JP2003523402A5 - - Google Patents

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Publication number: JP2003523402A5
Authority: JP; Japan
Prior art keywords: seq; epitope; amino acid; cell; app
Prior art date: 2001-02-19
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Granted

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JP2001561348A

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JP5025871B2 (ja

JP2003523402A (ja

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2001-02-19

Publication date

2008-03-27

2001-02-19 Application filed filed Critical

2001-02-19 Priority claimed from PCT/DK2001/000113 external-priority patent/WO2001062284A2/en

2003-08-05 Publication of JP2003523402A publication Critical patent/JP2003523402A/ja

2008-03-27 Publication of JP2003523402A5 publication Critical patent/JP2003523402A5/ja

2012-09-12 Application granted granted Critical

2012-09-12 Publication of JP5025871B2 publication Critical patent/JP5025871B2/ja

2021-02-19 Anticipated expiration legal-status Critical

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Description

【特許請求の範囲】
【請求項１】
ａ）アミノ酸の挿入、付加、欠失または置換によって少なくとも1つの単離された外来Tヘルパーエピトープ（T _H エピトープ）が導入された、動物のオートロガスAβ（βアミロイド）又はAPP（アミロイド前駆体タンパク質）の少なくとも1つの類似体であって、前記外来T _H エピトープがD-アミノ酸を有さずかつ図１のP2及びP30エピトープについて概略的に示すようにオートロガスAβ又はAPPに導入されている類似体、
ｂ）前記ａ）で定義される少なくとも１つの類似体をコードする核酸フラグメント、及び
ｃ）前記ｂ）で定義される核酸フラグメントを有する非病原性微生物又はウイルス
から選択される物質を含む、動物におけるアルツハイマー疾患又はAβの沈着によって特徴付けられる他の疾患及び症状の治療及び／又は予防及び／又は緩和用の医薬組成物。
【請求項２】
類似体がAβ又はAPPのB-細胞エピトープの実質的画分を保存し、かつ
- 抗原提示細胞(APC)又はB-リンパ球に類似体に類似体を標的化させる少なくとも1つの第一部分、及び/又は
- 免疫系を刺激する少なくとも1つの第二部分、及び/又は
- 免疫系への類似体の提示を最適化する少なくとも1つの第三部分
を含む請求項１による組成物。
【請求項３】
類似体が、第一及び/又は第二及び/又は第三の部分のAβ、APP又はそのサブ配列中の適当な化学基への共有又は非共有的な結合による側基としての導入によって修飾されている請求項２による組成物。
【請求項４】
類似体が、Aβ又はAPPの少なくとも1つのB-細胞エピトープの重複を含むか及び/又は類似体にハプテンが導入されている請求項１〜３のいずれか１つによる組成物。
【請求項５】
外来T-細胞エピトープが治療される動物において免疫優勢である請求項１〜４のいずれか１つによる組成物。
【請求項６】
外来T-細胞エピトープが乱交雑であり、例えば天然の乱交雑T-細胞エピトープ及び人為的なMHC-II結合ペプチド配列から選択される外来T-細胞エピトープである請求項１〜５のいずれか１つによる組成物。
【請求項７】
天然のT-細胞エピトープが、P2又はP30のような破傷風トキソイドエピトープ、ジフテリアトキソイドエピトープ、インフルエンザウイルス血球凝集素エピトープ及びピー・ファルシパルムCSエピトープから選択される請求項６による組成物。
【請求項８】
第一部分が、B-リンパ球特異的表面抗原又はAPC特異的表面抗原に実質的に特異的な結合パートナー、例えばB-リンパ球もしくはAPCに受容体があるハプテン又は炭水化物である請求項２〜７のいずれか１つによる組成物。
【請求項９】
第二部分が、サイトカイン、例えばインターフェロンγ（IFN-γ）もしくはその有効部分、Flt3Lもしくはその有効部分、インターロイキン1（IL-1）もしくはその有効部分、インターロイキン2（IL-2）もしくはその有効部分、インターロイキン4（IL-4）もしくはその有効部分、インターロイキン6（IL-6）もしくはその有効部分、インターロイキン12（IL-12）もしくはその有効部分、インターロイキン13（IL-13）もしくはその有効部分、インターロイキン15（IL-15）もしくはその有効部分、及び顆粒球-マクロファージコロニー刺激因子（GM-CSF）もしくはその有効部分；ホルモン；及び熱ショックタンパク質、例えばHSP70もしくはその有効部分、HSP90もしくはその有効部分、HSC70もしくはその有効部分、GRP94もしくはその有効部分、及びカルレチクリン（CRT）もしくはその有効部分から選択される請求項２〜８のいずれか１つによる組成物。
【請求項１０】
第三部分が、パルミトイル基、ミリスチル基、ファルネシル基、ゲラニル-ゲラニル基、GPI-アンカー及びN-アシルグリセリド基のような脂質性であるか、又は第三部分が多糖類のようなポリヒドロキシポリマーである請求項２〜９のいずれか１つによる組成物。
【請求項１１】
オートロガスAβ又はAPPが、オートロガスAPPの細胞結合型に存在するときに細胞外相に曝されないB-細胞エピトープを保存するように修飾されている請求項１〜１０のいずれかひとつによる組成物。
【請求項１２】
Aβ又はAPPが、オートロガスAPPの細胞結合型に存在するときに細胞外相に曝されるB-細胞エピトープを少なくとも1つ欠くように修飾されている請求項１１による組成物。
【請求項１３】
少なくとも１つの単離された外来T _H エピトープが、オートロガスAβ又はAPP内の少なくともひとつのアミノ酸配列の、長さが同じか異なるアミノ酸配列での置換により類似体に導入される請求項１〜１２のいずれか１つによる組成物。
【請求項１４】
類似体が、類似体に外来T_Hエピトープを生じるアミノ酸配列が導入されたSEQ ID NO:2の672〜714アミノ酸に相当するアミノ酸からなるか、又は類似体が、外来T_Hエピトープを生じる、長さが同じか異なるアミノ酸配列で少なくともひとつのアミノ酸配列が置換されたSEQ ID NO:2の672〜714アミノ酸に相当するアミノ酸配列からなる請求項１〜１３のいずれか１つによる組成物。
【請求項１５】
類似体が、N-末端からC-末端に、SEQ ID NO:2の672〜714のアミノ酸残基、続いてSEQ ID NO:4、続いてSEQ ID NO:2の672〜714のアミノ酸残基、続いてSEQ ID NO:6、続いてSEQ ID NO:2の672〜714のアミノ酸残基からなる請求項１〜１３のいずれか１つによる組成物。
【請求項１６】
類似体が、N-末端からC-末端に、SEQ ID NO:2の630〜634のアミノ酸残基、続いてSEQ ID NO:6、続いてSEQ ID NO:4、続いてSEQ ID NO:2の671〜714のアミノ酸残基からなる請求項１〜１３のいずれか１つによる組成物。
【請求項１７】
類似体が、N-末端からC-末端に、SEQ ID NO:2の672〜713のアミノ酸残基、続いてSEQ ID NO:6、続いてSEQ ID NO:2の729〜734のアミノ酸残基、続いてSEQ ID NO:4、続いてSEQ ID NO:2の750〜770のアミノ酸残基からなる請求項１〜１３のいずれか１つによる組成物。
【請求項１８】
類似体の少なくとも2つのコピーが、抗原決定基の複数のコピーを提示し得る担体分子に共有的又は非共有的に結合している請求項１〜１７のいずれか１つによる組成物。
【請求項１９】
類似体が、自己抗原に対する自己耐性の破壊を促進するアジュバントと製剤化されている請求項１〜１８のいずれか１つによる組成物。
【請求項２０】
非経口経路、例えば真皮内、真皮下及び筋肉内経路；腹腔内経路；経口経路；口腔経路；舌下経路；硬膜外経路；脊髄経路；肛門経路；及び頭蓋内経路から選択される経路を介して動物に投与されるように適合されている請求項１〜１９のいずれか１つによる組成物。
【請求項２１】
0.5〜2,000μgの類似体を含有する請求項２０による組成物。
【請求項２２】
類似体が、仮想リンパ節(VLN)装置に含まれる請求項２０又は２１による組成物。
【請求項２３】
核酸フラグメントが、裸のDNA、荷電又は非荷電脂質で製剤化したDNA、リポソームで製剤化したDNA、ウイルスベクターに含めたDNA、トランスフェクション促進タンパク質又はポリペプチドで製剤化したDNA、標的タンパク質又はポリペプチドで製剤化したDNA、カルシウム沈殿剤で製剤化したDNA、不活性担体分子に結合したDNA、キチン又はキトサンでカプセル化したDNA、ならびにアジュバントで製剤化したDNAから選択される請求項１〜２２のいずれか１つによる組成物。
【請求項２４】
核酸フラグメントが、VLN装置に含まれる請求項２３による組成物。
【請求項２５】
1年に少なくとも1回、例えば少なくとも2回、少なくとも3回、少なくとも4回、少なくとも6回及び少なくとも12回、投与/導入される請求項２１〜２４のいずれか１つによる組成物。
【請求項２６】
図１のP2及びP30エピトープについて概略的に示すように少なくとも１つの単離された外来T_Hエピトープが導入された動物のオートロガスAβ（βアミロイド）又はAPP（アミロイド前駆体タンパク質）から得られるアミロイド産生ポリペプチドの類似体であって、前記類似体での動物の免疫化により、アミロイド産生ポリペプチドに対する抗体の産生が誘発される類似体。
【請求項２７】
修飾が、請求項２〜１７のいずれかひとつに定義される請求項２６による類似体。
【請求項２８】
請求項２６又は２７による類似体の免疫学的に有効な量、さらに医薬的ならびに免疫学的に許容される担体及び/又は賦形剤、任意にアジュバントを含む免疫原性組成物。
【請求項２９】
請求項２６又は２７による類似体をエンコードする核酸フラグメント。
【請求項３０】
自律複製できるベクターのような、請求項２９による核酸フラグメントを有するベクター。
【請求項３１】
プラスミド、ファージ、コスミド、ミニ染色体及びウイルスからなる群から選択される請求項３０によるベクター。
【請求項３２】
5'→3'方向及び操作可能な連鎖において、請求項２９による核酸フラグメントの発現を駆動するプロモーター、任意に、ポリペプチドフラグメントの分泌又は膜への組み込みを可能にするリーダーペプチドをエンコードする核酸配列、請求項２９による核酸フラグメント及び任意に転写終結区からなる、請求項３０又は３１によるベクター。
【請求項３３】
宿主細胞に導入する場合に、宿主細胞ゲノムに組みこむことができるか、又は組み込むことができない請求項３０〜３２のいずれか１つによるベクター。
【請求項３４】
プロモーターが、真核細胞及び/又は原核細胞での発現を駆動する請求項３２又は３３によるベクター。
【請求項３５】
請求項２９による核酸フラグメントを複製しうる形質転換細胞のような、請求項３０〜３４のいずれか１つのベクターを有する形質転換細胞。
【請求項３６】
細菌、酵母、原生動物から選択される微生物、又は真菌、S₂もしくはSF細胞のような昆虫細胞、植物細胞及び哺乳動物細胞から選択される多細胞生物由来細胞である請求項３５による形質転換細胞。
【請求項３７】
請求項２６又は２７による類似体を分泌するかその表面で担持する形質転換細胞のような、請求項２９による核酸フラグメントを発現する請求項３５又は３６による形質転換細胞。
【請求項３８】
- 請求項２９による核酸フラグメント又は請求項３０〜３４のいずれか１つによるベクター、及び
- 医薬的及び免疫学的に受容な担体及び/又はビヒクル及び/又はアジュバント
からなる、Aβ又はAPPに対する抗体産生をこれらのタンパク質がオートロガスである動物において誘発するための組成物。
【請求項３９】
請求項３０〜３４のいずれか１つによるベクターを有し、請求項２９による核酸フラグメントを発現し、請求項２６又は２７による類似体を任意に分泌するか、その表面に担持する安定な細胞系。

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