JP2000507810A - ヒトTNFαに結合するヒト抗体 - Google Patents
ヒトTNFαに結合するヒト抗体Info
- Publication number
- JP2000507810A JP2000507810A JP09528755A JP52875597A JP2000507810A JP 2000507810 A JP2000507810 A JP 2000507810A JP 09528755 A JP09528755 A JP 09528755A JP 52875597 A JP52875597 A JP 52875597A JP 2000507810 A JP2000507810 A JP 2000507810A
- Authority
- JP
- Japan
- Prior art keywords
- antibody
- seq
- human
- tnfα
- amino acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.ヒトTNFαから、1×108M以下のKd及び1×10-3s-1以下のKoff 速度定数で解離し、この両者は表面プラズモン共鳴により測定されたものであり 、且つヒトTNFαの細胞障害性を、標準的イン・ビトロL929アッセイで1 ×10-7M以下のIC50で中和する単離されたヒト抗体又はその抗原結合部分。 2.ヒトTNFαから、5×10-4s-1以下のKoff速度定数で解離する、請求 項1に記載の単離されたヒト抗体又はその抗原結合部分。 3.ヒトTNFαから、1×10-4s-1以下のKoff速度定数で解離する、請求 項1に記載の単離されたヒト抗体又はその抗原結合部分。 4.ヒトTNFαの細胞障害性を、標準的イン・ビトロL929アッセイで1× 10-8M以下のIC50で中和する、請求項1に記載の単離されたヒト抗体又はそ の抗原結合部分。 5.ヒトTNFαの細胞障害性を、標準的イン・ビトロL929アッセイで1× 10-9M以下のIC50で中和する、請求項1に記載の単離されたヒト抗体又はそ の抗原結合部分。 6.ヒトTNFαの細胞障害性を、標準的イン・ビトロL929アッセイで1× 10-10M以下のIC50で中和する、請求項1に記載の単離されたヒト抗体又は その抗原結合部分。 7.組換え抗体又はその抗原結合部分である、請求項1に記載の単離されたヒト 抗体又はその抗原結合部分。 8.ヒトの臍静脈内皮細胞でのELAM−1のヒトTNFα誘導された発現を阻 害する、請求項1に記載の単離されたヒト抗体又はその抗原結合部分。 9.下記の特性を有する単離されたヒト抗体又はその抗原結合部分: a)ヒトTNFαから、表面プラズモン共鳴で測定して、1×10-3s-1以下 のKoff速度定数で解離し; b)SEQ ID NO:3のアミノ酸配列、又は位置1、4、5、7若しくは8におけ る単一アラニン置換又は位置1、3、4、6、7、8及び/若しくは9における 1〜5の保存的アミノ酸置換によりSEQ ID NO:3から改変されたアミノ酸配列を 含む軽鎖CDR3ドメインを有し; c)SEQ ID NO:4のアミノ酸配列、又は位置2、3、4、5、6、8、9、1 0若しくは11における単一アラニン置換又は位置2、3、4、5、6、8、9 、10、11及び/若しくは12における1〜5の保存的アミノ酸置換によりSE Q ID NO:4から改変されたアミノ酸配列を含む重鎖CDR3ドメインを有する。 10.ヒトTNFαから5×10-4s-1以下のKoff速度定数で解離する、請求 項9に記載の単離されたヒト抗体又はその抗原結合部分。 11.ヒトTNFαから1×10-4s-1以下のKoff速度定数で解離する、請求 項9に記載の単離されたヒト抗体又はその抗原結合部分。 12.SEQ ID NO:3のアミノ酸配列、又は位置1、4、5、7若しくは8におけ る単一アラニン置換によりSEQ ID NO:3から改変されたアミノ酸配列を含むCD R3ドメインを有する軽鎖可変領域(LCVR)及びSEQ ID NO:4のアミノ酸配 列、又は位置2、3、4、5、6、8、9、10若しくは11における単一アラ ニン置換によりSEQ ID NO:4から改変されたアミノ酸配列を含むCDR3ドメイ ンを有する重鎖可変領域(HCVR)を有する単離されたヒト抗体又はその抗原 結合部分。 13.LCVRが、更に、SEQ ID NO:5のアミノ酸配列を含むCDR2ドメイン を有し且つHCVRが、更に、SEQ ID NO:6のアミノ酸配列を含むCDR2ドメ インを有する、請求項12に記載の単離されたヒト抗体又はその抗原結合部分。 14.LCVRが、更に、SEQ ID NO:7のアミノ酸配列を含むCDR1ドメイン を有し且つHCVRが、SEQ ID NO:8のアミノ酸配列を含むCDR1ドメインを 有する、請求項13に記載の単離されたヒト抗体又はその抗原結合部分。 15.SEQ ID NO:1のアミノ酸配列を含む軽鎖可変領域(LCVR)及びSEQ ID NO:2のアミノ酸配列を含む重鎖可変領域(HCVR)を有する単離されたヒト 抗体又はその抗原結合部分。 16.IgG1重鎖定常領域を有する、請求項15に記載の単離されたヒト抗 体。 17.IgG4重鎖定常領域を有する、請求項15に記載の単離されたヒト抗体 。 18.Fab断片である、請求項15に記載の単離されたヒト抗体。 19.一本鎖Fv断片である、請求項15に記載の単離されたヒト抗体。 20.SEQ ID NO:3、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:1 8、SEQ ID NO:19、SEQ ID NO:20、SEQ ID NO:21、SEQ ID NO:22、SEQ ID NO:23、SEQ ID NO:24、SEQ ID NO:25及びSEQ ID NO:26よりなる群か ら選択するアミノ酸配列を含むCDR3ドメインを有する軽鎖可変領域(LCV R)を有するか又はSEQ ID NO:4、SEQ ID NO:27、SEQ ID NO:28、SEQ ID N O:29、SEQ ID NO:30、SEQ ID NO:31、SEQ ID NO:32、SEQ ID NO:33、 SEQ ID NO:34及びSEQ ID NO:35よりなる群から選択するアミノ酸配列を含む CDR3ドメインを有する重鎖可変領域(HCVR)を有する単離されたヒト抗 体又はその抗原結合部分。 21.ヒトTNFαの活性を中和するが、ヒトTNFβの活性は中和しない組換 えヒト抗体又はその抗原結合部分。 22.チンパンジーのTNFα及びヒヒTNFα、キヌザルTNFα、カニクイ ザルTNFα及びアカゲザルTNFαよりなる群から選択する少なくとも一つの 更なる霊長類TNFαの活性をも中和する、請求項21に記載の組換えヒト抗体 又はその抗原結合部分。 23.イヌTNFαの活性をも中和する、請求項22に記載の組換えヒト抗体又 はその抗原結合部分。 24.ブタTNFαの活性をも中和する、請求項22に記載の組換えヒト抗体又 はその抗原結合部分。 25.SEQ ID NO:3のアミノ酸配列、又は位置1、4、5、7若しくは8におけ る単一アラニン置換又は位置1、3、4、6、7、8及び/若しくは9における 1〜5の保存的アミノ酸置換によりSEQ ID NO:3から改変されたアミノ酸配列を 含む軽鎖CDR3ドメインをコードする単離された核酸。 26.抗体の軽鎖可変領域(LCVR)をコードする、請求項25に記載の単離 された核酸。 27.抗体のLCVRのCDR2ドメインがSEQ ID NO:5のアミノ酸配列を含む 、請求項26に記載の単離された核酸。 28.抗体のLCVRのCDR1ドメインがSEQ ID NO:7のアミノ酸配列を含む 、請求項27に記載の単離された核酸。 29.SEQ ID NO:4のアミノ酸配列、又は位置2、3、4、5、6、8、9、1 0若しくは11における単一アラニン置換又は位置2、3、4、5、6、8、9 、10、11及び/若しくは12における1〜5の保存的アミノ酸置換によりSE Q ID NO:4から改変されたアミノ酸配列を含む重鎖CDR3ドメインをコードす る単離された核酸。 30.抗体の重鎖可変領域(HCVR)をコードする、請求項29に記載の単離 された核酸。 31.抗体のHCVRのCDR2ドメインがSEQ ID NO:6のアミノ酸配列を含む 、請求項30に記載の単離された核酸。 32.抗体のHCVRのCDR1ドメインがSEQ ID NO:8のアミノ酸配列を含む 、請求項31に記載の単離された核酸。 33.SEQ ID NO:3、SEQ ID NO:4、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、SEQ ID NO:20、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、SEQ ID NO:30、SEQ ID NO:31、SEQ ID NO:32、SEQ ID NO:33及びSEQ ID NO:34よりなる群から 選択するアミノ酸配列を含むCDR3ドメインをコードする単離された核酸。 34.SEQ ID NO:1のアミノ酸配列を含む抗体軽鎖可変領域をコードする単離さ れた核酸。 35.抗体軽鎖可変領域及び抗体軽鎖定常領域をコードする、請求項34に記載 の単離された核酸。 36.組換え発現ベクターである、請求項35に記載の単離された核酸。 37.SEQ ID NO:2のアミノ酸配列を含む抗体重鎖可変領域をコードする単離さ れた核酸。 38.抗体重鎖可変領域及び抗体重鎖定常領域をコードする、請求項37に記載 の単離された核酸。 39.抗体重鎖定常領域がIgG1定常領域である、請求項38に記載の単離さ れた核酸。 40.抗体重鎖定常領域がIgG4定常領域である、請求項38に記載の単離さ れた核酸。 41.組換え発現ベクターである、請求項38に記載の単離された核酸。 42.下記をコードする組換え発現ベクター: a)SEQ ID NO:1のアミノ酸配列を含む可変領域を有する抗体軽鎖;及び b)SEQ ID NO:2のアミノ酸配列を含む可変領域を有する抗体重鎖。 43.請求項42に記載の組換え発現ベクターが導入された宿主細胞。 44.ヒトTNFαに結合するヒト抗体を合成する方法であって、請求項43に 記載の宿主細胞を培養培地中で、ヒトTNFαに結合するヒト抗体がその細胞に より合成されるまで培養することを含む当該方法。 45.請求項1〜24の何れかに記載の抗体又はその抗原結合部分及び製薬上許 容し得るキャリアーを含む製薬組成物。 46.TNFα活性が有害である病気の治療のための少なくとも一種の追加の治 療剤を更に含む、請求項45に記載の製薬組成物。 47.ヒトTNFα活性を阻害する方法であって、ヒトTNFαを、請求項1〜 24の何れかに記載の抗体又はその抗原結合部分と、ヒトTNFα活性が阻害さ れるように接触させることを含む当該方法。 48.TNFα活性が有害である病気を患っているヒト患者においてヒトTNF α活性を阻害する方法であって、そのヒト患者に、請求項1〜24の何れかに記 載の抗体又はその抗原結合部分を、そのヒト患者におけるヒトTNFα活性が阻 害されるように投与することを含む当該方法。 49.病気が敗血症である、請求項48に記載の方法。 50.抗体を、ヒト患者に、サイトカインインターロイキン6(IL−6)と一 緒に投与するか又は約500pg/mlの血清若しくは血漿IL−6濃度を有す るヒト患者に投与する、請求項49に記載の方法。 51.病気が自己免疫疾患である、請求項48に記載の方法。 52.自己免疫疾患を、リウマチ様関節炎、リウマチ様脊椎炎、骨関節炎及び通 風関節炎よりなる群から選択する、請求項51に記載の方法。 53.自己免疫疾患を、アレルギー、多発性硬化症、自己免疫性糖尿病、自己免 疫性ブドウ膜炎及びネフローゼ症候群よりなる群から選択する、請求項51に記 載の方法。 54.病気が感染性疾患である、請求項48に記載の方法。 55.病気が移植拒絶又は移植片対宿主病である、請求項48に記載の方法。 56.病気が悪性疾患である、請求項48に記載の方法。 57.病気が肺病である、請求項48に記載の方法。 58.病気が腸疾患である、請求項48に記載の方法。 59.病気が心臓病である、請求項48に記載の方法。 60.病気を、炎症性骨疾患、骨吸収病、アルコール性肝炎、ウイルス性肝炎、 劇症肝炎、凝固障害、火傷、再潅流傷害、ケロイド形成、瘢痕組織形成、発熱、 歯周病、肥満及び照射毒性よりなる群から選択する、請求項48に記載の方法。 61.TNFα活性が有害である病気の治療のための医薬の製造における請求項 1〜24の何れかに記載の抗体又はその抗原結合部分の利用。 62.病気が敗血症である、請求項61に記載の利用。 63.抗体を、ヒト患者に、サイトカインインターロイキン6(IL−6)と一 緒に投与するか又は約500pg/mlの血清若しくは血漿IL−6濃度を有す るヒト患者に投与する、請求項62に記載の利用。 64.病気が自己免疫疾患である、請求項61に記載の利用。 65.自己免疫疾患を、リウマチ様関節炎、リウマチ様脊椎炎、骨関節炎及び通 風関節炎よりなる群から選択する、請求項64に記載の利用。 66.自己免疫疾患を、アレルギー、多発性硬化症、自己免疫性糖尿病、自己免 疫性ブドウ膜炎及びネフローゼ症候群よりなる群から選択する、請求項64に記 載の利用。 67.病気が感染性疾患である、請求項61に記載の利用。 68.病気が移植拒絶又は移植片対宿主病である、請求項61に記載の利用。 69.病気が悪性疾患である、請求項61に記載の利用。 70.病気が肺病である、請求項61に記載の利用。 71.病気が腸疾患である、請求項61に記載の利用。 72.病気が心臓病である、請求項61に記載の利用。 73.病気を、炎症性骨疾患、骨吸収病、アルコール性肝炎、ウイルス性肝炎、 劇症肝炎、凝固障害、火傷、再潅流傷害、ケロイド形成、瘢痕組織形成、発熱、 歯周病、肥満及び照射毒性よりなる群から選択する、請求項61に記載の利用。 74.追加の治療剤を、非ステロイド系抗炎症性薬物、サイトカイン抑制性抗炎 症性薬物、CDP−571/BAY−10−3356、cA2、75kdTNF R−IgG、55kdTNFR−IgG、IDEC−CE9.1/SB2103 96、DAB486−IL−2、DAB389−IL−2、アンチ−Tac、I L−4、IL−10、IL−4アゴニスト、IL−10アゴニスト、IL−1R A、TNF−bp/s−TNFR、S284、R973401、MK−966、 イロプロスト、メトトレキセート、サリドマイド、サリドマイド関連薬物、レフ ルノマイド、トラネザミン酸、T−614、プロスタグランジンE1、テニダッ プ、ナプロキセン、メロキシカム、ピロキシカム、ジクロフェナック、インドメ タシン、スルファサラジン、アザチオプリン、ICE阻害剤、zap−70阻害 剤、lck阻害剤、VEGF阻害剤、VEGF−R阻害剤、コルコステロイド、 TNF変換阻害剤、抗IL−12抗体、インターロイキン11、インターロイキ ン13、インターロイキン17阻害剤、金、ペニシラミン、クロロキン、ヒドロ キシクロロキン、クロラムブシル、シクロホスファミド、シクロスポリン、抗胸 腺細胞グロブリン、抗CD4抗体、CD5トキシン、経口投与されるペプチド、 コラーゲン、ロベンザリト二ナトリウム、サイトカイン調節剤HP228及びH P466、ICAM−1アンチセンスホスホロチオエートオリゴデ オキシヌクレオチド、可溶性補体レセプター1、プレドニソン、オルゴテイン、 グリコサミノグリカンポリスルフェート、ミノシクリン、抗IL2R抗体、海洋 脂質、植物性脂質、オーラノフィン、フェニルブタゾン、メクロフェナミン酸、 フルフェナミン酸、静脈内免疫グロブリン、ジロイトン、ミコフェノール酸、タ クロリマス、シロリマス、アミプリロース、クラドリビン、アザリビン、ブデノ シド、表皮成長因子、アミノサリチレート、6−メルカプトプリン、メトロニダ ゾール、リポキシゲナーゼ阻害剤、メサラミン、オルサラジン、バルサラジド、 抗酸化剤、トロンボキサン阻害剤、IL−1レセプターアンタゴニスト、抗IL −1βモノクローナル抗体、抗IL−6モノクローナル抗体、成長因子、エラス ターゼ阻害剤、ピリジニル−イミダゾール化合物、プレドニゾロン、デキサメタ ゾン又はブデソニドのグルクロニド結合したプロドラッグ、プレドニゾロン、デ キサメタゾン又はブデソニドのデキストラン結合したプロドラッグ、可溶性補体 レセプター1、遅延放出用メサラジン、血小板活性化因子(PAF)のアンタゴ ニスト、シプロフロクサシン、リグノカイン、プレドニゾロン、メチルプレドニ ゾロン、シクロホスファミド、4−アミノピリジン、チザニジン、インターフェ ロン−β1a、インターフェロン−β1b、コポリマー1、高圧酸素、静脈内免 疫グロブリン、クラブリビン、高張塩溶液、抗生物質、連続的血液透過物、カル バペネム、サイトカイン例えばTNFα、IL−1β、IL−6及び/又はIL −8のアンタゴニスト、SK&F107647、4価のグアニルヒドラゾンCN I−1493、組織因子経路阻害剤、PHP、鉄キレート化剤及びキレート(ジ エチレントリアミン五酢酸−鉄(III)複合体を含む)、リソフィリン、PG G−グルカン、脂質で再構成されたアポリポ蛋白質A−1、キラルヒドロキサム 酸、抗エンドトキシン抗体、E5531、rBPI21、合成抗エンドトキシンペ プチド、界面活性剤置換治療及び抗IL−8抗体よりなる群から選択する、請求 項46に記載の製薬組成物。 75.請求項1〜24の何れかに記載の抗体又はその抗原結合部分の治療におけ る利用。 76.TNFα活性が有害である病気の治療のための少なくとも一種の追加の治 療剤と組み合わせた、請求項1〜24の何れかに記載の抗体又はその抗原結合 部分の治療における利用。 77.追加の治療剤を、非ステロイド系抗炎症性薬物、サイトカイン抑制性抗炎 症性薬物、CDP−571/BAY−10−3356、cA2、75kdTNF R−IgG、55kdTNFR−IgG、IDEC−CE9.1/SB2103 96、DAB486−IL−2、DAB389−IL−2、アンチ−Tac、I L−4、IL−10、IL−4アゴニスト、IL−10アゴニスト、IL−1R A、TNF−bp/s−TNFR、S284、R973401、MK−966、 イロプロスト、メトトレキセート、サリドマイド、サリドマイド関連薬物、レフ ルノマイド、トラネザミン酸、T−614、プロスタグランジンE1、テニダッ プ、ナプロキセン、メロキシカム、ピロキシカム、ジクロフェナック、インドメ タシン、スルファサラジン、アザチオプリン、ICE阻害剤、zap−70阻害 剤、lck阻害剤、VEGF阻害剤、VEGF−R阻害剤、コルコステロイド、 TNF変換阻害剤、抗IL−12抗体、インターロイキン11、インターロイキ ン13、インターロイキン17阻害剤、金、ペニシラミン、クロロキン、ヒドロ キシクロロキン、クロラムブシル、シクロホスファミド、シクロスポリン、抗胸 腺細胞グロブリン、抗CD4抗体、CD5トキシン、経口投与されるペプチド、 コラーゲン、ロベンザリトニナトリウム、サイトカイン調節剤HP228及びH P466、ICAM−1アンチセンスホスホロチオエートオリゴデオキシヌクレ オチド、可溶性補体レセプター1、プレドニソン、オルゴテイン、グリコサミノ グリカンポリスルフェート、ミノシクリン、抗IL2R抗体、海洋脂質、植物性 脂質、オーラノフィン、フェニルブタゾン、メクロフェナミン酸、フルフェナミ ン酸、静脈内免疫グロブリン、ジロイトン、ミコフェノール酸、タクロリマス、 シロリマス、アミプリロース、クラドリビン、アザリビン、ブデノシド、表皮成 長因子、アミノサリチレート、6−メルカプトプリン、メトロニダゾール、リポ キシゲナーゼ阻害剤、メサラミン、オルサラジン、バルサラジド、抗酸化剤、ト ロンボキサン阻害剤、IL−1レセプターアンタゴニスト、抗IL−1βモノク ローナル抗体、抗IL−6モノクローナル抗体、成長因子、エラスターゼ阻害剤 、ビリジニル−イミダゾール化合物、プレドニゾロン、デキサメタゾン又はブデ ソニドのグルクロニド結合したプロドラッグ、プレドニゾロ ン、デキサメタゾン又はブデソニドのデキストラン結合したプロドラッグ、可溶 性補体レセプター1、遅延放出用メサラジン、血小板活性化因子(PAF)のア ンタゴニスト、シプロフロクサシン、リグノカイン、プレドニゾロン、メチルプ レドニゾロン、シクロホスファミド、4−アミノピリジン、チザニジン、インタ ーフェロン−β1a、インターフェロン−β1b、コポリマー1、高圧酸素、静 脈内免疫グロブリン、クラブリビン、高張塩溶液、抗生物質、連続的血液透過物 、カルバペネム、サイトカイン例えばTNFα、IL−1β、IL−6及び/又 はIL−8のアンタゴニスト、SK&F107647、4価のグアニルヒドラゾ ンCNI−1493、組織因子経路阻害剤、PHP、鉄キレート化剤及びキレー ト(ジエチレントリアミン五酢酸−鉄(III)複合体を含む)、リソフィリン 、PGG−グルカン、脂質で再構成されたアポリポ蛋白質A−1、キラルヒドロ キサム酸、抗エンドトキシン抗体、E5531、rBPI21、合成抗エンドトキ シンペプチド、界面活性剤置換治療及び抗IL−8抗体よりなる群から選択する 、請求項76に記載の利用。
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US08/599,226 US6090382A (en) | 1996-02-09 | 1996-02-09 | Human antibodies that bind human TNFα |
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US3147696P | 1996-11-25 | 1996-11-25 | |
US60/031,476 | 1996-11-25 | ||
PCT/US1997/002219 WO1997029131A1 (en) | 1996-02-09 | 1997-02-10 | HUMAN ANTIBODIES THAT BIND HUMAN TNF$g(a) |
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