JP2021502970A - 免疫調節性ラクトコッカス(Lactococcus)細菌株を使用して免疫障害を処置するための組成物及び方法 - Google Patents
免疫調節性ラクトコッカス(Lactococcus)細菌株を使用して免疫障害を処置するための組成物及び方法 Download PDFInfo
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- UHTHHESEBZOYNR-UHFFFAOYSA-N vandetanib Chemical compound COC1=CC(C(/N=CN2)=N/C=3C(=CC(Br)=CC=3)F)=C2C=C1OCC1CCN(C)CC1 UHTHHESEBZOYNR-UHFFFAOYSA-N 0.000 description 1
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- 229960003048 vinblastine Drugs 0.000 description 1
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- C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
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- C12R—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
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Abstract
Description
本出願は、2017年11月15日に出願された、シリアル番号62/586,604号を有する米国仮特許出願、2018年4月20日に出願された、シリアル番号62/660,693号を有する米国仮特許出願、2018年4月23日に出願された、シリアル番号62/661,459号を有する米国仮特許出願、及び2018年8月23日に出願された、シリアル番号62/721,941号を有する米国仮特許出願に対する優先権の利益を主張しており、これらのそれぞれの内容は、その全体が参照に本明細書に組み込まれる。
いくつかの実施形態では、この細菌組成物は、1個、1.1個、1.2個、1.3個、1.4個、1.5個、1.6個、1.7個、1.8個、1.9個、2個、2.1個、2.2個、2.3個、2.4個、2.5個、2.6個、2.7個、2.8個、2.9個、3個、3.1個、3.2個、3.3個、3.4個、3.5個、3.6個、3.7個、3.8個、3.9個、4個、4.1個、4.2個、4.3個、4.4個、4.5個、4.6個、4.7個、4.8個、4.9個、5個、5.1個、5.2個、5.3個、5.4個、5.5個、5.6個、5.7個、5.8個、5.9個、6個、6.1個、6.2個、6.3個、6.4個、6.5個、6.6個、6.7個、6.8個、6.9個、7個、7.1個、7.2個、7.3個、7.4個、7.5個、7.6個、7.7個、7.8個、7.9個、8個、8.1個、8.2個、8.3個、8.4個、8.5個、8.6個、8.7個、8.8個、8.9個、9個、9.1個、9.2個、9.3個、9.4個、9.5個、9.6個、9.7個、9.8個、9.9個、10個、11個、12個、13個、14個、15個、16個、17個、18個、19個、20個、21個、22個、23個、24個、25個、26個、27個、28個、29個、30個、31個、32個、33個、34個、35個、36個、37個、38個、39個、40個、41個、42個、43個、44個、45個、46個、47個、48個、49個、50個、51個、52個、53個、54個、55個、56個、57個、58個、59個、60個、61個、62個、63個、64個、65個、66個、67個、68個、69個、70個、71個、72個、73個、74個、75個、76個、77個、78個、79個、80個、81個、82個、83個、84個、85個、86個、87個、88個、89個、90個、91個、92個、93個、94個、95個、96個、97個、98個、99個、100個、150個、200個、250個、300個、350個、400個、450個、500個、550個、600個、650個、700個、750個、800個、850個、900個、950個、1×103個、2×103個、3×103個、4×103個、5×103個、6×103個、7×103個、8×103個、9×103個、1×104個、2×104個、3×104個、4×104個、5×104個、6×104個、7×104個、8×104個、9×104個、1×105個、2×105個、3×105個、4×105個、5×105個、6×105個、7×105個、8×105個、9×105個、1×106個、2×106個、3×106個、4×106個、5×106個、6×106個、7×106個、8×106個、9×106個、1×107個、2×107個、3×107個、4×107個、5×107個、6×107個、7×107個、8×107個、9×107個、1×108個、2×108個、3×108個、4×108個、5×108個、6×108個、7×108個、8×108個、9×108個、1×109個、2×109個、3×109個、4×109個、5×109個、6×109個、7×109個、8×109個、9×109個、1×1010個、2×1010個、3×1010個、4×1010個、5×1010個、6×1010個、7×1010個、8×1010個、9×1010個、1×1011個、2×1011個、3×1011個、4×1011個、5×1011個、6×1011個、7×1011個、8×1011個、9×1011個、及び/又は1×1012個の免疫調節性ラクトコッカス(Lactococcus)株のEV粒子当たり約1個の免疫調節性ラクトコッカス(Lactococcus)株の細菌を含む。
いくつかの実施形態では、この細菌組成物は、1個、1.1個、1.2個、1.3個、1.4個、1.5個、1.6個、1.7個、1.8個、1.9個、2個、2.1個、2.2個、2.3個、2.4個、2.5個、2.6個、2.7個、2.8個、2.9個、3個、3.1個、3.2個、3.3個、3.4個、3.5個、3.6個、3.7個、3.8個、3.9個、4個、4.1個、4.2個、4.3個、4.4個、4.5個、4.6個、4.7個、4.8個、4.9個、5個、5.1個、5.2個、5.3個、5.4個、5.5個、5.6個、5.7個、5.8個、5.9個、6個、6.1個、6.2個、6.3個、6.4個、6.5個、6.6個、6.7個、6.8個、6.9個、7個、7.1個、7.2個、7.3個、7.4個、7.5個、7.6個、7.7個、7.8個、7.9個、8個、8.1個、8.2個、8.3個、8.4個、8.5個、8.6個、8.7個、8.8個、8.9個、9個、9.1個、9.2個、9.3個、9.4個、9.5個、9.6個、9.7個、9.8個、9.9個、10個、11個、12個、13個、14個、15個、16個、17個、18個、19個、20個、21個、22個、23個、24個、25個、26個、27個、28個、29個、30個、31個、32個、33個、34個、35個、36個、37個、38個、39個、40個、41個、42個、43個、44個、45個、46個、47個、48個、49個、50個、51個、52個、53個、54個、55個、56個、57個、58個、59個、60個、61個、62個、63個、64個、65個、66個、67個、68個、69個、70個、71個、72個、73個、74個、75個、76個、77個、78個、79個、80個、81個、82個、83個、84個、85個、86個、87個、88個、89個、90個、91個、92個、93個、94個、95個、96個、97個、98個、99個、100個、150個、200個、250個、300個、350個、400個、450個、500個、550個、600個、650個、700個、750個、800個、850個、900個、950個、1×103個、2×103個、3×103個、4×103個、5×103個、6×103個、7×103個、8×103個、9×103個、1×104個、2×104個、3×104個、4×104個、5×104個、6×104個、7×104個、8×104個、9×104個、1×105個、2×105個、3×105個、4×105個、5×105個、6×105個、7×105個、8×105個、9×105個、1×106個、2×106個、3×106個、4×106個、5×106個、6×106個、7×106個、8×106個、9×106個、1×107個、2×107個、3×107個、4×107個、5×107個、6×107個、7×107個、8×107個、9×107個、1×108個、2×108個、3×108個、4×108個、5×108個、6×108個、7×108個、8×108個、9×108個、1×109個、2×109個、3×109個、4×109個、5×109個、6×109個、7×109個、8×109個、9×109個、1×1010個、2×1010個、3×1010個、4×1010個、5×1010個、6×1010個、7×1010個、8×1010個、9×1010個、1×1011個、2×1011個、3×1011個、4×1011個、5×1011個、6×1011個、7×1011個、8×1011個、9×1011個、及び/又は1×1012個の免疫調節性ラクトコッカス(Lactococcus)株のEV粒子当たり最高で1個のラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株の細菌を含む。
いくつかの実施形態では、この細菌組成物は、1個、1.1個、1.2個、1.3個、1.4個、1.5個、1.6個、1.7個、1.8個、1.9個、2個、2.1個、2.2個、2.3個、2.4個、2.5個、2.6個、2.7個、2.8個、2.9個、3個、3.1個、3.2個、3.3個、3.4個、3.5個、3.6個、3.7個、3.8個、3.9個、4個、4.1個、4.2個、4.3個、4.4個、4.5個、4.6個、4.7個、4.8個、4.9個、5個、5.1個、5.2個、5.3個、5.4個、5.5個、5.6個、5.7個、5.8個、5.9個、6個、6.1個、6.2個、6.3個、6.4個、6.5個、6.6個、6.7個、6.8個、6.9個、7個、7.1個、7.2個、7.3個、7.4個、7.5個、7.6個、7.7個、7.8個、7.9個、8個、8.1個、8.2個、8.3個、8.4個、8.5個、8.6個、8.7個、8.8個、8.9個、9個、9.1個、9.2個、9.3個、9.4個、9.5個、9.6個、9.7個、9.8個、9.9個、10個、11個、12個、13個、14個、15個、16個、17個、18個、19個、20個、21個、22個、23個、24個、25個、26個、27個、28個、29個、30個、31個、32個、33個、34個、35個、36個、37個、38個、39個、40個、41個、42個、43個、44個、45個、46個、47個、48個、49個、50個、51個、52個、53個、54個、55個、56個、57個、58個、59個、60個、61個、62個、63個、64個、65個、66個、67個、68個、69個、70個、71個、72個、73個、74個、75個、76個、77個、78個、79個、80個、81個、82個、83個、84個、85個、86個、87個、88個、89個、90個、91個、92個、93個、94個、95個、96個、97個、98個、99個、100個、150個、200個、250個、300個、350個、400個、450個、500個、550個、600個、650個、700個、750個、800個、850個、900個、950個、1×103個、2×103個、3×103個、4×103個、5×103個、6×103個、7×103個、8×103個、9×103個、1×104個、2×104個、3×104個、4×104個、5×104個、6×104個、7×104個、8×104個、9×104個、1×105個、2×105個、3×105個、4×105個、5×105個、6×105個、7×105個、8×105個、9×105個、1×106個、2×106個、3×106個、4×106個、5×106個、6×106個、7×106個、8×106個、9×106個、1×107個、2×107個、3×107個、4×107個、5×107個、6×107個、7×107個、8×107個、9×107個、1×108個、2×108個、3×108個、4×108個、5×108個、6×108個、7×108個、8×108個、9×108個、1×109個、2×109個、3×109個、4×109個、5×109個、6×109個、7×109個、8×109個、9×109個、1×1010個、2×1010個、3×1010個、4×1010個、5×1010個、6×1010個、7×1010個、8×1010個、9×1010個、1×1011個、2×1011個、3×1011個、4×1011個、5×1011個、6×1011個、7×1011個、8×1011個、9×1011個、及び/又は1×1012個の免疫調節性ラクトコッカス(Lactococcus)株の細菌当たり少なくとも1個の免疫調節性ラクトコッカス(Lactococcus)株のEV粒子を含む。
いくつかの実施形態では、この細菌組成物は、1個、1.1個、1.2個、1.3個、1.4個、1.5個、1.6個、1.7個、1.8個、1.9個、2個、2.1個、2.2個、2.3個、2.4個、2.5個、2.6個、2.7個、2.8個、2.9個、3個、3.1個、3.2個、3.3個、3.4個、3.5個、3.6個、3.7個、3.8個、3.9個、4個、4.1個、4.2個、4.3個、4.4個、4.5個、4.6個、4.7個、4.8個、4.9個、5個、5.1個、5.2個、5.3個、5.4個、5.5個、5.6個、5.7個、5.8個、5.9個、6個、6.1個、6.2個、6.3個、6.4個、6.5個、6.6個、6.7個、6.8個、6.9個、7個、7.1個、7.2個、7.3個、7.4個、7.5個、7.6個、7.7個、7.8個、7.9個、8個、8.1個、8.2個、8.3個、8.4個、8.5個、8.6個、8.7個、8.8個、8.9個、9個、9.1個、9.2個、9.3個、9.4個、9.5個、9.6個、9.7個、9.8個、9.9個、10個、11個、12個、13個、14個、15個、16個、17個、18個、19個、20個、21個、22個、23個、24個、25個、26個、27個、28個、29個、30個、31個、32個、33個、34個、35個、36個、37個、38個、39個、40個、41個、42個、43個、44個、45個、46個、47個、48個、49個、50個、51個、52個、53個、54個、55個、56個、57個、58個、59個、60個、61個、62個、63個、64個、65個、66個、67個、68個、69個、70個、71個、72個、73個、74個、75個、76個、77個、78個、79個、80個、81個、82個、83個、84個、85個、86個、87個、88個、89個、90個、91個、92個、93個、94個、95個、96個、97個、98個、99個、100個、150個、200個、250個、300個、350個、400個、450個、500個、550個、600個、650個、700個、750個、800個、850個、900個、950個、1×103個、2×103個、3×103個、4×103個、5×103個、6×103個、7×103個、8×103個、9×103個、1×104個、2×104個、3×104個、4×104個、5×104個、6×104個、7×104個、8×104個、9×104個、1×105個、2×105個、3×105個、4×105個、5×105個、6×105個、7×105個、8×105個、9×105個、1×106個、2×106個、3×106個、4×106個、5×106個、6×106個、7×106個、8×106個、9×106個、1×107個、2×107個、3×107個、4×107個、5×107個、6×107個、7×107個、8×107個、9×107個、1×108個、2×108個、3×108個、4×108個、5×108個、6×108個、7×108個、8×108個、9×108個、1×109個、2×109個、3×109個、4×109個、5×109個、6×109個、7×109個、8×109個、9×109個、1×1010個、2×1010個、3×1010個、4×1010個、5×1010個、6×1010個、7×1010個、8×1010個、9×1010個、1×1011個、2×1011個、3×1011個、4×1011個、5×1011個、6×1011個、7×1011個、8×1011個、9×1011個、及び/又は1×1012個の免疫調節性ラクトコッカス(Lactococcus)株の細菌当たり約1個の免疫調節性ラクトコッカス(Lactococcus)株のEV粒子を含む。
いくつかの実施形態では、この細菌組成物は、1個、1.1個、1.2個、1.3個、1.4個、1.5個、1.6個、1.7個、1.8個、1.9個、2個、2.1個、2.2個、2.3個、2.4個、2.5個、2.6個、2.7個、2.8個、2.9個、3個、3.1個、3.2個、3.3個、3.4個、3.5個、3.6個、3.7個、3.8個、3.9個、4個、4.1個、4.2個、4.3個、4.4個、4.5個、4.6個、4.7個、4.8個、4.9個、5個、5.1個、5.2個、5.3個、5.4個、5.5個、5.6個、5.7個、5.8個、5.9個、6個、6.1個、6.2個、6.3個、6.4個、6.5個、6.6個、6.7個、6.8個、6.9個、7個、7.1個、7.2個、7.3個、7.4個、7.5個、7.6個、7.7個、7.8個、7.9個、8個、8.1個、8.2個、8.3個、8.4個、8.5個、8.6個、8.7個、8.8個、8.9個、9個、9.1個、9.2個、9.3個、9.4個、9.5個、9.6個、9.7個、9.8個、9.9個、10個、11個、12個、13個、14個、15個、16個、17個、18個、19個、20個、21個、22個、23個、24個、25個、26個、27個、28個、29個、30個、31個、32個、33個、34個、35個、36個、37個、38個、39個、40個、41個、42個、43個、44個、45個、46個、47個、48個、49個、50個、51個、52個、53個、54個、55個、56個、57個、58個、59個、60個、61個、62個、63個、64個、65個、66個、67個、68個、69個、70個、71個、72個、73個、74個、75個、76個、77個、78個、79個、80個、81個、82個、83個、84個、85個、86個、87個、88個、89個、90個、91個、92個、93個、94個、95個、96個、97個、98個、99個、100個、150個、200個、250個、300個、350個、400個、450個、500個、550個、600個、650個、700個、750個、800個、850個、900個、950個、1×103個、2×103個、3×103個、4×103個、5×103個、6×103個、7×103個、8×103個、9×103個、1×104個、2×104個、3×104個、4×104個、5×104個、6×104個、7×104個、8×104個、9×104個、1×105個、2×105個、3×105個、4×105個、5×105個、6×105個、7×105個、8×105個、9×105個、1×106個、2×106個、3×106個、4×106個、5×106個、6×106個、7×106個、8×106個、9×106個、1×107個、2×107個、3×107個、4×107個、5×107個、6×107個、7×107個、8×107個、9×107個、1×108個、2×108個、3×108個、4×108個、5×108個、6×108個、7×108個、8×108個、9×108個、1×109個、2×109個、3×109個、4×109個、5×109個、6×109個、7×109個、8×109個、9×109個、1×1010個、2×1010個、3×1010個、4×1010個、5×1010個、6×1010個、7×1010個、8×1010個、9×1010個、1×1011個、2×1011個、3×1011個、4×1011個、5×1011個、6×1011個、7×1011個、8×1011個、9×1011個、及び/又は1×1012個の免疫調節性ラクトコッカス(Lactococcus)株の細菌当たり最高で1個の免疫調節性ラクトコッカス(Lactococcus)株のEV粒子を含む。
ある特定の態様では、本明細書で提供されるのは、対象(例えばヒト対象)の疾患(例えば、癌、自己免疫疾患、炎症性疾患、代謝性疾患)の処置及び/又は予防に関連する方法及び組成物(例えば、細菌組成物、医薬組成物)であって、ラクトコッカス(Lactococcus)細菌、並びに/又はそのような細菌の産生物(例えば、細胞外小胞(EV)、及び/若しくは薬学的に活性なバイオマス(PhAB))を含む細菌組成物を投与することを含む方法及び組成物である。ある特定の態様では、同様に本明細書で提供されるのは、対象の免疫障害(例えば、自己免疫疾患、炎症性疾患、アレルギー)を処置する方法であって、本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株、本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株により生成されたか若しくはこの株から単離されたEV、及び/又は本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株から作られたか若しくはこの株を含むPhABを含む細菌組成物を対象に投与することを含む方法である。
「投与」は、対象への組成物の投与経路を広く指す。投与経路の例には、経口投与、直腸投与、局所投与、吸入(鼻)、又は注射が含まれる。注射による投与には、静脈内(IV)投与、筋肉内(IM)投与、腫瘍内(IT)投与、及び皮下(SC)投与が含まれる。本明細書に記載の医薬組成物は、限定されるものではないが、腫瘍内、経口、非経口、腸内、静脈内、腹腔内、局所、経皮(例えば、任意の標準的なパッチを使用)、皮内、眼内、経鼻(鼻腔内)、局所、非経口、例えば、エアロゾル、吸入、皮下、筋肉内、口腔、舌下、(経)直腸、膣内、動脈内、及び髄腔内、経粘膜(例えば、舌下、舌、(経)頬、(経)尿道、膣(例えば、経膣及び膣周囲)、埋め込み、膀胱内、肺内、十二指腸内、胃内、及び気管支内を含む任意の効果的な経路によって任意の形態で投与することができる。好ましい実施形態では、本明細書に記載の医薬組成物は、経口、直腸、腫瘍内、局所、膀胱内、排出リンパ節内又はその近傍への注射により、静脈内、吸入若しくはエアロゾルにより、又は皮下投与される。
例えば、対象は、非ヒト哺乳類(例えば、限定されないが、イヌ、ネコ、ウシ、ウマ、ブタ、ロバ、ヤギ、ラクダ、マウス、ラット、モルモット、ヒツジ、ラマ、サル、ゴリラ、又はチンパンジー)であり得る。対象又は患者は、健康であってもよいし任意の発育段階で免疫障害に罹患していてもよい。
ある特定の態様では、本明細書で提供されるのは、本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株、本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株により生成されたか若しくはこの株から単離されたEV、及び/又は本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株から作られたか若しくはこの株を含むPhABを含む細菌組成物を使用する方法である。いくつかの実施形態では、この免疫調節性ラクトコッカス(Lactococcus)株はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)の株である。いくつかの実施形態では、この免疫調節性ラクトコッカス(Lactococcus)株はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A(ATCC受託番号PTA−125368)である。いくつかの実施形態では、この免疫調節性ラクトコッカス(Lactococcus)株は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A(ATCC受託番号PTA−125368)のヌクレオチド配列(例えば、ゲノムヌクレオチド配列、16Sヌクレオチド配列、又はCRISPRヌクレオチド配列)に対して少なくとも90%、少なくとも91%、少なくとも92%、少なくとも93%、少なくとも94%、少なくとも95%、少なくとも96%、少なくとも97%、少なくとも98%、又は少なくとも99%の配列同一性(例えば、少なくとも99.5%の配列同一性、少なくとも99.6%の配列同一性、少なくとも99.7%配列同一性、少なくとも99.8%の配列同一性、少なくとも99.9%の配列同一性)を含む株である。
ある特定の態様では、本明細書で説明されている免疫調節性ラクトコッカス(Lactococcus)株のEVを、当該技術分野で既知の任意の方法を使用して調製し得る。
ある特定の態様では、本明細書で提供されるのは、本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株、本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株のEV、及び/又は本明細書で提供される免疫調節性ラクトコッカス(Lactococcus)株のPhABを含む細菌組成物である。いくつかの実施形態では、この細菌製剤は薬学的に許容される担体をさらに含む。
いくつかの実施形態では、この医薬組成物は、1個、1.1個、1.2個、1.3個、1.4個、1.5個、1.6個、1.7個、1.8個、1.9個、2個、2.1個、2.2個、2.3個、2.4個、2.5個、2.6個、2.7個、2.8個、2.9個、3個、3.1個、3.2個、3.3個、3.4個、3.5個、3.6個、3.7個、3.8個、3.9個、4個、4.1個、4.2個、4.3個、4.4個、4.5個、4.6個、4.7個、4.8個、4.9個、5個、5.1個、5.2個、5.3個、5.4個、5.5個、5.6個、5.7個、5.8個、5.9個、6個、6.1個、6.2個、6.3個、6.4個、6.5個、6.6個、6.7個、6.8個、6.9個、7個、7.1個、7.2個、7.3個、7.4個、7.5個、7.6個、7.7個、7.8個、7.9個、8個、8.1個、8.2個、8.3個、8.4個、8.5個、8.6個、8.7個、8.8個、8.9個、9個、9.1個、9.2個、9.3個、9.4個、9.5個、9.6個、9.7個、9.8個、9.9個、10個、11個、12個、13個、14個、15個、16個、17個、18個、19個、20個、21個、22個、23個、24個、25個、26個、27個、28個、29個、30個、31個、32個、33個、34個、35個、36個、37個、38個、39個、40個、41個、42個、43個、44個、45個、46個、47個、48個、49個、50個、51個、52個、53個、54個、55個、56個、57個、58個、59個、60個、61個、62個、63個、64個、65個、66個、67個、68個、69個、70個、71個、72個、73個、74個、75個、76個、77個、78個、79個、80個、81個、82個、83個、84個、85個、86個、87個、88個、89個、90個、91個、92個、93個、94個、95個、96個、97個、98個、99個、100個、150個、200個、250個、300個、350個、400個、450個、500個、550個、600個、650個、700個、750個、800個、850個、900個、950個、1×103個、2×103個、3×103個、4×103個、5×103個、6×103個、7×103個、8×103個、9×103個、1×104個、2×104個、3×104個、4×104個、5×104個、6×104個、7×104個、8×104個、9×104個、1×105個、2×105個、3×105個、4×105個、5×105個、6×105個、7×105個、8×105個、9×105個、1×106個、2×106個、3×106個、4×106個、5×106個、6×106個、7×106個、8×106個、9×106個、1×107個、2×107個、3×107個、4×107個、5×107個、6×107個、7×107個、8×107個、9×107個、1×108個、2×108個、3×108個、4×108個、5×108個、6×108個、7×108個、8×108個、9×108個、1×109個、2×109個、3×109個、4×109個、5×109個、6×109個、7×109個、8×109個、9×109個、1×1010個、2×1010個、3×1010個、4×1010個、5×1010個、6×1010個、7×1010個、8×1010個、9×1010個、1×1011個、2×1011個、3×1011個、4×1011個、5×1011個、6×1011個、7×1011個、8×1011個、9×1011個、及び/又は1×1012個の免疫調節性ラクトコッカス(Lactococcus)株の細菌当たり最高で1個の免疫調節性ラクトコッカス(Lactococcus)株のEV粒子を含む。
ある特定の態様では、本明細書で説明されているPhABを、当該技術分野で既知の任意の方法を使用して調製し得る。
ある特定の態様では、本明細書で提供されるのは、対象に本明細書で説明されている細菌及び/又は細菌組成物を送達する方法である。本明細書で提供される方法のいくつかの実施形態では、この細菌を追加の治療薬の投与と共に投与する。いくつかの実施形態では、この細菌を、この追加の治療薬と共に医薬組成物に共製剤化する。いくつかの実施形態では、この細菌をこの追加の治療薬と共投与する。いくつかの実施形態では、この追加の治療薬を、この細菌の投与前(例えば、約1、2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、45、50、若しくは55分前、約1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21、22、若しくは23時間前、又は約1、2、3、4、5、6、7、8、9、10、11、12、13、若しくは14日前)に対象に投与する。いくつかの実施形態では、この追加の治療薬を、この細菌の投与後(例えば、約1、2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、45、50、若しくは55分後、約1、2、3、4、5、6、7、8、9、10、11、12、13、14、15、16、17、18、19、20、21、22、若しくは23時間後、又は約1、2、3、4、5、6、7、8、9、10、11、12、13、若しくは14日後)に対象に投与する。いくつかの実施形態では、同一の送達モードを使用して、この細菌とこの追加の治療薬との両方を送達する。いくつかの実施形態では、異なる送達モードを使用して、この細菌とこの追加の治療薬とを投与する。例えば、いくつかの実施形態では、この細菌を経口投与し、この追加の治療薬を注射(例えば、静脈内注射、筋肉内注釈、及び/又は腫瘍内注射)により投与する。
ある特定の態様では、本明細書で提供される方法は、単独又は別の治療薬との組み合わせのいずれかでの、本明細書で説明されている細菌及び/又は細菌組成物(例えば、免疫調節性ラクトコッカス(Lactococcus)株含有細菌組成物)の対象への投与を含む。いくつかの実施形態では、この細菌組成物及び他の治療を、任意の順序で対象に投与し得る。いくつかの実施形態では、この細菌組成物及び他の治療を併せて投与する。
IL−6拮抗薬、CD20拮抗薬、CTLA4拮抗薬、IL−8拮抗薬、IL−21拮抗薬、IL−22拮抗薬、インテグリン拮抗薬(Tysarbri(登録商標)(ナタリズマブ))、VGEF拮抗薬、CXCL拮抗薬、MMP拮抗薬、デフェンシン拮抗薬、IL−1拮抗薬(例えばIL−1ベータ拮抗薬)、並びにIL−23拮抗薬(例えば、レセプターデコイ、拮抗性抗体等)。
ピリミジン類似体、例えば、アンシタビン、アザシチジン、6−アザウリジン、カルモフール、シタラビン、ジデオキシウリジン、ドキシフルリジン、エノシタビン、フロクスウリジン;アンドロゲン、例えば、カルステロン、プロピオン酸ドロモスタノロン、エピチオスタノール、メピチオスタン、テストラクトン;抗副腎、例えば、アミノグルテチミド、ミトタン、トリロスタン;葉酸補充剤、例えば、フォリン酸;アセグラトン;アルドホスファミドグリコシド;アミノレブリン酸;エニルウラシル;アムサクリン;ベストラブシル;ビサントレン;エダトラキサート;デフォファミン;デメコルシン;ジアジコン;エルホルミチン;酢酸エリプチニウム;エポチロン;エトグルシド;硝酸ガリウム;ヒドロキシ尿素;レンチナン;ロニダイニン;メイタンシノイド、例えば、メイタンシン及びアンサミトシン;ミトグアゾン;ミトキサントロン;モピダンモール;ニトラエリン;ペントスタチン;フェナメット;ピラルビシン;ロソキサントロン;ポドフィリン酸;2−エチルヒドラジド;プロカルバジン;PSK多糖複合体);ラゾキサン;リゾキシン;シゾフラン;スピロゲルマニウム;テヌアゾン酸;トリアジコン;2,2’、2’’−トリクロロトリエチルアミン;トリコテセン(特に、T−2毒素、ベラクリンA、ロリジンA、及びアンギジン);ウレタン;ビンデシン;ダカルバジン;マンノムスチン;ミトブロニトール;ミトラクトール;ピポブロマン;ガシトシン;アラビノシド(「Ara−C」);シクロホスファミド;チオテパ;タキソイド、例えば、パクリタキセル及びドキセタキセル;クロラムブシル;ゲムシタビン;6−チオグアニン;メルカプトプリン;メトトレキサート;白金配位錯体、例えば、シスプラチン、オキサリプラチン、及びカルボプラチン;ビンブラスチン;白金;エトポシド(VP−16);イホスファミド;ミトキサントロン;ビンクリスチン;ビノレルビン;ノバントロン;テニポシド;エダトレキサート;ダウノマイシン;アミノプテリン;ゼローダ;イバンドロネート;イリノテカン(例えば、CPT−11);トポイソメラーゼ阻害剤RFS 2000;ジフルオロメチルオミチン(DMFO);レチノイド、例えば、レチノイン酸;カペシタビン;及び上記のいずれかの薬学的に許容される塩、酸、又は誘導体が含まれる。
インスリン様成長因子結合タンパク質3(「IGFBP−3」)、インスリン様成長因子結合タンパク質4(「IGFBP−4」)、インスリン様成長因子結合タンパク質6(「IGFBP」−6」)、インスリン様成長因子1(「IGF−1」)、インスリン、マクロファージコロニー刺激因子(「M−CSF R」)、神経成長因子受容体(「NGF R」)、ニューロトロフィン−3(「NT−3」)、ニューロトロフィン−4(「NT−4」)、破骨細胞形成抑制因子(「オステオプロテグリン」)、血小板由来成長因子受容体(「PDGF−AA」)、ホスファチジルイノシトール−グリカン生合成(「PIGF」)、Skp、カリン、F−ボックス含有複合体(「SCF」)、幹細胞因子受容体(「SCF R」)、形質転換成長因子α(「TGFα」)、形質転換成長因子β−1(「TGFβ1」)、形質転換成長因子β3(「TGFβ3」)、血管内皮成長因子(「VEGF」)、血管内皮成長因子受容体2(「VEGFR2」)、血管内皮成長因子受容体3(「VEGFR3」)、VEGF−D 6Ckine、チロシン−プロテインキナーゼ受容体UFO(「Axl」)、ベータセルリン(「BTC」)、粘膜関連上皮ケモカイン(「CCL28」)、ケモカイン(C−Cモチーフ)リガンド27(「CTACK」)、ケモカイン(C−X−Cモチーフ)リガンド16(「CXCL16」)、C−X−Cモチーフケモカイン5(「ENA−78」)、ケモカイン(C−Cモチーフ)リガンド26(「エオタキシン−3」)、顆粒球走化性タンパク質2(「GCP−2」)、GRO、ケモカイン(C−Cモチーフ)リガンド14(「HCC−1」)、ケモカイン(C−Cモチーフ)リガンド16(「HCC−4」)、インターロイキン−9(「IL−9」)、インターロイキン−17F(「IL−17F」)、インターロイキン−18結合タンパク質(「IL−18 BPa」)、インターロイキン−28A(「IL−28A」)、インターロイキン29(「IL−29」)、インターロイキン31(「IL−31」)、C−X−Cモチーフケモカイン10(「IP−10」)、ケモカイン受容体CXCR3(「I−TAC」)、白血病抑制因子(「LIF」)、Light、ケモカイン(Cモチーフ)リガンド(「リンホタクチン」)、単球化学誘引物質タンパク質2(「MCP−2」)、単球化学誘引物質タンパク質3(「MCP−3」)、単球化学誘引物質タンパク質4(「MCP−4」)、マクロファージ由来ケモカイン(「MDC」)、マクロファージ遊走阻止因子(「MIF」)、ケモカイン(C−Cモチーフ)リガンド20(「MIP−3α」)、C−Cモチーフケモカイン19(「MIP−3β」)、ケモカイン(C−Cモチーフ)リガンド23(「MPIF−1」)、マクロファージ刺激タンパク質α鎖(「MSPalpha」)、ヌクレオソームアセンブリタンパク質1様4(「NAP−2」)、分泌リンタンパク質1(「オステオポンチン」)、肺及び活性化調節サイトカイン(「PARC」)、血小板因子4(「PF4」)、ストロマ細胞由来因子1α(「SDF−1α」)、ケモカイン(C−Cモチーフ)リガンド17(「TARC」)、胸腺発現ケモカイン(「TECK」)、胸腺間質リンホポエチン(「TSLP4−IBB」)、CD166抗原(「ALCAM」)、分化クラスター80(「B7−1」)、腫瘍壊死因子受容体スーパーファミリーメンバー17(「BCMA」)、分化クラスター14(「CD14」)、分化クラスター30(「CD30」)、分化クラスター40(「CD40リガンド」)、癌胎児性抗原関連細胞接着分子1(胆汁糖タンパク質)(「CEACAM−1」)、死受容体6(「DR6」)、デオキシチミジンキナーゼ(「Dtk」)、1型膜糖タンパク質(「エンドグリン」」)、受容体チロシン−プロテインキナーゼerbB−3(「ErbB3」)、内皮−白血球接着分子1(「E−セレクチン」)、アポトーシス抗原1(「Fas」)、Fms様チロシンキナーゼ3(「Flt−3L」)、腫瘍壊死因子受容体スーパーファミリーメンバー1(「GITR」)、腫瘍壊死因子受容体スーパーファミリーメンバー14(「HVEM」)、
細胞間接着分子3(「ICAM−3」)、IL−1 R4、IL−1 RI、IL−10 Rβ、IL−17R、IL−2Rγ、IL−21R、リソソーム膜タンパク質2(「LIMPII」)、好中球ゼラチナーゼ関連リポカリン(「リポカリン−2」)、CD62L(「L−セレクチン」)、リンパ管内皮(「LYVE−1」)、MHCクラスIポリペプチド関連配列A(「MICA」)、MHCクラスIポリペプチド関連配列B(「MICB」)、NRGl−betal、β型血小板由来成長因子受容体(「PDGF Rβ」)、血小板内皮細胞接着分子(「PECAM−1」)、RAGE、A型肝炎ウイルス細胞受容体1(「TIΜ−1」)、腫瘍壊死因子受容体スーパーファミリーメンバーIOC(「TRAIL R3」)、Trappinタンパク質トランスグルタミナーゼ結合ドメイン(「Trappin−2」)、ウロキナーゼ受容体(「uPAR」)、血管細胞接着タンパク質1(「VCAM−1」)、XEDARActivin A、アグーチ関連タンパク質(「AgRP」)、リボヌクレアーゼ5(「アンジオゲニン」)、アンジオポエチン1、アンジオスタチン、カテプリンS、CD40、潜在性ファミリータンパク質IB(「Cripto−1」)、DAN、Dickkopf関連タンパク質1(「DKK−1」)、E−カドヘリン、上皮細胞接着分子(「EpCAM」)、Fasリガンド(FasL又はCD95L)、Fcg RIIB/C、フォリスタチン(FoUistatin)、ガレクチン−7、細胞間接着分子2(「ICAM−2」)、IL−13R1、IL−13R2、IL−17B、IL−2Ra、IL−2Rb、IL−23、LAP、神経細胞接着分子(「NrCAM」)、プラスミノーゲン活性化因子阻害剤−1(「PAI−1」)、血小板由来成長因子受容体(「PDGF−AB」)、レジスチン、ストロマ細胞由来因子1(「SDF−1β」)、sgpl30、分泌型frizzled関連タンパク質2(「ShhN」)、シアル酸結合免疫グロブリン型レクチン(「Siglec−5」)、ST2、形質転換成長因子−β2(「TGFβ2」)、Tie−2、トロンボポエチン(「TPO」)、腫瘍壊死因子受容体スーパーファミリーメンバー10D(「TRAIL R4」)、骨髄細胞に発現されるトリガー受容体1(「TREM−1」)、血管内皮成長因子C(「VEGF−C」)、VEGFRlアディポネクチン、アジプシン(「AND」)、α−フェトプロテイン(「AFP」)、アンジオポエチン様4(「ANGPTL4」)、β−2−ミクログロブリン(「B2M」)、基底細胞接着分子(「BCAM」)、糖鎖抗原125(「CA125」)、癌抗原15−3(「CA15−3」)、癌胎児性抗原(「CEA」)、cAMP受容体タンパク質(「CRP」)、ヒト上皮成長因子受容体2(「ErbB2」)、フォリスタチン、卵胞刺激ホルモン(「FSH」)、ケモカイン(C−X−Cモチーフ)リガンド1(「GROα」)、ヒト絨毛性ゴナドトロピン(「βHCG」)、インスリン様成長因子1受容体(「IGF−l sR」)、IL−1 sRII、IL−3、IL−18 Rb、IL−21、レプチン、マトリックスメタロプロテイナーゼ−1(「MMP−1」)、マトリックスメタロプロテイナーゼ−2(「MMP−2」)、マトリックスメタロプロテイナーゼ−3(「MMP−3」)、マトリックスメタロプロテイナーゼ−8(「MMP−8」)、マトリックスメタロプロテイナーゼ−9(「MMP−9」)、マトリックスメタロプロテイナーゼ−10(「MMP−10」)、マトリックスメタロプロテイナーゼ−13(「MMP−13」)、神経細胞接着分子(「NCAM−1」)、エンタクチン(「Nidogen−1」)、ニューロン特異的エノラーゼ(「NSE」)、オンコスタチンM(「OSM」)、プロカルシトニン、プロラクチン、前立腺特異的抗原(「PSA」)、シアル酸結合Ig様レクチン9(「Siglec−9」)、ADAM17エンドペプチダーゼ(「TACE」)、チログロブリン、メタロプロテイナーゼ阻害剤4(「TIMP−4」)、TSH2B4、ディスインテグリン及びメタロプロテイナーゼドメイン含有タンパク質9(「ADAM−9」)、
アンジオポエチン2、腫瘍壊死因子リガンドスーパーファミリーメンバー13/酸性ロイシンリッチ核リンタンパク質32ファミリーメンバーB(「APRIL」)、骨形成タンパク質2(「BMP−2」)、骨形成タンパク質9(「BMP−9」)、補体成分5a(「C5a」)、カテプシンL、CD200、CD97、ケメリン、腫瘍壊死因子受容体スーパーファミリーメンバー6B(「DcR3」)、脂肪酸結合タンパク質2(「FABP2」)、線維芽細胞活性化タンパク質、α(「FAP」)、線維芽細胞成長因子19(「FGF−19」)、ガレクチン3、肝細胞成長因子受容体(「HGF R」)、IFN−γα/βR2、インスリン様成長因子2(「IGF−2」)、インスリン様成長因子2受容体(「IGF−2R」)、インターロイキン−1受容体6(「IL−1R6」)、インターロイキン24(「IL−24」)、インターロイキン33(「IL−33」)、カリクレイン14、アスパラギニルエンドペプチダーゼ(「Legumain」)、酸化低密度リポタンパク質受容体1(「LOX−1」)、マンノース結合レクチン(「MBL」)、ネプリライシン(「NEP」)、ノッチホモログ1、転座関連(ショウジョウバエ(Drosophila))(「ノッチ−1」)、腎芽細胞腫過剰発現(「NOV」)、オステオアクチビン、プログラム細胞死タンパク質1(「PD−1」」)、N−アセチルムラモイル−L−アラニンアミダーゼ(「PGRP−5」)、セルピンA4、分泌型frizzled関連タンパク質3(「sFRP−3」)、トロンボモジュリン、Toll様受容体2(「TLR2」)、腫瘍壊死因子受容体スーパーファミリーメンバー10A(「TRAIL R1」)、トランスフェリン(「TRF」)、WIF−lACE−2、アルブミン、AMICA、アンジオポエチン4、B細胞活性化因子(「BAFF」)、糖鎖抗原19−9(「CA19−9」)、CD163、クラスタリン、CRT AM、ケモカイン(C−X−Cモチーフ)リガンド14(「CXCL14」)、シスタチンC、デコリン(「DCN」)、Dickkopf関連タンパク質3(「Dkk−3」)、δ様タンパク質1(「DLL1」)、フェチュインA、ヘパリン結合成長因子1(「aFGF」)、葉酸受容体α(「FOLR1」)、フューリン、GPCR関連ソーティングタンパク質1(「GASP−1」)、GPCR関連ソーティングタンパク質2(「GASP−2」)、顆粒球コロニー刺激因子受容体(「GCSF R」)、セリンプロテアーゼヘプシン(「HAI−2」)、インターロイキン−17B受容体(「IL−17B R」)、インターロイキン27(「IL−27」)、リンパ球活性化遺伝子3(「LAG−3」)、アポリポタンパク質A−V(「LDL R」)、ペプシノーゲンI、レチノール結合タンパク質4(「RBP4」)、SOST、ヘパラン硫酸プロテオグリカン(「シンデカン−1」)、腫瘍壊死因子受容体スーパーファミリーメンバー13B(「TACI」)、組織因子経路阻害剤(「TFPI」)、TSP−1、腫瘍壊死因子受容体スーパーファミリーメンバー10b(「TRAIL R2」)、TRANCE、トロポニンI、ウロキナーゼ型プラスミノーゲン活性化因子(「uPA」)、カドヘリン5、CD144としても知られる2型又はVE−カドヘリン(血管内皮)(「VE−カドヘリン」)、WNT1誘導シグナル伝達経路タンパク質1(「WISP−1」)、及び核因子κBの活性化受容体(「RANK」)が含まれる。
いくつかの実施形態では、本明細書で説明されている方法及び組成物は、病理学的免疫反応に関連する疾患又は障害(例えば、自己免疫疾患、アレルギー反応、及び/又は炎症性疾患)の処置又は予防に関する。いくつかの実施形態では、この疾患又は障害は炎症性腸疾患(例えば、クローン病又は潰瘍性大腸炎)である。いくつかの実施形態では、本明細書で説明されている方法及び組成物は、遅延型過敏症、自己免疫性心筋炎、肉芽腫、末梢神経障害、橋本甲状腺炎、結腸の炎症、大腸炎、顕微鏡的大腸炎、コラーゲン大腸炎、空置大腸炎、化学的大腸炎、虚血性大腸炎、不確定大腸炎、非定型大腸炎の処置又は予防に関する。
いくつかの実施形態では、本明細書で説明されている方法及び組成物は、癌の処置に関する。いくつかの実施形態では、本明細書で説明されている方法を使用して、あらゆる癌を処置し得る。本明細書で説明されている方法及び組成物により処置され得る癌の例として、下記が挙げられるがこれらに限定されない:膀胱、血液、骨、骨髄、脳、乳房、結腸、食道、胃腸、歯肉、頭、腎臓、肝臓、肺、上咽頭、首、卵巣、前立腺、皮膚、胃、精巣、舌、又は子宮からの癌細胞。加えて、癌は、具体的には下記の組織型であり得るが、これらに限定されない:新生物、悪性;癌腫;癌腫、未分化;巨細胞癌及び紡錘細胞癌;小細胞癌;乳頭癌;扁平上皮癌;リンパ上皮癌;基底細胞癌;石灰化上皮癌(pilomatrix carcinoma);移行上皮癌;乳頭状移行上皮癌;腺癌;ガストリノーマ、悪性;胆管癌;肝細胞癌;組み合わされた肝細胞癌及び胆管癌;小柱状腺癌(trabecular adenocarcinoma);腺様嚢胞癌;腺腫性ポリープ中の腺癌;腺癌、家族性大腸ポリポーシス;固形癌;カルチノイド腫瘍、悪性;細気管支肺胞腺癌;乳頭状腺癌;色素嫌性癌;好酸性癌;好酸性腺癌;好塩基性癌;明細胞腺癌;顆粒細胞癌;濾胞腺癌;乳頭状及び濾胞腺癌;非被包性硬化性癌;副腎皮質癌;類内膜癌;皮膚付属器癌;アポクリン腺癌;皮脂腺癌;耳垢腺癌;粘表皮癌;嚢胞腺癌;乳頭状嚢腺癌;乳頭状漿液嚢胞腺癌;粘液性嚢胞腺癌;粘液癌;印環細胞癌;浸潤性乳管癌;髄様癌;小葉癌;丹毒様癌;パジェット病、乳房;腺房細胞癌;腺扁平上皮癌;扁平上皮化生随伴腺癌(adenocarcinoma w/squamous metaplasia);胸腺腫、悪性;卵巣間質腫、悪性;莢膜細胞腫、悪性;顆粒膜細胞腫瘍、悪性;及び神経芽細胞腫(roblastoma)、悪性;セルトリ細胞癌;ライディッヒ細胞腫、悪性;脂質細胞腫瘍、悪性;傍神経節腫、悪性;乳房外傍神経節腫、悪性;褐色細胞腫;血管球血管肉腫;悪性黒色腫;メラニン欠乏性黒色腫;表在拡大型黒色腫;巨大色素性母斑中の悪性黒色腫;類上皮細胞黒色腫;青色母斑、悪性;肉腫;線維肉腫;線維性組織球腫、悪性;粘液肉腫;脂肪肉腫;平滑筋肉腫;横紋筋肉腫;胎児性横紋筋肉腫;胞巣状横紋筋肉腫;間質性肉腫;混合腫瘍、悪性;ミュラー管混合腫瘍;腎芽腫;肝芽腫;癌肉腫;間葉腫、悪性;ブレンナー腫瘍、悪性;葉状腫瘍、悪性;滑膜肉腫;中皮腫、悪性;未分化胚細胞腫;胚性癌腫;奇形腫、悪性;卵巣甲状腺腫、悪性;絨毛癌;中腎腫、悪性;血管肉腫;血管内皮腫、悪性;カポジ肉腫;血管外皮細胞腫、悪性;リンパ管肉腫;骨肉腫;傍骨性骨肉腫;軟骨肉腫;軟骨芽細胞腫、悪性;間葉性軟骨肉腫;骨の巨細胞腫;ユーイング肉腫;歯原性腫瘍、悪性;エナメル芽細胞歯牙肉腫;エナメル上皮腫、悪性;エナメル上皮線維肉腫;松果体腫、悪性;脊索腫;神経膠腫、悪性;上衣腫;星細胞腫;原形質性星状細胞腫;線維性星細胞腫;星状芽細胞腫;膠芽腫;乏突起膠腫;乏突起膠芽細胞腫;原始神経外胚葉性;小脳肉腫;神経節細胞芽腫;神経芽細胞腫;網膜芽細胞腫;嗅神経腫瘍;髄膜腫、悪性;神経線維肉腫;神経鞘腫、悪性;顆粒細胞腫、悪性;悪性リンパ腫;ホジキン病;ホジキンリンパ腫;側肉芽腫;悪性リンパ腫、小リンパ球性;悪性リンパ腫、大細胞、びまん性;悪性リンパ腫、濾胞性;菌状息肉腫;他の特定の非ホジキンスリンパ腫;悪性組織球症;多発性骨髄腫;肥満細胞肉腫;免疫増殖性小腸疾患;白血病;リンパ性白血病;形質細胞性白血病;赤白血病;リンパ肉腫細胞性白血病;骨髄性白血病;好塩基球性白血病;好酸球性白血病;単球性白血病;肥満細胞白血病;巨核芽球性白血病;骨髄肉腫;形質細胞腫、結腸直腸癌、直腸癌、及び有毛細胞白血病。
遅延型過敏症(DTH)は、Petersen他(In vivo pharmacological disease models for psoriasis and atopic dermatitis in drug discovery.Basic & Clinical Pharm & Toxicology.2006.99(2):104−115;Irving C.Allen(ed.)Mouse Models of Innate Immunity:Methods and Protocols,Methods in Molecular Biology,2013.vol.1031,DOI 10.1007/978−1−62703−481−4_13も参照されたい)により概説されているように、アトピー性皮膚炎(又はアレルギー性接触性皮膚炎)の動物モデルである。様々なハプテン又は抗原(例えば、アジュバントで乳化した抗原)を使用して、様々なマウス株及びラット株で遅延型過敏症(DTH)を誘導し得る。DTHは、感作と、紅斑、浮腫、並びに細胞浸潤、特に抗原提示細胞(APC)、好酸球、活性化されたCD4+T細胞、及びサイトカイン発現Th2細胞の浸潤を生じる抗原特異的T細胞媒介反応とにより特徴付けられる。
デキストラン硫酸ナトリウム(DSS)誘発大腸炎は、Randhawa他(A review on chemical−induced inflammatory bowel disease models in rodents.Korean J Physiol Pharmacol.2014.18(4):279−288;Chassaing et al.Dextran sulfate sodium(DSS)−induced colitis in mice.Curr Protoc Immunol.2014 Feb 4;104:Unit 15.25も参照されたい)により概説されているように、大腸炎の十分に研究されている動物モデルである。このモデルでは、マウスを飲料水中のDSSで処理し、結果として下痢及び体重減少が起こる。
Constantinescu他(Experimental autoimmune encephalomyelitis(EAE)as a model for multiple sclerosis(MS).Br J Pharmacol.2011 Oct;164(4):1079−1106)により概説されているように、EAEは、多発性硬化症の十分に研究された動物モデルである。Mangalam他(Two discreet subsets of CD8+T cells modulate PLP91−110 induced experimental autoimmune encephalomyelitis in HLA−DR3 transgenic mice.J Autoimmun.2012 Jun;38(4):344−353)で論じられているように、活性化された脳炎惹起性T細胞の養子移入、又はEVEに対して感受性を示すTCRトランスジェニックマウスの使用により、様々なミエリン関連ペプチドを使用して、EAEを様々なマウス株及びラット株に導入し得る。
コラーゲン誘発関節炎(CIA)は、Caplazi他(Mouse models of rheumatoid arthritis.Veterinary Pathology.Sept.1,2015.52(5):819−826)により説明されているように、関節リウマチ(RA)を研究するために一般に使用される動物モデルである(Brand et al.Collagen−induced arthritis.Nature Protocols.2007.2:1269−1275;Pietrosimone et al.Collagen−induced arthritis:a model for murine autoimmune arthritis.Bio Protoc.2015 Oct.20;5(20):e1626も参照されたい)。
1型糖尿病(T1D)は、免疫系が膵臓のランゲルハンス島を標的とし、それによりインスリンを産生する身体の能力が破壊される自己免疫疾患である。
原発性硬化性胆管炎(PSC)は、胆管を徐々に破壊して末期肝硬変を引き起こす慢性肝疾患である。原発性硬化性胆管炎(PSC)は炎症性腸疾患(IBD)と関連している。
例えば、6〜8週齢のC57bl/6マウスをTaconic又は他のベンダーから得る。マウスに、様々な持続期間にわたり0.1%DCC補充飼料を給餌する。一部の群に、1週間にわたりDCC補充飼料を与え、他には4週間にわたり与え、他には8週間にわたり与える。マウスの一部の群に、一定期間にわたりDCC補充飼料を与えることができ、次いで回復させ、その後に通常の飼料を与える。これらのマウスを、疾患から回復する能力に関して研究し得、及び/又はDCCへのその後の曝露時の再発に対する感受性に関して研究し得る。ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVによる処置を、DCC給餌の前後又はDCCへの最初の曝露の後のいずれかの時点で開始する。例えば、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVを1日目に投与してもよいし、その後のどこかで投与してもよい。ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVを、様々な用量で及び定められた間隔で投与する。例えば、一部のマウスに、マウス1匹当たり1×104〜5×109個の細菌細胞の用量でラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Aを静脈内注射する。他のマウスに、マウス1匹当たりラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A 25、50、100mgを投与し得る。一部のマウスにi.v.注射でラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVを投与し、他のマウスに、i.p.注射、皮下(s.c.)注射、経鼻投与、経口経管栄養、又は他の投与手段によりラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Aを投与し得る。一部のマウスに毎日ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVを投与し得(例えば1日目に開始する)、他には別の間隔(例えば、1日おき、又は3日に1回)でラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVを投与し得る。マウスの追加の群に、いくつかの比の細菌細胞対ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVを投与し得る。細菌細胞は、生きていてもよいし、死んでいてもよいし、弱っていてもよい。細菌細胞を、新たに採取して(又は凍結して)投与してもよいし、又は投与前に放射線を照射してもよいし加熱により死滅させてもよい。
例えば、マウスの一部の群に、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVの投与とは別の投与で又はこの投与と併せた投与で、1×104〜5×109個の細菌細胞を投与し得る。ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVと同様に、細菌細胞の投与を、投与経路、用量、及びスケジュールにより変更し得る。これは、経口経管栄養、i.v.注射、i.p.注射、又は経鼻投与を含み得る。マウスの一部の群を、様々な時点で及び有効用量で、追加の薬剤及び/又は適切なコントロール(例えばビヒクル若しくは抗体)で処置し得る。
或いは、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A含有細菌組成物及び/又はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A由来のEVを、BDL誘発性胆管炎における有効性に関して試験する。例えば、6〜8週齢のC57Bl/6JマウスをTaconic又は他のベンダーから得る。順化期間の後、マウスを外科的処置して胆管結紮(BDL)を実施する。一部のコントロール動物には偽手術を施す。BDL処理により、7〜21日以内に肝臓損傷、炎症、及び線維化が引き起こされる。
これは、経口経管栄養、i.v.注射、i.p.注射、又は経鼻投与を含み得る。マウスの一部の群を、様々な時点で及び有効用量で、追加の薬剤及び/又は適切なコントロール(例えばビヒクル若しくは抗体)で処置し得る。
非アルコール性脂肪性肝炎(NASH)は、肝臓脂肪の蓄積(脂肪症)及び炎症が肝臓損傷及び肝細胞死(バルーニング)につながる非アルコール性脂肪性肝疾患(NAFLD)の重度の形態である。
乾癬は、T細胞により媒介される慢性炎症性皮膚疾患である。いわゆる「プラーク型」乾癬は、乾癬の最も一般的な形態であり、乾燥した鱗屑、赤色のプラーク、並びに真皮及び上皮への免疫細胞の浸潤に起因する皮膚の肥厚という特徴を示す。Gudjonsson他(Mouse models of psoriasis.J Invest Derm.2007.127:1292−1308;van der Fits et al.Imiquimod−induced psoriasis−like skin inflammation in mice is mediated via the IL−23/IL−17 axis.J.Immunol.2009 May 1.182(9):5836−45も参照されたい)により概説されているように、いくつかの動物モデルが、この疾患の理解に寄与している。
ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Aの予備的な安全性、忍容性、及薬学的効果を、健康な参加者と、軽度から中程度の乾癬又はアトピー性皮膚炎を有するが他の点では健康である参加者とで決定する単施設第1相臨床試験を実施する。
この試験の全てのパートに関する選択基準は下記を含む:
1.参加者は、スクリーニング時に肥満指数が≧18kg/m2〜≦35kg/m2である。
2.病歴、身体検査、臨床検査、及び噴門モニタリング等の医学的評価により決定した場合に明らかに健康である参加者。
3.軽度から中程度の乾癬を有する患者に関しては:
a.参加者は、体表面積(BSA)(頭皮を除く)の≦5%が関与する少なくとも6ヶ月にわたる軽度から中程度のプラーク型乾癬の確定診断を受けている。
b.参加者は、生検に適した部位において少なくとも1つのプラークを有する少なくとも2つの乾癬病変を有する。
4.軽度から中程度のアトピー性皮膚炎を有する患者に関しては:
a.参加者は、BSA関与が少なくとも3から最大で15%の軽度から中程度のアトピー性皮膚炎を有する。
b.参加者は、IGAスコアが2又は3である少なくとも6ヶ月にわたる軽度から中程度のアトピー性皮膚炎の確定診断を受けている。
c.参加者は、少なくとも1つが生検に適した部位である少なくとも2つのアトピー性皮膚炎病変を有する。
1.この試験中に妊娠しているか若しくは妊娠する予定である女性参加者、及び/又は授乳中であるか若しくは医学的に受け入れられている避妊方法を使用してない妊娠の可能性がある性的活動をしている女性参加者。
2.参加者は、スクリーニング前6週間以内に弱毒化生ワクチン接種を受けているか、又はこの試験の経過中にそのようなワクチン接種を受ける予定である。
3.参加者は、試験介入投与の前に、90日又は5半減期のいずれか長い方で任意の介入薬物又は実験手順を受けている。
4.参加者は、試験期間中に抗炎症薬による処置を必要とする。パラセタモールは、解熱剤及び/又は鎮痛剤としての使用が許可される(任意の24時間で最大2グラム/日)。
5.参加者は、活動性感染(例えば、敗血症、肺炎、膿瘍)を有するか、又は介入医薬品(IMP)投与前6週間以内に抗生物質による処置を必要とする感染を有している。疑わしい場合には、治験責任医師は治験依頼者の治験担当医師と相談すべきである。
6.参加者は、下記のように定義される腎障害又は肝障害を有する:
a.健康なボランティアの場合:i.女性の場合、血清クレアチニンレベル≧125μmol/L;男性の場合、≧135μmol/L、又はii:アラニンアミノトランスフェラーゼ(ALT)及びアスパラギン酸アミノトランスフェラーゼ(AST)≧1.5×正常上限(ULN)、又はiii.アルカリホスファターゼ(ALP)及び/又はビリルビン>1.5×ULN。
b.軽度から中程度のアトピー性皮膚炎又は乾癬を有する参加者の場合:i.女性の場合、血清クレアチニンレベル≧125μmol/L;男性の場合≧135μmol/L、又はii.ALT若しくはAST>2×ULN、及び/若しくはビリルビン>1.5×ULN。
患者に、処置期間中に全てのラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Aの用量を投与するか、又は患者は、処置期間内に用量制限毒性(DLT)を有している場合には、用量漸増の決定のために評価可能であると見なされ得る。患者のコホートがこれらの基準を満たしている場合に、用量漸増の決定を行なう。
特定のプラスミドを欠いているL.ラクティス・クレモリス(L.lactis cremoris)株の有効性を評価した。当該技術分野で既知のエレクトロポレーション技術を使用して、ノックアウト株を作成した。簡潔に説明すると、1%のグルコースを含むM17培地(1L当たり、カゼインの膵臓消化物5g、大豆ペプトン5g、牛肉抽出物5g、酵母抽出物2.5g、アスコルビン酸0.5g、MgSO4 0.25g、β−グリセロリン酸二ナトリウム19g)中で一晩株を培養することにより、エレクトロコンピテント細胞を調製した。一晩培養物2mLをM17培地50mLに播種し、0.5〜0.7の600nmでの光学密度まで培養した(約5〜7時間)。次いで、この培養物を10分にわたり氷上で冷却した。細胞を3000gで15分にわたり遠心沈殿させ、エレクトロポレーション緩衝液(0.5Mのスクロース+10%のグリセロール)に再懸濁させ、さらに2回繰り返した。次いで、細胞をエレクトロポレーション緩衝液500μLに再懸濁させ、100μLのアリコートに分割し、エレクトロポレーションまで−80℃で保存した。
強化培地を使用して、インビトロでの使用及びインビボでの使用のために細菌を増殖させて調製する。例えば、培地は、糖、酵母抽出物、植物ベースのペプトン、バッファー、塩、微量元素、界面活性剤、消泡剤、及びビタミンを含み得る。酵母抽出物及びペプトン等の複雑な成分の組成は、定義されていなくてもよいし、部分的に定義されていてもよい(例えば、アミノ酸、糖等のおおよその濃度)。微生物の代謝産物は、炭素及び窒素等の資源の利用可能性に依存する場合がある。様々な糖又は他の炭素源を試験し得る。或いは、参照により本明細書に組み込まれる、Saarela et al.,J.Applied Microbiology.2005.99:1330−1339に示されているように、培地を調製し、選択された細菌を増殖させることができる。乳ベースの成分なしで生産される選択された細菌の凍結乾燥生存、貯蔵安定性、及び酸と胆汁への曝露に対する発酵時間、凍結保護物質、細胞濃縮物の中和の影響。
簡潔に説明すると、マウスをJackson Labsから購入し、実験を開始する前に1週間にわたり飼育器に慣れさせた。マウスを、標準的な寝床及びエンリッチメントを有する、個別に換気されているケージに、1つのケージ当たり5匹の動物で収容する。標準的なPurina齧歯類飼料(5001)及びオートクレーブされた水を自由に摂取させ、毎日チェックする。換気されているケージを1週間に1回交換する。動物飼育室は、12時間のオン及び12時間のオフからなる照明サイクルを受ける。床、壁、及び天井を1ヶ月に1回消毒し、部屋を30%〜70%の範囲の湿度及び華氏68〜79度の範囲の温度に維持する。動物の健康のチェックを1日に2回行なう。
イミキモド誘発乾癬モデルは、Th17誘発皮膚炎症モデルである。マウスは、皮膚の扁平化(flakiness)、及び0〜4のスケールでスコア化されるヒト乾癬に関連する病理の内のいくつかを模倣する紅斑を発症する。加えて、耳の炎症をDTHと同様に評価し得る。
本明細書で言及する全ての刊行物及び特許出願は、あたかも個々の刊行物又は特許出願が参照により組み込まれることが具体的且つ個別に示されたかのように、その全内容が参照により組み込まれる。矛盾する場合、本明細書の全ての定義を含む本出願が優先される。
当業者は、本明細書に記載の本発明の特定の実施形態に対する多数の同等物を認識する、又は日常的な実験のみを使用して多数の同等物を確認することができるであろう。そのような同等物は、添付の特許請求の範囲に含まれるものとする。
Claims (94)
- 対象の免疫障害を処置する方法であって、免疫調節性ラクトコッカス(Lactococcus)株を含む細菌組成物を前記対象に投与することを含む方法。
- 前記免疫調節性ラクトコッカス(Lactococcus)株は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A(ATCC受託番号PTA−125368)のヌクレオチド配列に対して少なくとも90%のゲノム配列同一性、16S配列同一性、及び/又はCRISPR配列同一性を含む株である、請求項1に記載の方法。
- 前記免疫調節性ラクトコッカス(Lactococcus)株は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A(ATCC受託番号PTA−125368)のヌクレオチド配列に対して少なくとも99%のゲノム配列同一性、16S配列同一性、及び/又はCRISPR配列同一性を含む株である、請求項1に記載の方法。
- 前記免疫調節性ラクトコッカス(Lactococcus)株はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A(ATCC受託番号PTA−125368)である、請求項1に記載の方法。
- 前記細菌組成物は、免疫調節性ラクトコッカス(Lactococcus)株の細胞外小胞(EV)と、免疫調節性ラクトコッカス(Lactococcus)株の細菌とを含む、請求項4に記載の方法。
- 前記医薬組成物中の前記免疫調節性ラクトコッカス(Lactococcus)株のEV及び免疫調節性ラクトコッカス(Lactococcus)株の細菌粒子の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株のEVである、請求項5に記載の方法。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV及び細菌粒子の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株の細菌である、請求項5に記載の方法。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV及び免疫調節性ラクトコッカス(Lactococcus)株の細菌タンパク質の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株のEVタンパク質である、請求項5に記載の方法。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV及び免疫調節性ラクトコッカス(Lactococcus)株の細菌タンパク質の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株の細菌タンパク質である、請求項5に記載の方法。
- 前記医薬組成物中の前記免疫調節性ラクトコッカス(Lactococcus)株のEV及び細菌脂質の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株のEV脂質である、請求項5に記載の方法。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV免疫調節性ラクトコッカス(Lactococcus)株の細菌脂質の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株の細菌脂質である、請求項5に記載の方法、請求項103に記載の細菌組成物。
- 前記細菌組成物は、EVから単離された免疫調節性ラクトコッカス(Lactococcus)株の細菌を含む、請求項1に記載の方法。
- 前記免疫障害は、アレルギー反応、炎症性疾患、炎症性腸疾患、クローン病、潰瘍性大腸炎、遅延型過敏症、自己免疫性心筋炎、肉芽腫、末梢神経障害、橋本甲状腺炎、結腸の炎症、大腸炎、顕微鏡的大腸炎、コラーゲン大腸炎、空置大腸炎、化学的大腸炎、虚血性大腸炎、不確定大腸炎、非定型大腸炎、多発性硬化症、橋本病、アレルギー性疾患、食物アレルギー、花粉症、喘息、感染性疾患、クロストリジウム・ディフィシル(Clostridium difficile)による感染、炎症性疾患、TNFにより媒介される炎症性疾患、胃腸管の炎症性疾患、嚢炎、心血管の炎症状態、アテローム性動脈硬化症、炎症性肺疾患、慢性の閉塞性肺疾患、関節炎、変形性関節症、関節リウマチ、乾癬性関節炎、強直性脊椎炎、急性及び慢性の感染性関節炎、痛風及び偽痛風と関連する関節炎、若年性特発性関節炎、腱炎、滑膜炎、腱鞘炎、滑液包炎、結合織炎、線維筋痛症、上顆炎、筋炎、及び骨炎、パジェット病、恥骨骨炎、嚢胞性線維性骨炎、眼の免疫異常、眼瞼炎、眼瞼皮膚弛緩症、結膜炎、涙腺炎、角膜炎、乾性角結膜炎(ドライアイ)、強膜炎、睫毛乱生症、ぶどう膜炎、神経系免疫、脳炎、ギラン・バレー症候群、髄膜炎、神経性筋強直症、ナルコレプシー、多発性硬化症、脊髄炎、統合失調症、脈管構造及びリンパ系の炎症、関節硬化症、関節炎、静脈炎、血管炎、リンパ管炎、消化器系の免疫障害、胆道炎、胆嚢炎、腸炎(enteritis)、腸炎(enterocolitis)、胃炎、胃腸炎、回腸炎、直腸炎、過敏性腸症候群、顕微鏡的大腸炎、リンパ球プラズマ細胞性腸炎(lymphocytic−plasmocytic enteritis)、セリアック病、コラーゲン大腸炎、リンパ球性大腸炎、好酸球性腸炎、不確定大腸炎、偽膜性大腸炎(壊死性大腸炎)、虚血性炎症性腸疾患、ベーチェット病、サルコイドーシス、強皮症、IBD関連の異形成、異形成関連の腫瘤又は病変、原発性硬化性胆管炎、生殖系の免疫障害、子宮頸管炎、絨毛羊膜炎、子宮内膜炎、精巣上体炎、臍炎、卵巣炎、精巣炎、卵管炎、卵管卵巣膿瘍、尿道炎、腟炎、外陰炎、外陰部痛、自己免疫性状態、急性汎発性全身性脱毛症(acute disseminated alopecia universalise)、ベーチェット病、シャーガス病、慢性疲労症候群、自律神経障害、脳脊髄炎、強直性脊椎炎、再生不良性貧血、化膿性汗腺炎、自己免疫性肝炎、自己免疫性卵巣炎、セリアック病、1型糖尿病、巨細胞性動脈炎、グッドパスチャー症候群、グレーブス病、ギラン・バレー症候群、ヘノッホ・シェーンライン紫斑病、川崎病、紅斑性狼瘡、顕微鏡的大腸炎、顕微鏡的多発動脈炎、混合性結合組織病、マックル・ウェルズ症候群、多発性硬化症、重症筋無力症、眼球クローヌス・ミオクローヌス運動失調、視神経炎、オード甲状腺炎(ord’s thyroiditis)、天疱瘡、結節性多発動脈炎、多発性筋痛、関節リウマチ、ライター症候群、シェーグレン症候群、側頭動脈炎、ウェゲナー肉芽腫症、温式自己免疫性溶血性貧血、間質性膀胱炎、ライム病、モルフェア、乾癬、サルコイドーシス、強皮症、潰瘍性大腸炎、白斑、T細胞により媒介される過敏性疾患、接触過敏症、接触性皮膚炎、じんま疹、皮膚アレルギー、呼吸アレルギー、枯草熱、アレルギー性鼻炎、チリダニアレルギー、グルテン過敏性腸症、セリアック病、虫垂炎、皮膚炎、皮膚筋炎、心内膜炎、結合織炎、歯肉炎、舌炎、肝炎、化膿性汗腺炎、虹彩炎、喉頭炎、乳腺炎、心筋炎、腎炎、耳炎、膵炎、耳下腺炎、心膜炎、腹膜炎、咽頭炎、胸膜炎、間質性肺炎、前立腺炎(prostatistis)、腎盂腎炎、口内炎(stomatisi)、移植拒絶反応、急性膵炎、慢性膵炎、急性呼吸促迫症候群、セザール症候群(Sexary’s syndrome)、先天性副腎過形成(congenital adrenal hyperplasis)、非化膿性甲状腺炎、癌と関連する高カルシウム血症、天疱瘡、水疱性ヘルペス状皮膚炎(bullous dermatitis herpetiformis)、重度の多形性紅斑、剥離性皮膚炎、脂漏性皮膚炎、季節性又は通年性のアレルギー性鼻炎、気管支喘息、接触性皮膚炎、アトピー性皮膚炎、薬物過敏症反応、アレルギー性結膜炎、角膜炎、眼部帯状疱疹、虹彩炎及び虹彩毛様体炎(oiridocyclitis)、脈絡網膜炎、視神経炎、症候性サルコイドーシス、劇症性又は播種性の肺結核化学療法、成人の特発性血小板減少性紫斑病、成人の続発性血小板減少症、後天性(自己免疫性)溶血性貧血、成人の白血病及びリンパ腫、小児の急性白血病、局所性腸炎、自己免疫性血管炎、多発性硬化症、慢性閉塞性肺疾患、固形臓器移植拒絶反応、敗血症、関節リウマチ、乾癬性関節炎、多発性硬化症、1型糖尿病、喘息、炎症性腸疾患、全身性紅斑性狼瘡、乾癬、慢性閉塞性肺疾患、感染状態を伴う炎症、並びに敗血症から選択される、請求項1〜12のいずれか一項に記載の方法。
- 前記免疫障害は、遅延型過敏症、アレルギー性接触性皮膚炎、自己免疫性心筋炎、1型糖尿病、肉芽腫、末梢神経障害、橋本甲状腺炎、多発性硬化症、関節リウマチ、結腸の炎症、大腸炎、潰瘍性大腸炎、顕微鏡的大腸炎、コラーゲン大腸炎、便流変更性大腸炎、化学的大腸炎、虚血性大腸炎、不確定大腸炎、非定型大腸炎、消化器系疾患、クローン病、又は炎症性腸疾患である、請求項1〜12のいずれか一項に記載の方法。
- 前記細菌組成物を経口投与するか、直腸投与するか、静脈内投与するか、腫瘍内投与するか、又は皮下投与する、請求項1〜14のいずれか一項に記載の方法。
- 前記細菌組成物中の細菌の少なくとも50%は免疫調節性ラクトコッカス(Lactococcus)株である、請求項1〜15のいずれか一項に記載の方法。
- 前記細菌組成物中の細菌の少なくとも90%は免疫調節性ラクトコッカス(Lactococcus)株である、請求項1〜15のいずれか一項に記載の方法。
- 前記細菌組成物中の細菌の実質的に全ては免疫調節性ラクトコッカス(Lactococcus)株である、請求項1〜15のいずれか一項に記載の方法。
- 前記細菌組成物は少なくとも1×106コロニー形成単位(CFU)の免疫調節性ラクトコッカス(Lactococcus)株を含む、請求項1〜18のいずれか一項に記載の方法。
- 前記細菌組成物は少なくとも1×107CFUの免疫調節性ラクトコッカス(Lactococcus)株を含む、請求項19に記載の方法。
- 前記細菌組成物は少なくとも1×108CFUの免疫調節性ラクトコッカス(Lactococcus)株を含む、請求項1に記載の方法。
- 前記ラクトコッカス(Lactococcus)株は、表6で特定されたアミノ酸配列を有するタンパク質を含む、請求項1に記載の方法。
- 前記ラクトコッカス(Lactococcus)株は、表5で特定されたアミノ酸配列を有するタンパク質を含まないか、又は実質的に含まない、請求項1〜22のいずれか一項に記載の方法。
- 前記ラクトコッカス(Lactococcus)株は、表6で特定されたアミノ酸配列を有するタンパク質を含み、且つ表5で特定されたアミノ酸配列を有するタンパク質を含まないか、又は実質的に含まない、請求項22又は23に記載の方法組成物。
- 前記細菌組成物を2つ以上の用量で投与する、請求項1〜24のいずれか一項に記載の方法。
- 前記2つ以上の用量の前記対象への投与は少なくとも1日離れている、請求項25に記載の方法。
- 前記2つ以上の用量の投与は少なくとも1週間離れている、請求項26に記載の方法。
- 前記細菌組成物は生細菌を含む、請求項1〜27のいずれか一項に記載の方法。
- 前記細菌組成物は弱毒化細菌を含む、請求項1〜28のいずれか一項に記載の方法。
- 前記細菌組成物は死滅細菌を含む、請求項1〜29のいずれか一項に記載の方法。
- 前記細菌組成物は放射線を照射された細菌を含む、請求項30に記載の方法。
- 前記細菌組成物はガンマ線を照射された細菌を含む、請求項30に記載の方法。
- 前記細菌組成物の投与により前記免疫障害を処置する、請求項1〜32のいずれか一項に記載の方法。
- 前記細菌組成物の投与により免疫反応を誘発する、請求項1〜22のいずれか一項に記載の方法。
- 前記方法は、追加の治療薬を前記対象に投与することをさらに含む、請求項1〜34のいずれか一項に記載の方法。
- 前記追加の治療薬は、免疫抑制剤、DMARD、疼痛制御剤、ステロイド、非ステロイド系抗炎症薬(NSAID)、サイトカイン拮抗薬、シクロスポリン、レチノイド、副腎皮質ステロイド、プロピオン酸誘導体、酢酸誘導体、エノール酸誘導体、フェナム酸誘導体、Cox−2阻害剤、ルミラコキシブ、イブプロフェン、サリチル酸コリンマグネシウム、フェノプロフェン、サルサラート、ジフニサル、トルメチン、ケトプロフェン、フルルビプロフェン、オキサプロジン、インドメタシン、スリンダク、エトドラク、ケトロラック、ナブメトン、ナプロキセン、バルデコキシブ、エトリコキシブ、MK0966;ロフェコキシブ、アセトアミノフェン、セレコキシブ、ジクロフェナク、トラマドール、ピロキシカム、メロキシカム、テノキシカム、ドロキシカム、ロルノキシカム、イソキシカム、メフェナム酸、メクロフェナム酸、フルフェナム酸、トルフェナム酸、バルデコキシブ、パレコキシブ、エトドラク、インドメタシン、アスピリン、イブプロフェン、フィロコキシブ、メトトレキサート(MTX)、抗マラリア剤、ヒドロキシクロロキン、クロロキン、スルファサラジン、レフルノミド、アザチオプリン、シクロスポリン、金塩、ミノサイクリン、シクロホスファミド、D−ペニシラミン、ミノサイクリン、オーラノフィン、タクロリムス、ミオクリシン、クロラムブシル、TNFアルファ拮抗薬、TNFアルファ拮抗薬、TNFアルファレセプター拮抗薬、アダリムマブ(Humira(登録商標))、エタネルセプト(Enbrel(登録商標))、インフリキシマブ(Remicade(登録商標);TA−650)、セルトリズマブペゴル(Cimzia(登録商標);CDP870)、ゴリムマブ(Simpom(登録商標);CNTO 148)、アナキンラ(Kineret(登録商標))、リツキシマブ(Rituxan(登録商標);MabThera(登録商標))、アバタセプト(Orencia(登録商標))、トシリズマブ(RoActemra/Actemra(登録商標))、インテグリン拮抗薬、TYSABRI(登録商標)(ナタリズマブ)、IL−1拮抗薬、ACZ885(イラリス)、アナキンラ(Kineret(登録商標)))、CD4拮抗薬、IL−23拮抗薬、IL−20拮抗薬、IL−6拮抗薬、BLyS拮抗薬、アタシセプト、Benlysta(登録商標)/LymphoStat−B(登録商標)(ベリムマブ))、p38阻害剤、CD20拮抗薬、オクレリズマブ、オファツムマブ(Arzerra(登録商標)))、インターフェロンガンマ拮抗薬、フォントリズマブ、プレドニゾロン、プレドニゾン、デキサメタゾン、コルチゾール、コルチゾン、ヒドロコルチゾン、メチルプレドニゾロン、ベタメタゾン、トリアムシノロン、ベクロメタゾン、フルドロコルチゾン、デオキシコルチコステロン、アルドステロン、ドキシサイクリン、バンコマイシン、ピオグリタゾン、SBI−087、SCIO−469、Cura−100、オンコキシン+ビウシド、TwHF、メトキサレン、ビタミンD−エルゴカルシフェロール、ミルナシプラン、パクリタキセル、ロージングタゾン、タクロリムス、Prograf(登録商標)、RADOOl、ラパミューン、ラパマイシン、フォスタマチニブ、フェンタニル、XOMA 052、フォスタマチニブ二ナトリウム、ロシグリタゾン、クルクミン、Longvida(商標)、ロスバスタチン、マラビロク、ラミピニル、ミルナシプラン、コビプロストン、ソマトロピン、tgAAC94遺伝子治療用ベクター、MK0359、GW856553、エソメプラゾール、エベロリムス、トラスツズマブ、JAKl阻害剤及びJAK2阻害剤、パンJAK阻害剤、例えば、四環系ピリドン6(P6)、325、PF−956980、デノスマブ、IL−6拮抗薬、CD20拮抗薬、CTLA4拮抗薬、IL−8拮抗薬、IL−21拮抗薬、IL−22拮抗薬、インテグリン拮抗薬、Tysarbri(登録商標)(ナタリズマブ)、VGEF拮抗薬、CXCL拮抗薬、MMP拮抗薬、デフェンシン拮抗薬、IL−1拮抗薬、IL−1ベータ拮抗薬、IL−23拮抗薬、レセプターデコイ、拮抗性抗体、副腎皮質ステロイド、メサラジン、メサラミン、スルファサラジン、スルファサラジン誘導体、免疫抑制薬、シクロスポリンA、メルカプトプリン、アザチオプリン、プレドニゾン、メトトレキサート、抗ヒスタミン薬、グルココルチコイド、エピネフリン、テオフィリン、クロモグリク酸ナトリウム、抗ロイコトリエン、鼻炎用の抗コリン薬、TLR拮抗薬、インフラマソーム阻害剤、抗コリン性うっ血除去薬、肥満細胞安定化薬、モノクローナル抗IgE抗体、ワクチン、サイトカイン阻害剤、抗IL−6抗体、TNF阻害剤、インフリキシマブ、アダリムマブ、セルトリズマブペゴル、ゴリムマブ、並びにエタネルセプトからなる群から選択される、請求項35に記載の方法。
- 前記追加の治療薬は抗生物質である、請求項35又は36に記載の方法。
- 前記抗生物質が、アミノグリコシド、アンサマイシン、カルバセフェム、カルバペネム、セファロスポリン、グリコペプチド、リンコサミド、リポペプチド、マクロライド、モノバクタム、ニトロフラン、オキサゾリドノン、ペニシリン、ポリペプチド抗生物質、キノロン、フルオロキノロン、スルホンアミド、テトラサイクリン、抗マイコバクテリア化合物、及びそれらの組み合わせからなる群から選択される、請求項37に記載の方法。
- 前記方法は、第2の治療用細菌を前記対象に投与することをさらに含む、請求項35〜38のいずれか一項に記載の方法。
- 前記方法は、前記対象にプレバイオティックを投与することをさらに含む、請求項1〜39のいずれか一項に記載の方法。
- 前記プレバイオティックは、フルクトオリゴ糖、ガラクトオリゴ糖、トランス−ガラクトオリゴ糖、キシロオリゴ糖、キトオリゴ糖、大豆オリゴ糖、ゲンチオオリゴ糖、イソマルトオリゴ糖、マンノオリゴ糖、マルトオリゴ糖、マンナンオリゴ糖、ラクツロース、ラクトスクロース、パラチノース、グリコシルスクロース、グアーガム、アラビアゴム、タガロース(tagalose)、アミロース、アミロペクチン、ペクチン、キシラン、又はシクロデキストリンである、請求項40に記載の方法。
- 前記対象はヒトである、請求項1〜41のいずれか一項に記載の方法。
- 前記対象が非ヒト哺乳動物である、請求項1〜41のいずれか一項に記載の方法。
- 前記哺乳動物が、イヌ、ネコ、ウシ、ウマ、ブタ、ロバ、ヤギ、ラクダ、マウス、ラット、モルモット、ヒツジ、ラマ、サル、ゴリラ、又はチンパンジーからなる群から選択される、請求項43に記載の方法。
- 第2の細菌を生態学的コンソーシアムの一部として投与する、請求項1〜44のいずれか一項に記載の方法。
- 免疫調節性ラクトコッカス(Lactococcus)株と、薬学的に許容される担体とを含む細菌組成物。
- 前記免疫調節性ラクトコッカス(Lactococcus)株は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A(ATCC受託番号PTA−125368)のヌクレオチド配列に対して少なくとも99%のゲノム配列同一性、16S配列同一性、及び/又はCRISPR配列同一性を含む株である、請求項46に記載の細菌組成物。
- 前記免疫調節性ラクトコッカス(Lactococcus)株は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A(ATCC受託番号PTA−125368)のヌクレオチド配列に対して少なくとも99.9%のゲノム配列同一性、16S配列同一性、及び/又はCRISPR配列同一性を含む株である、請求項46に記載の細菌組成物。
- 前記免疫調節性ラクトコッカス(Lactococcus)株はラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株A(ATCC受託番号PTA−125368)である、請求項46に記載の細菌組成物。
- 前記細菌組成物は、経口投与用に、直腸投与用に、静脈内投与用に、腫瘍内投与用に、又は皮下投与用に製剤化されている、請求項46〜49のいずれか一項に記載の細菌組成物。
- 前記細菌組成物中の細菌の少なくとも50%は免疫調節性ラクトコッカス(Lactococcus)株である、請求項46〜50のいずれか一項に記載の細菌組成物。
- 前記細菌組成物中の細菌の少なくとも90%は免疫調節性ラクトコッカス(Lactococcus)株である、請求項46〜50のいずれか一項に記載の細菌組成物。
- 前記細菌組成物中の細菌の実質的に全ては免疫調節性ラクトコッカス(Lactococcus)株である、請求項46〜52のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は少なくとも1×106コロニー形成単位(CFU)の免疫調節性ラクトコッカス(Lactococcus)株を含む、請求項46〜53のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は少なくとも1×107CFUの免疫調節性ラクトコッカス(Lactococcus)株を含む、請求項54に記載の細菌組成物。
- 前記細菌組成物は少なくとも1×108CFUの免疫調節性ラクトコッカス(Lactococcus)株を含む、請求項54に記載の細菌組成物。
- 前記ラクトコッカス(Lactococcus)株は、表6で特定されたアミノ酸配列を有するタンパク質を含む、請求項56に記載の細菌組成物。
- 前記ラクトコッカス(Lactococcus)株は、表5で特定されたアミノ酸配列を有するタンパク質を含まないか、又は実質的に含まない、請求項46〜57のいずれか一項に記載の細菌組成物。
- 前記ラクトコッカス(Lactococcus)株は、表6で特定されたアミノ酸配列を有するタンパク質を含み、且つ表5で特定されたアミノ酸配列を有するタンパク質を含まないか、又は実質的に含まない、請求項56に記載の細菌組成物。
- 前記細菌組成物は生細菌を含む、請求項46〜59のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は弱毒化細菌を含む、請求項46〜60のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は死滅細菌を含む、請求項46〜60のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は放射線を照射された細菌を含む、請求項46〜62のいずれか一項に記載の細菌組成物。
- 前記細菌組成物はガンマ線を照射された細菌を含む、請求項63に記載の細菌組成物。
- 前記細菌組成物の投与により免疫障害を処置する、請求項46〜64のいずれか一項に記載の細菌組成物。
- 前記細菌組成物の投与により免疫反応を誘発する、請求項46〜65のいずれか一項に記載の細菌組成物。
- 前記免疫調節性ラクトコッカス(Lactococcus)株は腸溶コーティング又はマイクロカプセル化で製剤化されている、請求項46〜66のいずれか一項に記載の細菌組成物。
- 前記免疫調節性ラクトコッカス(Lactococcus)株は、表1で列挙されている1種若しくは複数種のタンパク質を含むか、又は表3からの1種若しくは複数種のタンパク質を含まない、請求項46〜67のいずれか一項に記載の細菌組成物。
- 前記免疫調節性ラクトコッカス(Lactococcus)株は、表2で列挙された1種又は複数種のタンパク質を含む、請求項46〜68のいずれか一項に記載の細菌組成物。
- 前記免疫調節性ラクトコッカス(Lactococcus)株は、表4で列挙された1種若しくは複数種のタンパク質、及び/又は表4で列挙されたタンパク質で作られたEPSを含まない、請求項46〜69のいずれか一項に記載の細菌組成物。
- 単離された免疫調節性ラクトコッカス(Lactococcus)株の細胞外小胞(EV)を含む細菌組成物。
- 免疫調節性ラクトコッカス(Lactococcus)株の細胞外小胞(EV)と、免疫調節性ラクトコッカス(Lactococcus)株の細菌とを含む細菌組成物。
- 前記医薬組成物中のラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)のEV及び免疫調節性ラクトコッカス(Lactococcus)株の細菌粒子の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株のEVである、請求項71に記載の細菌組成物。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV及び細菌粒子の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株の細菌である、請求項71に記載の細菌組成物。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV及び免疫調節性ラクトコッカス(Lactococcus)株の細菌タンパク質の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株のEVタンパク質である、請求項71に記載の細菌組成物。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV及び免疫調節性ラクトコッカス(Lactococcus)株の細菌タンパク質の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株の細菌タンパク質である、請求項71に記載の細菌組成物。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV及び細菌脂質の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株のEV脂質である、請求項71に記載の細菌組成物。
- 前記医薬組成物中の免疫調節性ラクトコッカス(Lactococcus)株のEV及び免疫調節性ラクトコッカス(Lactococcus)株の細菌脂質の合計の少なくとも、約、又は最高で1%、2%、3%、4%、5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、30%、31%、32%、33%、34%、35%、36%、37%、38%、39%、40%、41%、42%、43%、44%、45%、46%、47%、48%、49%、50%、51%、52%、53%、54%、55%、56%、57%、58%、59%、60%、61%、62%、63%、64%、65%、66%、67%、68%、69%、70%、71%、72%、73%、74%、75%、76%、77%、78%、79%、80%、81%、82%、83%、84%、85%、86%、87%、88%、89%、90%、91%、92%、93%、94%、95%、96%、97%、98%、又は99%は免疫調節性ラクトコッカス(Lactococcus)株の細菌脂質である、請求項71に記載の細菌組成物。
- EVから単離された免疫調節性ラクトコッカス(Lactococcus)株の細菌を含む細菌組成物。
- 前記細菌組成物は菌体外多糖を実質的に含まない、請求項46〜79のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は、経口投与用に、直腸投与用に、静脈内投与用に、腫瘍内投与用に、又は皮下投与用に製剤化されている、請求項46〜80のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は生細菌を含む、請求項46〜81のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は弱毒化細菌を含む、請求項46〜81のいずれか一項に記載の細菌組成物。
- 前記細菌組成物は死滅細菌を含む、請求項46〜81のいずれか一項に記載の細菌組成物。
- 前記細菌組成物の投与により免疫障害を処置する、請求項46〜84のいずれか一項に記載の細菌組成物。
- 前記細菌組成物の投与により免疫反応を誘発する、請求項46〜85のいずれか一項に記載の細菌組成物。
- 前記ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Aは腸溶コーティング又はマイクロカプセル化で製剤化されている、請求項46〜86のいずれか一項に記載の細菌組成物。
- 対象の免疫障害を処置する方法であって、請求項46〜87のいずれか一項に記載の細菌組成物を前記対象に投与することを含む方法。
- ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)の細菌を含むバイオリアクタ。
- 前記細菌は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Aのヌクレオチド配列に対して少なくとも90%のゲノム配列同一性、16S配列同一性、及び/又はCRISPR配列同一性を含む株である、請求項89に記載のバイオリアクタ。
- 前記細菌は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Aのヌクレオチド配列に対して少なくとも99%のゲノム配列同一性、16S配列同一性、及び/又はCRISPR配列同一性を含む株である、請求項89に記載のバイオリアクタ。
- 前記細菌は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Bのヌクレオチド配列に対して少なくとも90%のゲノム配列同一性、16S配列同一性、及び/又はCRISPR配列同一性を含む株である、請求項89に記載のバイオリアクタ。
- 前記細菌は、ラクトコッカス・ラクティス・クレモリス(Lactococcus lactis cremoris)株Bのヌクレオチド配列に対して少なくとも99%のゲノム配列同一性、16S配列同一性、及び/又はCRISPR配列同一性を含む株である、請求項89に記載のバイオリアクタ。
- バイオリアクタ中で細菌を培養する方法であって、
請求項89〜93のいずれか一項に記載のバイオリアクタを準備すること、
及び
一定期間にわたり前記細菌を発酵させること
を含む方法。
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AU2018367596A1 (en) | 2020-05-21 |
WO2019099682A1 (en) | 2019-05-23 |
WO2019099682A9 (en) | 2019-07-04 |
EP3710024A1 (en) | 2020-09-23 |
KR20200090189A (ko) | 2020-07-28 |
BR112020009133A2 (pt) | 2020-10-13 |
CN111787932A (zh) | 2020-10-16 |
CO2020007142A2 (es) | 2020-06-19 |
TW201922270A (zh) | 2019-06-16 |
CA3082578A1 (en) | 2019-05-23 |
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