JP2019533989A5 - 抗pd−1抗体及びその使用 - Google Patents

抗pd−1抗体及びその使用 Download PDF

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JP2019533989A5
JP2019533989A5 JP2019512990A JP2019512990A JP2019533989A5 JP 2019533989 A5 JP2019533989 A5 JP 2019533989A5 JP 2019512990 A JP2019512990 A JP 2019512990A JP 2019512990 A JP2019512990 A JP 2019512990A JP 2019533989 A5 JP2019533989 A5 JP 2019533989A5
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  1. (i)3つのCDRを含むV鎖;及び(ii)3つのCDRを含むV鎖を含む抗ヒトPD−1抗体であって、
    CDR#1は、GYTFTHYGMN(配列番号11)であり、
    CDR#2は、WVNTYTGEPTYADDFKG(配列番号12)であり、
    CDR#3は、EGEGLGFGD(配列番号13)であり、
    CDR#1は、RSSQSIVHSHGDTYLE(配列番号14)であり、
    CDR#2は、KVSNRFS(配列番号15)であり、
    CDR#3は、FQGSHIPVT(配列番号16)である、抗ヒトPD−1抗体。
  2. ヒト化されている、請求項1に記載の抗ヒトPD−1抗体。
  3. 配列番号36の配列に対応するV鎖;及び配列番号42の配列に対応するV鎖を含む、請求項1又は2に記載の抗ヒトPD−1抗体。
  4. IgGである、請求項1から3のいずれか一項に記載の抗ヒトPD−1抗体。
  5. IgGである、請求項1から4のいずれか一項に記載の抗ヒトPD−1抗体。
  6. アミノ酸置換L234A及びL235Aを有する変異体CH2ドメインを含む、請求項5に記載の抗ヒトPD−1抗体。
  7. IgGである、請求項4に記載の抗ヒトPD−1抗体。
  8. アミノ酸置換S228Pを有する変異体Fc領域を含む、請求項7に記載の抗ヒトPD−1抗体。
  9. カッパ軽定常領域を含む、請求項1から8のいずれか一項に記載の抗ヒトPD−1抗体。
  10. 配列番号51又は配列番号52の配列に対応する重鎖、及び配列番号61の配列に対応する軽鎖を含む、請求項3に記載の抗ヒトPD−1抗体。
  11. 配列番号51のアミノ酸配列からそれぞれなる重鎖及び配列番号61のアミノ酸配列からそれぞれなる軽鎖からなるIgG抗体である、請求項1に記載の抗ヒトPD−1抗体。
  12. 配列番号52のアミノ酸配列からそれぞれなる重鎖及び配列番号61のアミノ酸配列からそれぞれなる軽鎖からなるIgG抗体である、請求項1に記載の抗ヒトPD−1抗体。
  13. 請求項1から12のいずれか一項に記載の抗ヒトPD−1抗体及び薬学的に許容される担体を含む医薬組成物。
  14. 抗ヒトPD−1抗体をコードするヌクレオチド配列を含む核酸であって、抗体は、(i)3つのCDRを含むV鎖;及び(ii)3つのCDRを含むV鎖を含み、ここで
    CDR#1は、GYTFTHYGMN(配列番号11)であり、
    CDR#2は、WVNTYTGEPTYADDFKG(配列番号12)であり、
    CDR#3は、EGEGLGFGD(配列番号13)であり、
    CDR#1は、RSSQSIVHSHGDTYLE(配列番号14)であり、
    CDR#2は、KVSNRFS(配列番号15)であり、
    CDR#3は、FQGSHIPVT(配列番号16)である、核酸。
  15. 請求項14に記載の核酸を含むベクター。
  16. 請求項15に記載のベクターで形質転換された真核宿主細胞。
  17. 請求項14に記載の核酸を発現するように遺伝子操作された真核宿主細胞。
  18. 哺乳動物宿主細胞である、請求項16又は17に記載の真核宿主細胞。
  19. 抗ヒトPD−1抗体を生成する方法であって、(a)請求項16から18のいずれか一項に記載の宿主細胞を培養すること及び(b)抗ヒトPD−1抗体を回収することを含む、方法。
  20. 免疫系を活性化する必要のある患者の、免疫系の活性化に使用するための、請求項1から12のいずれか一項に記載の抗ヒトPD−1抗体。
  21. がんを治療する必要のある患者において、がんの治療に使用するための、請求項1から12のいずれか一項に記載の抗ヒトPD−1抗体。
  22. がんが、膀胱がん、乳がん、頭頸部がん、腎臓がん、肺がん、リンパ腫、黒色腫又は胃がんから選択される、請求項21に記載の使用のための抗ヒトPD−1抗体。
  23. 肺がんが、非小細胞肺がんである、請求項22に記載の使用のための抗ヒトPD−1抗体。
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US201662394314P 2016-09-14 2016-09-14
US62/394,314 2016-09-14
PCT/US2017/051531 WO2018053106A1 (en) 2016-09-14 2017-09-14 Anti-pd-1(cd279) antibodies

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