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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- 239000000427 antigen Substances 0.000 title claims description 75
- 108090001123 antibodies Proteins 0.000 title claims description 59
- 102000004965 antibodies Human genes 0.000 title claims description 59
- 102000038129 antigens Human genes 0.000 title claims description 57
- 108091007172 antigens Proteins 0.000 title claims description 57
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 3
- 239000000203 mixture Substances 0.000 claims description 46
- 108090001095 Immunoglobulin G Proteins 0.000 claims description 14
- 102000004851 Immunoglobulin G Human genes 0.000 claims description 14
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims description 6
- 102100019764 PDCD1 Human genes 0.000 claims description 6
- 108060007796 SPATA2 Proteins 0.000 claims description 6
- NFGXHKASABOEEW-UHFFFAOYSA-N (+)-methoprene Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims description 4
- 102000000588 Interleukin-2 Human genes 0.000 claims description 4
- 108010002350 Interleukin-2 Proteins 0.000 claims description 4
- 108091006028 chimera Proteins 0.000 claims description 4
- 102100007290 CD274 Human genes 0.000 claims description 2
- 101710012053 CD274 Proteins 0.000 claims description 2
- 102100008191 CD8A Human genes 0.000 claims description 2
- 101700054655 CD8A Proteins 0.000 claims description 2
- 108090000393 Muromonab-CD3 Proteins 0.000 claims description 2
- 102000000034 Programmed Cell Death 1 Receptor Human genes 0.000 claims description 2
- 108010080196 Programmed Cell Death 1 Receptor Proteins 0.000 claims description 2
- 108010070144 Single-Chain Antibodies Proteins 0.000 claims description 2
- 102000005632 Single-Chain Antibodies Human genes 0.000 claims description 2
- 206010047461 Viral infection Diseases 0.000 claims description 2
- 208000001756 Virus Disease Diseases 0.000 claims description 2
- 201000011510 cancer Diseases 0.000 claims description 2
- 230000000875 corresponding Effects 0.000 claims description 2
- 230000001086 cytosolic Effects 0.000 claims description 2
- 230000028327 secretion Effects 0.000 claims description 2
- 230000017613 viral reproduction Effects 0.000 claims description 2
- 102100007289 PDCD1LG2 Human genes 0.000 claims 1
- 101710011976 PDCD1LG2 Proteins 0.000 claims 1
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。
(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。
Claims (35)
- (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。
- 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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