JP2020522495A5 - - Google Patents
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- JP2020522495A5 JP2020522495A5 JP2019566156A JP2019566156A JP2020522495A5 JP 2020522495 A5 JP2020522495 A5 JP 2020522495A5 JP 2019566156 A JP2019566156 A JP 2019566156A JP 2019566156 A JP2019566156 A JP 2019566156A JP 2020522495 A5 JP2020522495 A5 JP 2020522495A5
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Claims (30)
- PD−1経路阻害剤および免疫療法剤と組み合わせてヒト患者における悪性腫瘍を処置することにおいて使用するための、LAG−3阻害剤を含む医薬組成物。
- LAG−3阻害剤が、抗LAG−3抗体またはその抗原結合フラグメント、またはLAG−3細胞外ドメインのリガンド結合フラグメントを含む可溶性LAG−3ポリペプチドを含む、請求項1に記載の医薬組成物。
- 抗LAG−3抗体が二特異性抗体を含む、請求項2に記載の医薬組成物。
- (a)抗LAG−3抗体またはその抗原結合フラグメントが(i)配列番号7に示す配列を含む重鎖可変領域CDR1;(ii)配列番号8に示す配列を含む重鎖可変領域CDR2;(iii)配列番号9に示す配列を含む重鎖可変領域CDR3;(iv)配列番号10に示す配列を含む軽鎖可変領域CDR1;(v)配列番号11に示す配列を含む軽鎖可変領域CDR2;および(vi)配列番号12に示す配列を含む軽鎖可変領域CDR3を含む、
(b)抗LAG−3抗体またはその抗原結合フラグメントがそれぞれ配列番号3および5に示す配列を含む重鎖および軽鎖可変領域を含む、または
(c)抗LAG−3抗体がBMS 986016、MK−4280(28G−10)、REGN3767、GSK2831781、IMP731(H5L7BW)、BAP050、IMP−701(LAG−5250)、TSR−033、LAG525、BI 754111またはFS−118を含む、
請求項2または3に記載の医薬組成物。 - LAG−3細胞外ドメインのリガンド結合フラグメントが配列番号44に少なくとも90%、少なくとも95%、少なくとも98%または少なくとも99%配列同一性を有するアミノ酸配列を含む、請求項2に記載の医薬組成物。
- 可溶性LAG−3ポリペプチドが融合ポリペプチドを含む、請求項2または5に記載の医薬組成物。
- 可溶性LAG−3ポリペプチドがFcドメインを含む、請求項2、5または6の何れかに記載の医薬組成物。
- 可溶性LAG−3ポリペプチドがIMP321(Eftilagimod Alpha)を含む、請求項2または5〜7に記載の医薬組成物。
- PD−1経路阻害剤が抗PD−1抗体またはその抗原結合フラグメント、抗PD−L1抗体またはその抗原結合フラグメント、小分子薬物、細胞ベースの治療、またはPD−1細胞外ドメインのリガンド結合フラグメントを含む可溶性PD−1ポリペプチドを含む、請求項1〜8の何れかに記載の医薬組成物。
- 抗PD−1抗体が、ペムブロリズマブ(キイトルーダ;MK−3475)、ピディリズマブ(CT−011)、ニボルマブ(オプジーボ;BMS−936558)、PDR001、MEDI0680(AMP−514)、TSR−042、REGN2810、JS001、AMP−224(GSK−2661380)、PF−06801591、BGB−A317、BI 754091またはSHR−1210を含む、請求項9に記載の医薬組成物。
- 抗PD−L1抗体が、アテゾリズマブ(テセントリク;RG7446;MPDL3280A;RO5541267)、デュルバルマブ(MEDI4736)、BMS−936559、アベルマブ(バベンチオ)、LY3300054、CX−072(Proclaim−CX−072)、FAZ053、KN035またはMDX−1105を含む、請求項9に記載の医薬組成物。
- 小分子薬物がCA−170を含む、請求項9に記載の医薬組成物。
- 細胞ベースの治療が、MiHA負荷PD−L1/L2発現抑制樹状細胞ワクチン、多能性キラーTリンパ球を発現する抗プログラム細胞死タンパク質1抗体、自己PD−1標的化キメラスイッチ受容体修飾Tリンパ球またはPD−1ノックアウト自己Tリンパ球を含む、請求項9に記載の医薬組成物。
- 可溶性PD−1ポリペプチドがFcドメインを含む融合ポリペプチドを含む、請求項9に記載の医薬組成物。
- 免疫療法剤が、CTLA−4活性のモジュレーター、CD28活性のモジュレーター、CD80活性のモジュレーター、CD86活性のモジュレーター、4−1BB活性のモジュレーター、OX40活性のモジュレーター、KIR活性のモジュレーター、Tim−3活性のモジュレーター、CD27活性のモジュレーター、CD40活性のモジュレーター、GITR活性のモジュレーター、TIGIT活性のモジュレーター、CD20活性のモジュレーター、CD96活性のモジュレーター、IDO1活性のモジュレーター、STING活性のモジュレーター、GARP活性のモジュレーター、A2aR活性のモジュレーター、CEACAM1活性のモジュレーター、CEA活性のモジュレーター、CD47活性のモジュレーター、PVRIG活性のモジュレーター、TDO活性のモジュレーター、VISTA活性のモジュレーター、サイトカイン、ケモカイン、インターフェロン、インターロイキン、リンホカイン、腫瘍壊死因子(TNF)ファミリーのメンバー、免疫刺激オリゴヌクレオチド、免疫チェックポイント阻害剤、免疫チェックポイント増強因子または刺激因子、TLR9アゴニスト、サイトカイン、TGF−βアンタゴニスト、iNOSアンタゴニスト、SHP−1アンタゴニスト、CSF1R(コロニー刺激因子1受容体)アンタゴニスト、TNFファミリーメンバーのアゴニスト、アルデスロイキン、トシリズマブ、MEDI5083、CD160(NK1)アゴニスト、またはこれらの何らかの組み合わせを含む、請求項1〜14の何れかに記載の医薬組成物。
- 免疫チェックポイント阻害剤が、CTLA−4アンタゴニスト、CD80アンタゴニスト、CD86アンタゴニスト、Tim−3アンタゴニスト、TIGITアンタゴニスト、CD20アンタゴニスト、CD96アンタゴニスト、IDO1アンタゴニスト、STINGアンタゴニスト、GARPアンタゴニスト、CD40アンタゴニスト、A2aRアンタゴニスト、CEACAM1(CD66a)アンタゴニスト、CEAアンタゴニスト、CD47アンタゴニスト、PVRIGアンタゴニスト、TDOアンタゴニスト、VISTAアンタゴニスト、KIRアンタゴニスト、またはこれらの何らかの組み合わせを含む、請求項15に記載の医薬組成物。
- CTLA−4アンタゴニストが、抗CTLA−4抗体またはその抗原結合フラグメント、可溶性CTLA−4ポリペプチド、または細胞ベースの治療を含む、請求項16に記載の医薬組成物。
- 抗CTLA−4抗体が、イピリムマブ(ヤーボイ)、トレメリムマブ(チシリムマブ;CP−675,206)、AGEN−1884またはATOR−1015を含む、請求項17に記載の医薬組成物。
- 可溶性CTLA−4ポリペプチドが、アバタセプト(オレンシア)、ベラタセプト(Nulojix)、RG2077またはRG−1046を含む、請求項17に記載の医薬組成物。
- 細胞ベースの治療が、抗CTLA4 mAb RNA/GITRL RNAトランスフェクト自己樹状細胞ワクチンまたは抗CTLA−4 mAb RNAトランスフェクト自己樹状細胞ワクチンを含む、請求項17に記載の医薬組成物。
- 免疫チェックポイント増強因子または刺激因子がCD28アゴニスト、4−1BBアゴニスト、OX40アゴニスト、CD27アゴニスト、CD80アゴニスト、CD86アゴニスト、CD40アゴニスト、ICOSアゴニスト、CD70アゴニスト、GITRアゴニスト、またはこれらの何らかの組み合わせを含む、請求項15に記載の医薬組成物。
- LAG−3阻害剤およびPD−1経路阻害剤が、非経腸投与用に製剤される、請求項1〜21の何れかに記載の医薬組成物。
- LAG−3阻害剤およびPD−1経路阻害剤が、一製剤に製剤される、請求項1〜22の何れかに記載の医薬組成物。
- LAG−3阻害剤、PD−1経路阻害剤および免疫療法剤が、別々に製剤される、請求項1〜22の何れかに記載の医薬組成物。
- 悪性腫瘍が肝臓癌、骨癌、膵臓癌、皮膚癌、口腔癌、頭頚部癌、乳癌、肺癌、皮膚または眼内悪性黒色腫、腎臓癌、子宮癌、卵巣癌、結腸直腸癌、結腸癌、直腸癌、肛門癌、胃癌、精巣癌、子宮癌、卵管癌、子宮内膜癌、子宮頸癌、膣癌、外陰癌、非ホジキンリンパ腫、食道癌、小腸癌、内分泌系癌、甲状腺癌、副甲状腺癌、副腎癌、軟組織肉腫、尿道癌、陰茎癌、小児癌、リンパ球性リンパ腫、膀胱癌、腎臓または輸尿管癌、腎盂癌、中枢神経系(CNS)新生物、原発性CNSリンパ腫、腫瘍血管形成、脊髄軸腫瘍、脳幹神経膠腫、下垂体腺腫、カポジ肉腫、類表皮癌、扁平上皮細胞癌、環境誘発癌、血液系腫瘍、ウイルス関連癌、またはこれらの何らかの組み合わせからなる群から選択される、請求項1〜24の何れかに記載の医薬組成物。
- 悪性腫瘍が、黒色腫、小細胞肺癌、非小細胞肺癌(NSCLC)、ヒトパピローマウイルス(HPV)関連腫瘍、胃腺癌、多発性骨髄腫、B細胞リンパ腫、ホジキンリンパ腫/原発性縦隔B細胞リンパ腫、非ホジキンリンパ腫、急性骨髄リンパ腫、慢性骨髄性白血病、慢性リンパ系白血病、濾胞性リンパ腫、汎発性大B細胞リンパ腫、バーキットリンパ腫、免疫芽球性大細胞リンパ腫、前駆体Bリンパ芽球性リンパ腫、マントル細胞リンパ腫、急性リンパ芽球性白血病、菌状息肉症、未分化大細胞リンパ腫、T細胞リンパ腫、前駆体Tリンパ芽球性リンパ腫、胃食道接合部癌、頭頚部扁平上皮細胞癌、腎細胞癌、肝細胞癌、またはこれらの何らかの組み合わせである、請求項1〜25の何れかに記載の医薬組成物。
- 抗LAG−3抗体またはその抗原結合フラグメントおよび免疫療法剤が第一選択処置または第二選択処置として投与される、請求項1〜26のいずれかに記載の医薬組成物。
- 悪性腫瘍が第一選択処置に難治性である、請求項1〜27の何れかに記載の医薬組成物。
- 少なくとも一つの付加的治療剤の投与をさらに含む、請求項1〜28の何れかに記載の医薬組成物。
- 少なくとも一つの付加的治療剤が化学療法剤を含む、請求項29に記載の医薬組成物。
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-
2018
- 2018-05-30 KR KR1020197038188A patent/KR20200010500A/ko unknown
- 2018-05-30 US US16/616,569 patent/US20210340250A1/en not_active Abandoned
- 2018-05-30 EP EP18734678.8A patent/EP3630842A2/en not_active Withdrawn
- 2018-05-30 CA CA3060989A patent/CA3060989A1/en active Pending
- 2018-05-30 AU AU2018277559A patent/AU2018277559A1/en active Pending
- 2018-05-30 EP EP23174625.6A patent/EP4245375A3/en active Pending
- 2018-05-30 JP JP2019566156A patent/JP2020522495A/ja active Pending
- 2018-05-30 MX MX2019012038A patent/MX2019012038A/es unknown
- 2018-05-30 WO PCT/US2018/035125 patent/WO2018222711A2/en active Application Filing
- 2018-05-30 CN CN201880036532.7A patent/CN110691795A/zh active Pending
- 2018-05-30 BR BR112019018759A patent/BR112019018759A2/pt unknown
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2019
- 2019-09-03 IL IL26909019A patent/IL269090A/en unknown
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2022
- 2022-08-10 US US17/818,838 patent/US20230111786A1/en active Pending
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2023
- 2023-07-06 JP JP2023111618A patent/JP2023126946A/ja active Pending
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