JP2022043071A5 - - Google Patents
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- JP2022043071A5 JP2022043071A5 JP2021193530A JP2021193530A JP2022043071A5 JP 2022043071 A5 JP2022043071 A5 JP 2022043071A5 JP 2021193530 A JP2021193530 A JP 2021193530A JP 2021193530 A JP2021193530 A JP 2021193530A JP 2022043071 A5 JP2022043071 A5 JP 2022043071A5
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Claims (17)
- (1)(1-a)いかなる合成ナノ担体にも付着されていない治療用高分子と、
(1-b)免疫抑制剤に付着されており、および、治療用高分子の治療用高分子抗原提示細胞(APC)を含まない、合成ナノ担体の集団と
を併用投与することを含む、第1の投薬;
(2)(c)いかなる合成ナノ担体にも付着されていない治療用高分子を投与し、および、いかなる合成ナノ担体も投与しないことを含む、第2の投薬;ならびに
(3)治療用高分子に対する望ましくない液性免疫応答を低減する投与スケジュールに従って、第1および第2の投薬を対象へ施すこと;
を含む方法であって、
任意に、(4)第1および第2の投薬のための、治療用高分子に対する望ましくない液性免疫応答を低減する投与スケジュールを決定すること;をさらに含む、
前記方法
における使用のための、免疫抑制剤に付着されている合成ナノ担体の集団を含む組成物。 - (a)治療用高分子に対する望ましくない液性免疫応答が、第1の投薬なしの第2の投薬に起因する;
(b)第1の投薬が、(1-a)および(1-b)を対象へ1回以上、任意には、少なくとも1回、2回、3回、4回または5回投与される;
(c)第2の投薬が、第1の投薬から少なくとも1、2、3、4、5、6、7または8週間後に対象へ施される;
(d)方法が、第1の投薬および第2の投薬の施行の前および/または後に、対象における望ましくない液性免疫応答を査定すること、をさらに含む;
(e)第1の投薬および/または第2の投薬の施行が、静脈内、腹腔内または皮下投与による;ならびに/もしくは
(f)方法が、治療用高分子に対する望ましくない液性免疫応答を有するか、またはそれを有するリスクがあるものとして対象を識別することをさらに含む、請求項1に記載の組成物。 - (1)(a)いかなる合成ナノ担体にも付着されていない治療用高分子と、
(b)免疫抑制剤に付着されており、および、治療用高分子の治療用高分子APC提示可能抗原を含まない、合成ナノ担体の集団と
を各々含む、1つまたは2つ以上の第1の用量;および
(2)いかなる合成ナノ担体にも付着されていない治療用高分子を含む1つまたは2つ以上の第2の用量、
を含む、治療用高分子に対する望ましくない液性免疫応答を低減する方法における使用のための組成物であって、ここで方法が、投与スケジュールに従って対象へ第1および第2の用量を投与することを含む、
前記組成物。 - (a)第2の用量が、いかなる合成ナノ担体も含まない;
(b)方法が、第1および第2の投薬のための、治療用高分子に対する望ましくない液性免疫応答を低減する投与スケジュールを決定すること、をさらに含む;
(c)方法が、本明細書に規定されるいずれかの方法である;
(d)組成物がキットであり、および、第1の用量および第2の用量の1つ以上が各々、キット中の容器に収納されている;ならびに/または
(e)組成物が、薬学的に許容し得る担体をさらに含む、請求項3に記載の組成物。 - (a)免疫抑制剤が、スタチン、mTORインヒビター、TGF-βシグナル剤、コルチコステロイド、ミトコンドリア機能のインヒビター、P38インヒビター、NF-κβインヒビター、アデノシン受容体アゴニスト、プロスタグランジンE2アゴニスト、ホスホジエステラーゼ4インヒビター、HDACインヒビターまたはプロテアソームインヒビターを含む;および/または、
(b)治療用高分子が、治療用タンパク質である、請求項1~4のいずれか一項に記載の組成物。 - mTORインヒビターが、ラパマイシンまたはラパマイシン類縁体である、請求項5に記載の組成物。
- (a)治療用タンパク質が、タンパク質補充またはタンパク質補強治療用である;または、
(b)治療用高分子が、点滴可能または注射可能な治療用のタンパク質、酵素、酵素補助因子、ホルモン、血液または血液凝固因子、サイトカイン、インターフェロン、成長因子、モノクローナル抗体、ポリクローナル抗体、または、ポンペ病に関連するタンパク質を含む、請求項5に記載の組成物。 - (a)点滴可能または注射可能な治療用のタンパク質が、トシリズマブ、アルファ-1アンチトリプシン、ヘマタイド、アルブインターフェロンアルファ-2b、ルシン、テサモレリン、オクレリズマブ、ベリムマブ、ペグロチカーゼ、タリグルセラーゼアルファ、アガルシダーゼアルファまたはベラグルセラーゼアルファを含む;
(b)酵素が、オキシドレダクターゼ、トランスフェラーゼ、ヒドロラーゼ、リアーゼ、イソメラーゼまたはリガーゼを含む;
(c)酵素が、リソソーム蓄積障害のための酵素補充治療用の酵素を含む;
(d)酵素が、KRYSTEXXA(ペグロチカーゼ)またはペグシチカーゼを含む;
(e)モノクローナル抗体が、HUMIRA(アダリムマブ)を含む;
(f)サイトカインが、リンホカイン、インターロイキン、ケモカイン、タイプ1サイトカインまたはタイプ2サイトカインを含む;
(g)血液または血液凝固因子が、第I因子、第II因子、組織因子、第V因子、第VII因子、第VIII因子、第IX因子、第X因子、第Xa因子、第XII因子、第XIII因子、フォン・ヴィレブランド因子、プレカリクレイン、高分子量キニノゲン、フィブロネクチン、アンチトロンビンIII、ヘパリン補助因子II、プロテインC、プロテインS、プロテインZ、プロテインZ関係プロテアーゼインヒビター(ZPI)、プラスミノーゲン、アルファ2-アンチプラスミン、組織プラスミノーゲンアクチベーター(tPA)、ウロキナーゼ、プラスミノーゲンアクチベーターインヒビター-1(PAI1)、プラスミノーゲンアクチベーターインヒビター-2(PAI2)、がんプロコアグラントまたはエポエチンアルファを含む、請求項7に記載の組成物。 - リソソーム蓄積障害のための酵素補充治療用の酵素が、イミグルセラーゼ、a-ガラクトシダーゼA(a-galA)、アガルシダーゼベータ、酸性αグルコシダーゼ(GAA)、アルグルコシダーゼアルファ(ルミザイム(LUMIZYME)(登録商標)またはミオザイム(MYOZYME)(登録商標)等)、アリールスルファターゼB、ラロニダーゼ(アウドラザイム(ALDURAZYME)(登録商標)等)、イデュルスルファーゼ(エラプラーゼ(ELAPRASE)(登録商標)等)、アリールスルファターゼBまたはナグラザイム(NAGLAZYME)(登録商標)を含む、請求項8に記載の組成物。
- 免疫抑制剤の積載量が、合成ナノ担体の集団にわたる平均で、0.1%と50%との間、任意には、0.1%と20%との間である、請求項1~9のいずれか一項に記載の組成物。
- 合成ナノ担体の集団が、脂質ナノ粒子、リポソーム、ポリマーナノ粒子、金属ナノ粒子、界面活性物質系エマルション、デンドリマー、バッキーボール、ナノワイヤ、ウイルス様粒子、または、ペプチドまたはタンパク質粒子を含む、任意には、合成ナノ担体の集団が、金ナノ粒子を含む、請求項1~10のいずれか一項に記載の組成物。
- 合成ナノ担体の集団が、非メトキシ末端のプルロニック(登録商標)ポリマーであるポリマーを含む、ポリマーナノ粒子を含む、請求項11に記載の組成物。
- ポリマーナノ粒子が、ポリエステル、ポリエーテルに連結されたポリエステル、ポリアミノ酸、ポリカーボネート、ポリアセタール、ポリケタール、多糖、ポリエチルオキサゾリンまたはポリエチレンイミンを含む、請求項12に記載の組成物。
- ポリエステルが、ポリ(乳酸)、ポリ(グリコール酸)、ポリ(乳酸-co-グリコール酸)またはポリカプロラクトンを含む、請求項13に記載の組成物。
- ポリマーナノ粒子が、ポリエステル、および、ポリエーテルに連結されたポリエステルを含む、請求項13または14に記載の組成物。
- ポリエーテルが、ポリエチレングリコールまたはポリプロピレングリコールを含む、請求項13~15のいずれか一項に記載の組成物。
- (a)合成ナノ担体の集団の動的光散乱を使用して得られる粒子サイズ分布の平均値が、(i)100nm、(ii)150nm、(iii)200nm、(iv)250nm、(v)300nmよりも大きな径である:および/あるいは、
(b)合成ナノ担体の集団のアスペクト比が、1:1、1:1.2、1:1.5、1:2、1:3、1:5、1:7または1:10よりも大きい、請求項1~16のいずれか一項に記載の組成物。
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