JP2019514396A - チェックポイント不全およびそれに関する方法 - Google Patents
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Abstract
Description
本発明の分野は、免疫療法に関する治療の層別化を可能にするための様々なオーミクスのデータのコンピュータ解析、特には、チェックポイント阻害剤の治療に対して起こり得るレスポンダーを同定するための経路ベースの解析である。
既知の病歴を有する患者の集団からのデータセットを使用して、乳癌に関連した経路の同定を行った。この試験において乳癌を有するMicMa患者(n=101)は、1995年から1998年までに限局性乳癌を治療した患者のコホートの一部であった。UPPSALAコホート由来の試料を、Fresh Tissue Biobank, Department of Pathology, Uppsala University Hospitalで回収し、3種類の原発性乳癌の病変(a)純性のDCIS(pure DCIS)、(b)直径15mm以下の純性の浸潤性乳癌、または(c)混合性病変(in situでの成分を伴う浸潤性細胞腫)のうちの1つを有すると、1986年〜2004年に診断された854名の女性の集団をベースとするコホートから選択した。本明細書中健常な女性と呼ばれる、悪性疾患を有さないが、マンモグラム上でいくらかの眼に見える濃度を伴う120名の健常な女性を含む、マンモグラフィー濃度および遺伝子コホート(Mammographic Density and Genetics)を、この試験に含めた。2つの乳癌の生検および3つの血液試料を、各女性から回収した。Chinバリデーションセットは、両方の発現(GEO寄託番号第GSE6757)およびCGHデータ(MIAMEExpress accession E−Ucon−1)を有する113個の腫瘍試料からなるものであった。UNCバリデーションのデータセットは、両方の発現(44K;Agilent Technologies)およびSNP−CGH(109K;Illumina)を有する78個の腫瘍の試料からなるものであった。
Claims (20)
- チェックポイント阻害剤での癌の免疫療法に関する起こり得る治療上のアウトカムを予測する方法であって、
全ゲノムのシークエンシングデータおよびRNAのシークエンシングデータのうちの少なくとも1つを含む、患者の腫瘍由来のオーミクスのデータを得るステップと、
前記オーミクスのデータから、複数の各経路の要素を有する複数の免疫関連経路において高度に発現する複数の遺伝子を同定するための経路解析を使用するステップと、
前記高度に発現した遺伝子が、Th2/液性応答および低いTh1/Th2比を表す場合に、前記高度に発現した遺伝子を、前記チェックポイント阻害剤での治療に対して起こり得る癌の応答に関連させるステップと、
前記高度に発現した遺伝子が、Th2/液性応答および低いTh1/Th2比を表す場合に、前記チェックポイント阻害剤での治療に対して起こり得る癌の応答の徴候で、患者の記録を更新または作製するステップと
を含む、方法。 - 前記免疫関連経路が、免疫細胞機能経路、炎症促進性シグナリング経路、および免疫抑制経路からなる群から選択される、請求項1に記載の方法。
- 前記経路の要素が、Th1の分化、Th2の分化、B細胞の分化、マクロファージの分化、T細胞の活性化、および免疫プロテアソームのうちの少なくとも1つの活性を制御する、請求項1に記載の方法。
- 前記経路の要素が、NFkB、IFNαの応答遺伝子のうちの少なくとも1つの活性を制御する、請求項1に記載の方法。
- 前記経路の要素が、サイトカインである、請求項1に記載の方法。
- 前記サイトカインが、IL12β、IFNγ、IL4、IL5、およびIL10からなる群から選択される、請求項1に記載の方法。
- 前記経路の要素が、ケモカインである、請求項1に記載の方法。
- 前記ケモカインが、CCL17、CCL11、およびCCL26からなる群から選択される、請求項1に記載の方法。
- 前記経路の要素が、IL12B、IFNG、PSMA3、THY1、CCL17、PRKCQ、NFATC3、NFATC2、CCL11、CCL26、IFNAR2、SQSTM1、IRAK4、NFKBIA、IL6ST、MAP3K1、IRF1、IRF9、PTGS2、IL4、IL5、IGHG3、IL4R、IL13RA2、PIGR、IL13RA1、STAT6、FCER2、IGHG1、IL10、STAT5A、PRKCE、CSF1R、ARG1、LTA、SELP、FKBP3、LCP2、およびDOK2からなる群から選択される、請求項1に記載の方法。
- 前記経路の要素が、IFN−γ/IRF1、STAT6(二量体)/PARP14、IL4/IL4R/JAK1、IL4R/JAK1、STAT6(二量体)/ETS1、PI3K/BCAP/CD19、IL4/IL4R/JAK1/IL2Rγ/JAK3/DOK2、IL4/IL4R/JAK1/IL2Rγ/JAK3/SHIP、IL4/IL4R/JAK1/IL13RA1/JAK2、IL4/IL4R/JAK1/IL2Rγ/JAK3/SHC/SHIP、IL4/IL4R/JAK1/IL2Rγ/JAK3/FES/IRS2、IL4/IL4R/JAK1/IL2Rγ/JAK3、IL4/IL4R/JAK1/IL2Rγ/JAK3/SHC/SHIP/GRB2、IL4/IL4R/JAK1/IL2Rγ/JAK3/IRS1、IL4/IL4R/JAK1/IL2Rγ/JAK3/FES、IL4/IL4R/JAK1/IL2Rγ/JAK3/SHP1からなる群から選択される複合体である、請求項1に記載の方法。
- 前記オーミクスのデータが、siRNAのデータ、DNAのメチル化状態のデータ、転写レベルのデータ、およびプロテオミクスのデータのうちの少なくとも1つをさらに含む、請求項1に記載の方法。
- 前記経路解析が、PARADIGM解析を含む、請求項1に記載の方法。
- 前記オーミクスのデータを、同じ患者に対して正規化する、請求項1に記載の方法。
- 前記チェックポイント阻害剤が、CTLA−4阻害剤またはPD−1阻害剤である、請求項1に記載の方法。
- 前記癌が、乳癌であり、前記高度に発現した遺伝子が、FOXM1をさらに含む、請求項1に記載の方法。
- 前記高度に発現した遺伝子が、分裂促進のシグナリング、ストレスのシグナリング、アポトーシス、カルシウム/カルモジュリンのシグナリング、Gタンパク質のシグナリング、PI3K/AKTのシグナリング、RTKのシグナリング、Wntのシグナリング、およびcAMPのシグナリングのうちの少なくとも1つに関与しているタンパク質をコードする非免疫遺伝子をさらに含む、請求項1に記載の方法。
- 前記高度に発現した遺伝子が、細胞周期の制御、DNA損傷の応答、およびクロマチンのリモデリングのうちの少なくとも1つに関与しているタンパク質をコードする非免疫遺伝子をさらに含む、請求項1に記載の方法。
- 前記高度に発現した遺伝子が、MAPK1、MAPK14、NRP2、HIF1A、CALM1、CREB1、CSNK1A1、CSNK1G3、CCNH、FANCE、FANCA、TFIIH、ITGB3、RASA1、GNG2、PDGFRB、AKT1、およびPIK3R1からなる群から選択される非免疫遺伝子をさらに含む、請求項1に記載の方法。
- 前記チェックポイント阻害剤での治療の前に、起こり得る治療上のアウトカムを予測する、請求項1に記載の方法。
- 前記免疫療法が、遺伝子改変したウイルスおよび遺伝子改変したNK細胞のうちの少なくとも1つの投与をさらに含む、請求項1に記載の方法。
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US201662332047P | 2016-05-05 | 2016-05-05 | |
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PCT/US2017/031418 WO2017193080A1 (en) | 2016-05-05 | 2017-05-05 | Checkpoint failure and methods therefor |
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WO2020136667A1 (en) * | 2018-12-27 | 2020-07-02 | Srinivasan N A Mahalakshmi | Incorporating variant information into omics data |
EP3778923A1 (en) * | 2019-08-14 | 2021-02-17 | Eberhard Karls Universität Tübingen Medizinische Fakultät | Method for classifying a patient's responsiveness to immune checkpoint inhibitor therapy |
CN111773380A (zh) * | 2020-04-26 | 2020-10-16 | 郑州大学第一附属医院 | Plpp1在制备t细胞免疫肿瘤相关药剂中的应用 |
WO2023244026A1 (ko) * | 2022-06-16 | 2023-12-21 | 국립암센터 | Foxm1 억제제 및 면역관문 억제제를 포함하는 암의 예방 또는 치료용 약학적 조성물 |
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SI1853721T1 (sl) * | 2005-02-18 | 2010-06-30 | Astrazeneca Ab | Postopek za ugotavljanje odzivnosti na CHK inhibitorje |
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US20190147976A1 (en) | 2019-05-16 |
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KR20180126085A (ko) | 2018-11-26 |
AU2017261353A1 (en) | 2018-11-08 |
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