KR20050072814A - 종양 괴사 인자-알파에 대한 단일 도메인 항체 및 그 용도 - Google Patents
종양 괴사 인자-알파에 대한 단일 도메인 항체 및 그 용도 Download PDFInfo
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- KR20050072814A KR20050072814A KR1020057008180A KR20057008180A KR20050072814A KR 20050072814 A KR20050072814 A KR 20050072814A KR 1020057008180 A KR1020057008180 A KR 1020057008180A KR 20057008180 A KR20057008180 A KR 20057008180A KR 20050072814 A KR20050072814 A KR 20050072814A
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- tnf
- alpha
- polypeptide
- alpha polypeptide
- disease
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
Abstract
Description
그룹 | 동물 | 설명 | 스케쥴 |
1 | 8 | 음성 대조 1, 복강내 | 매일 100㎕ PBS 복강내 투여 |
2 | 8 | 음성 대조 2, 직장 | 2주동안 2일마다 100㎕ PBS 직장 투여 |
3 | 8 | 음성 대조 3, 위내 | 연속 14일동안 매일 100㎕ PBS를 위내 투여 |
4 | 8 | 양성 대조 1, 덱사메타손 | 7일 연속동안 5㎍ 복강내 투여 |
5 | 8 | 양성 대조 2, IL10을 발현하는 아이.락티스 | 연속 14일동안 하루에 한번씩 경구 적용 |
6 | 8 | 2가 VHH 3F, 위내 | 연속 14일동안 2가 VHH 3F2 100㎍을 매일 위내 투여 |
7 | 8 | 2가 VHH3F, 복강내 | 연속 14일동안 2가 VHH 3F 100㎍을 매일 위내 투여 |
8 | 8 | 2가 VHH3F, 직장 | 2주동안 2일마다 100 ㎕ PBS중의 100 ㎍ 2가 VHH 3F 직장 투여 |
Claims (49)
- 적어도 하나의 항-TNF-알파 단일 도메인 항체를 포함하는 항-TNF-알파 폴리펩티드.
- 제1항에 있어서, 단일 도메인 항체가 서열 번호 1 내지 16 및 79 내지 84 중 어느 하나에 의해 나타내지는 서열에 해당하는 것인 항-TNF-알파 폴리펩티드.
- 제1항 및 제2항에 있어서, 혈청 단백질에 대한 적어도 하나의 단일 도메인 항체를 추가로 포함하는 것인 항-TNF-알파 폴리펩티드.
- 제1항 내지 제3항 중 어느 하나의 항에 있어서, 상기 혈청 단백질이 혈청 알부민, 혈청 면역글로불린, 티록신-결합 단백질, 트랜스페린, 또는 피브리노겐 중 어느 하나인 것인 항-TNF-알파 폴리펩티드.
- 제3항 및 제4항에 있어서, 단일 도메인 항-혈청 단백질 단일 도메인 항체가 서열 번호 26 내지 29 및 85 내지 97 중 어느 하나에 의해 나타내지는 서열에 해당하는 것인 항-TNF-알파 폴리펩티드.
- 제3항 내지 제5항 중 어느 하나의 항에 있어서, 서열 번호 30 내지 43 중 어느 하나에 의해 나타내지는 서열에 해당하는 것인 항-TNF-알파 폴리펩티드.
- 제1항 내지 제6항 중 어느 하나의 항에 있어서, 항-IFN-감마 단일 도메인 항체, 항-TNF-알파 수용체 단일 도메인 항체 및 항-IFN-감마 수용체 단일 도메인 항체로 구성된 군으로부터 선택된 적어도 하나의 단일 도메인 항체를 추가로 포함하는 것인 항-TNF-알파 폴리펩티드.
- 제1항 내지 제7항 중 어느 하나의 항에 있어서, TNF-알파에 대한 단일 도메인 항체의 수가 적어도 2개인 것인 항-TNF-알파 폴리펩티드.
- 제8항에 있어서, 서열 번호 73 내지 76 중 어느 하나에 의해 나타내지는 서열에 해당하는 것인 항-TNF-알파 폴리펩티드.
- 제1항 내지 제9항 중 어느 하나의 항에 있어서, 적어도 하나의 단일 도메인 항체가 인간화된 카멜리대(Camelidae) VHH인 것인 항-TNF-알파 폴리펩티드.
- 제10항에 있어서, 인간화된 카멜리대 VHH가 서열 번호 17 내지 19 및 21 내지 24 중 어느 하나에 의해 나타내지는 서열에 해당하는 것인 항-TNF-알파 폴리펩티드.
- 제1항 내지 제11항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 및 항-IFN-감마 단일 도메인 항체, 항-TNF-알파 수용체 단일 도메인 항체 및 항-IFN-감마 수용체 단일 도메인 항체로 구성된 군으로부터 선택된 적어도 하나의 단일 도메인 항체를 포함하는, 대상에의 동시, 분리 또는 순차적 투여를 위한 조성물.
- 적어도 하나의 항-IFN-감마 단일 도메인 항체가 서열 번호 44 내지 72 중 어느 하나에 의해 나타내지는 서열에 해당하는, 제7항 내지 제11항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드 또는 제12항의 조성물.
- 상기 단일 도메인 항체가 전길이 단일 도메인 항체의 상동성 서열, 기능적 부분, 또는 상동성 서열의 기능적 부분인, 제1항 내지 제11항 및 제13항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드 또는 제12항 및 제13항의 조성물.
- 항-TNF-알파 폴리펩티드가 전길이 항-TNF-알파 폴리펩티드의 상동성 서열, 기능적 부분, 또는 상동성 서열의 기능적 부분인, 제1항 내지 제11항 및 제13항 및 제14항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드 또는 제12항 내지 제14항의 조성물.
- 적어도 하나의 단일 도메인 항체가 카멜리대 VHH인, 제1항 내지 제11항 및 제13항 내지 제15항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드 또는 제12항 내지 제15항의 조성물.
- 제1항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드를 암호하는 핵산.
- 하기의 단계를 포함하는, 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드의 종양 괴사 인자-알파에의 결합을 조절하는 제제를 확인하는 방법:(a) 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드를, 상기 폴리펩티드와 표적간의 결합을 허용하는 조건하에서 후보 조절자의 존재 및 부재하에서 종양 괴사 인자 알파인 표적과 접촉시키는 단계, 및(b) 단계 (a)의 폴리펩티드와 표적간의 결합을 측정하며, 이때 상기 후보 조절자의 부재하에서의 결합에 비하여 상기 후보 조절자의 존재하에서의 결합의 감소는 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드와 종양 괴사 인자-알파의 결합을 조절하는 제제로서 상기 후보 조절자를 확인하는 단계.
- 하기 단계를 포함하는, 종양 괴사 인자-알파에의 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드의 결합을 통해 종양 괴사 인자-알파-매개된 질환을 조절하는 제제를 확인하는 방법:(a) 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드를, 상기 폴리펩티드와 표적간의 결합을 허용하는 조건하에서 후보 조절자의 존재 및 부재하에서 종양 괴사 인자 알파인 표적과 접촉시키는 단계, 및(b) 단계 (a)의 폴리펩티드와 표적간의 결합을 측정하며, 이때 상기 후보 조절자의 부재하에서의 결합에 비하여 후보 조절자의 존재하에서의 결합의 감소는 종양 괴사 인자-알파-매개 질환을 조절하는 제제로서 상기 후보 조절자를 확인하는 단계.
- 하기 단계를 포함하는, 종양 괴사 인자-알파에의 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드의 결합을 통해 종양 괴사 인자-알파의 그 수용체에의 결합을 조절하는 제제를 확인하는 방법:(a) 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드를, 상기 폴리펩티드와 표적간의 결합을 허용하는 조건하에서 후보 조절자의 존재 및 부재하에서 종양 괴사 인자 알파인 표적과 접촉시키는 단계, 및(b) 단계 (a)의 폴리펩티드와 표적간의 결합을 측정하며, 이때 상기 후보 조절자의 부재하에서의 결합에 비하여 후보 조절자의 존재하에서의 결합의 감소는 종양 괴사 인자-알파의 그 수용체에의 결합을 조절하는 제제로서 상기 후보 조절자를 확인하는 단계.
- 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드 및 종양 괴사 인자-알파를 포함하는 종양 괴사 인자-알파-매개된 질환을 조절하는 제제에 대한 스크리닝용 키트.
- 제18항의 방법에 따라 확인된, 제1항 내지 제11항, 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드의 종양 괴사 인자-알파에의 결합을 조절하는 미지의 제제.
- 제19항 및 제20항의 방법에 따라 확인된, 종양 괴사 인자-알파-매개 질환을 조절하는 미지의 제제.
- 제23항에 있어서, 상기 질환이 염증, 류마티스 관절염, 크론 질병, 궤양성 대장염, 염증성 장 증후군 및 다발성 경화증 중 하나 이상인 것인 미지의 제제.
- 염증성 과정에 관련된 질환을 치료 및/또는 방지 및/또는 완화시키기 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제17항의 핵산, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물, 또는 제22항 내지 제24항 중 어느 하나의 항의 제제.
- 염증성 과정에 관련된 질환을 치료 및/또는 방지 및/또는 완화시키기 위한 의약의 제조를 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제17항의 핵산, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물, 또는 제20항 또는 제21항의 항의 제제의 용도.
- 불활성화되지 않고 위장 환경을 통과할 수 있는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환을 치료 및/또는 방지 및/또는 완화시키기 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물.
- 불활성화되지 않고 위장 환경을 통과할 수 있는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환의 증상을 치료, 방지 및/또는 완화시키기 위한 의약의 제조를 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물의 용도.
- 질 및/또는 직장관에 전달되는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환을 치료 및/또는 방지 및/또는 완화시키기 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물.
- 질 및/또는 직장관에 전달되는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환의 증상을 치료, 방지 및/또는 완화시키기 위한 의약의 제조를 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물의 용도.
- 코, 상부 호흡기 및/또는 폐에 전달되는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환을 치료 및/또는 방지 및/또는 완화시키기 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물.
- 코, 상부 호흡기 및/또는 폐에 전달되는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환의 증상을 치료, 방지 및/또는 완화시키기 위한 의약의 제조를 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물의 용도.
- 장 점막에 전달되는 TNF-알파 조절 물질에 의한 조절을 받아들이며 장 점막의 투과성을 증가시키는 질환을 치료 및/또는 방지 및/또는 완화시키기 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물.
- 장 점막에 전달되는 TNF-알파 조절 물질에 의한 조절을 받아들이며 장 점막의 투과성을 증가시키는 질환의 증상을 치료, 방지 및/또는 완화시키기 위한 의약의 제조를 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물의 용도.
- 혀 밑의 조직을 효과적으로 통과할 수 있는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환을 치료 및/또는 방지 및/또는 완화시키기 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물.
- 혀 밑의 조직을 효과적으로 통과할 수 있는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환의 증상을 치료, 방지 및/또는 완화시키기 위한 의약의 제조를 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물의 용도.
- 피부를 효과적으로 통과할 수 있는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환을 치료 및/또는 방지 및/또는 완화시키기 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물.
- 피부를 효과적으로 통과할 수 있는 TNF-알파 조절 물질에 의한 조절을 받아들이는 질환의 증상을 치료, 방지 및/또는 완화시키기 위한 의약의 제조를 위한, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물의 용도.
- 상기 질환이 염증, 류마티스 관절염, 크론 질병, 궤양성 대장염, 염증성 장 증후군, 다발성 경화증, 애디슨 질병, 자가면역 간염, 자가면역 이하선염, 타입 I 당뇨병, 부고환염, 사구체신염, 그레이브 질병, 길리안-바레 증후군, 하시모토 질병, 용혈성 빈혈, 전신성 루푸스 홍반, 남성 불임, 다발성 경화증, 중증근육무력증, 천포창, 건선, 류마티스성 열, 류마티스 관절염, 사르코이드종, 피부경화증, 쇼그렌 증후군, 척추관절병증, 갑상샘염, 및 혈관염 중 어느 것인 제19항의 방법, 제21항의 키트, 제25항의 핵산 또는 제제, 제26항의 핵산 또는 제제의 용도, 제25항, 제27항, 제29항, 제31항, 제33항, 제35항, 제37항 및 제39항 중 어느 하나의 항의 조성물, 제26항, 제28항, 제30항, 제32항, 제34항, 제36항 및 제38항 중 어느 하나의 항의 조성물의 용도, 제25항, 제27항, 제29항, 제31항, 제33항, 제35항, 제37항 및 제39항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 제26항, 제28항, 제30항, 제32항, 제34항, 제36항 및 제38항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드의 용도.
- 제25항의 핵산 또는 제제, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드, 또는 제12항 내지 제16항 중 어느 하나의 항의 조성물, 및 적합한 약학적 비히클을 포함하는 조성물.
- 하기 단계를 포함하는 종양 괴사 인자-알파의 기능장애를 특징으로 하는 질환을 진단하는 방법:(a) 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드와 샘플을 접촉시키는 단계,(b) 상기 폴리펩티드의 상기 샘플에의 결합을 검출하는 단계, 및(c) 단계 (b)에서 검출된 결합을 표준과 비교하며, 이때 상기 샘플에 비하여 결합의 차이는 종양 괴사 인자-알파의 기능장애를 특징으로 하는 질환의 진단인 단계.
- 제38항의 방법을 이용하여 제39항에 개시된 질환을 스크리닝하기 위한 키트.
- 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 분리된 항-TNF-알파 폴리펩티드를 포함하는 제39항에 개시된 질환을 스크리닝하기 위한 키트.
- 종양 괴사 인자-알파의 정제를 위한 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드의 용도.
- 종양 괴사 인자-알파와 하나 이상의 종양 괴사 인자-알파 수용체간의 상호작용을 억제하기 위한 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드의 용도.
- 하기 단계를 포함하는 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드를 생산하는 방법:(a) 종양 괴사 인자 알파에 대한 카멜리대 VHH를 암호하는 이중쇄 DNA를 얻는 단계, 및(b) 단계 (a)에서 선택된 DNA를 클로닝하고 발현시키는 단계.
- 하기 단계를 포함하는 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드를 생산하는 방법:(a) 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드의 발현을 허용하는 조건하에서, 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드를 암호할 수 있는 핵산을 포함하는 숙주 세포를 배양하는 단계, 및(b) 상기 배양으로부터 생산된 폴리펩티드를 회수하는 단계.
- 제47항에 있어서, 상기 숙주 세포가 박테리아 또는 효모인 방법.
- 제1항 내지 제11항 및 제13항 내지 제16항 중 어느 하나의 항의 항-TNF-알파 폴리펩티드를 포함하는, 염증, 류마티스 관절염, 크론 질병, 궤양성 대장염, 염증성 장 증후군 또는 다발성 경화증 중 어느 것을 스크리닝하기 위한 키트.
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EPPCT/EP03/06581 | 2003-06-23 | ||
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