JP2016533763A5 - ヒトｐｄ−１に特異的に結合する抗体抗原結合ドメインおよびそれを含む医薬組成物 - Google Patents
ヒトｐｄ−１に特異的に結合する抗体抗原結合ドメインおよびそれを含む医薬組成物 Download PDFInfo
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Description
本発明は、以下のように把握される。
（１）ヒトＰＤ−１に特異的に結合する抗体抗原結合ドメインであって、
以下の（ａ）ないし（ｒ）から選択されたＣＤＲ（相補性決定領域）１、ＣＤＲ２及びＣＤＲ３の組み合わせを含み、
以下の（ａ）ないし（ｒ）において、抗体（Ａｂ）、重鎖（ＨＣ）又は軽鎖（ＬＣ）、及び、ＣＤＲの組み合わせの由来した命名方式（Ｋａｂａｔ、ＩＭＧＴ又は複合）を最初のカラムに示し、太字の残基はＫａｂａｔ命名方式であり、下線のある残基はＩＭＧＴ命名方式である、抗体抗原結合ドメイン。
（２）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（３）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（４）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（５）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（６）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（７）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（８）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（９）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１０）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１１）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１２）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１３）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１４）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１５）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１６）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１７）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１８）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（１９）以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（２０）（ｇ）、（ｈ）、及び（ｉ）から選択されたＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む重鎖可変領域（Ｖｈ）と、（ｊ）、（ｋ）、及び（ｌ）から選択されたＣＤＲ１，ＣＤＲ２及びＣＤＲ３の組み合わせを含む軽鎖可変領域（Ｖｋ）と、を含む、（１）の抗体抗原結合ドメイン。
（２１）以下の（ｃ）、（ｆ）、（ｉ）、（ｌ）、（ｏ）及び（ｒ）から選択されたＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（２２）以下の群から選択された配列を含む、重鎖可変領域（Ｖｈ）又は軽鎖可変領域（Ｖｋ）を含む、（１）の抗体抗原結合ドメイン。
（２３）以下の群から選択された配列を含む、重鎖可変領域（Ｖｈ）及び軽鎖可変領域（Ｖｋ）を含む、（１）の抗体抗原結合ドメイン。
（２４）３１７−４Ｂ６ Ｈ（配列番号２４）又は３１７−４Ｂ６ Ｌ（配列番号２６）を含む、重鎖可変領域（Ｖｈ）又は軽鎖可変領域（Ｖｋ）を含む、（１）の抗体抗原結合ドメイン。
（２５）３１７−４Ｂ６ Ｈ（配列番号２４）及び３１７−４Ｂ６ Ｌ（配列番号２６）を含む、重鎖可変領域（Ｖｈ）及び軽鎖可変領域（Ｖｋ）を含む、（１）の抗体抗原結合ドメイン。
（２６）ＰＤ１残基：Ｋ４５及びＩ９３（配列番号２におけるＫ５８及びＩ１０６に相当する）に特異的に結合する、（１）の抗体抗原結合ドメイン。
（２７）前記抗体抗原結合ドメインは、ＯＳ８／ＰＤ−Ｌ１又はＯＳ８／ＰＤ−Ｌ２−共形質転換細胞と共培養したＰＤ−１−形質転換細胞におけるＩＬ−２放出を誘導し、及び／又は、ＰＤ−Ｌ１−又はＰＤ−Ｌ２−形質転換細胞と共培養したＰ３Ｚ−形質転換細胞におけるＩＬ−２分泌を阻害し、
ＯＳ８（配列番号８９）は、抗−ヒトＣＤ３ ｍＡｂ ＯＫＴ３の単鎖可変断片（ｓｃＦｖ）がマウスＣＤ８αのＣ末端ドメイン（１１３−２２０）に融合された膜固定キメラＡｂであり、
Ｐ３Ｚ（配列番号９０）は、ヒトＰＤ−１の細胞外及び膜貫通ドメインがヒトＣＤ３ζ鎖の細胞質ドメインに融合されたキメラＰＤ−１受容体である、（１）の抗体抗原結合ドメイン。
（２８）（１）の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
（２９）（２０）の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
（３０）（２５）の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
（３１）（１）の抗体抗原結合ドメインと、配列番号８３−８８のいずれかを含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、モノクローナルＩｇＧ抗体。
（３２）（１）の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
（３３）（２０）の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
（３４）（２５）の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
（３５）（１）の抗体抗原結合ドメインを含む、癌又はウイルス感染症の治療用医薬組成物。
（１）ヒトＰＤ−１に特異的に結合する抗体抗原結合ドメインであって、
以下の（ａ）ないし（ｒ）から選択されたＣＤＲ（相補性決定領域）１、ＣＤＲ２及びＣＤＲ３の組み合わせを含み、
以下の（ａ）ないし（ｒ）において、抗体（Ａｂ）、重鎖（ＨＣ）又は軽鎖（ＬＣ）、及び、ＣＤＲの組み合わせの由来した命名方式（Ｋａｂａｔ、ＩＭＧＴ又は複合）を最初のカラムに示し、太字の残基はＫａｂａｔ命名方式であり、下線のある残基はＩＭＧＴ命名方式である、抗体抗原結合ドメイン。
（２１）以下の（ｃ）、（ｆ）、（ｉ）、（ｌ）、（ｏ）及び（ｒ）から選択されたＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、（１）の抗体抗原結合ドメイン。
（２５）３１７−４Ｂ６ Ｈ（配列番号２４）及び３１７−４Ｂ６ Ｌ（配列番号２６）を含む、重鎖可変領域（Ｖｈ）及び軽鎖可変領域（Ｖｋ）を含む、（１）の抗体抗原結合ドメイン。
（２６）ＰＤ１残基：Ｋ４５及びＩ９３（配列番号２におけるＫ５８及びＩ１０６に相当する）に特異的に結合する、（１）の抗体抗原結合ドメイン。
（２７）前記抗体抗原結合ドメインは、ＯＳ８／ＰＤ−Ｌ１又はＯＳ８／ＰＤ−Ｌ２−共形質転換細胞と共培養したＰＤ−１−形質転換細胞におけるＩＬ−２放出を誘導し、及び／又は、ＰＤ−Ｌ１−又はＰＤ−Ｌ２−形質転換細胞と共培養したＰ３Ｚ−形質転換細胞におけるＩＬ−２分泌を阻害し、
ＯＳ８（配列番号８９）は、抗−ヒトＣＤ３ ｍＡｂ ＯＫＴ３の単鎖可変断片（ｓｃＦｖ）がマウスＣＤ８αのＣ末端ドメイン（１１３−２２０）に融合された膜固定キメラＡｂであり、
Ｐ３Ｚ（配列番号９０）は、ヒトＰＤ−１の細胞外及び膜貫通ドメインがヒトＣＤ３ζ鎖の細胞質ドメインに融合されたキメラＰＤ−１受容体である、（１）の抗体抗原結合ドメイン。
（２８）（１）の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
（２９）（２０）の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
（３０）（２５）の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
（３１）（１）の抗体抗原結合ドメインと、配列番号８３−８８のいずれかを含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、モノクローナルＩｇＧ抗体。
（３２）（１）の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
（３３）（２０）の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
（３４）（２５）の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
（３５）（１）の抗体抗原結合ドメインを含む、癌又はウイルス感染症の治療用医薬組成物。
Claims (35)
- ヒトＰＤ−１に特異的に結合する抗体抗原結合ドメインであって、
以下の（ａ）ないし（ｒ）から選択されたＣＤＲ（相補性決定領域）１、ＣＤＲ２及びＣＤＲ３の組み合わせを含み、
以下の（ａ）ないし（ｒ）において、抗体（Ａｂ）、重鎖（ＨＣ）又は軽鎖（ＬＣ）、及び、ＣＤＲの組み合わせの由来した命名方式（Ｋａｂａｔ、ＩＭＧＴ又は複合）を最初のカラムに示し、太字の残基はＫａｂａｔ命名方式であり、下線のある残基はＩＭＧＴ命名方式である、抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下のＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- （ｇ）、（ｈ）、及び（ｉ）から選択されたＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む重鎖可変領域（Ｖｈ）と、（ｊ）、（ｋ）、及び（ｌ）から選択されたＣＤＲ１，ＣＤＲ２及びＣＤＲ３の組み合わせを含む軽鎖可変領域（Ｖｋ）と、を含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下の（ｃ）、（ｆ）、（ｉ）、（ｌ）、（ｏ）及び（ｒ）から選択されたＣＤＲ１、ＣＤＲ２及びＣＤＲ３の組み合わせを含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下の群から選択された配列を含む、重鎖可変領域（Ｖｈ）又は軽鎖可変領域（Ｖｋ）を含む、請求項１に記載の抗体抗原結合ドメイン。
- 以下の群から選択された配列を含む、重鎖可変領域（Ｖｈ）及び軽鎖可変領域（Ｖｋ）を含む、請求項１に記載の抗体抗原結合ドメイン。
- ３１７−４Ｂ６ Ｈ（配列番号２４）又は３１７−４Ｂ６ Ｌ（配列番号２６）を含む、重鎖可変領域（Ｖｈ）又は軽鎖可変領域（Ｖｋ）を含む、請求項１に記載の抗体抗原結合ドメイン。
- ３１７−４Ｂ６ Ｈ（配列番号２４）及び３１７−４Ｂ６ Ｌ（配列番号２６）を含む、重鎖可変領域（Ｖｈ）及び軽鎖可変領域（Ｖｋ）を含む、請求項１に記載の抗体抗原結合ドメイン。
- ＰＤ１残基：Ｋ４５及びＩ９３（配列番号２におけるＫ５８及びＩ１０６に相当する）に特異的に結合する、請求項１に記載の抗体抗原結合ドメイン。
- 前記抗体抗原結合ドメインは、ＯＳ８／ＰＤ−Ｌ１又はＯＳ８／ＰＤ−Ｌ２共形質転換細胞と共培養したＰＤ−１−形質転換細胞におけるＩＬ−２放出を誘導し、及び／又は、ＰＤ−Ｌ１−又はＰＤ−Ｌ２−形質転換細胞と共培養したＰ３Ｚ−形質転換細胞におけるＩＬ−２分泌を阻害し、
ＯＳ８（配列番号８９）は、抗−ヒトＣＤ３ ｍＡｂ ＯＫＴ３の単鎖可変断片（ｓｃＦｖ）がマウスＣＤ８αのＣ末端ドメイン（１１３−２２０）に融合された膜固定キメラＡｂであり、
Ｐ３Ｚ（配列番号９０）は、ヒトＰＤ−１の細胞外及び膜貫通ドメインがヒトＣＤ３ζ鎖の細胞質ドメインに融合されたキメラＰＤ−１受容体である、請求項１に記載の抗体抗原結合ドメイン。 - 請求項１に記載の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
- 請求項２０に記載の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
- 請求項２５に記載の抗体抗原結合ドメインを含む、モノクローナルＩｇＧ抗体。
- 請求項１に記載の抗体抗原結合ドメインと、配列番号８３−８８のいずれかを含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、モノクローナルＩｇＧ抗体。
- 請求項１に記載の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
- 請求項２０に記載の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
- 請求項２５に記載の抗体抗原結合ドメインと、配列番号８７又は８８を含む、ＩｇＧ４重鎖エフェクター又は定常領域と、を含む、ＩｇＧ抗体。
- 請求項１に記載の抗体抗原結合ドメインを含む、癌又はウイルス感染症の治療用医薬組成物。
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| GB201803746D0 (en) | 2018-03-08 | 2018-04-25 | Ultrahuman Eight Ltd | PD1 binding agents |
| CN112165939A (zh) | 2018-03-21 | 2021-01-01 | 梅制药公司 | 联合疗法 |
| TW202112369A (zh) | 2019-06-10 | 2021-04-01 | 英屬開曼群島商百濟神州有限公司 | 口服膠囊劑及其製備方法 |
| CN113939289A (zh) | 2019-06-10 | 2022-01-14 | 百济神州瑞士有限责任公司 | 一种含有布鲁顿氏酪氨酸激酶抑制剂的口服固体片剂及其制备方法 |
| TW202123936A (zh) * | 2019-09-11 | 2021-07-01 | 英屬開曼群島商百濟神州有限公司 | 使用包含多重酪胺酸激酶抑制劑和免疫檢查點抑制劑之組合治療癌症 |
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