JP2008544755A5 - - Google Patents

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JP2008544755A5
JP2008544755A5 JP2008519704A JP2008519704A JP2008544755A5 JP 2008544755 A5 JP2008544755 A5 JP 2008544755A5 JP 2008519704 A JP2008519704 A JP 2008519704A JP 2008519704 A JP2008519704 A JP 2008519704A JP 2008544755 A5 JP2008544755 A5 JP 2008544755A5
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antibody
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  1. ヒトPD-L1に特異的に結合し、かつ以下の特性のうち少なくとも1種を示す、単離されたヒトモノクローナル抗体、またはその抗原結合部分：
    (a)1×10-7Mもしくはそれ以下のKDでヒトPD-L1に結合する;
    (b)混合リンパ球反応(MLR)アッセイ法においてT細胞増殖を増加させる;
    (c)MLRアッセイ法においてインターフェロン-γ産生を増加させる;または
    (d)MLRアッセイ法においてインターロイキン-2(IL-2)分泌を増加させる。
  2. 5×10-9Mもしくはそれ以下のKDでヒトPD-L1に結合する、請求項1記載の抗体。
  3. 2×10-9Mもしくはそれ以下のKDでヒトPD-L1に結合する、請求項1記載の抗体。
  4. PD-L1への結合に関して、以下を含む参照抗体と交差競合する、単離されたヒトモノクローナル抗体、またはその抗原結合部分：
    (a)SEQ ID NO：1、SEQ ID NO：2、SEQ ID NO：3、SEQ ID NO：4、SEQ ID NO：5、SEQ ID NO：6、SEQ ID NO：7、SEQ ID NO：8、SEQ ID NO：9、およびSEQ ID NO：10からなる群より選択されるアミノ酸配列を含むヒト重鎖可変領域、ならびに
    (b)SEQ ID NO：11、SEQ ID NO：12、SEQ ID NO：13、SEQ ID NO：14、SEQ ID NO：15、SEQ ID NO：16、SEQ ID NO：17、SEQ ID NO：18、SEQ ID NO：19、およびSEQ ID NO：20からなる群より選択されるアミノ酸配列を含むヒト軽鎖可変領域。
  5. ヒト重鎖可変領域が、SEQ ID NO：1のアミノ酸配列を含み、かつヒト軽鎖可変領域が、SEQ ID NO：11のアミノ酸配列を含む、請求項4記載の抗体。
  6. ヒト重鎖可変領域が、SEQ ID NO：2のアミノ酸配列を含み、かつヒト軽鎖可変領域が、SEQ ID NO：12のアミノ酸配列を含む、請求項4記載の抗体。
  7. ヒト重鎖可変領域が、SEQ ID NO：3のアミノ酸配列を含み、かつヒト軽鎖可変領域が、SEQ ID NO：13のアミノ酸配列を含む、請求項4記載の抗体。
  8. 以下を含む、PD-L1に特異的に結合する単離されたモノクローナル抗体、またはその抗原結合部分：
    (a)ヒトVH1-18遺伝子、V H 1-69遺伝子、またはV H 1-3遺伝子の重鎖可変領域;および
    (b)ヒトVkL6遺伝子またはV k L15遺伝子の軽鎖可変領域。
  9. CDR1配列、CDR2配列、およびCDR3配列を含む重鎖可変領域;ならびにCDR1配列、CDR2配列、およびCDR3配列を含む軽鎖可変領域を含み、
    (a)重鎖可変領域のCDR3配列が、SEQ ID NO：41、SEQ ID NO：42、SEQ ID NO：43、SEQ ID NO：44、SEQ ID NO：45、SEQ ID NO：46、SEQ ID NO：47、SEQ ID NO：48、SEQ ID NO：49、およびSEQ ID NO：50、ならびにそれらの保存的改変体からなる群より選択されるアミノ酸配列を含み、
    (b)軽鎖可変領域のCDR3配列が、SEQ ID NO：71、SEQ ID NO：72、SEQ ID NO：73、SEQ ID NO：74、SEQ ID NO：75、SEQ ID NO：76、SEQ ID NO：77、SEQ ID NO：78、SEQ ID NO：79、およびSEQ ID NO：80、ならびにそれらの保存的改変体からなる群より選択されるアミノ酸配列を含み;かつ、
    (c)抗体が、ヒトPD-L1に特異的に結合する、
    単離されたモノクローナル抗体またはその抗原結合部分。
  10. 重鎖可変領域のCDR2配列が、SEQ ID NO：31、SEQ ID NO：32、SEQ ID NO：33、SEQ ID NO：34、SEQ ID NO：35、SEQ ID NO：36、SEQ ID NO：37、SEQ ID NO：38、SEQ ID NO：39、およびSEQ ID NO：40のアミノ酸配列ならびにそれらの保存的改変体からなる群より選択されるアミノ酸配列を含み、かつ、軽鎖可変領域のCDR2配列が、SEQ ID NO：61、SEQ ID NO：62、SEQ ID NO：63、SEQ ID NO：64、SEQ ID NO：65、SEQ ID NO：66、SEQ ID NO：67、SEQ ID NO：68、SEQ ID NO：69、およびSEQ ID NO：70のアミノ酸配列ならびにそれらの保存的改変体からなる群より選択されるアミノ酸配列を含む、請求項9記載の抗体。
  11. 重鎖可変領域のCDR1配列が、SEQ ID NO：21、SEQ ID NO：22、SEQ ID NO：23、SEQ ID NO：24、SEQ ID NO：25、SEQ ID NO：26、SEQ ID NO：27、SEQ ID NO：28、SEQ ID NO：29、およびSEQ ID NO：30のアミノ酸配列ならびにそれらの保存的改変体からなる群より選択されるアミノ酸配列を含み、かつ、軽鎖可変領域のCDR1配列が、SEQ ID NO：51、SEQ ID NO：52、SEQ ID NO：53、SEQ ID NO：54、SEQ ID NO：55、SEQ ID NO：56、SEQ ID NO：57、SEQ ID NO：58、SEQ ID NO：59、およびSEQ ID NO：60のアミノ酸配列ならびにそれらの保存的改変体からなる群より選択されるアミノ酸配列を含む、請求項10記載の抗体。
  12. 重鎖可変領域および軽鎖可変領域を含み、
    (a)重鎖可変領域が、SEQ ID NO：1、SEQ ID NO：2、SEQ ID NO：3、SEQ ID NO：4、SEQ ID NO：5、SEQ ID NO：6、SEQ ID NO：7、SEQ ID NO：8、SEQ ID NO：9、およびSEQ ID NO：10からなる群より選択されるアミノ酸配列に少なくとも80％相同であるアミノ酸配列を含み、
    (b)軽鎖可変領域が、SEQ ID NO：11、SEQ ID NO：12、SEQ ID NO：13、SEQ ID NO：14、SEQ ID NO：15、SEQ ID NO：16、SEQ ID NO：17、SEQ ID NO：18、SEQ ID NO：19、およびSEQ ID NO：20からなる群より選択されるアミノ酸配列に少なくとも80％相同であるアミノ酸配列を含み;かつ、
    抗体が、1×10-7Mまたはそれ以下のKDでヒトPD-L1に結合する、
    請求項1記載の抗体。
  13. 以下より選択される1種または複数種の特性をさらに含む、請求項12記載の抗体：
    (a)抗体が、混合リンパ球反応(MLR)アッセイ法においてT細胞増殖を増加させる;
    (b)抗体が、MLRアッセイ法においてインターフェロン-γ産生を増加させる;および
    (c)抗体が、MLRアッセイ法においてIL-2分泌を増加させる。
  14. 以下を含む、PD-L1に特異的に結合する単離されたモノクローナル抗体、またはその抗原結合部分：
    (a)SEQ ID NO：21、SEQ ID NO：22、SEQ ID NO：23、SEQ ID NO：24、SEQ ID NO：25、SEQ ID NO：26、SEQ ID NO：27、SEQ ID NO：28、SEQ ID NO：29、およびSEQ ID NO：30からなる群より選択されるアミノ酸配列を含む、重鎖可変領域のCDR1;
    (b)SEQ ID NO：31、SEQ ID NO：32、SEQ ID NO：33、SEQ ID NO：34、SEQ ID NO：35、SEQ ID NO：36、SEQ ID NO：37、SEQ ID NO：38、SEQ ID NO：39、およびSEQ ID NO：40からなる群より選択されるアミノ酸配列を含む、重鎖可変領域のCDR2;
    (c)SEQ ID NO：41、SEQ ID NO：42、SEQ ID NO：43、SEQ ID NO：44、SEQ ID NO：45、SEQ ID NO：46、SEQ ID NO：47、SEQ ID NO：48、SEQ ID NO：49、およびSEQ ID NO：50からなる群より選択されるアミノ酸配列を含む、重鎖可変領域のCDR3;
    (d)SEQ ID NO：51、SEQ ID NO：52、SEQ ID NO：53、SEQ ID NO：54、SEQ ID NO：55、SEQ ID NO：56、SEQ ID NO：57、SEQ ID NO：58、SEQ ID NO：59、およびSEQ ID NO：60からなる群より選択されるアミノ酸配列を含む、軽鎖可変領域のCDR1;
    (e)SEQ ID NO：61、SEQ ID NO：62、SEQ ID NO：63、SEQ ID NO：64、SEQ ID NO：65、SEQ ID NO：66、SEQ ID NO：67、SEQ ID NO：68、SEQ ID NO：69、およびSEQ ID NO：70からなる群より選択されるアミノ酸配列を含む、軽鎖可変領域のCDR2;ならびに、
    (f)SEQ ID NO：71、SEQ ID NO：72、SEQ ID NO：73、SEQ ID NO：74、SEQ ID NO：75、SEQ ID NO：76、SEQ ID NO：77、SEQ ID NO：78、SEQ ID NO：79、およびSEQ ID NO：80からなる群より選択されるアミノ酸配列を含む、軽鎖可変領域のCDR3。
  15. 以下を含む、請求項14記載の抗体：
    (a)SEQ ID NO：21を含む重鎖可変領域CDR1;
    (b)SEQ ID NO：31を含む重鎖可変領域CDR2;
    (c)SEQ ID NO：41を含む重鎖可変領域CDR3;
    (d)SEQ ID NO：51を含む軽鎖可変領域CDR1;
    (e)SEQ ID NO：61を含む軽鎖可変領域CDR2;および
    (f)SEQ ID NO：71を含む軽鎖可変領域CDR3。
  16. 以下を含む、請求項14記載の抗体：
    (a)SEQ ID NO：22を含む重鎖可変領域CDR1;
    (b)SEQ ID NO：32を含む重鎖可変領域CDR2;
    (c)SEQ ID NO：42を含む重鎖可変領域CDR3;
    (d)SEQ ID NO：52を含む軽鎖可変領域CDR1;
    (e)SEQ ID NO：62を含む軽鎖可変領域CDR2;および
    (f)SEQ ID NO：72を含む軽鎖可変領域CDR3。
  17. 以下を含む、請求項14記載の抗体：
    (a)SEQ ID NO：23を含む重鎖可変領域CDR1;
    (b)SEQ ID NO：33を含む重鎖可変領域CDR2;
    (c)SEQ ID NO：43を含む重鎖可変領域CDR3;
    (d)SEQ ID NO：53を含む軽鎖可変領域CDR1;
    (e)SEQ ID NO：63を含む軽鎖可変領域CDR2;および
    (f)SEQ ID NO：73を含む軽鎖可変領域CDR3。
  18. 以下を含む、PD-L1に特異的に結合する単離されたモノクローナル抗体、またはその抗原結合部分
    (a)SEQ ID NO：1、SEQ ID NO：2、SEQ ID NO：3、SEQ ID NO：4、SEQ ID NO：5、SEQ ID NO：6、SEQ ID NO：7、SEQ ID NO：8、SEQ ID NO：9、およびSEQ ID NO：10からなる群より選択されるアミノ酸配列を含む重鎖可変領域;ならびに、
    (b)SEQ ID NO：11、SEQ ID NO：12、SEQ ID NO：13、SEQ ID NO：14、SEQ ID NO：15、SEQ ID NO：16、SEQ ID NO：17、SEQ ID NO：18、SEQ ID NO：19、およびSEQ ID NO：20からなる群より選択されるアミノ酸配列を含む軽鎖可変領域。
  19. 以下を含む、請求項18記載の抗体：
    (a)SEQ ID NO：1のアミノ酸配列を含む重鎖可変領域;および
    (b)SEQ ID NO：11のアミノ酸配列を含む軽鎖可変領域。
  20. 以下を含む、請求項18記載の抗体：
    (a)SEQ ID NO：2のアミノ酸配列を含む重鎖可変領域;および
    (b)SEQ ID NO：12のアミノ酸配列を含む軽鎖可変領域。
  21. 以下を含む、請求項18記載の抗体：
    (a)SEQ ID NO：3のアミノ酸配列を含む重鎖可変領域;および
    (b)SEQ ID NO：13のアミノ酸配列を含む軽鎖可変領域。
  22. 請求項1記載の抗体またはその抗原結合部分および薬学的に許容される担体を含む、組成物。
  23. 治療物質に連結された請求項1記載の抗体またはその抗原結合部分を含む、免疫複合体。
  24. 治療物質がサイトトキシンまたは放射性同位体である、請求項23記載の免疫複合体。
  25. 抗体またはその抗原結合部分とは異なる結合特異性を有する第2の機能的部分に連結された、請求項1記載の抗体またはその抗原結合部分を含む二重特異性分子。
  26. 請求項1項記載の抗体またはその抗原結合部分をコードする、単離された核酸分子。
  27. 請求項26の核酸分子を含む発現ベクター。
  28. 請求項27の発現ベクターを含む宿主細胞。
  29. 請求項1記載の抗体を発現する、ヒト免疫グロブリンの重鎖導入遺伝子および軽鎖導入遺伝子を含むトランスジェニックマウス。
  30. 対象における免疫応答を調整する方法であって、対象における免疫応答が調整されるように、請求項1記載の抗体またはその抗原結合部分を対象に投与する段階を含む方法。
  31. 対象において腫瘍細胞の増殖を阻害する方法であって、対象における腫瘍細胞の増殖を阻害するように、請求項1記載の抗体またはその抗原結合部分を対象に投与する段階を含む方法。
  32. 腫瘍細胞が、黒色腫、腎臓癌、前立腺癌、乳癌、結腸癌、および肺癌からなる群より選択される癌のものである、請求項31記載の方法。
  33. 腫瘍細胞が、骨癌、膵臓癌、皮膚癌、頭部または頸部の癌、皮膚または眼内の悪性黒色腫、子宮癌、卵巣癌、直腸癌、肛門領域の癌、胃癌、精巣癌、子宮癌、ファロピウス管癌、子宮内膜癌、子宮頸癌、腟癌、外陰癌、ホジキン病、非ホジキンリンパ腫、食道癌、小腸癌、内分泌系の癌、甲状腺癌、副甲状腺癌、副腎癌、軟部組織肉腫、尿道癌、陰茎癌、急性骨髄性白血病、慢性骨髄性白血病、急性リンパ芽球性白血病、慢性リンパ球性白血病を含む慢性または急性の白血病、幼児期の固形腫瘍、リンパ球性リンパ腫、膀胱癌、腎臓または尿管の癌、腎う癌、中枢神経系(CNS)の新生物、原発性CNSリンパ腫、腫瘍血管新生、脊椎腫瘍、脳幹神経膠腫、脳下垂体腺腫、カポジ肉腫、類表皮癌、扁平上皮癌、T細胞リンパ腫、アスベストによって誘発されるものを含む環境的に誘発される癌、および前記癌の組合せからなるリストより選択される癌のものである、請求項31記載の方法。
  34. 対象において感染症を治療する方法であって、対象の感染症が治療されるように、請求項1記載の抗体またはその抗原結合部分を対象に投与する段階を含む方法。
  35. 感染症が、以下からなるリストより選択される、請求項34記載の方法：HIV、インフルエンザ(Influenza)、ヘルペス(Herpes)、ジアルジア(Giardia)、マラリア(Malaria)、リーシュマニア(Leishmania);肝炎ウイルス(A、B、およびC)、ヘルペスウイルス、アデノウイルス、インフルエンザウイルス、フラビウイルス、エコーウイルス、ライノウイルス、コクサッキーウイルス、コルノウイルス(cornovirus)、呼吸器合胞体ウイルス、ムンプスウイルス、ロタウイルス、麻疹ウイルス、風疹ウイルス、パルボウイルス、ワクシニアウイルス、HTLVウイルス、デング熱ウイルス、パピローマウイルス、軟属腫ウイルス、ポリオウイルス、狂犬病ウイルス、JCウイルス、およびアルボウイルス脳炎ウイルスによる病原性感染症;クラミジア(chlamydia)、リケッチア細菌、ミコバクテリア(mycobacteria)、ブドウ球菌(staphylococci)、連鎖球菌(streptococci)、肺炎連鎖球菌(pneumonococci)、髄膜炎菌(meningococci)およびコノコッカス(conococci)、クレブシエラ(klebsiella)、プロテウス(proteus)、セラチア(serratia)、シュードモナス(pseudomonas)、レジオネラ(legionella)、ジフテリア(diphtheria)、サルモネラ(salmonella)、桿菌(bacilli)、コレラ菌、破傷風菌、ボツリヌス菌、炭疽菌、ペスト菌、レプトスピラ菌、およびライム病菌による病原性感染症;真菌のカンジダ属(Candida)、クリプトコックス・ネオフォルマンス(Cryptococcus neoformans)、アスペルギルス(Aspergillus)属、ケカビ目(Mucorales)の属、スポロスリックス・シェンキー(Sporothrix schenkii)、ブラストミセス・デルマチチジス(Blastomyces dermatitidis)、ブラジル・パラコクシジオイデス(Paracoccidioides brasiliensis)、コクシジオイデス・イミチス(Coccidioides immitis)およびヒストプラスマ・カプスラーツム(Histoplasma capsulatum)による病原性感染症;ならびに、寄生虫の赤痢アメーバ(Entamoeba histolytica)、大腸バランチジウム(Balantidium coli)、ネグレリア・フォーレリ(Naegleria fowleri)、アカントアメーバ(Acanthamoeba)種、ランブル鞭毛虫(Giardia lambia)、クリプトスポリジウム(Cryptosporidium)種、ニューモシスティス・カリニ(Pneumocystis carinii)、三日熱マラリア原虫(Plasmodium vivax)、ネズミバベシア(Babesia microti)、トリパノソーマ・ブルセイ(Trypanosoma brucei)、クルーズ・トリパノソーマ(Trypanosoma cruzi)、ドノバンリーシュマニア(Leishmania donovani)、トキソプラズマ・ゴンジ(Toxoplasma gondii)、ブラジル鉤虫(Nippostrongylus brasiliensis)による病原性感染症。
  36. 対象における抗原に対する免疫応答を増強する方法であって、対象における抗原に対する免疫応答が増強されるように、(i)抗原、および(ii)請求項1記載の抗体またはその抗原結合部分を対象に投与する段階を含む方法。
  37. 抗原が、腫瘍抗原、ウイルス抗原、細菌抗原、または病原体由来の抗原である、請求項36記載の方法。
  38. 対象において炎症性疾患を治療または予防する方法であって、対象の炎症性疾患が治療されるように、請求項1記載の抗体またはその抗原結合部分を対象に投与する段階を含む方法。
  39. 炎症性疾患が扁平苔癬(LP)である、請求項38記載の方法。
  40. 以下の段階を含む、請求項1記載の抗PD-L1抗体を調製するための方法：
    (a)(i)SEQ ID NO：21、SEQ ID NO：22、SEQ ID NO：23、SEQ ID NO：24、SEQ ID NO：25、SEQ ID NO：26、SEQ ID NO：27、SEQ ID NO：28、SEQ ID NO：29、およびSEQ ID NO：30からなる群より選択されるCDR1配列、SEQ ID NO：31、SEQ ID NO：32、SEQ ID NO：33、SEQ ID NO：34、SEQ ID NO：35、SEQ ID NO：36、SEQ ID NO：37、SEQ ID NO：38、SEQ ID NO：39、およびSEQ ID NO：40からなる群より選択されるCDR2配列、ならびにSEQ ID NO：41、SEQ ID NO：42、SEQ ID NO：43、SEQ ID NO：44、SEQ ID NO：45、SEQ ID NO：46、SEQ ID NO：47、SEQ ID NO：48、SEQ ID NO：49、およびSEQ ID NO：50からなる群より選択されるCDR3配列を含む重鎖可変領域抗体配列、または(ii)SEQ ID NO：51、SEQ ID NO：52、SEQ ID NO：53、SEQ ID NO：54、SEQ ID NO：55、SEQ ID NO：56、SEQ ID NO：57、SEQ ID NO：58、SEQ ID NO：59、およびSEQ ID NO：60からなる群より選択されるCDR1配列、SEQ ID NO：61、SEQ ID NO：62、SEQ ID NO：63、SEQ ID NO：64、SEQ ID NO：65、SEQ ID NO：66、SEQ ID NO：67、SEQ ID NO：68、SEQ ID NO：69、およびSEQ ID NO：70からなる群より選択されるCDR2配列、ならびにSEQ ID NO：71、SEQ ID NO：72、SEQ ID NO：73、SEQ ID NO：74、SEQ ID NO：75、SEQ ID NO：76、SEQ ID NO：77、SEQ ID NO：78、SEQ ID NO：79、およびSEQ ID NO：80からなる群より選択されるCDR3配列を含む軽鎖可変領域抗体配列を提供する段階;
    (b)重鎖可変領域抗体配列および軽鎖可変領域抗体配列より選択される少なくとも1つの可変領域抗体配列内の少なくとも1つのアミノ酸残基を変更して、少なくとも1つの改変抗体配列を作製する段階;ならびに
    (c)改変抗体配列をタンパク質として発現させる段階。
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