JP2018197246A - 細菌株を含む組成物 - Google Patents
細菌株を含む組成物 Download PDFInfo
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- JP2018197246A JP2018197246A JP2018139488A JP2018139488A JP2018197246A JP 2018197246 A JP2018197246 A JP 2018197246A JP 2018139488 A JP2018139488 A JP 2018139488A JP 2018139488 A JP2018139488 A JP 2018139488A JP 2018197246 A JP2018197246 A JP 2018197246A
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Abstract
Description
腸内微生物叢は、2つの主要な細菌門、バクテロイデス門(Bacteroidetes)及びフィル
ミクテス門(Firmicutes)に本質的に属する、500〜1000を超える様々なフィロタイプを含む(Eckburg et al. (2005) Science. 10;308(5728):1635-8)。ヒトの腸の細菌の定着から生じる共生関係の成功により、極めて多様な代謝機能、構造機能、保護機能及び他の有益な機能がもたらされてきた。定着した腸の代謝活性が増強することにより、そうでなければ消化されない食物成分が分解され、副生成物の放出により宿主にとって重要な栄養源がもたらされることが、確実となる。同様に、腸内微生物叢の免疫学的重要性は、十分に認識されており、共生細菌の導入に続いて機能的に再構築される免疫系に障害のある無菌動物において例示されている(Macpherson et al. (2001) Microbes Infect. 3(12):1021-35、Macpherson et al. (2002) Cell Mol Life Sci. 59(12):2088-96、Mazmanian et al. (2005) Cell 15;122(1):107-18)。
ラスターXIVa細菌のレベルが、IBD患者において減少し、一方で大腸菌(E. coli)の数が増加し、これは、腸内での共生生物及び病原性共生生物の均衡のシフトを示唆している(Frank et al. (2007) PNAS 104(34):13780-5、Scanlan et al. (2006) J Clin Microbiol. 44(11):3980-8、Kang et al. (2010) Inflamm Bowel Dis. 16(12):2034-42、Machiels et al. (2013) Gut. 63(8):1275-83)。興味深いことに、この腸内菌共生バランス失調はまた、Tエフェクター細胞集団の不均衡と関連付けられる。
疫系障害を治療するのに有用な可能性があると推測しているが、どの細菌が効果的であるかについては指針が提供されていない。
様々な属からなる20種の細菌混合物がどのようにTh17細胞の増殖及び集積を誘導す
るかについて記載している。Honda et al.の組成物は、免疫機能の改善、及び感染性疾患の予防又は治療に有用であるといわれている。しかし、Honda et al.は、個体において自己免疫疾患及び炎症性疾患を治療するために、Th17を誘導する細菌は、例えば患者に抗生物質を投与することにより、抑制すべき又は死滅させるべきであると教示している。
にTh17炎症応答を緩和することができることを特定している。
病;アテローム性動脈硬化症;アトピー性皮膚炎;肺気腫;歯周炎;アレルギー性鼻炎;及び同種異系移植片拒絶からなる群から選択される疾患又は状態を治療又は予防する方法に使用するための、エリシペラトクロストリジウム属の細菌株を含む組成物を提供する。Th17炎症応答に対して並びにIL−17及びTh17経路によって媒介される疾患に対して、エリシペラトクロストリジウム属の細菌株について示された効果は、上に列記されたものなどの、IL−17及びTh17経路によって媒介される他の疾患及び状態に対して、治療上の利益を提供することができる。
使用するための、エリシペラトクロストリジウム属の細菌株を含む組成物を提供する。エリシペラトクロストリジウム株での治療により、多発性硬化症のマウスモデルにおいて疾患の発生率及び疾患の重症度を低減させることができる。好ましい実施形態において、本発明は、多発性硬化症の治療に使用するための、エリシペラトクロストリジウム・ラモスム種の細菌株を含む組成物を提供する。エリシペラトクロストリジウム・ラモスムを使用している組成物は、多発性硬化症を治療するのに特に有効でありうる。
は、細菌の送達を可能とする安定な組成物を調製するのに有効で簡便な技法である。
42688として寄託されたMRX027)又はその派生物の細胞を提供する。
細菌株
本発明の組成物は、エリシペラトクロストリジウム属の細菌株を含む。実施例は、この属の細菌がブドウ膜炎並びにIL−17又はTh17経路によって媒介される疾患及び状態を治療又は予防するのに有用であることを実証している。好ましい細菌株は、エリシペラトクロストリジウム・ラモスム種である。
ッカログミア(saccharogumia)、(C.)スピロフォルム(spiroforme)及び(C.)
イノキューム(innocuum)(最近Yutin and Galperin (2013) Environ Microbiol. 15(10): 2631-2641において再分類された)が挙げられる。エリシペラトクロストリジウムは、0.3〜1.0μm×2〜4μmのグラム陽性染色、非運動性、偏性嫌気性桿菌及びらせん菌である。胞子形成は稀であるか又は非存在である。したがって、本発明の一部の実施形態において、エリシペラトクロストリジウム細菌株は胞子形成の形態ではなく又は胞子がある場合それはごく微量で存在する。ゲノムDNAのG+C含量は、27〜33mol%である。エリシペラトクロストリジウム属はグルコース、フラクトース、及びショ糖を発酵する(Yutin and Galperin (2013) Environ Microbiol. 15(10): 2631-2641)。エリシペラトクロストリジウム・ラモスムの基準株はATCC 25582=DSM 1402である。エリシペラトクロストリジウム・ラモスムDSM 1402株の16S rRNA遺伝子配列のGenBank受託番号はX73440である(配列番号1として本明細書で
開示されている)。例示的エリシペラトクロストリジウム・ラモスム株はYutin and Galperin (2013) Environ Microbiol. 15(10): 2631-2641に記載されている。本発明で使用する別の株はエリシペラトクロストリジウム・ラモスムJCM 1298株である。エリシペラトクロストリジウム・ラモスムJCM 1298株の16S rRNA遺伝子配列のGenBank受託番号はNR_113243.1である(配列番号2として本明細書で開示さ
れている)。
Ltd.社(Life Sciences Innovation Building, Aberdeen, AB25 2ZS, Scotland)により国際寄託当局NCIMB, Ltd.社(Ferguson Building, Aberdeen, AB21 9YA, Scotland)に寄託され、受託番号NCIMB 42688が割り当てられた。用語「MRX027」及び「MRx0027」は本明細書では相互交換可能に使用される。
全ゲノムにわたって)少なくとも95%、96%、97%、98%、99%、99.5%又は99.9%の配列同一性を有することができる。例えば、一部の実施形態において、バイオタイプの株は、そのゲノムの少なくとも98%にわたって少なくとも98%の配列同一性を又はそのゲノムの99%にわたって少なくとも99%の配列同一性を有する。バイオタイプの株の同定に使用するのに適した他の配列としては、hsp60又はBOX、ERIC、(GTG)5、若しくはREPなどの反復配列又はMasco et al. (2003) Systematic and Applied Microbiology, 26:557-563を挙げることができる。バイオタイプの
株は、MRX027株(特にNCIMB 42688として寄託されたMRX027)、ATCC 25582株又はJCM 1298株の相応する配列と少なくとも95%、96%、97%、98%、99%、99.5%又は99.9%の配列同一性を有する配列を有することができる。一部の実施形態において、バイオタイプの株は、NCIMB 42688として寄託されたMRX027株の相応する配列と少なくとも95%、96%、97%、98%、99%、99.5%又は99.9%の配列同一性を有する配列を有し、配列番号3と少なくとも99%同一である(例えば少なくとも99.5%又は少なくとも99.9%同一である)16S rRNA配列を含む。一部の実施形態において、バイオタイプの株は、NCIMB 42688として寄託されたMRX027株の相応する配列と少なくとも95%、96%、97%、98%、99%、99.5%又は99.9%の配列同一性を有する配列を有し、配列番号3の16S rRNA配列を有する。
類似の増殖パターン、代謝型及び/又は表面抗原を有する細菌株が、本発明において有用でありうる。有用な株は、MRX027株(特にNCIMB 42688として寄託されたMRX027)、ATCC 25582株又はJCM 1298株に匹敵する免疫調節活性を有することになる。具体的には、バイオタイプの株は、ブドウ膜炎疾患に対して、実施例において示される効果に匹敵する効果を誘発することになるが、これは、実施例に記載の培養プロトコル及び投与プロトコルを使用することにより特定することができる。
1を使用して入手可能である。特定の実施形態において、本発明で使用する細菌株は、配列番号4と配列同一性を有する染色体を有する。一部の実施形態において、本発明で使用する細菌株は、配列番号4の少なくとも30%にわたって(例えば少なくとも35%、40%、45%、50%、55%、60%、65%、70%、75%、80%、85%、95%、96%、97%、98%、99%又は100%にわたって)配列番号4と少なくとも90%の配列同一性(例えば少なくとも92%、94%、95%、96%、97%、98%、99%又は100%の配列同一性)を有する染色体を有する。例えば、本発明で使用する細菌株は、配列番号4の35%にわたって配列番号4と少なくとも95%の配列同一性、又は配列番号4の45%にわたって配列番号4と少なくとも95%の配列同一性、又は配列番号4の70%にわたって配列番号4と少なくとも90%の配列同一性、又は配
列番号4の80%にわたって配列番号4と少なくとも90%の配列同一性、又は配列番号4の90%にわたって配列番号4と少なくとも90%の配列同一性、又は配列番号4の100%にわたって配列番号4と少なくとも90%の配列同一性、又は配列番号4の70%にわたって配列番号4と少なくとも95%の配列同一性、又は配列番号4の80%にわたって配列番号4と少なくとも95%の配列同一性、又は配列番号4の90%にわたって配列番号4と少なくとも95%の配列同一性、又は配列番号4の100%にわたって配列番号4と少なくとも95%の配列同一性、又は配列番号4の70%にわたって配列番号4と少なくとも98%の配列同一性、又は配列番号4の80%にわたって配列番号4と少なくとも98%の配列同一性、又は配列番号4の90%にわたって配列番号4と少なくとも98%の配列同一性、又は配列番号4の95%にわたって配列番号4と少なくとも98%の配列同一性、又は配列番号4の100%にわたって配列番号4と少なくとも98%の配列同一性、又は配列番号4の90%にわたって配列番号4と少なくとも99.5%の配列同一性、又は配列番号4の95%にわたって配列番号4と少なくとも99.5%の配列同一性、又は配列番号4の98%にわたって配列番号4と少なくとも99.5%の配列同一性、又は配列番号4の100%にわたって配列番号4と少なくとも99.5%の配列同一性を有する染色体を有する。
rRNA配列と(例えば、配列番号3の16S rRNA配列を含む)、配列番号4の少なくとも40%にわたって配列番号4と少なくとも95%の配列同一性を有する染色体とを有し、IL−17又はTh17経路によって媒介される疾患及び状態を治療又は予防するのに有効である。
実施例に示されるように、本発明の細菌組成物はTh17炎症応答を低減させるのに有効である。具体的には、本発明の組成物での治療により、IL−17及びTh17経路によって媒介される状態の動物モデルにおいて臨床的改善が達成され、IL−17Aレベル及びTh17経路の他のサイトカインの低減が可能である。したがって、本発明の組成物は、炎症性疾患及び自己免疫疾患、特にIL−17によって媒介される疾患又は状態を治療又は予防するのに有用でありうる。具体的には、本発明の組成物は、IL−17炎症応答の上昇を低減させるのに又は予防するのに有用でありうる。
et al. (2015) PLoS One. 10(1):e0117704、Fabro et al. (2015) Immunobiology. 220(1):124-35 、Yin et al. (2014) Immunogenetics. 66(3):215-8、Cheluvappa et al. (2014) Clin Exp Immunol. 175(2):316-22、Schieck et al. (2014) J Allergy Clin Immunol. 133(3):888-91、Balato et al. (2014) J Eur Acad Dermatol Venereol. 28(8):1016-24)に記載のように)。Th17経路が活性化されている疾患はTh17経路によって媒介される疾患である。Th17経路によって媒介される疾患は、Th17経路を抑えることにより改善するか又は緩和することができ、これは、Th17細胞の分化における低減若しくはそれら細胞の活性における低減又はTh17経路サイトカインのレベルにおける低減を介している可能性がある。Th17経路によって媒介される疾患は、IL−17A、IL−17F、IL−21、IL−22、IL−26、IL−9などの、Th17細胞に産生されるサイトカインレベルの上昇を特徴とすることができる(Monteleone et al. (2011) BMC Medicine. 2011, 9:122において総説されている)。Th17経路によって媒
介される疾患は、Stat3又はIL−23Rなどの、Th17関連遺伝子の発現上昇を特徴とすることができる。Th17経路によって媒介される疾患は、Th17細胞のレベルの増加と関連付けることができる。
予防するのに特に有用でありうる。特定の実施形態において、組成物は慢性疾患の患者に使用するためのものである。特定の実施形態において、組成物は慢性疾患の進行を予防するのに使用するためのものである。
好ましい実施形態において、本発明の組成物は、ブドウ膜炎を治療又は予防するのに使用するためのものである。実施例は、本発明の組成物が、ブドウ膜炎の動物モデルにおいて疾患の発生率及び疾患の重症度の低減を達成することを実証しており、したがって本発明の組成物はブドウ膜炎の治療又は予防において有用でありうる。ブドウ膜炎は、ブドウ膜の炎症であり、網膜組織の破壊をもたらす恐れがある。ブドウ膜炎は、様々な解剖学的形態で存在することができ(前部、中間、後部又はびまん)、全身性自己免疫障害を含めて、様々な、しかし関連した、原因の結果である。IL−17及びTh17経路がブドウ膜炎に中心的に関与し、したがってブドウ膜炎を治療するための本発明の組成物の有効性は、本発明の組成物はIL−17又はTh17経路によって媒介される疾患及び状態を治療するのに及び予防するのに特に有用でありうることを示している。参考文献(Zhang (2015) Inflammation. Aug 23、Sun et al. (2015) Cytokine. 74(1):76-80、Mucientes et
al. (2015) Br J Ophthalmol. 99(4):566-70、Jawad et al. (2013) Ocul Immunol Inflamm. 21(6):434-9、Maya et al. (2014) J. Ophthalmology. 310329、Chi et al. (2007)
J. Allergy and Clinical Immunology. 119(5):1218-1224、Chi et al. (2008) Investigative Ophthalmology &Visual Science. 49(7): 3058-3064、Luger and Caspi (2008) Semin. Immunopathol. 30(2): 134-143)には、ブドウ膜炎の患者においてインターロイキン−17Aの血清レベルが上昇していること、IL17Aの遺伝的バリアントと全ブドウ膜炎との特異的関連性、実験的自己免疫ブドウ膜炎の病原性におけるTh17関連サイトカインの役割、単相性の実験的自己免疫ブドウ膜炎時のTh17細胞と調節性T細胞との間の不均衡、ブドウ膜炎並びに活動型ベーチェット病及びフォークト小柳原田(VKH,Vogt-Koyanagi-Harada)病の患者におけるIL−17Aのアップレギュレーション、セクキヌマブ(抗IL−17A抗体)での非感染性ブドウ膜炎の治療、並びにブドウ膜炎の眼におけるTh17、について記載されている。
好ましい実施形態において、本発明の組成物はがんを治療又は予防するのに使用するためのものである。IL−17又はTh17経路はがんの発症及び進行において中枢的役割を担っており、したがって本発明の組成物はがんを治療するか又は予防するのに有用でありうる。
物は、乳がんの治療において腫瘍のサイズを低減させる、腫瘍の増殖を低減させる、又は血管新生を低減させるのに使用するためのものである。好ましい実施形態において、がんは乳癌である。好ましい実施形態において、がんはステージIVの乳がんである。
療において腫瘍のサイズを低減させる、腫瘍の増殖を低減させる、又は血管新生を低減させるのに使用するためのものである。好ましい実施形態において、がんは肺癌である。
Yervoy(イピリムマブ、BMS社製);Keytruda(ペンブロリズマブ、Merck社製);Opdivo(ニボルマブ、BMS社製);MEDI4736(AZ/MedImmune社製);MPDL3280A(Roche/Genentech社製);トレメリムマブ(AZ/MedImmune社製);CT-011(ピジリズマブ、CureTech社製
);BMS-986015(リリルマブ、BMS社製);MEDI0680(AZ/MedImmune社製);MSB-0010718C(Merck社製);PF-05082566(Pfizer社製);MEDI6469(AZ/MedImmune社製);BMS-986
016(BMS社製);BMS-663513(ウレルマブ、BMS社製);IMP321(Prima Biomed社製);LAG525(Novartis社製);ARGX-110(arGEN-X社製);PF-05082466(Pfizer社製);CDX-1127(バルリルマブ;CellDex Therapeutics社製);TRX-518(GITR Inc.社製);MK-4166(Merck社製);JTX-2011(Jounce Therapeutics社製);ARGX-115(arGEN-X社製);NLG-9189(インドキシモド、NewLink Genetics社製);INCB024360(Incyte社製);IPH2201(Innate Immotherapeutics/AZ社製);NLG-919(NewLink Genetics社製);anti-VISTA
(JnJ社製);エパカドスタット(INCB24360、Incyte社製);F001287(Flexus/BMS社製
);CP 870893(University of Pennsylvania製);MGA271(Macrogenix社製);Emactuzumab(Roche/Genentech社製);ガルニセルチブ(Eli Lilly社製);ウロクプルマブ(BMS社製);BKT140/BL8040(Biokine Therapeutics社製);バビツキシマブ(Peregrine Pharmaceuticals社製);CC 90002(Celgene社製);852A(Pfizer社製);VTX-2337(VentiRx Pharmaceuticals社製);IMO-2055(Hybridon社製、Idera Pharmaceuticals社製);LY2157299(Eli Lilly社製);EW-7197(Ewha Women's University製、韓国);ベムラフェニブ(Plexxikon社製);ダブラフェニブ(Genentech/GSK社製);BMS-777607(BMS社
製);BLZ945(Memorial Sloan-Kettering Cancer Centre製);Unituxin(ジヌツキシマブ、United Therapeutics Corporation社製);Blincyto(ブリナツモマブ、Amgen社製);Cyramza(ラムシルマブ、Eli Lilly社製);Gazyva(オビヌツズマブ、Roche/Biogen社製);Kadcyla(ado−トラスツズマブ エムタンシン、Roche/Genentech社製);Perjeta(パーツズマブ、Roche/Genentech社製);Adcetris(ブレンツキシマブ ベドチン、Takeda/Millennium社製);Arzerra(オファツムマブ、GSK社製);Vectibix(パニツブ
マブ、Amgen社製);Avastin(ベバシズマブ、Roche/Genentech社製);Erbitux(セツキシマブ、BMS/Merck社製);Bexxar(トシツモマブ−I131、GSK社製);Zevalin(イ
ブリツモマブ チウキセタン、Biogen社製);Campath(アレムツズマブ、Bayer社製);Mylotarg(ゲムツズマブ オゾガマイシン、Pfizer社製);Herceptin(トラスツズマブ
、Roche/Genentech社製);Rituxan(リツキシマブ、Genentech/Biogen社製);ボロシキシマブ(Abbvie社製);エナバツズマブ(Abbvie社製);ABT-414(Abbvie社製);エロ
ツズマブ(Abbvie/BMS社製);ALX-0141(Ablynx社製);オゾラリズマブ(Ablynx社製);アクチマブ−C(Actinium社製);アクチマブ−P(Actinium社製);ミラツズマブ−dox(Actinium社製);Emab-SN-38(Actinium社製);ナプツモマブ エスタフェナトクス(Active Biotech社製);AFM13(Affimed社製);AFM11(Affimed社製);AGS-16C3F(Agensys社製);AGS-16M8F(Agensys社製);AGS-22ME(Agensys社製);AGS-15ME(Agensys社製);GS-67E(Agensys社製);ALXN6000(サマリズマブ、Alexion社製);ALT-836(Altor Bioscience社製);ALT-801(Altor Bioscience社製);ALT-803(Altor Bioscience社製);AMG780(Amgen社製);AMG 228(Amgen社製);AMG820(Amgen社製);AMG172(Amgen社製);AMG595(Amgen社製);AMG110(Amgen社製);AMG232(アデカツムマブ、Amgen社製);AMG211(Amgen/MedImmune社製);BAY20-10112(Amgen/Bayer社製);リロツムマブ(Amgen社製);デノスマブ(Amgen社製);AMP-514(Amgen社製);MEDI575(AZ/MedImmune社製);MEDI3617(AZ/MedImmune社製);MEDI6383(AZ/MedImmune社
製);MEDI551(AZ/MedImmune社製);モキセツモマブ パスドトックス(AZ/MedImmune
社製);MEDI565(AZ/MedImmune社製);MEDI0639(AZ/MedImmune社製);MEDI0680(AZ/MedImmune社製);MEDI562(AZ/MedImmune社製);AV-380(AVEO社製);AV203(AVEO社
製);AV299(AVEO社製);BAY79-4620(Bayer社製);アネツマブ ラブタンシン(Bayer社製);バンチクツマブ(Bayer社製);BAY94-9343(Bayer社製);シブロツヅマブ(Boehringer Ingleheim社製);BI-836845(Boehringer Ingleheim社製);B-701(BioClin社製);BIIB015(Biogen社製);オビヌツズマブ(Biogen/Genentech社製);BI-505(Bioinvent社製);BI-1206(Bioinvent社製);TB-403(Bioinvent社製);BT-062(Biotest)BIL-010t(Biosceptre社製);MDX-1203(BMS社製);MDX-1204(BMS社製);ネシツムマブ(BMS社製);CAN-4(Cantargia AB社製);CDX-011(Celldex社製);CDX1401(Celldex社製);CDX301(Celldex社製);U3-1565(Daiichi Sankyo社製);パトリツマブ(Daiichi Sankyo社製);ティガツズマブ(Daiichi Sankyo社製);ニモツズマブ(Daii
chi Sankyo社製);DS-8895(Daiichi Sankyo社製);DS-8873(Daiichi Sankyo社製);DS-5573(Daiichi Sankyo社製);MORab-004(Eisai社製);MORab-009(Eisai社製);MORab-003(Eisai社製);MORab-066(Eisai社製);LY3012207(Eli Lilly社製);LY2875358(Eli Lilly社製);LY2812176(Eli Lilly社製);LY3012217(Eli Lilly社製);LY2495655(Eli Lilly社製);LY3012212(Eli Lilly社製);LY3012211(Eli Lilly社製
);LY3009806(Eli Lilly社製);シクスツムマブ(Eli Lilly社製);フランボツマブ
(Eli Lilly社製);IMC-TR1(Eli Lilly社製);ラムシルマブ(Eli Lilly社製);タバルマブ(Eli Lilly社製);ザノリムマブ(Emergent Biosolution社製);FG-3019(FibroGen社製);FPA008(Five Prime Therapeutics社製);FP-1039(Five Prime Therapeutics社製);FPA144(Five Prime Therapeutics社製);カツマキソマブ(Fresenius Biotech社製);IMAB362(Ganymed社製);IMAB027(Ganymed社製);HuMax-CD74(Genmab社
製);HuMax-TFADC(Genmab社製);GS-5745(Gilead社製);GS-6624(Gilead社製);OMP-21M18(デムシズマブ、GSK社製);マパツムマブ(GSK社製);IMGN289(ImmunoGen社製);IMGN901(ImmunoGen社製);IMGN853(ImmunoGen社製);IMGN529(ImmunoGen社製);IMMU-130(Immunomedics社製);ミラツズマブ−dox(Immunomedics社製);IMMU-115(Immunomedics社製);IMMU-132(Immunomedics社製);IMMU-106(Immunomedics社製);IMMU-102(Immunomedics社製);エプラツズマブ(Immunomedics社製);クリバツズマブ(Immunomedics社製);IPH41(Innate Immunotherapeutics社製);ダラツムマブ(Janssen/Genmab社製);CNTO-95(インテツムマブ、Janssen社製);CNTO-328(シルツキシマブ、Janssen社製);KB004(KaloBios社製);モガムリズマブ(Kyowa Hakko Kirrin社製);KW-2871(エクロメキシマブ、Life Science社製);ソネプシズマブ(Lpath社製);マージツキシマブ(Macrogenics社製);エノビリツズマブ(Macrogenics社製);MGD006(Macrogenics社製);MGF007(Macrogenics社製);MK-0646(ダロツズマブ、Merck社製);MK-3475(Merck社製);Sym004(Symphogen/Merck Serono社製);DI17E6(Merck Serono社製);MOR208(Morphosys社製);MOR202(Morphosys社製);Xmab5574(Morphosys社製);BPC-1C(エンシツキシマブ、Precision Biologics社製);TAS266(Novartis社製);LFA102(Novartis社製);BHQ880(Novartis/Morphosys社製);QGE031(Novartis社製);HCD122(ルカツムマブ、Novartis社製);LJM716(Novartis社製);AT355(Novartis社製);OMP-21M18(Demcizumab、OncoMed社製);OMP52M51(Oncomed/GSK社製);OMP-59R5(Oncomed/GSK社製);バンチクツマブ(Oncomed/Bayer社製);CMC-544
(イノツズマブ オゾガマイシン、Pfizer社製);PF-03446962(Pfizer社製);PF-04856884(Pfizer社製);PSMA-ADC(Progenics社製);REGN1400(Regeneron社製);REGN910(ネスバクマブ、Regeneron/Sanofi社製);REGN421(エノチクマブ、Regeneron/Sanofi社製);RG7221、RG7356、RG7155、RG7444、RG7116、RG7458、RG7598、RG7599、RG7600、RG7636、RG7450、RG7593、RG7596、DCDS3410A、RG7414(パルサツズマブ)、RG7160(イ
ムガツズマブ)、RG7159(オビヌツズマブ)、RG7686、RG3638(オナルツズマブ)、RG7597(Roche/Genentech社製);SAR307746(Sanofi社製);SAR566658(Sanofi社製);SAR650984(Sanofi社製);SAR153192(Sanofi社製);SAR3419(Sanofi社製);SAR256212
(Sanofi社製)、SGN-LIV1A(リンツズマブ、Seattle Genetics社製);SGN-CD33A(Seattle Genetics社製);SGN-75(ボルセツズマブマホドチン、Seattle Genetics社製);SGN-19A(Seattle Genetics) SGN-CD70A(Seattle Genetics社製);SEA-CD40(Seattle Genetics社製);イブリツモマブ チウキセタン(Spectrum社製);MLN0264(Takeda社製);ガニツマブ(Takeda/Amgen社製);CEP-37250(Teva社製);TB-403(Thrombogenic
社製);VB4-845(Viventia社製);Xmab2512(Xencor社製);Xmab5574(Xencor社製)
;ニモツズマブ(YM Biosciences社製);カルルマブ(Janssen社製);NY-ESO TCR(Adaptimmune社製);MAGE-A-10 TCR(Adaptimmune社製);CTL019(Novartis社製);JCAR015(Juno Therapeutics社製);KTE-C19 CAR(Kite Pharma社製);UCART19(Cellectis社製);BPX-401(Bellicum Pharmaceuticals社製);BPX-601(Bellicum Pharmaceuticals社製);ATTCK20(Unum Therapeutics社製);CAR-NKG2D(Celyad社製);Onyx-015(Onyx Pharmaceuticals社製);H101(Shanghai Sunwaybio社製);DNX-2401(DNAtrix社製)
;VCN-01(VCN Biosciences社製);Colo-Ad1(PsiOxus Therapeutics社製);ProstAtak(Advantagene社製);Oncos-102(Oncos Therapeutics社製);CG0070(Cold Genesys社製);Pexa-vac(JX-594、Jennerex Biotherapeutics社製);GL-ONC1(Genelux社製);T-VEC(Amgen社製);G207(Medigene社製);HF10(Takara Bio社製);SEPREHVIR(HSV1716、Virttu Biologics社製);OrienX010(OrienGene Biotechnology社製);Reolysin(Oncolytics Biotech社製);SVV-001(Neotropix社製);Cacatak(CVA21、Viralytics社製);Alimta(Eli Lilly社製)、シスプラチン、オキサリプラチン、イリノテカン、
フォリン酸、メトトレキサート、シクロホスファミド、5−フルオロウラシル、Zykadia (Novartis社製)、Tafinlar(GSK社製)、Xalkori(Pfizer社製)、Iressa(AZ社製)、Gilotrif(Boehringer Ingelheim社製)、Tarceva(Astellas Pharma社製)、Halaven(Eisai Pharma社製)、ベリパリブ(Abbvie社製)、AZD9291(AZ社製)、アレクチニブ(Chugai社製)、LDK378(Novartis社製)、Genetespib(Synta Pharma社製)、テルジェンプマツセル−L(NewLink Genetics社製)、GV1001(Kael-GemVax社製)、チバンチニブ(ArQule社製);Cytoxan(BMS社製);Oncovin(Eli Lilly社製);アドリアマイシン(Pfizer社製);Gemzar(Eli Lilly社製);Xeloda(Roche社製);Ixempra(BMS社製);Abraxane(Celgene社製);Trelstar(Debiopharm社製);Taxotere(Sanofi社製);Nexavar(Bayer社製);IMMU-132(Immunomedics社製);E7449(Eisai社製);Thermodox(Celsion社製);Cometriq(Exellxis社製);Lonsurf(Taiho Pharmaceuticals社製);Camptosar(Pfizer社製);UFT(Taiho Pharmaceuticals社製);及びTS-1(Taiho Pharmaceuticals社製)、
からなる群から選択される抗がん剤を含む。
好ましい実施形態において、本発明の組成物は、喘息を治療又は予防するのに使用するためのものである。本発明の組成物は、ハウスダストダニの抽出物による感作及びチャレンジの後、好中球及び/又は好酸球の気道への動員を低減させることができ、したがって喘息の治療又は予防において有用でありうる。喘息は、気道の炎症及び制限を特徴とする慢性疾患である。喘息の炎症はIL−17及び/又はTh17細胞によって媒介されることもあり、したがって本発明の組成物は、喘息を予防又は治療するのに特に有効でありうる。喘息の炎症は好酸球及び/又は好中球によって媒介されることもある。
好ましい実施形態において、本発明の組成物は、関節リウマチ(RA,rheumatoid arthritis)を治療又は予防するのに使用するためのものである。本発明の組成物は、マウスモデルにおいてRAの徴候の低減を達成すること、軟骨損傷及び骨損傷を低減させること、及びIL−17炎症性応答を低減させることができ、したがってRAの治療又は予防において有用でありうる。RAとは、主として関節に影響を与える全身性の炎症性障害である。RAは関節の腫脹、滑膜過形成、及び軟骨及び骨の破壊をもたらす炎症性応答と関連付けられる。例えば、IL−17は、軟骨細胞及び骨芽細胞においてマトリクス産生を阻害し、マトリクスメタロプロテアーゼの産生及び機能を活性化させることから、並びにR
A疾患活動性はIL−17レベル及びTh−17細胞数と相関することから、IL−17及びTh17細胞はRAにおいて主要な役割を担っている可能性があり(Miossec and Kolls (2012) Nat Rev Drug Discov. 11(10):763-76、Yang et al. (2014) Trends Pharmacol Sci. 35(10):493-500)、したがって本発明の組成物は、RAの予防又は治療に特に有効でありうる。
al. (2014) Trends Pharmacol Sci. 35(10):493-500)。IL−17は軟骨組織及び骨組織においてマトリクス破壊を活性化すると知られ、IL−17は軟骨細胞及び骨芽細胞においてマトリクス産生に対して阻害効果を有する。したがって特定の実施形態において、本発明の組成物は、RAの治療において骨びらん又は軟骨損傷を予防するのに使用するためのものである。特定の実施形態において、組成物は、骨びらん又は軟骨損傷を示す患者又は骨びらん又は軟骨損傷のリスクがあると特定された患者を治療するのに使用するためのものである。
でありうる。RAの治療又は予防とは、例えば、症状の重症度の緩和、又は発作頻度の低減若しくは患者にとって問題であるトリガーの範囲の低減を指すことができる。
好ましい実施形態において、本発明の組成物は、多発性硬化症を治療又は予防するのに使用するためのものである。本発明の組成物は、多発性硬化症のマウスモデル(EAEモデル)において疾患の発生率及び疾患の重症度の低減を達成することができ、したがって本組成物は多発性硬化症の治療又は予防において有用でありうる。多発性硬化症とは、特に脊柱及び脳における、ニューロンのミエリン鞘への損傷と関連付けられる炎症性障害である。多発性硬化症は慢性疾患であり、この疾患は進行的に機能不能となり、症状の発現において徐々に進展する。例えば、IL−17レベルは多発性硬化症の病変と相関しうることから、IL−17は血液脳関門の内皮細胞接合部を破壊しうることから、及びTh17細胞は中枢神経系にマイグレーションしニューロンの欠損を起こしうることから(Amedei et al. (2012) Int J Mol Sci. 13(10):13438-60、Shabgah et al. (2014) Postepy. Dermatol. Alergol. 31(4):256-61)、IL−17及びTh17細胞は多発性硬化症にお
いて主要な役割を担っている可能性がある。したがって本発明の組成物は、多発性硬化症を予防又は治療するのに特に有効でありうる。
本発明の組成物は、本発明の細菌株とともに腸管への送達及び/又は部分的又は全体的な定着を可能とするために、消化管に投与することが好ましい。一般に、本発明の組成物は、経口的に投与するが、これらは直腸に、鼻腔内に、又はバッカル経路若しくは舌下経路を介して投与してもよい。
ハードファット(例えばsuppocire、witepsol)、グリセロゼラチン、ポリエチレングリ
コール、又はグリセリンせっけん組成物の形態で、肛門坐剤などの、坐剤として投与してもよい。
胃、空腸へのアクセスを可能とする胸壁ポートなどのポート及び他の適切なアクセスポートを介して、消化管に投与する。
一般に、本発明の組成物は、細菌を含む。本発明の好ましい実施形態において、組成物は凍結乾燥の形態で製剤化される。例えば、本発明の組成物は、本発明の細菌株を含む顆粒又はゼラチンカプセル、例えば硬質ゼラチンカプセルを含みうる。
J. Gen. Appl. Microbiol., 54, 9-24、Cryopreservation and Freeze-Drying Protocols, ed. by Day and McLellan, Humana Press、Leslie et al. (1995) Appl. Environ. Mi
crobiol. 61, 3592-3597で入手可能である。
(2002) Curr Issues Intest Microbiol. 3(2):39-48で入手可能である。
U;別の例では例えば約1×106〜約1×1010のCFUでありうる。
を含む。用量は、例えば、1g、3g、5g、及び10gでありうる。
る。適切な担体の例には、ラクトース、デンプン、グルコース、メチルセルロース、ステアリン酸マグネシウム、マンニトール、ソルビトールなどが含まれる。適切な希釈剤の例には、エタノール、グリセロール及び水が含まれる。医薬担体、賦形剤又は希釈剤の選択は、目的とする投与経路及び標準的な薬務に対して選択することができる。医薬組成物は、担体、賦形剤又は希釈剤として、又はこれらに加えて、適切な任意の結合剤、潤滑剤、懸濁化剤、コーティング剤、可溶化剤を含みうる。適切な結合剤の例には、デンプン、ゼラチン、グルコースなどの天然糖、無水ラクトース、フリーフローラクトース、ベータ−ラクトース、コーンシロップ、アカシア、トラガカント又はアルギン酸ナトリウムなどの天然及び合成ゴム、カルボキシメチルセルロース並びにポリエチレングリコールが含まれる。適切な潤滑剤の例には、オレイン酸ナトリウム、ステアリン酸ナトリウム、ステアリン酸マグネシウム、安息香酸ナトリウム、酢酸ナトリウム、塩化ナトリウムなどが含まれる。保存料、安定剤、染料及びさらに香味料が、医薬組成物中に提供されてもよい。保存料の例には、安息香酸ナトリウム、ソルビン酸及びp−ヒドロキシ安息香酸のエステルが含まれる。抗酸化剤及び懸濁化剤もまた、使用してもよい。
ンスミルク、幼児用又は乳児用ミルクなどの乳飲料、フレーバーミルク、アイスクリーム、スイーツなどのミルクを含有する食品が含まれる。
態において、微生物コンソーシアは、異なる少なくとも2つの生物の糞便試料から得た細菌株を含む。一部の実施形態において、異なる2つの生物は同一種、例えば異なる2人のヒトに由来する。一部の実施形態において、異なる2つの生物はヒト幼児及び成人である。一部の実施形態において、異なる2つの生物はヒト及びヒト以外の哺乳動物である。
チ、変形性関節症、乾癬性関節炎、又は若年性特発性関節炎などの関節炎;視神経脊髄炎(デビック病);強直性脊椎炎;脊椎関節炎;乾癬;全身性紅斑性狼瘡;クローン病又は潰瘍性大腸炎などの炎症性腸疾患;セリアック病;アレルギー性喘息又は好中球性喘息などの喘息;慢性閉塞性肺疾患(COPD);強膜炎;血管炎;ベーチェット病;アテローム性動脈硬化症;アトピー性皮膚炎;肺気腫;歯周炎;アレルギー性鼻炎;及び同種異系移植片拒絶からなる群から選択される。
。一部の実施形態において、製剤は本質的に腸溶性カプセルである(例えば、Capsugel社製のVcaps(登録商標))。
本発明で使用する細菌株は、例えば、参考文献Handbook of Microbiological Media, Fourth Edition (2010) Ronald Atlas, CRC Press、Maintaining Cultures for Biotechnology and Industry (1996) Jennie C. Hunter-Cevera, Academic Press、Strobel (2009)
Methods Mol Biol. 581:247-61に詳述のように標準微生物技法を使用して培養すること
ができる。
本発明者らは、本発明の細菌株は、IL−17又はTh17経路によって媒介される疾患又は状態を治療又は予防するのに有用であることを特定している。これは、本発明の細菌株が宿主免疫系に対して有する効果の結果と思われる。したがって、本発明の組成物もまた、ワクチン組成物として投与した場合、IL−17又はTh17経路によって媒介される疾患又は状態を予防するのに有用でありうる。特定のそのような実施形態において、本発明の細菌株は生存している。特定のそのような実施形態において、本発明の細菌株は腸管に部分的又は全体的に定着することができる。特定のそのような実施形態において、本発明の細菌株は生存しており、腸管に部分的又は全体的に定着することができる。他の特定のそのような実施形態において、本発明の細菌株は殺菌されていても、不活化されていても又は弱毒化されていてもよい。特定のそのような実施形態において、組成物はワクチンアジュバントを含みうる。特定の実施形態において、組成物は、皮下注射によるなどの、注射による投与用である。
本発明の実施は、他に指摘しない限り、当業者の能力内である、化学、生化学、分子生物学、免疫学及び薬理学の従来技術を使用するであろう。そのような技術は、文献に十分に説明されている。例えば、参考文献Gennaro (2000) Remington: The Science and Practice of Pharmacy. 20th edition, ISBN: 0683306472及びMolecular Biology Techniques: An Intensive Laboratory Course, (Ream et al., eds., 1998, Academic Press)、Methods In Enzymology (S. Colowick and N. Kaplan, eds., Academic Press, Inc.)、Handbook of Experimental Immunology, Vols. I IV (D.M. Weir and C.C. Blackwell, eds, 1986, Blackwell Scientific Publications)、Sambrook et al. (2001) Molecular Cloning: A Laboratory Manual, 3rd edition (Cold Spring Harbor Laboratory Press)、Hand
book of Surface and Colloidal Chemistry (Birdi, K.S. ed., CRC Press, 1997)、Ausubel et al. (eds) (2002) Short protocols in molecular biology, 5th edition (Current Protocols)、PCR (Introduction to Biotechniques Series), 2nd ed. (Newton & Graham eds., 1997, Springer Verlag)などを参照のこと。
からなる場合もあり、さらなる何か、例えばX+Yを含む場合もある。
する。
ば、Yを「実質的に含まない(substantially free)」組成物は、完全にYを含まなくてもよい。必要な場合、単語「実質的に(substantially)」は本発明の定義から省略して
もよい。
Biology (F.M. Ausubel et al., eds., 1987) Supplement 30の第7.7.18節に記載されるソフトウェアを使用して、決定することができる。好ましいアライメントは、ギャップオープンペナルティ12及びギャップエクステンションペナルティ2、BLOSUMマトリクス62とともにアフィンギャップサーチを使用して、Smith-Waterman相同性サーチアルゴリズムによって決定される。このSmith-Waterman相同性サーチアルゴリズムは、参考文献Smith & Waterman (1981) Adv. Appl. Math. 2: 482-489に開示されている。
概要
この研究では、光受容体間のレチノイド結合タンパク質(IRBP,interphotoreceptor retinoid-binding protein)に誘導されるブドウ膜炎のマウスモデルを使用して、ブ
ドウ膜炎に対する細菌投与の効果について試験した。ブドウ膜炎は眼内炎症及び網膜組織崩壊に起因する視覚を脅かす状態である。この疾患は実験的自己免疫ブドウ膜網膜炎(EAU,experimental autoimmune uveoretinitis)のモデルのげっ歯類において研究する
ことができる(Caspi (2003) Curr Protoc Immunol. Chapter 15:Unit 15.6)。EAUとは、Th1/Th17細胞が、網膜抗原を標的とし、常在及び浸潤単核細胞を活性化し組織破壊をもたらすことになるサイトカインを産生している、器官特異的障害である。EA
Uは、光受容体間のレチノイド結合タンパク質ペプチド(IRBPp,interphotoreceptor retinoid binding protein peptide)を含む網膜抗原でのチャレンジによってマウス
において誘導することができる。疾患の発症は8〜9日目から通常起こり、14〜15日後にピークとなる。臨床疾患の徴候を局所的内視鏡眼底画像法(TEFI,topical endoscopic fundal imaging)を使用してモニタリングすることができる。
MRX027:エリシペラトクロストリジウム・ラモスム
この例において使用した株はNCIMB 42688として寄託されている。
マウスはC57BL/6系統で、研究開始時には6週齢を超えていた。72匹のマウスを使用した(+36匹のサテライト動物)。不健康動物は研究から除外した。動物は、特定病原体感染防止(spf,specific pathogen free)条件下で、サーモスタットでモニタリングされている飼育室(22±4℃)に収容した。動物は、使用前に最短でも1週間、標準動物飼育条件下で馴致させた。動物の健康状態をこの期間を通してモニタリングし、研究開始前に各動物の実験使用への適切性を評価した。マウスは、研究期間の間は1ケージ当たり最高10匹の動物の群で収容した。馴致期間及び研究期間を通して、照射ペレット飼料(実験室飼料、EU Rodent diet 22%、5LF5)及び水を自由摂取で利用できた。飼料の任意の成分又は水が本研究を妨害した可能性は低い。
C57BL/6の成熟雌マウスを実験群に無作為に割り付け、1週間馴致させた。以下のスケジュールに従って治療剤を投与した。0日目、結核菌(Mycobacterium Tuberculosis)H37 RA 2.5mg/mlを添加した完全フロインドアジュバント(CFA,complete Freund’s adjuvant)中に光受容体間のレチノイド結合タンパク質ペプチド1
〜20(IRBPp1〜20)200μgを含有するエマルジョンを皮下注射で、動物に投与した。また0日目に、百日咳菌(Bordetella Pertussis)毒素1.5μgを腹腔内注射で、動物に投与した。−14日目から、動物を1週当たり3回秤量する。−1日目から42日目の実験終了まで、動物を、局所的内視鏡眼底画像法(TEFI)を使用してブドウ膜炎の臨床徴候について1週当たり2回モニタリングする。
全ての群はn=12である。
体重。−14日目から、動物を1週当たり3回秤量する。2回連続して、動物の初期(0日目)体重の15%に等しいか又はそれより大きい体重ロスを伴う動物を間引く。
本研究の結果を、図1及び図2に示す。
本明細書に記載の少なくとも1の細菌株を含有する、本明細書に記載の組成物を、25℃又は4℃で密封容器に貯蔵し、この容器を30%、40%、50%、60%、70%、75%、80%、90%又は95%の相対湿度である雰囲気中に置く。1ヵ月、2ヵ月、3ヵ月、6ヵ月、1年、1.5年、2年、2.5年又は3年後に、標準プロトコルにて決定されるコロニー形成ユニットで測定して、細菌株の少なくとも50%、60%、70%、80%又は90%が残存しているものとする。
配列
配列番号1(エリシペラトクロストリジウム(クロストリジウム)・ラモスムの16S
rRNA遺伝子、DSM 1402−X73440株)
1 nnnnnnngag agtttgatcc tggctcagga tgaacgctgg cggcgtgcct aatacatgca
61 agtcgaacgc gagcacttgt gctcgagtgg cgaacgggtg agtaatacat aagtaacctg
121 ccctagacag ggggataact attggaaacg gatagctaag accgcatagg tacggacact
181 gcatggtgac cgtattaaaa gtgcctcaaa gcactggtag aggatggact tatggcgcat
241 tagctggttg gcggggtaac ggcccaccaa ggcgacgatg cgtagccgac ctgagagggt
301 gaccggccac actgggactg agacacggcc cagactccta cgggaggcag cagtagggaa
361 ttttcggcaa tgggggaaac cctgaccgag caacgccgcg tgaaggaaga aggttttcgg
421 attgtaaact tctgttataa agaagaacgg cggctacagg aaatggtagc cgagtgacgg
481 tactttattt tagaaagcca cggctaacta cgtgccagca gccgcggtaa tacgtaggtg
541 gcaagcgtta tccggaatta ttgggcgtaa agagggagca ggcggcagca agggtctgtg
601 gtgaaagcct gaagcttaac ttcagtaagc catagaaacc aggcagctag agtgcaggag
661 aggatcgtgg aattccatgt gtagcggtga aatgcgtaga tatatggagg aacaccagtg
721 gcgaaggcga cgatctggcc tgcaactgac gctcagtccc gaaagcgtgg ggagcaaata
781 ggattagata ccctagtagt ccacgccgta aacgatgagt actaagtgtt ggatgtcaaa
841 gttcagtgct gcagttaacg caataagtac tccgcctgag tagtacgttc gcaagaatga
901 aactcaaagg aattgacggg ggccgcacaa gcggtggagc atgtggttta attcgaagca
961 acgcgaagaa ccttaccagg tcttgacata ctcataaagg ctccagagat ggagagatag
1021 ctatatgaga tacaggtggt gcatggttgt cgtcagctcg tgtcgtgaga tgttgggtta
1081 agtcccgcaa cgagcgcaac ccttatcgtt agttaccatc attaagttgg ggactctagc
1141 gagactgcca gtgacaagct ggaggaaggc ggggatgacg tcaaatcatc atgcccctta
1201 tgacctgggc tacacacgtg ctacaatgga tggtgcagag ggaagcgaac cgcgaggtga
1261 agcaaaaccc ataaaaacca ttctcagttc ggattgtagt ctgcaactcg actacatgaa
1321 gttggaatcg ctagtaatcg cgaatcagca tgtcgcggtg aatacgttct cgggccttgt
1381 acacaccgcc cgtcacacca cgagagttga taacacccga agccggtggc ctaaccgcaa
1441 ggaaggagct gtctaaggtg ggattgatga ttggggtgaa gtcgtaacaa ggtatcccta
1501 cgggaacgtg cggctggatc acctcc
1 agagtttgat cctggctcag gatgaacgct ggcggcgtgc ctaatacatg caagtcgaac
61 gcgagcactt gtgctcgagt ggcgaacggg tgagtaatac ataagtaacc tgccctagac
121 agggggataa ctattggaaa cgatagctaa gaccgcatag gtacggacac tgcatggtga
181 ccgtattaaa agtgcctcaa agcactggta gaggatggac ttatggcgca ttagctggtt
241 ggcggggtaa cggcccacca aggcgacgat gcgtagccga cctgagaggg tgaccggcca
301 cactgggact gagacacggc ccagactcct acgggaggca gcagtaggga attttcggca
361 atgggggaaa ccctgaccga gcaacgccgc gtgaaggaag aaggttttcg gattgtaaac
421 ttctgttata aaggaagaac ggcggctaca ggaaatggta gccgagtgac ggtactttat
481 tagaaagcca cggctaacta cgtgccagca gccgcggtaa tacgtaggtg gcaagcgtta
541 tccggaatta ttgggcgtaa agagggagca ggcggcagca agggtctgtg gtgaaagcct
601 gaagcttaac ttcagtaagc catagaaacc aggcagctag agtgcaggag aggatcgtgg
661 aattccatgt gtagcggtga aatgcgtaga tatatggagg aacaccagtg gcgaaggcga
721 cgatctggcc tgcaactgac gctcagtccc gaaagcgtgg ggagcaaata ggattagata
781 ccctagtagt ccacgccgta aacgatgagt actaagtgtt ggatgtcaaa gttcagtgct
841 gcagttaacg caataagtac tccgcctgag tagtacgttc gcaagaatga aactcaaagg
901 aattgacggg ggcccgcaca agcggtggag catgtggttt aattcgaagc aacgcgaaga
961 accttaccag gtcttgacat actcataaag gctccagaga tggagagata gctatatgag
1021 atacaggtgg tgcatggttg tcgtcagctc gtgtcgtgag atgttgggtt aagtcccgca
1081 acgagcgcaa cccttatcgt tagttaccat cattaagttg gggactctag cgagactgcc
1141 agtgacaagc tggaggaagg cggggatgac gtcaaatcat catgcccctt atgacctggg
1201 ctacacacgt gctacaatgg atggtgcaga gggaagcgaa gccgcgaggt gaagcaaaac
1261 ccataaaacc attctcagtt cggattgtag tctgcaactc gactacatga agttggaatc
1321 gctagtaatc gcgaatcagc atgtcgcggt gaatacgttc tcgggccttg tacacaccgc
1381 ccgtcacacc acgagagttg ataacacccg aagccggtgg cctaaccgca aggaaggagc
1441 tgtctaaggt gggattgatg attggggtga agtcgtaaca aggtaacc
TGCGGTTAGGCCACCGGCTTCGGGTGTTATCAACTCTCGTGGTGTGACGGGCGGTGTGTACAAGGCCCGAGAACGTATTCACCGCGACATGCTGATTCGCGATTACTAGCGATTCCAACTTCATGTAGTCGAGTTGCAGACTACAATCCGAACTGAGAATGGTTTTATGGGTTTTGCTTCACCTCGCGGCTTCGCTTCCCTCTGCACCATCCATTGTAGCACGTGTGTAGCCCAGGTCATAAGGGGCATGATGATTTGACGTCATCCCCGCCTTCCTCCAGCTTGTCACTGGCAGTCTCGCTAGAGTCCCCAACTTAATGATGGTAACTAACGATAAGGGTTGCGCTCGTTGCGGGACTTAACCCAACATCTCACGACACGAGCTGACGACAACCATGCACCACCTGTATCTCATATAGCTATCTCTCCATCTCTGGAGCCTTTATGAGTATGTCAAGACCTGGTAAGGTTCTTCGCGTTGCTTCGAATTAAACCACATGCTCCACCGCTTGTGCGGGCCCCCGTCAATTCCTTTGAGTTTCATTCTTGCGAACGTACTACTCAGGCGGAGTACTTATTGCGTTAACTGCAGCACTGAACTTTGACATCCAACACTTAGTACTCATCGTTTACGGCGTGGACTACTAGGGTATCTAATCCTATTTGCTCCCCACGCTTTCGGGACTGAGCGTCAGTTGCAGGCCAGATCGTCGCCTTCGCCACTGGTGTTCCTCCATATATCTACGCATTTCACCGCTACACATGGAATTCCACGATCCTCTCCTGCACTCTAGCTGCCTGGTTTCTATGGCTTACTGAAGTTAAGCTTCAGGCTTTCACCACAGACCCTTGCTGCCGCCTGCTCCCTCTTTACGCCCAATAATTCCGGATAACGCTTGCCACCTACGTATTACCGCGGCTGCTGGCACGTAGTTAGCCGTGGCTTTCTAATAAAGTACCGTCACTCGGCTACCATTTCCTGTAGCCGCCGTTCTTCCTTTATAACAGAAGTTTACAATCCGAAAACCTTCTTCCTTCACGCGGCGTTGCTCGGTCAGGGTTTCCCCCATTGCCGAAAATTCCCTACTGCTGCCTCCCGTAGGAGTCTGGGCCGTGTCTCAGTCCCAGTGTGGCCGGTCACCCTCTCAGGTCGGCTACGCATCGTCGCCTTGGTGGGCCGTTACCCCGCCAACCAGCTAATGCGCCATAAGTCCATCCTCTACCAGTGCTTTGAGGCACTTTTAATACGGTCACCATGCAGTGTCCGTACCTATGCGGTCTTAGCTATCGTTTCCAATAGTTATCCCCCTGTCTAGGGCAGGTTACTTATGTATTACTCACCCGTTCGCCACTCGAGCACAAGTGCTCGC
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Claims (39)
- IL−17又はTh17経路によって媒介される疾患又は状態を治療又は予防する方法に使用するための、エリシペラトクロストリジウム属の細菌株を含む組成物。
- ブドウ膜炎;乳がん、肺がん、肝臓がん、結腸がん、又は卵巣がんなどのがん;多発性硬化症;関節リウマチ、変形性関節症、乾癬性関節炎、又は若年性特発性関節炎などの関節炎;視神経脊髄炎(デビック病);強直性脊椎炎;脊椎関節炎;乾癬;全身性紅斑性狼瘡;クローン病又は潰瘍性大腸炎などの炎症性腸疾患;セリアック病;アレルギー性喘息又は好中球性喘息などの喘息;慢性閉塞性肺疾患(COPD);強膜炎;血管炎;ベーチェット病;アテローム性動脈硬化症;アトピー性皮膚炎;肺気腫;歯周炎;アレルギー性鼻炎;及び同種異系移植片拒絶からなる群から選択される疾患又は状態を治療又は予防する方法に使用するための、請求項1に記載の組成物。
- ブドウ膜炎を治療又は予防する方法に使用するための、請求項2に記載の組成物。
- ブドウ膜炎における網膜損傷を低減又は予防する方法に使用するための、請求項3に記載の組成物。
- 肺がん、乳がん又は肝臓がんなどのがんを治療又は予防する方法に使用するための、請求項2に記載の組成物。
- 腫瘍のサイズを低減させる、腫瘍の増殖を低減させる、転移を予防する、又は血管新生を予防する方法に使用するための、請求項5に記載の組成物。
- 好中球性喘息又はアレルギー性喘息などの喘息を治療又は予防する方法に使用するための、請求項2に記載の組成物。
- 喘息の治療において、好中球増加又は好酸球増加を低減させる方法に使用するための、請求項7に記載の組成物。
- 関節リウマチを治療又は予防する方法に使用するための、請求項2に記載の組成物。
- 関節リウマチにおける関節の腫脹を低減させる方法に使用するための、請求項9に記載の組成物。
- 多発性硬化症を治療又は予防する方法に使用するための、請求項2に記載の組成物。
- 疾患の発生率又は疾患の重症度を低減させる方法に使用するための、請求項11に記載の組成物。
- IL−17又はTh17経路によって媒介される疾患又は状態の治療又は予防において、IL−17産生を低減させる又はTh17細胞の分化を低減させる方法に使用するための、請求項1〜12のいずれかに記載の組成物。
- IL−17レベル又はTh17細胞が上昇している患者に使用するための、請求項1〜13のいずれかに記載の組成物。
- 細菌株がエリシペラトクロストリジウム・ラモスムの細菌株である、請求項1〜14のいずれかに記載の組成物。
- 細菌株が、エリシペラトクロストリジウム・ラモスムの細菌株の16s rRNA配列と少なくとも95%、96%、97%、98%、99%、99.5%又は99.9%同一である16s rRNA配列を有する、請求項1〜14のいずれかに記載の組成物。
- 細菌株が、配列番号1、2又は3と少なくとも95%、96%、97%、98%、99%、99.5%又は99.9%同一である16s rRNA配列を有する、請求項1〜14のいずれかに記載の組成物。
- 細菌株が、配列番号3と少なくとも95%、96%、97%、98%、99%、99.5%若しくは99.9%同一である16s rRNA配列を有するか、又は細菌株が、配列番号3によって表される16s rRNA配列を有する、請求項17に記載の組成物。
- 関節リウマチを治療又は予防する方法に使用するための、エリシペラトクロストリジウム・ラモスム種の細菌株を含む、請求項1に記載の組成物。
- 好中球性喘息又はアレルギー性喘息などの喘息を治療又は予防する方法に使用するための、エリシペラトクロストリジウム・ラモスム種の細菌株を含む、請求項1に記載の組成物。
- 多発性硬化症を治療又は予防する方法に使用するための、エリシペラトクロストリジウム・ラモスム種の細菌株を含む、請求項1に記載の組成物。
- ブドウ膜炎の治療を治療又は予防する方法に使用するための、エリシペラトクロストリジウム・ラモスム種の細菌株を含む、請求項1に記載の組成物。
- がんを治療又は予防する方法に使用するための、エリシペラトクロストリジウム・ラモスム種の細菌株を含む、請求項1に記載の組成物。
- 経口投与用である、請求項1〜23のいずれかに記載の組成物。
- 1又は2以上の薬学的に許容される賦形剤又は担体を含む、請求項1〜24のいずれかに記載の組成物。
- 細菌株が凍結乾燥されている、請求項1〜25のいずれかに記載の組成物。
- 細菌株が生存しており、腸管に部分的又は全体的に定着することができる、請求項1〜26のいずれかに記載の組成物。
- エリシペラトクロストリジウム属の単一株を含む、請求項1〜27のいずれかに記載の組成物。
- 微生物コンソーシアの一部としてエリシペラトクロストリジウム細菌株を含む、請求項1〜28のいずれかに記載の組成物。
- 請求項1〜14、及び19〜23のいずれかに記載の使用のための、請求項1〜29のいずれかに記載の組成物を含む食品。
- 請求項1〜14、及び19〜23のいずれかに記載の使用のための、請求項1〜29のいずれかに記載の組成物を含むワクチン組成物。
- IL−17又はTh17経路によって媒介される疾患又は状態を治療又は予防する方法であって、それを必要とする患者にエリシペラトクロストリジウム属の細菌株を含む組成物を投与することを含む、前記方法。
- NCIMB 42688として寄託されたエリシペラトクロストリジウム・ラモスムMRX027株又はその派生物の細胞。
- 請求項33に記載の細胞を含む組成物。
- 薬学的に許容される担体又は賦形剤を含む、請求項34に記載の組成物。
- NCIMB 42688として寄託されたエリシペラトクロストリジウム・ラモスムMRX027株又はその派生物の生物学的に純粋な培養物。
- 治療に使用するための、NCIMB 42688として寄託されたエリシペラトクロストリジウム・ラモスムMRX027株又はその派生物の細胞。
- 請求項1〜14のいずれかに規定の方法に使用するための、請求項37に記載の細胞。
- エリシペラトクロストリジウム属の1又は2以上の細菌株を含み、他の属の細菌を含有していないか又はごく微量の若しくは生物学的に無関係な量の別の属の細菌のみを含む、治療に使用するための組成物。
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