항에 있어서, 질환이 B 세포 만성 림프구성 백혈병 (CLL)/소림프구성 림프종 (SLL), B 세포 전림프구성 백혈병, 림프형질세포성 림프종, 외투 세포 림프종 (MCL), 여포성 림프종 (FL), 피부 여포 중심 림프종, 변연대 B 세포 림프종 (MALT 타입, 결절 및 비장 타입), 모세포 백혈병, 미만성 거대 B 세포 림프종, 버킷 림프종, 형질세포종, 혈장 세포 골수종, 이식후 림프세포증식성 질환, 왈덴스트룀 (Waldenstroem) 마크로글로불린혈증 및 퇴행성 대세포 림프종 (ALCL)을 포함하는 전구체 B 세포 림프아구성 백혈병/림프종 및 성숙 B 세포 신생물로 이루어진 군으로부터 선택된 것인 제약 조성물.
- 제29항에 있어서, 질환이 여포성 림프종 (FL)인 제약 조성물.
- 제29항에 있어서, 질환이 B 세포 만성 림프구성 백혈병 (CLL)/소림프구성 림프종 (SLL)인 제약 조성물.
- 제29항에 있어서, 질환이 림프종성 육아종증, 1차 삼출성 림프종, 혈관내 거대 B 세포 림프종, 종격 거대 B 세포 림프종, 중쇄 질병 (γ, μ 및 α 질병을 포함함), 및 사이클로스포린-유도성 림프종 및 메토트렉세이트-유도된 림프종을 포함하는 면역억제제로의 치료에 의해 유도된 림프종으로 이루어진 군으로부터 선택된 것인 제약 조성물.
- 제1항 내지 제3항 중 어느 한 항의 항체, 또는 제24항 또는 제25항에 따른 발현 벡터를 염증, 면역 및(또는) 자가면역 질환의 치료 또는 예방에 효과적인 양으로 포함하는, 염증, 면역 및(또는) 자가면역 질환을 치료 또는 예방하기 위한 제약 조성물.
- 제17항의 면역콘쥬게이트를 염증, 면역 및(또는) 자가면역 질환의 치료 또는 예방에 효과적인 양으로 포함하는, 염증, 면역 및(또는) 자가면역 질환을 치료 또는 예방하기 위한 제약 조성물.
- 제18항의 이중특이적 분자를 염증, 면역 및(또는) 자가면역 질환의 치료 또는 예방에 효과적인 양으로 포함하는, 염증, 면역 및(또는) 자가면역 질환을 치료 또는 예방하기 위한 제약 조성물.
- 제37항에 있어서, 치료가 자가항원에 대한 항체를 생산하는 B 세포의 사멸을 포함하는 것인 제약 조성물.
- 제37항에 있어서, 질환이 건선, 건선성 관절염, 피부염, 전신성 경피증 및 경화증, 염증성 장질환 (IBD), 크론병, 궤양성 대장염, 호흡곤란 증후군, 수막염, 뇌염, 포도막염, 사구체 신염, 습진, 천식, 죽상경화증, 백혈구 부착 결핍증, 다발성 경화증, 레이노 증후군, 쉐그렌 증후군, 청소년 발병 당뇨병, 레이터병, 베체트병, 면역 복합체 신염, IgA 신장병증, IgM 다발성 신경병증, 급성 특발성 혈소판 감소성 자반병 및 만성 특발성 혈소판 감소성 자반병을 포함하는 면역-매개 혈소판 감소증, 용혈성 빈혈, 중증 근무력증, 루푸스 신염, 전신성 홍반성 루푸스, 류마티스 관절염 (RA), 아토피성 피부염, 천포창, 그레이브스병, 하시모토 갑상선염, 베게너 육아종증, 오멘 증후군, 만성 신부전, 급성 감염성 단핵구증, HIV, 및 허피스 바이러스 관련 질환으로 이루어진 군으로부터 선택되는 것인 제약 조성물.
- 제37항에 있어서, 자가면역 질환이 류마티스 관절염 (RA)인 제약 조성물.
- 제37항에 있어서, 질환이 궤양성 대장염, 크론병, 청소년 발병 당뇨병, 다발성 경화증, 급성 특발성 혈소판 감소성 자반병 및 만성 특발성 혈소판 감소성 자반병을 포함하는 면역-매개 혈소판 감소증, 용혈성 빈혈, 중증 근무력증, 전신성 경화증, 및 심상성 천포창으로부터 선택된 염증, 면역 및(또는) 자가면역 질환인 제약 조성물.
- 제37항에 있어서, 질환이 염증성 장질환 (IBD), 궤양성 대장염, 크론병, 및 다발성 경화증으로부터 선택된 염증성, 면역 및(또는) 자가면역 질환인 제약 조성물.
- 제29항에 있어서, 다른 치료제를 추가로 포함하는 제약 조성물.
- 제45항에 있어서, 치료제가 세포독성제 또는 방사성독성제인 제약 조성물.
- 제45항에 있어서, 치료제가 면역억제제인 제약 조성물.
- 제45항에 있어서, 치료제가 사이토카인 또는 케모카인과 같은 면역 조절제인 제약 조성물.
- 제45항에 있어서, 치료제가 독소루비신, 시스플라틴, 블레오마이신, 카르무스틴, 클로람부실 및 시클로포스파미드로 이루어진 군으로부터 선택되는 것인 제약 조성물.
- 제45항에 있어서, 치료제가 항-CD25 항체, 항-CD19 항체, 항-CD21 항체, 항-CD22 항체, 항-CD37 항체, 항-CD38 항체, 항-IL6R 항체, 항-IL8 항체, 항-IL15 항체, 항-IL15R 항체, 항-CD4 항체, 항-CD11a 항체, 항-알파-4/베타-1 인테그린 (VLA4) 항체, CTLA4-Ig, 및 항-C3b(i) 항체로 이루어진 군으로부터 선택되는 것인 제약 조성물.
- 인간 CD20에 결합하는 인간 모노클로날 항체를 구성하거나 그의 일부를 형성하는, 서열 번호 27의 서열 또는 그의 보존적 서열 변형체의 VH CDR3.
- 제27항의 항체를 사용하여 시료에서 CD20에 대한 인간 모노클로날 항체의 수준을 검출하는 방법.
- 제37항에 있어서, 다른 치료제를 추가로 포함하는 제약 조성물.
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