JP2016523265A - 抗pd−1抗体およびその応用 - Google Patents
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Abstract
Description
実施例実施例1.ヒトPD1細胞外ドメインの真核発現プラスミドへのクローニング
実施例2.細胞にけるPD−1とリガンドPD−L1との結合の検出1.T細胞のヒト末梢血球からの分離
2.ビオチンによるrh−PD−L1組み換え蛋白質に対する標識
実施例3.抗rh−PD−1抗体の調製1.動物の免疫
2.細胞の融合
実施例4.リガンドと受容体の遮断実験
実施例5.他のCD28ファミリー蛋白質との結合
実施例6.候補抗体の可変領域配列
実施例7.キメラ抗体発現ベクターの構築
実施例8.キメラ抗体によるT細胞機能への外部刺激実験−破傷風毒素刺激試験
実施例9.異なる抗体の軽鎖と重鎖の交換後のPD−1との相互作用
38重鎖
38軽鎖
39重鎖
39軽鎖
41重鎖
41軽鎖
48重鎖
48軽鎖
実施例11.T細胞に対するヒト型抗体の外部刺激
実施例12.T細胞に対するヒト型抗体の外部刺激に起因した腫瘍細胞に対する殺傷の可能性
実施例13.ヒト化抗体と異なる種のPD−1蛋白質との結合
実施例14.ヒト化抗体で外部からT細胞を刺激して増殖させる実験−破傷風抗原の記憶応答実験
実施例15.ヒト化抗体で外部からT細胞を刺激して増殖させる実験−ウイルスポリペプチド抗原の記憶応答実験
Claims (15)
- アミノ酸配列SEQ ID NO:1、2、3、7、8、9、13、14、15若しくはあらゆる前記配列の変異体から選ばれる重鎖CDR、および/又は、アミノ酸配列SEQ ID NO:4、5、6、10、11、12、16、17、18若しくはあらゆる前記配列の変異体から選ばれる軽鎖CDRを含む、プログラム細胞死因子1(PD−1)と結合できる抗体又はその機能性断片。
- 前記重鎖CDRのCDR1、CDR2およびCDR3のアミノ酸配列は、下記A〜Cの各アミノ酸配列若しくはそれらの変異体群の組合せのうちから選ばれる:
および/又は、前記軽鎖CDRのCDR1、CDR2およびCDR3のアミノ酸配列は、下記A〜Cの各アミノ酸配列若しくはそれらの変異体群の組合せのうちから選ばれる:
請求項1に記載された抗体又はその機能性断片。 - 重鎖CDR1、CDR2およびCDR3と軽鎖CDR1、CDR2およびCDR3のアミノ酸配列とは、下記A〜Cの各アミノ酸配列又はそれらの変異体群の組合せから選ばれる:
請求項1又は2に記載された抗体又はその機能性断片。 - アミノ酸配列SEQ ID NO:19、21、23若しくはあらゆる前記配列の変異体から選ばれる重鎖可変領域、および/又は、アミノ酸配列SEQ ID NO:20、22、24若しくはあらゆる前記配列の変異体から選ばれる軽鎖可変領域を含む、請求項1から3のいずれかに記載された抗体又はその機能性断片。
- 前記重鎖可変領域はSEQ ID NO:19若しくはその変異体であり、且つ前記軽鎖可変領域はSEQ ID NO:20若しくはその変異体であり、あるいは、
前記重鎖可変領域はSEQ ID NO:21若しくはその変異体であり、且つ前記軽鎖可変領域はSEQ ID NO:22若しくはその変異体であり、あるいは、
前記重鎖可変領域はSEQ ID NO:23若しくはその変異体であり、且つ前記軽鎖可変領域はSEQ ID NO:24若しくはその変異体である、請求項1から4のいずれかに記載された抗体又はその機能性断片。 - キメラ抗体、ヒト化抗体又は完全ヒト型抗体である、請求項1から5のいずれかに記載された抗体又はその機能性断片。
- アミノ酸配列SEQ ID NO:33、35、36若しくはあらゆる前記配列の変異体から選ばれる重鎖可変領域、および/又は、アミノ酸配列SEQ ID NO:34、37若しくはあらゆる前記配列の変異体から選ばれる軽鎖可変領域を含む、請求項1から6のいずれかに記載された抗体又はその機能性断片。
- 前記重鎖可変領域はSEQ ID NO:33若しくはその変異体であり、且つ前記軽鎖可変領域はSEQ ID NO:34若しくはその変異体であり、あるいは、
前記重鎖可変領域はSEQ ID NO:35若しくはその変異体であり、且つ前記軽鎖可変領域はSEQ ID NO:34若しくはその変異体であり、あるいは、
前記重鎖可変領域はSEQ ID NO:36若しくはその変異体であり、且つ前記軽鎖可変領域はSEQ ID NO:34若しくはその変異体であり、あるいは、
前記重鎖可変領域はSEQ ID NO:35若しくはその変異体であり、且つ前記軽鎖可変領域はSEQ ID NO:37若しくはその変異体である、請求項1から7のいずれかに記載された抗体又はその機能性断片。 - 請求項1から8のいずれかに記載された抗体又は機能性断片をコードする分離された核酸分子。
- 請求項9に記載された核酸分子を含む発現ベクター。
- 請求項10に記載された発現ベクターを含む宿主細胞。
- 抗PD−1抗体又はその機能性断片を産生できる条件で請求項11に記載された宿主細胞を培養し、このように産生された前記抗体又はその機能性断片を回収することを含む、抗PD−1抗体又はその機能性断片を産生する方法。
- 治療剤とカップリングされた請求項1から8のいずれかに記載された抗体又はその機能性断片を含み、好ましくは、前記治療剤は毒素、放射性同位体、薬物又は細胞毒性薬である、免疫抱合体。
- 請求項1から8のいずれかに記載された抗体又はその機能性断片および薬用可能なベクターを含む薬物組成物。
- PD−1の活性を取り除き、抑制し又は低減することにより、疾患や病症を予防し又は治療するための方法において、この需要のある対象に治療有効量の請求項1から8に記載された抗体又はその機能性断片、請求項9に記載された核酸、請求項10に記載された発現ベクター、請求項11に記載された宿主細胞、請求項13に記載された免疫抱合体又は請求項14に記載された薬物組成物を投薬することを含み、前記疾患や病症はがん、感染症又は炎症性疾患から選ばれ、
前記がんは、好ましくは黒色腫、腎臓がん、前立腺がん、乳がん、結腸がん、肺がん、骨がん、膵臓がん、皮膚がん、頭頸部がん、皮膚又は眼内悪性黒色腫、子宮がん、卵巣がん、直腸がん、肛門領域がん、胃がん、睾丸がん、子宮がん、卵管がん、子宮内膜がん、子宮頸がん、膣がん、陰門がん、ホジキン病、非ホジキンリンパ腫、食道がん、小腸がん、内分泌系がん、甲状腺がん、副甲状腺がん、副腎がん、軟部組織肉腫、尿道がん、陰茎がん、急性骨髄性白血病と、慢性骨髄性白血病と、急性リンパ球性白血病と、慢性リンパ球性白血病とを含む慢性又は急性白血病、小児期固形腫瘍、リンパ球性リンパ腫、膀胱がん、腎細胞がん又は尿管がん、腎盂がん、中枢神経系の贅生、原発性中枢神経系リンパ腫、腫瘍血管新生、脊髄軸腫瘍、脳幹膠腫、下垂体腺腫、カポジ肉腫、類表皮がん、扁平上皮がん、T細胞リンパ腫、アスベストに誘発されたがんを含む環境に誘発されたがん、および、前記がんの組合せから選ばれ、
前記感染症は好ましくはHIV、インフルエンザ、疱疹、ランブル鞭毛虫症、マラリア、リーシュマニア症、肝炎ウイルス(A型、B型およびC型),疱疹ウイルス(例えば、VZV、HSV−1、HAV−6、HSV−IIとCMV、エプスタイン・バーウイルス),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,コロナウイルス,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,乳頭腫ウイルス,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,アルボウイルス脳炎ウイルスというウイルスによる病原性感染症、クラミジア,リケッチア,マイコバクテリア,葡萄球菌,連鎖球菌,肺炎球菌,髄膜炎菌とconococci,クレブシエラ菌,プロテウス菌,セラチア菌,シュードモナス菌,レジオネラ菌,ジフテリア菌,サルモネラ菌,桿菌,コレラ菌,破傷風菌,ボツリヌス中毒菌,炭疽菌,ペスト菌,レプトスピラ菌,ライム病菌という細菌による病原性感染症、カンジダ(カンジダ・アルビカンス、カンジダ・クルセイ、カンジダ・グラブラタ、カンジダ・トロピカリス等),クリプトコックス・ネオフォルマンス,アスペルギルス(アスペルギルス・フミガーツス、黒色アスペルギルス等),ケカビ目属(ケカビ属、アブシディア属、リゾープス属),スポロトリクム・シェンキー,皮膚炎出芽酵母,ブラジル・パラコクシジオイデス,コクシジオイデス・イミティス,ヒストプラスマ・カプスラーツムという真菌による病原性感染症、および、赤痢アメーバ,大腸バランチジウム,ネグレリア・フォーレリ,アカントアメーバ,ランブル鞭毛虫,クリプトスポリジウム,ニューモシスティス・カリニ,三日熱マラリア原虫,バベシア・ミクロチ,トリパノソーマ・ブルーセイ,クルーズ・トリパノソーマ,ドノバン・リーシュマニア,トキソプラズマ原虫,ニッポストロンジラス・ブラジリエンシスという寄生虫による病原性感染症から選ばれ、
前記炎症性疾患は、好ましくは急性散在性脳脊髄炎、アジソン病、強直性脊椎炎、抗リン脂質抗体症候群、自己免疫性溶血性貧血、自己免疫性肝炎、関節炎、ベーチェット病、水疱性類天疱瘡、セリアック病、シャーガス病、クローン病、皮膚筋炎、1型糖尿病、グッドパスチャー症候群、移植片対宿主病、グレーブス病、ギラン−バレー症候群、橋本病、高IgE症候群、特発性血小板減少性紫斑病、紅斑性狼瘡、多発性硬化症、重症筋無力、天疱瘡、悪性貧血、多発性筋炎、原発性胆汁性肝硬変、乾癬、関節リウマチ、シェーグレン症候群、側頭動脈炎、血管炎、および、ヴェグナー肉芽腫症から選ばれる方法。
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JP2019533989A (ja) * | 2016-09-14 | 2019-11-28 | アッヴィ・バイオセラピューティクス・インコーポレイテッド | 抗pd−1(cd279)抗体 |
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JP6681327B2 (ja) | 2020-04-15 |
RU2663795C2 (ru) | 2018-08-09 |
BR112015031883A2 (pt) | 2018-02-14 |
US20160272708A1 (en) | 2016-09-22 |
CN104250302A (zh) | 2014-12-31 |
CN104250302B (zh) | 2017-11-14 |
US10815302B2 (en) | 2020-10-27 |
PT3026062T (pt) | 2020-10-13 |
HRP20201600T1 (hr) | 2021-03-05 |
US10066013B2 (en) | 2018-09-04 |
US20190023782A1 (en) | 2019-01-24 |
EP3026062A4 (en) | 2017-08-16 |
HUE052487T2 (hu) | 2021-05-28 |
ES2822927T3 (es) | 2021-05-05 |
EP3026062A1 (en) | 2016-06-01 |
PH12015502819A1 (en) | 2016-03-21 |
MY176822A (en) | 2020-08-24 |
US20210009688A1 (en) | 2021-01-14 |
RU2016102176A (ru) | 2017-07-31 |
PL3026062T3 (pl) | 2021-01-11 |
EP3845562A1 (en) | 2021-07-07 |
SI3026062T1 (sl) | 2020-12-31 |
EP3026062B1 (en) | 2020-08-05 |
WO2014206107A1 (zh) | 2014-12-31 |
DK3026062T3 (da) | 2020-10-12 |
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