JP2023027097A - 組成物 - Google Patents
組成物 Download PDFInfo
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- JP2023027097A JP2023027097A JP2022185229A JP2022185229A JP2023027097A JP 2023027097 A JP2023027097 A JP 2023027097A JP 2022185229 A JP2022185229 A JP 2022185229A JP 2022185229 A JP2022185229 A JP 2022185229A JP 2023027097 A JP2023027097 A JP 2023027097A
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Abstract
Description
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。一態様では、組成物は、
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)
を含み、このとき、該MBPペプチドは、同時投与、分離投与または連続的投与のためのものであり得る。
ミエリン塩基性タンパク質(MBP)は、ヒトの脳白質から単離可能なタンパク質である。成熟タンパク質は170アミノ酸を有し、その配列は、文献中で広く入手可能である(例えば、Chou et al (1986) J. Neurochem. 46:47-53、図1;Kamholz et al (1986), PNAS 83:4962-4966、図2;米国特許第5,817,629号、配列番号1;Roth et al (1987), J. Neurosci. Res. 17:321-328、図4;Medeveczky et al (2006), FEBS Letters 580:545-552、図3を参照されたい)。MBPのオルタナティブスプライシング変異体/アイソフォームが、MBPのオルタナティブスプライシングに起因して生成される場合がある(例えば、Kamholz、上掲を参照されたい)。
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。
本発明に従う使用のための組成物およびキット中で用いることができるペプチドは、以下の通りである:
MBP 30-44(配列番号1):
H-Pro-Arg-His-Arg-Asp-Thr-Gly-Ile-Leu-Asp-Ser-Ile-Gly-Arg-Phe-NH2
MBP 83-99(配列番号2):
H-Glu-Asn-Pro-Val-Val-His-Phe-Phe-Lys-Asn-Ile-Val-Thr-Pro-Arg-Thr-Pro-NH2
MBP 131-145(配列番号3):
H-Ala-Ser-Asp-Tyr-Lys-Ser-Ala-His-Lys-Gly-Phe-Lys-Gly-Val-Asp-NH2
MBP 140-154(配列番号4):
H-Gly-Phe-Lys-Gly-Val-Asp-Ala-Gln-Gly-Thr-Leu-Ser-Lys-Ile-Phe-NH2
適応免疫応答では、Tリンパ球は、タンパク質抗原の内部エピトープを認識することができる。APCは、タンパク質抗原を取り込み、それらを短いペプチド断片に分解する。ペプチドは、細胞内部の主要組織適合性複合体(MHCクラスII)に結合し、細胞表面に運ばれ得る。MHC分子と共に細胞表面に提示された場合、ペプチドは、T細胞によって(T細胞受容体(TCR)を介して)認識されることができ、その場合、ペプチドは、T細胞エピトープである。
本発明のペプチドは、配列番号1~4として示されるMBP由来ペプチドの全体または一部分を含み得る。
臨床的には、ブドウ膜炎は一般的に、主に罹患する目の部分に基づいて、以下のうちの1種として分類される:前部ブドウ膜炎、中間部ブドウ膜炎、後部ブドウ膜炎または汎ブドウ膜炎(panuveitis uveitis)。
T細胞エピトープは、自己であれまたは外来性であれ、任意の抗原に対する適応免疫応答において中心的役割を果たす。過敏性疾患(アレルギー、自己免疫疾患および移植拒絶を含む)におけるT細胞エピトープによって果たされる中心的役割は、実験モデルの使用によって実証されている。アジュバントと組み合わせた自己抗原または合成ペプチド(T細胞エピトープの構造に基づく)の注射によって、炎症またはアレルギー疾患を誘発することが可能である。
本発明に従う1つ以上のペプチドを含む組成物は、ブドウ膜炎を有する患者での予防的または治療的使用のためのものであり得る。
(i)MBP自己抗体
(ii)MBPに特異的な炎症性CD4+ T細胞
(iii)MBP自己抗体を分泌するB細胞。
本明細書中に記載される通りの本発明に従う組成物は、液体溶液または懸濁液のいずれかとして、注射剤として調製することができ;注射前の液体における溶液または懸濁液に好適な固体形態も調製され得る。調製物はまた、乳化することができ、またはペプチドは、リポソームに封入されることができる。ペプチドは、あるいは、担体(例えば、ナノ粒子)中にカプセル化されるか、または担体の表面に結合されることができる。活性成分は、薬学的に許容され、かつ活性成分と相溶性のある添加剤と混合されることができる。好適な添加剤は、例えば、水、生理食塩水(例えば、リン酸緩衝生理食塩水)、デキストロース、グリセロール、エタノールなど、およびそれらの組み合わせである。
MBPに由来するペプチドは、混合組成物またはカクテルの形態で、一緒に投与することができる。しかしながら、同時、別々、連続または併用投与のために、ペプチドをキットの形態で別個に提供することが好ましい状況があり得る。
本発明はまた、ブドウ膜炎の動物モデルも包含する。実施例で述べられる通り、本発明に従う動物モデルは、脳脊髄炎(EAE)を誘導することなく、ブドウ膜炎を誘導するという利点を提供する。
本研究は、Lewisラットでの、モルモットミエリン塩基性タンパク質(gpMBP)、ヒトミエリン塩基性タンパク質(huMBP)および/または光受容体間レチノイド結合性タンパク質による免疫化の、脳脊髄炎(EAE)および/またはブドウ膜炎(EAU)の発症に関する効果を研究することが目的であった。
成体雌Lewisラットを実験群に無作為に割り当て、1週間馴れさせた。0日目に、動物に、皮下注入により、5mg/mLのヒト型結核菌H37Ra(500μg/ラット)(Becton Dickenson, UK)を添加した不完全フロイントアジュバント(Sigma, UK)中に20マイクログラムのIRBP1177-1191(Cambridge Bioscience, UK)および/または100マイクログラムのヒト(Fitzgerald Industries International, MA, US)またはモルモットミエリン塩基性タンパク質(gpMBP)を含有する200マイクロリットルのエマルションを投与した。0日目から実験の終了まで、毎日動物の体重を計測した。0日目から実験の終了まで、尾、後肢および/もしくは前肢のひきずり(limpness)、知覚異常(paresis)および/または麻痺(paralysis)を含めた実験的自己免疫性脳脊髄炎の臨床的徴候について、動物を毎日スコア付けした。0日目から実験の終了まで、ブドウ膜炎の臨床的徴候について、週2回、動物をスコア付けした。21日目(第1群、第2群、および第3群)または28日目(第4群および第5群)に、動物を間引きし、以下のサンプルを解剖により切り出し、任意的な組織病理分析のために組織固定剤の中に保存した:脳、脊髄、右眼および左眼。
非特異的臨床所見
0日目から実験の終了まで、異常な姿勢(身体を丸める)、異常な被毛の状態(立毛)および異常な活動性レベル(活動性の低下または増大)を含めた非特異的な臨床的徴候について、動物を毎日チェックした。
0日目から実験の終了まで、毎日動物の体重を計測した。
0日目から実験の終了まで、以下のスコア付けシステムを用いて、前部ブドウ膜炎の臨床的徴候について、週2回、動物を目視でスコア付けした。想定上の最大スコアは3であった。データをグラフ化した(平均±SEM)。
非特異的臨床所見
0日目から実験の終了まで、動物は、異常な姿勢(身体を丸める)、異常な被毛の状態(立毛)または異常な活動性レベル(活動性の低下または増大)などのいずれの非特異的な臨床的徴候も示さなかった。gpMBPを投与された動物では、IRBP投与群と比較して、11日目から21日目の実験の終了までに、有意な体重低下が観察された(p<0.0001)。
少なくとも2回の連続するTEFIセッションで0.5超の両眼についての平均スコア(図2を参照されたい)またはいずれかの時点での1.0超のスコアを有した動物は、後部ブドウ膜炎の臨床的徴候を生じていると考えられた。
huMBPの投与は、前部ブドウ膜炎および後部ブドウ膜炎の両方の徴候を生じさせた。
本実施例は、実施例1に記載される通りの、ヒトミエリン塩基性タンパク質(huMBP)および光受容体間レチノイド結合性タンパク質(IRBP)誘導型ブドウ膜炎のLewisラットモデルでの、ATX-UV-3の効果の研究を詳述する。
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。
実験概要
成体雌Lewisラットを実験群に無作為に割り当て、1週間馴れさせた。0日目に、動物に、皮下注入により、5mg/mLのヒト型結核菌H37Ra(500μg/ラット)(Becton Dickenson, UK)および20マイクログラムのIRBP 1177-1191(Cambridge Bioscience, UK)を添加した不完全フロイントアジュバント(Sigma, UK)中に100マイクログラムのヒトミエリン塩基性タンパク質(MBP)(Fitzgerald Industries International, MA, US)を含有する200マイクロリットルのエマルションを投与した。0日目から実験の終了まで、ブドウ膜炎の臨床的徴候について、週2回、動物をスコア付けした。21日目に、臨床スコアを解析し、研究を35日目まで延長した。35日目に、動物を間引きし、眼(右および左)を解剖により切り出し、組織病理分析のために組織固定剤の中に保存した。
0日目から実験の終了まで、異常な姿勢(身体を丸める)、異常な被毛の状態(立毛)および異常な活動性レベル(活動性の低下または増大)を含めた非特異的な臨床的徴候について、動物を毎日チェックした。
0日目から実験の終了まで、以下のスコア付けシステムを用いて、眼部炎症(前部ブドウ膜炎)の臨床的徴候について、週2回、動物をスコア付けした:(0)正常、(1)若干の虹彩血管拡張および虹彩実質の肥厚、数個の散らばった炎症細胞、またはその両方、(2)虹彩内の血管うっ血、異常な瞳孔収縮および(3)前房の混濁。データをグラフ化した(平均±SEM)。
非特異的臨床所見
0日目から実験の終了まで、動物は、異常な姿勢(身体を丸める)、異常な被毛の状態(立毛)または異常な活動性レベル(活動性の低下または増大)などのいずれの非特異的な臨床的徴候も示さなかった。
後部ブドウ膜炎
少なくとも2回の連続するTEFIセッションで0.5超の両眼についての平均スコアまたはいずれかの時点での1.0超のスコアを有した動物は、後部ブドウ膜炎の臨床的徴候を生じていると考えられた(図5)。
ブドウ膜炎の動物モデルでのATX-UV-3の有効性を調べるために、さらなる研究を行なった。シクロスポリンAが、陽性対照として含められた(ヒトに対する生理的用量ではないであろうが、そのモデルを立証する目的で選択された高用量のシクロスポリンAを用いた)。
成体雌Lewisラットを実験群に無作為に割り当て、1週間馴れさせた。処置は、以下のスケジュールに従って行なった。0日目に、動物に、皮下注入により、5mg/mLのヒト型結核菌H37Ra(500μg/ラット)および/または20マイクログラムのIRBP1177-1191を添加した不完全フロイントアジュバント中に100マイクログラムのヒトミエリン塩基性タンパク質(MBP)を含有する200マイクロリットルのエマルションを投与した。0日目から実験の終了まで、前部および後部ブドウ膜炎の臨床的徴候について、週2回、動物をスコア付けした。28日目に、動物を間引きし、眼(右および左)を解剖により切り出し、任意的な組織病理分析のために、組織固定剤の中に移し、続いてパラフィン包埋のために加工し、パラフィンブロック中で保存した。
すべての実験群は、n=12とした。
投与体積は、PO投与に対しては5mL/kgであり、SC投与に対してはラット1頭当たり100μLの固定体積とした。
非特異的臨床所見
0日目から実験の終了まで、異常な姿勢(身体を丸める)、異常な被毛の状態(立毛)および異常な活動性レベル(活動性の低下または増大)を含めた非特異的な臨床的徴候について、動物を毎日チェックした。非特異的な臨床的徴候が重度過ぎると判断した場合には、予定された研究の終了前に、動物を間引いた。
0日目から実験の終了まで、毎日動物の体重を計測した。
0日目から実験の終了まで、以下のスコア付けシステムを用いて、眼部炎症(前部ブドウ膜炎)の臨床的徴候について、処置に対して不知である1人の担当者により、週2回、動物をスコア付けした:(0)正常、(1)若干の虹彩血管拡張および虹彩実質の肥厚、数個の散らばった炎症細胞、またはその両方、(2)虹彩内の血管うっ血、異常な瞳孔収縮および(3)前房の混濁。データをグラフ化した(平均±SEM)。
非特異的臨床所見
-22日目から実験の終了まで、動物は、いかなる非特異的な臨床的徴候も示さなかった。
当初(-22日目)の体重のパーセンテージとして表されるhuMBPモデルおよびhuMBP+IRBPモデルについての体重を、二元配置分散分析および続いて実験群とビヒクル群の間での多重比較のためのダネットの事後検定(Dunnett's post-test)により解析した。二元配置分散分析により、huMBPモデルおよびhuMBP+IRBPモデルの両方での、時間および治療の有意な効果が明らかになった(すべてp<0.0001)。huMBPモデルでは、ダネットの事後検定により、22日目、24日目および28日目での体重の、ビヒクル群に対する、シクロスポリンA群(すべてp<0.05)およびATXペプチド群(それぞれ、p<0.05、p<0.05およびp<0.01)での有意な増大が明らかになった。huMBP+IRBPモデルでは、ダネットの事後検定により、13日目、15日目、22日目、24日目および28日目での体重の、ビヒクル群に対する、シクロスポリンA群(それぞれ、p<0.05、p<0.05、p<0.05、p<0.01およびp<0.01)での有意な増大が明らかになった。
2回の連続する時点での平均合計スコア(左眼+右眼の平均)1またはいずれかのTEFIセッション後に平均合計スコア1超を有する動物は、前部ブドウ膜炎の臨床的徴候を生じていると考えられた。前部ブドウ膜炎臨床スコアを、二元配置分散分析および続いて実験群とビヒクル群の間での多重比較のためのダネットの事後検定(Dunnett's post-test)により解析した。huMBPモデルでは、すべてのマウスが、研究期間の全体を通して、前部ブドウ膜炎の臨床的徴候を示さなかった。huMBP+IRBPモデルでは、二元配置分散分析により、時間および治療の有意な効果が明らかになった(両方ともp<0.0001)。ダネットの事後検定により、ビヒクル群に対する、7日目、10日目、14日目、17日目、21日目および28日目でのシクロスポリンA群(それぞれ、p<0.05、p<0.0001、p<0.0001、p<0.0001、p<0.0001およびp<0.05)ならびに10日目でのATXペプチド群(p<0.0001)での臨床スコアの有意な改善が明らかになった(図7A)。前部ブドウ膜炎臨床スコアデータの曲線下面積(AUC)解析の対応のない両側二標本スチューデントt検定により、ビヒクルに対する、シクロスポリンA(p<0.0001)およびATXペプチド(p<0.05)の有意な効果が明らかになった(図7B)。
2回の連続する時点での平均合計スコア(左眼+右眼の平均)1またはいずれかのTEFIセッション後に平均合計スコア1超を有する動物は、後部ブドウ膜炎の臨床的徴候を生じていると考えられた。後部ブドウ膜炎臨床スコアを、二元配置分散分析および続いて実験群とビヒクル群の間での多重比較のためのダネットの事後検定(Dunnett's post-test)により解析した。huMBPモデルでは、二元配置分散分析により、時間および治療の有意な効果が明らかになった(両方ともp<0.0001)。ダネットの事後検定により、ビヒクル群に対する、7日目、10日目、14日目、17日目、21日目、24日目および28日目でのシクロスポリンA群(それぞれ、p<0.05、p<0.0001、p<0.0001、p<0.0001、p<0.0001、p<0.01およびp<0.05)ならびに7日目、10日目、14日目、17日目、21日目、24日目および28日目でのATXペプチド群(それぞれ、p<0.05、p<0.0001、p<0.0001、p<0.0001、p<0.0001、p<0.01およびp<0.05)での臨床スコアの有意な改善が明らかになった(図8A)。huMBPモデルでは、後部ブドウ膜炎臨床スコアデータの曲線下面積(AUC)解析の対応のない両側二標本スチューデントt検定により、ビヒクルに対する、シクロスポリンA(p<0.0001)およびATXペプチド(p<0.0001)の有意な効果が明らかになった(図8B)。
2回の連続する時点での平均合計スコア(左眼+右眼)1またはいずれかのTEFIセッション後に平均合計スコア1超を有する動物は、後部ブドウ膜炎の臨床的徴候を生じていると考えられた。
huMBP単独またはIRBPと組み合わせた投与は、後部ブドウ膜炎の臨床的徴候を誘導し、それにより、EAUのこれらのモデルで予測される通り、血管拡張、網膜炎症および細胞浸潤が生じた。後部ブドウ膜炎の臨床的徴候は、huMBP+IRBPを投与された動物と比較して、huMBPモデルでは重症度が低かった。
<110> WORG PHARMACEUTICALS(HANGZHOU) CO., LTD.
<120> COMPOSITION
<130> PA22-577
<140> JP 2022-185229
<141> 2018-01-04
<150> GB 1700095.1
<151> 2017-01-04
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Glu Val Leu Pro Gly Gln Leu Gly Tyr Leu Arg Phe Asp Ala Met Ala
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Glu Leu Glu Thr Val Lys Ala Val Gly Pro Gln Leu Val Arg Leu Val
755 760 765
Trp Gln Gln Leu Val Asp Thr Ala Ala Leu Val Ile Asp Leu Arg Tyr
770 775 780
Asn Pro Gly Ser Tyr Ser Thr Ala Ile Pro Leu Leu Cys Ser Tyr Phe
785 790 795 800
Phe Glu Ala Glu Pro Arg Gln His Leu Tyr Ser Val Phe Asp Arg Ala
805 810 815
Thr Ser Lys Val Thr Glu Val Trp Thr Leu Pro Gln Val Ala Gly Gln
820 825 830
Arg Tyr Gly Ser His Lys Asp Leu Tyr Ile Leu Met Ser His Thr Ser
835 840 845
Gly Ser Ala Ala Glu Ala Phe Ala His Thr Met Gln Asp Leu Gln Arg
850 855 860
Ala Thr Val Ile Gly Glu Pro Thr Ala Gly Gly Ala Leu Ser Val Gly
865 870 875 880
Ile Tyr Gln Val Gly Ser Ser Pro Leu Tyr Ala Ser Met Pro Thr Gln
885 890 895
Met Ala Met Ser Ala Thr Thr Gly Lys Ala Trp Asp Leu Ala Gly Val
900 905 910
Glu Pro Asp Ile Thr Val Pro Met Ser Glu Ala Leu Ser Ile Ala Gln
915 920 925
Asp Ile Val Ala Leu Arg Ala Lys Val Pro Thr Val Leu Gln Thr Ala
930 935 940
Gly Lys Leu Val Ala Asp Asn Tyr Ala Ser Ala Glu Leu Gly Ala Lys
945 950 955 960
Met Ala Thr Lys Leu Ser Gly Leu Gln Ser Arg Tyr Ser Arg Val Thr
965 970 975
Ser Glu Val Ala Leu Ala Glu Ile Leu Gly Ala Asp Leu Gln Met Leu
980 985 990
Ser Gly Asp Pro His Leu Lys Ala Ala His Ile Pro Glu Asn Ala Lys
995 1000 1005
Asp Arg Ile Pro Gly Ile Val Pro Met Gln Ile Pro Ser Pro Glu
1010 1015 1020
Val Phe Glu Glu Leu Ile Lys Phe Ser Phe His Thr Asn Val Leu
1025 1030 1035
Glu Asp Asn Ile Gly Tyr Leu Arg Phe Asp Met Phe Gly Asp Gly
1040 1045 1050
Glu Leu Leu Thr Gln Val Ser Arg Leu Leu Val Glu His Ile Trp
1055 1060 1065
Lys Lys Ile Met His Thr Asp Ala Met Ile Ile Asp Met Arg Phe
1070 1075 1080
Asn Ile Gly Gly Pro Thr Ser Ser Ile Pro Ile Leu Cys Ser Tyr
1085 1090 1095
Phe Phe Asp Glu Gly Pro Pro Val Leu Leu Asp Lys Ile Tyr Ser
1100 1105 1110
Arg Pro Asp Asp Ser Val Ser Glu Leu Trp Thr His Ala Gln Val
1115 1120 1125
Val Gly Glu Arg Tyr Gly Ser Lys Lys Ser Met Val Ile Leu Thr
1130 1135 1140
Ser Ser Val Thr Ala Gly Thr Ala Glu Glu Phe Thr Tyr Ile Met
1145 1150 1155
Lys Arg Leu Gly Arg Ala Leu Val Ile Gly Glu Val Thr Ser Gly
1160 1165 1170
Gly Cys Gln Pro Pro Gln Thr Tyr His Val Asp Asp Thr Asn Leu
1175 1180 1185
Tyr Leu Thr Ile Pro Thr Ala Arg Ser Val Gly Ala Ser Asp Gly
1190 1195 1200
Ser Ser Trp Glu Gly Val Gly Val Thr Pro His Val Val Val Pro
1205 1210 1215
Ala Glu Glu Ala Leu Ala Arg Ala Lys Glu Met Leu Gln His Asn
1220 1225 1230
Gln Leu Arg Val Lys Arg Ser Pro Gly Leu Gln Asp His Leu
1235 1240 1245
<210> 8
<211> 1286
<212> PRT
<213> Bos taurus
<400> 8
Met Val Arg Lys Trp Ala Leu Leu Leu Pro Met Leu Leu Cys Gly Leu
1 5 10 15
Thr Gly Pro Ala His Leu Phe Gln Pro Ser Leu Val Leu Glu Met Ala
20 25 30
Gln Val Leu Leu Asp Asn Tyr Cys Phe Pro Glu Asn Leu Met Gly Met
35 40 45
Gln Gly Ala Ile Glu Gln Ala Ile Lys Ser Gln Glu Ile Leu Ser Ile
50 55 60
Ser Asp Pro Gln Thr Leu Ala His Val Leu Thr Ala Gly Val Gln Ser
65 70 75 80
Ser Leu Asn Asp Pro Arg Leu Val Ile Ser Tyr Glu Pro Ser Thr Leu
85 90 95
Glu Ala Pro Pro Arg Ala Pro Ala Val Thr Asn Leu Thr Leu Glu Glu
100 105 110
Ile Ile Ala Gly Leu Gln Asp Gly Leu Arg His Glu Ile Leu Glu Gly
115 120 125
Asn Val Gly Tyr Leu Arg Val Asp Asp Ile Pro Gly Gln Glu Val Met
130 135 140
Ser Lys Leu Arg Ser Phe Leu Val Ala Asn Val Trp Arg Lys Leu Val
145 150 155 160
Asn Thr Ser Ala Leu Val Leu Asp Leu Arg His Cys Thr Gly Gly His
165 170 175
Val Ser Gly Ile Pro Tyr Val Ile Ser Tyr Leu His Pro Gly Ser Thr
180 185 190
Val Ser His Val Asp Thr Val Tyr Asp Arg Pro Ser Asn Thr Thr Thr
195 200 205
Glu Ile Trp Thr Leu Pro Glu Ala Leu Gly Glu Lys Tyr Ser Ala Asp
210 215 220
Lys Asp Val Val Val Leu Thr Ser Ser Arg Thr Gly Gly Val Ala Glu
225 230 235 240
Asp Ile Ala Tyr Ile Leu Lys Gln Met Arg Arg Ala Ile Val Val Gly
245 250 255
Glu Arg Thr Val Gly Gly Ala Leu Asn Leu Gln Lys Leu Arg Val Gly
260 265 270
Gln Ser Asp Phe Phe Leu Thr Val Pro Val Ser Arg Ser Leu Gly Pro
275 280 285
Leu Gly Glu Gly Ser Gln Thr Trp Glu Gly Ser Gly Val Leu Pro Cys
290 295 300
Val Gly Thr Pro Ala Glu Gln Ala Leu Glu Lys Ala Leu Ala Val Leu
305 310 315 320
Met Leu Arg Arg Ala Leu Pro Gly Val Ile Gln Arg Leu Gln Glu Ala
325 330 335
Leu Arg Glu Tyr Tyr Thr Leu Val Asp Arg Val Pro Ala Leu Leu Ser
340 345 350
His Leu Ala Ala Met Asp Leu Ser Ser Val Val Ser Glu Asp Asp Leu
355 360 365
Val Thr Lys Leu Asn Ala Gly Leu Gln Ala Val Ser Glu Asp Pro Arg
370 375 380
Leu Gln Val Gln Val Val Arg Pro Lys Glu Ala Ser Ser Gly Pro Glu
385 390 395 400
Glu Glu Ala Glu Glu Pro Pro Glu Ala Val Pro Glu Val Pro Glu Asp
405 410 415
Glu Ala Val Arg Arg Ala Leu Val Asp Ser Val Phe Gln Val Ser Val
420 425 430
Leu Pro Gly Asn Val Gly Tyr Leu Arg Phe Asp Ser Phe Ala Asp Ala
435 440 445
Ser Val Leu Glu Val Leu Gly Pro Tyr Ile Leu His Gln Val Trp Glu
450 455 460
Pro Leu Gln Asp Thr Glu His Leu Ile Met Asp Leu Arg Gln Asn Pro
465 470 475 480
Gly Gly Pro Ser Ser Ala Val Pro Leu Leu Leu Ser Tyr Phe Gln Ser
485 490 495
Pro Asp Ala Ser Pro Val Arg Leu Phe Ser Thr Tyr Asp Arg Arg Thr
500 505 510
Asn Ile Thr Arg Glu His Phe Ser Gln Thr Glu Leu Leu Gly Arg Pro
515 520 525
Tyr Gly Thr Gln Arg Gly Val Tyr Leu Leu Thr Ser His Arg Thr Ala
530 535 540
Thr Ala Ala Glu Glu Leu Ala Phe Leu Met Gln Ser Leu Gly Trp Ala
545 550 555 560
Thr Leu Val Gly Glu Ile Thr Ala Gly Ser Leu Leu His Thr His Thr
565 570 575
Val Ser Leu Leu Glu Thr Pro Glu Gly Gly Leu Ala Leu Thr Val Pro
580 585 590
Val Leu Thr Phe Ile Asp Asn His Gly Glu Cys Trp Leu Gly Gly Gly
595 600 605
Val Val Pro Asp Ala Ile Val Leu Ala Glu Glu Ala Leu Asp Arg Ala
610 615 620
Gln Glu Val Leu Glu Phe His Arg Ser Leu Gly Glu Leu Val Glu Gly
625 630 635 640
Thr Gly Arg Leu Leu Glu Ala His Tyr Ala Arg Pro Glu Val Val Gly
645 650 655
Gln Met Gly Ala Leu Leu Arg Ala Lys Leu Ala Gln Gly Ala Tyr Arg
660 665 670
Thr Ala Val Asp Leu Glu Ser Leu Ala Ser Gln Leu Thr Ala Asp Leu
675 680 685
Gln Glu Met Ser Gly Asp His Arg Leu Leu Val Phe His Ser Pro Gly
690 695 700
Glu Met Val Ala Glu Glu Ala Pro Pro Pro Pro Pro Val Val Pro Ser
705 710 715 720
Pro Glu Glu Leu Ser Tyr Leu Ile Glu Ala Leu Phe Lys Thr Glu Val
725 730 735
Leu Pro Gly Gln Leu Gly Tyr Leu Arg Phe Asp Ala Met Ala Glu Leu
740 745 750
Glu Thr Val Lys Ala Val Gly Pro Gln Leu Val Gln Leu Val Trp Gln
755 760 765
Lys Leu Val Asp Thr Ala Ala Leu Val Val Asp Leu Arg Tyr Asn Pro
770 775 780
Gly Ser Tyr Ser Thr Ala Val Pro Leu Leu Cys Ser Tyr Phe Phe Glu
785 790 795 800
Ala Glu Pro Arg Arg His Leu Tyr Ser Val Phe Asp Arg Ala Thr Ser
805 810 815
Arg Val Thr Glu Val Trp Thr Leu Pro His Val Thr Gly Gln Arg Tyr
820 825 830
Gly Ser His Lys Asp Leu Tyr Val Leu Val Ser His Thr Ser Gly Ser
835 840 845
Ala Ala Glu Ala Phe Ala His Thr Met Gln Asp Leu Gln Arg Ala Thr
850 855 860
Ile Ile Gly Glu Pro Thr Ala Gly Gly Ala Leu Ser Val Gly Ile Tyr
865 870 875 880
Gln Val Gly Ser Ser Ala Leu Tyr Ala Ser Met Pro Thr Gln Met Ala
885 890 895
Met Ser Ala Ser Thr Gly Glu Ala Trp Asp Leu Ala Gly Val Glu Pro
900 905 910
Asp Ile Thr Val Pro Met Ser Val Ala Leu Ser Thr Ala Arg Asp Ile
915 920 925
Val Thr Leu Arg Ala Lys Val Pro Thr Val Leu Gln Thr Ala Gly Lys
930 935 940
Leu Val Ala Asp Asn Tyr Ala Ser Pro Glu Leu Gly Val Lys Met Ala
945 950 955 960
Ala Glu Leu Ser Gly Leu Gln Ser Arg Tyr Ala Arg Val Thr Ser Glu
965 970 975
Ala Ala Leu Ala Glu Leu Leu Gln Ala Asp Leu Gln Val Leu Ser Gly
980 985 990
Asp Pro His Leu Lys Thr Ala His Ile Pro Glu Asp Ala Lys Asp Arg
995 1000 1005
Ile Pro Gly Ile Val Pro Met Gln Ile Pro Ser Pro Glu Val Phe
1010 1015 1020
Glu Asp Leu Ile Lys Phe Ser Phe His Thr Asn Val Leu Glu Gly
1025 1030 1035
Asn Val Gly Tyr Leu Arg Phe Asp Met Phe Gly Asp Cys Glu Leu
1040 1045 1050
Leu Thr Gln Val Ser Glu Leu Leu Val Glu His Val Trp Lys Lys
1055 1060 1065
Ile Val His Thr Asp Ala Leu Ile Val Asp Met Arg Phe Asn Ile
1070 1075 1080
Gly Gly Pro Thr Ser Ser Ile Ser Ala Leu Cys Ser Tyr Phe Phe
1085 1090 1095
Asp Glu Gly Pro Pro Ile Leu Leu Asp Lys Ile Tyr Asn Arg Pro
1100 1105 1110
Asn Asn Ser Val Ser Glu Leu Trp Thr Leu Ser Gln Leu Glu Gly
1115 1120 1125
Glu Arg Tyr Gly Ser Lys Lys Ser Met Val Ile Leu Thr Ser Thr
1130 1135 1140
Leu Thr Ala Gly Ala Ala Glu Glu Phe Thr Tyr Ile Met Lys Arg
1145 1150 1155
Leu Gly Arg Ala Leu Val Ile Gly Glu Val Thr Ser Gly Gly Cys
1160 1165 1170
Gln Pro Pro Gln Thr Tyr His Val Asp Asp Thr Asp Leu Tyr Leu
1175 1180 1185
Thr Ile Pro Thr Ala Arg Ser Val Gly Ala Ala Asp Gly Ser Ser
1190 1195 1200
Trp Glu Gly Val Gly Val Val Pro Asp Val Ala Val Pro Ala Glu
1205 1210 1215
Ala Ala Leu Thr Arg Ala Gln Glu Met Leu Gln His Thr Pro Leu
1220 1225 1230
Arg Ala Arg Arg Ser Pro Arg Leu His Gly Arg Arg Lys Gly His
1235 1240 1245
His Arg Gln Ser Gln Gly Arg Ala Gly Ser Leu Gly Arg Asn Gln
1250 1255 1260
Gly Val Val Arg Pro Glu Val Leu Thr Glu Ala Pro Ser Gly Gln
1265 1270 1275
Lys Arg Gly Leu Leu Gln Cys Gly
1280 1285
<210> 9
<211> 15
<212> PRT
<213> Artificial sequence
<220>
<223> Synthetic peptide
<400> 9
Ala Asp Gly Ser Ser Trp Glu Gly Val Gly Val Val Pro Asp Val
1 5 10 15
本発明は以下の態様も提供する。
[1] 被験体のブドウ膜炎の治療または予防での使用のための、以下のペプチドから選択されるミエリン塩基性タンパク質ペプチドを含む組成物:
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。
[2] 以下のペプチドを含む、[1]に記載の使用のための組成物:
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。
[3] ブドウ膜炎が、後部ブドウ膜炎、前部ブドウ膜炎または中間部ブドウ膜炎である、[1]に記載の使用のための組成物。
[4] 被験体のブドウ膜炎の治療および/または予防のための医薬の製造における、[1]または[2]に規定される組成物の使用。
[5] ブドウ膜炎が、後部ブドウ膜炎、前部ブドウ膜炎または中間部ブドウ膜炎である、[4]に記載の使用。
[6] [1]または[2]に規定される組成物を被験体に投与するステップを含む、被験体のブドウ膜炎を治療または予防するための方法。
[7] ブドウ膜炎が、後部ブドウ膜炎、前部ブドウ膜炎、後部ブドウ膜炎または中間部ブドウ膜炎である、[8]に記載の方法。
[8] 被験体のブドウ膜炎の治療または予防での使用のための、以下のペプチドから選択されるミエリン塩基性タンパク質ペプチドを含むキット:
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。
[9] 以下のペプチドを含む、[8]に記載の使用のためのキット:
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。
[10] 前記MBPペプチドが、同時投与、分離投与または連続的投与のためのものである、[9]に記載の使用のためのキット。
[11] ブドウ膜炎の動物モデルであって、該動物が、ヒトMBPおよび光受容体間レチノイド結合性タンパク質(IRBP)ペプチドにより免疫化されている、動物モデル。
[12] 前記ブドウ膜炎が、後部ブドウ膜炎、前部ブドウ膜炎、後部ブドウ膜炎または中間部ブドウ膜炎である、[11]に記載の動物モデル。
[13] MBPがヒトMBPであり、かつIRBPがウシIRBPである、[11]または[12]に記載の動物モデル。
[14] MBPおよびIRBPが皮下注入により投与される、[11]~[13]のいずれかに記載の動物モデル。
[15] 動物がラットである、[11]~[14]のいずれかに記載の動物モデル。
[16] ラットがLewisラットである、[15]に記載の動物モデル。
[17] Lewisラットが雌Lewisラットである、[16]に記載の動物モデル。
Claims (17)
- 被験体のブドウ膜炎の治療または予防での使用のための、以下のペプチドから選択されるミエリン塩基性タンパク質ペプチドを含む組成物:
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。 - 以下のペプチドを含む、請求項1に記載の使用のための組成物:
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。 - ブドウ膜炎が、後部ブドウ膜炎、前部ブドウ膜炎または中間部ブドウ膜炎である、請求項1に記載の使用のための組成物。
- 被験体のブドウ膜炎の治療および/または予防のための医薬の製造における、請求項1または請求項2に規定される組成物の使用。
- ブドウ膜炎が、後部ブドウ膜炎、前部ブドウ膜炎または中間部ブドウ膜炎である、請求項4に記載の使用。
- 請求項1または請求項2に規定される組成物を被験体に投与するステップを含む、被験体のブドウ膜炎を治療または予防するための方法。
- ブドウ膜炎が、後部ブドウ膜炎、前部ブドウ膜炎、後部ブドウ膜炎または中間部ブドウ膜炎である、請求項8に記載の方法。
- 被験体のブドウ膜炎の治療または予防での使用のための、以下のペプチドから選択されるミエリン塩基性タンパク質ペプチドを含むキット:
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。 - 以下のペプチドを含む、請求項8に記載の使用のためのキット:
MBP 30-44(配列番号1);
MBP 83-99(配列番号2);
MBP 131-145(配列番号3);および
MBP 140-154(配列番号4)。 - 前記MBPペプチドが、同時投与、分離投与または連続的投与のためのものである、請求項9に記載の使用のためのキット。
- ブドウ膜炎の動物モデルであって、該動物が、ヒトMBPおよび光受容体間レチノイド結合性タンパク質(IRBP)ペプチドにより免疫化されている、動物モデル。
- 前記ブドウ膜炎が、後部ブドウ膜炎、前部ブドウ膜炎、後部ブドウ膜炎または中間部ブドウ膜炎である、請求項11に記載の動物モデル。
- MBPがヒトMBPであり、かつIRBPがウシIRBPである、請求項11または12に記載の動物モデル。
- MBPおよびIRBPが皮下注入により投与される、請求項11~13のいずれか1項に記載の動物モデル。
- 動物がラットである、請求項11~14のいずれか1項に記載の動物モデル。
- ラットがLewisラットである、請求項15に記載の動物モデル。
- Lewisラットが雌Lewisラットである、請求項16に記載の動物モデル。
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GB1700095.1 | 2017-01-04 | ||
GBGB1700095.1A GB201700095D0 (en) | 2017-01-04 | 2017-01-04 | Composition |
PCT/IB2018/050062 WO2018127829A1 (en) | 2017-01-04 | 2018-01-04 | Composition |
JP2019536175A JP2020514288A (ja) | 2017-01-04 | 2018-01-04 | 組成物 |
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EP (1) | EP3565570B1 (ja) |
JP (2) | JP2020514288A (ja) |
AU (1) | AU2018206357B2 (ja) |
CA (1) | CA3049180A1 (ja) |
GB (1) | GB201700095D0 (ja) |
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US20030191063A1 (en) * | 2000-08-21 | 2003-10-09 | Wraith David Cameron | Peptide selection method |
CA2445640A1 (en) * | 2001-03-23 | 2002-10-03 | John Matsoukas | Peptide analogues of myelin basic protein epitopes in the treatment of experimental autoimmune encephalomyelitis (eae) and multiple sclerosis (ms) |
US20140105980A1 (en) * | 2012-10-11 | 2014-04-17 | Uti Limited Partnership | Methods and compositions for treating multiple sclerosis and related disorders |
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-
2017
- 2017-01-04 GB GBGB1700095.1A patent/GB201700095D0/en not_active Ceased
-
2018
- 2018-01-04 CA CA3049180A patent/CA3049180A1/en active Pending
- 2018-01-04 EP EP18701798.3A patent/EP3565570B1/en active Active
- 2018-01-04 US US16/474,583 patent/US20190330294A1/en not_active Abandoned
- 2018-01-04 AU AU2018206357A patent/AU2018206357B2/en active Active
- 2018-01-04 JP JP2019536175A patent/JP2020514288A/ja active Pending
- 2018-01-04 WO PCT/IB2018/050062 patent/WO2018127829A1/en unknown
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2019
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CA3049180A1 (en) | 2018-07-12 |
EP3565570A1 (en) | 2019-11-13 |
AU2018206357A1 (en) | 2019-07-18 |
AU2018206357B2 (en) | 2021-07-29 |
US20190330294A1 (en) | 2019-10-31 |
JP2020514288A (ja) | 2020-05-21 |
ZA201904385B (en) | 2023-04-26 |
WO2018127829A1 (en) | 2018-07-12 |
GB201700095D0 (en) | 2017-02-22 |
EP3565570B1 (en) | 2024-07-03 |
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