JP2020090503A - 天然に存在するCpGオリゴヌクレオチド組成物およびその治療的適用 - Google Patents
天然に存在するCpGオリゴヌクレオチド組成物およびその治療的適用 Download PDFInfo
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Abstract
Description
この出願は、2012年9月21日に出願された米国仮特許出願第61/704,090号の優先権を主張し、その米国仮特許出願の内容は、全体として参照により本明細書に組み入れられている。
適用なし。
適用なし。
哺乳類における肝障害およびいくつかの他のウイルス性障害を処置する従来の手法は、ウイルス自体を治療、例えば、ウイルス特異的化学療法剤の標的とすることである。そのような障害を処置する代替手法は、ウイルス自体を標的とする代わりに、またはそれに加えて、対象の免疫系を標的とすることである(「免疫治療」)。免疫治療の潜在的利益は、正常な健康細胞に対する有害効果を最小限にしながら、腫瘍に対する患者自身の免疫応答を増強することにより有効性の向上を実現することである。
以下の定義は、本発明の詳細な説明を理解することにおいて当業者を助けるために、提供される。ここで他に定義がない限り、本発明に関連して使用される科学的および技術的用語は、当業者によって一般的に理解されている意味をもつものとする。さらに、文脈上、他に要求がない限り、単数形の用語は、複数形を含むものとし、複数形の用語は、単数形を含むものとする。一般的に、ここで記載された細胞および組織培養、分子生物学、免疫学、微生物学、遺伝学、ならびにタンパク質および核酸化学およびハイブリダイゼーションに関連して使用される命名法ならびに技術は、当技術分野においてよく知られ、かつ一般的に使用されるものである。
本開示の治療的活性のある組成物は、第1の生物学的活性物質、好ましくは、例えば、可溶化液の形をとる、1種類以上のグラム陽性細菌の1種類以上の細胞壁画分;第2の生物学的活性物質、好ましくは天然に存在するCpG ODN;任意の促進剤;および任意で、組成物が、治療を必要としている対象の粘膜壁へ吸収され、またはそれと相互作用することを可能にするための、徐放性成分を含む1種以上の他の添加剤を含む。
本発明の治療用組成物はまた、徐放性添加剤を含んでもよい。治療用組成物における徐放性添加剤の存在は、対象の粘膜への送達後の初期の最初の1〜2分間中に治療用組成物から放出される生物学的活性物質の「初期バースト」を実質的に低下させる。ここで使用される場合、用語「実質的に低下させる」は、その添加剤なしの組成物と比較して、治療用組成物から放出される生物学的活性物質の少なくとも15%の減少を意味する。好ましくは、徐放性添加剤は、ポリマー組成物から放出される生物学的活性物質の初期バーストを、徐放性添加剤を含まない治療用組成物と比較して、約15%〜約70%、より好ましくは約30%〜約60%、低下させる。
本発明の治療用組成物は、固体、半固体、凍結乾燥粉末、または液体剤形、例えば錠剤(例えば咀嚼錠、低速溶解錠、急速溶解錠)、丸剤、カプセル剤、トローチ、キャンディ、ガム、散剤、溶液剤、懸濁剤、エマルジョン、エアロゾル、または同種のものなどの形態をとっていてもよい。好ましくは、剤形は、チューインガム、急速溶解錠、キャンディ、またはトローチである。本開示のさらなる側面によれば、本組成物は、栄養補助食品、例えば錠剤、丸剤、カプセル剤、または他の経口送達製剤の形態である。
した加工形態である。典型的には、製剤中に結合剤が含まれる場合、本発明の組成物は、重量で約15%から約90%まで、好ましくは約35%から約80%までの結合剤を含む。しかしながら、当業者は、結合剤をまったく用いずに本発明の組成物を作製して、例えば高度に砕けやすい剤形を生産できることを理解されよう。
剤形がチューインガムである場合、本発明の組成物は、グラム陽性細菌に由来した活性治療剤またはその薬学的に許容される塩、促進剤、担体、例えばガムベース、二成分または三成分の緩衝系を含み、任意に保護剤を含んでいてもよい。チューインガム組成物は、滑沢剤、湿潤剤、乳化剤、懸濁化剤、保存剤、甘味剤、香味剤、および着色剤をさらに含んでいてもよい。典型的には、チューインガム組成物は、重量で約0.001%から約10.0%まで、より典型的には約0.01%から約5.0%まで、さらにより典型的には約0.1%から約3.0%までの活性治療剤(どのような形態が選ばれたとしても、その遊離塩基の形態として測定される)を含む。当業者は、前述のパーセンテージは、利用されたグラム陽性ベースの活性治療剤の特定の供給源、最終的な製剤で望まれる活性治療剤の量、加えて所望の活性治療剤の特定の放出速度に応じて変更されることを理解する。チューインガム組成物の任意の緩衝系は、少なくとも約8.0を超える、好ましくは少なくとも約9.5を超える、より好ましくは約9.9から約11までの範囲の最終的な唾液のpHをもたらすことができる。チューインガム組成物は、典型的には、重量で約20%から約95%までのガムベース、より典型的には約30%から約85%まで、最も典型的には約50%から約70%までのガムベースを含む。
剤形が錠剤、例えば溶解錠(すなわち崩壊性錠剤)または咀嚼錠である場合、本発明の組成物は、ここで説明されるような1種類以上のグラム陽性細菌に由来した治療剤、またはその薬学的に許容される塩、天然に存在する免疫刺激性オリゴデオキシヌクレオチド、例えばCpG ODNモチーフもしくは等価体、任意の促進剤、担体、例えば結合剤、および緩衝系、例えば二成分または三成分の緩衝系などを含む。錠剤組成物は、滑沢剤、湿潤剤、乳化剤、懸濁化剤、保存剤、甘味剤、香味剤、着色剤、および崩壊剤をさらに含んでいてもよい。典型的には、本発明の錠剤組成物は、重量で約0.001%から約10.0%まで、より典型的には約1.0%から約5.0%までの活性治療剤(どのような形態が選ばれたとしても、その遊離塩基の形態として測定される)を含む。当業者は、前述のパーセンテージは、利用される活性治療剤の特定の供給源、最終的な製剤で望まれる活性治療剤の量、加えて所望の活性治療剤の特定の放出速度に応じて変更されることを理解する。錠剤組成物の緩衝系は、少なくとも約8.0を超える、好ましくは少なくとも約9.5を超える、より好ましくは約pH9.9から約pH11までの範囲の最終的な唾液のpHをもたらす。
剤形がトローチまたはキャンディである場合、本発明の組成物は、グラム陽性細菌に由来した活性物質またはその薬学的に許容される塩、任意の促進剤、担体、例えば結合剤、および緩衝系、例えば二成分または三成分の緩衝系などを含む。トローチまたはキャンディ組成物は、滑沢剤、湿潤剤、乳化剤、懸濁化剤、保存剤、甘味剤、香味剤、着色剤、および崩壊剤をさらに含んでいてもよい。トローチおよびキャンディの総括的な論考は、例えば”Pharmaceutical Dosage Forms, Volume 1: Tablets”[第2版、Marcel Dekker, Inc., New York, N.Y., pp 75-418 (1989)]に示されている。
本発明の組成物は、例えば、肝臓の疾患または障害、例えば、A型、B型、および/またはC型肝炎を含む免疫疾患または障害の処置を、そのような処置を必要としている対象において行うための、治療的適用において有用である。本発明の方法は、様々な肝障害、特に、対象の補体系における代替経路との関連リンクによって特徴づけられる肝障害の処置において有用である。したがって、本開示によれば、肝障害は、肝臓または周囲脈管構造における任意の肝臓疾患または障害である。例えば、本発明の方法および組成物は、感染、医原性障害、遺伝性障害、自己免疫障害、胆汁うっ滞性症候群、サルコイドーシス、臓器移植、肝癌などに起因するものを含む、様々な肝障害の処置において有用である。
例1:活性成分組成物調製
治療試験およびさらなる細胞系試験、例えば、スクリーニング試験および対象試験において適した、ここで記載されているような例示的な製剤を調製する。
TLR刺激を、所定のTLRまたはNLRを発現するHEK293細胞においてNF−κB活性化を評価することにより、試験した。試料の活性を、7個の異なるヒトTLR:TLR2、3、4、5、7、8、および9(Invivogen, San Diego, CA)、ならびに2つの異なるヒトNLR(NOD1およびNOD2)に関して試験した。各リガンドを、TLRまたはNLR細胞に関して、ストック溶液の1/100の最終濃度で試験し、下記のような対照リガンドと比較した。この工程を3連で実施した。
以下に、出願当初の特許請求の範囲に記載された発明を付記する。
[1] 肝障害の処置のための、治療剤の対象の粘膜を通しての送達のための組成物であって、前記組成物が、
(a)1種類以上のグラム陽性細菌に由来した、もしくはそれから単離された可溶化液もしくは細胞壁抽出物、またはその薬学的に許容される塩、および
(b)天然に存在する免疫刺激性オリゴデオキシヌクレオチド(ODN)
を含み、前記細胞壁可溶化液および前記ODNが、免疫障害を処置するのに有効な量で存在する、組成物。
[2] 徐放剤、促進剤、担体、またはそれらの組合せをさらに含む、[1]に記載の組成物。
[3] 前記グラム陽性細菌が、バチルス・コアグランス(Bacillus coagulans)(ラクトバチルス・スポロゲネス(Lactobacillus sporogenes))、ストレプトコッカス・サーモフィラス(Streptococcus thermophilus)、ビフィドバクテリウム・アニマーリス(Bifidobacterium animalis)(特に、B.アニマーリス(B. animalis)亜種アニマーリス(animalis))、ビフィドバクテリウム・インファンティス(Bifidobacterium infantis)、ビフィドバクテリウム・ロングム(Bifidobacterium longum)、ビフィドバクテリウム・ブレーベ(Bifidobacterium breve)、ラクトバチルス・アシドフィラス(Lactobacillus acidophilus)、ラクトバチルス・プランタラム(Lactobacillus plantarum)、ラクトバチルス・カゼイ(Lactobacillus casei)、ラクトバチルス・デルブレッキイ(Lactobacillus delbrueckii)亜種ブルガリカス(bulgaricus)、ラクトコッカス・ラクティス(Lactococcus lactis)、ラクトコッカス・ラクティス(Lactococcus lactis)亜種ラクティス(lactis)(ストレプトコッカス・ラクティス(Streptococcus lactis))、ストレプトコッカス・サーモフィラス(Streptococcus thermophilus)、ビフィドバクテリウム・ラクティス(Bifidobacterium lactis)、ビフィドバクテリウム・ブレーベ(Bifidobacterium breve)、ラクトバチルス・アシドフィラス(Lactobacillus acidophilus)、ラクトバチルス・プランタラム(Lactobacillus plantarum)、ラクトバチルス・カゼイ(Lactobacillus casei)、ラクトバチルス・ラムノーサス(Lactobacillus rhamnosus)、およびラクトバチルス・ヘルベティカス(Lactobacillus helveticus)、ならびにそれらの組合せからなる群から選択される、[1]に記載の組成物。
[4] 前記促進剤が、アミノ酸、アミノ糖、および糖からなる群から選択される、[2]に記載の組成物。
[5] 前記グラム陽性細菌がラクトバチルス・デルブレッキイである、[1]に記載の組成物。
[6] 1つ以上の肝障害を患っている対象における肝障害の合併症の処置のための組成物であって、前記組成物が、治療的有効量の、1種類以上のグラム陽性細菌に由来した、もしくはそれから単離された可溶化液もしくは細胞壁抽出物、またはその薬学的に許容される塩、および
少なくとも1つのトール様受容体(TLR)9アゴニストを含み、前記グラム陽性細菌がラクトバチルス科の細菌から選択される、組成物。
[7] 前記TLR9アゴニストがCpGオリゴデオキシヌクレオチド(CpG ODN)である、[6]に記載の組成物。
[8] 前記CpG ODNが細菌可溶化液内に天然に存在する、[7]に記載の組成物。
[9] 前記肝障害が、TLR9、ならびにTLR2、TLR4、およびTLR7のうちの1つ以上の過剰発現により特徴づけられる、[6]に記載の組成物。
[10] 前記組成物が、トローチ、チューインガム、咀嚼錠、キャンディ、および溶解錠からなる群から選択される剤形である、[1]に記載の組成物。
[11] 前記溶解錠が、低速溶解錠および急速溶解錠からなる群から選択される、[10]に記載の組成物。
[12] 前記粘膜が、口腔粘膜、舌下粘膜、頬側粘膜、およびそれらの組合せからなる群から選択される、[1]に記載の組成物。
[13] 化学療法剤をさらに含む、[1]に記載の組成物。
[14] 前記組成物が、前記組成物が投与される対象において少なくとも1つのトール様受容体(TLR)の調節を示す、[1]に記載の組成物。
[15] 調節される前記TLRが、TLR2、TLR4、TLR7、およびTLR9から選ばれる、[14]に記載の組成物。
[16] [1]に記載の組成物を含む栄養補助食品。
[17] 対象において腫瘍に対する免疫応答を誘導する方法であって、
腫瘍を有する対象を選択すること、ならびに
前記対象に
(a)1種類以上のグラム陽性細菌に由来した、もしくはそれから単離された可溶化液もしくは細胞壁抽出物、またはその薬学的に許容される塩、および
(b)天然に存在するCpGオリゴデオキシヌクレオチド(ODN)
を含む治療的有効量の組成物を投与し、それにより前記対象において前記腫瘍に対する前記免疫応答を誘導すること
を含む、方法。
[18] 前記天然に存在するCpGオリゴデオキシヌクレオチドが細菌可溶化液に由来する、[17]に記載の方法。
[19] 前記CpG ODNが、C型、D型、またはK型CpG ODNからなる群から選択される、[17]に記載の方法。
[20] 前記免疫応答が抗体の産生を含む、[17]に記載の方法。
Claims (20)
- 肝障害の処置のための、治療剤の対象の粘膜を通しての送達のための組成物であって、前記組成物が、
(a)1種類以上のグラム陽性細菌に由来した、もしくはそれから単離された可溶化液もしくは細胞壁抽出物、またはその薬学的に許容される塩、および
(b)天然に存在する免疫刺激性オリゴデオキシヌクレオチド(ODN)
を含み、前記細胞壁可溶化液および前記ODNが、免疫障害を処置するのに有効な量で存在する、組成物。 - 徐放剤、促進剤、担体、またはそれらの組合せをさらに含む、請求項1に記載の組成物。
- 前記グラム陽性細菌が、バチルス・コアグランス(Bacillus coagulans)(ラクトバチルス・スポロゲネス(Lactobacillus sporogenes))、ストレプトコッカス・サーモフィラス(Streptococcus thermophilus)、ビフィドバクテリウム・アニマーリス(Bifidobacterium animalis)(特に、B.アニマーリス(B. animalis)亜種アニマーリス(animalis))、ビフィドバクテリウム・インファンティス(Bifidobacterium infantis)、ビフィドバクテリウム・ロングム(Bifidobacterium longum)、ビフィドバクテリウム・ブレーベ(Bifidobacterium breve)、ラクトバチルス・アシドフィラス(Lactobacillus acidophilus)、ラクトバチルス・プランタラム(Lactobacillus plantarum)、ラクトバチルス・カゼイ(Lactobacillus casei)、ラクトバチルス・デルブレッキイ(Lactobacillus delbrueckii)亜種ブルガリカス(bulgaricus)、ラクトコッカス・ラクティス(Lactococcus lactis)、ラクトコッカス・ラクティス(Lactococcus lactis)亜種ラクティス(lactis)(ストレプトコッカス・ラクティス(Streptococcus lactis))、ストレプトコッカス・サーモフィラス(Streptococcus thermophilus)、ビフィドバクテリウム・ラクティス(Bifidobacterium lactis)、ビフィドバクテリウム・ブレーベ(Bifidobacterium breve)、ラクトバチルス・アシドフィラス(Lactobacillus acidophilus)、ラクトバチルス・プランタラム(Lactobacillus plantarum)、ラクトバチルス・カゼイ(Lactobacillus casei)、ラクトバチルス・ラムノーサス(Lactobacillus rhamnosus)、およびラクトバチルス・ヘルベティカス(Lactobacillus helveticus)、ならびにそれらの組合せからなる群から選択される、請求項1に記載の組成物。
- 前記促進剤が、アミノ酸、アミノ糖、および糖からなる群から選択される、請求項2に記載の組成物。
- 前記グラム陽性細菌がラクトバチルス・デルブレッキイである、請求項1に記載の組成物。
- 1つ以上の肝障害を患っている対象における肝障害の合併症の処置のための組成物であって、前記組成物が、治療的有効量の、
1種類以上のグラム陽性細菌に由来した、もしくはそれから単離された可溶化液もしくは細胞壁抽出物、またはその薬学的に許容される塩、および
少なくとも1つのトール様受容体(TLR)9アゴニスト
を含み、前記グラム陽性細菌がラクトバチルス科の細菌から選択される、組成物。 - 前記TLR9アゴニストがCpGオリゴデオキシヌクレオチド(CpG ODN)である、請求項6に記載の組成物。
- 前記CpG ODNが細菌可溶化液内に天然に存在する、請求項7に記載の組成物。
- 前記肝障害が、TLR9、ならびにTLR2、TLR4、およびTLR7のうちの1つ以上の過剰発現により特徴づけられる、請求項6に記載の組成物。
- 前記組成物が、トローチ、チューインガム、咀嚼錠、キャンディ、および溶解錠からなる群から選択される剤形である、請求項1に記載の組成物。
- 前記溶解錠が、低速溶解錠および急速溶解錠からなる群から選択される、請求項10に記載の組成物。
- 前記粘膜が、口腔粘膜、舌下粘膜、頬側粘膜、およびそれらの組合せからなる群から選択される、請求項1に記載の組成物。
- 化学療法剤をさらに含む、請求項1に記載の組成物。
- 前記組成物が、前記組成物が投与される対象において少なくとも1つのトール様受容体(TLR)の調節を示す、請求項1に記載の組成物。
- 調節される前記TLRが、TLR2、TLR4、TLR7、およびTLR9から選ばれる、請求項14に記載の組成物。
- 請求項1に記載の組成物を含む栄養補助食品。
- 対象において腫瘍に対する免疫応答を誘導する方法であって、
腫瘍を有する対象を選択すること、ならびに
前記対象に
(a)1種類以上のグラム陽性細菌に由来した、もしくはそれから単離された可溶化液もしくは細胞壁抽出物、またはその薬学的に許容される塩、および
(b)天然に存在するCpGオリゴデオキシヌクレオチド(ODN)
を含む治療的有効量の組成物を投与し、それにより前記対象において前記腫瘍に対する前記免疫応答を誘導すること
を含む、方法。 - 前記天然に存在するCpGオリゴデオキシヌクレオチドが細菌可溶化液に由来する、請求項17に記載の方法。
- 前記CpG ODNが、C型、D型、またはK型CpG ODNからなる群から選択される、請求項17に記載の方法。
- 前記免疫応答が抗体の産生を含む、請求項17に記載の方法。
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JP2022020362A Pending JP2022078078A (ja) | 2012-09-21 | 2022-02-14 | 天然に存在するCpGオリゴヌクレオチド組成物およびその治療的適用 |
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US20170232047A1 (en) * | 2012-01-16 | 2017-08-17 | Elizabeth McKenna | Control of Cellular Redox Levels |
JP6632802B2 (ja) | 2012-01-16 | 2020-01-22 | マッケンナ,エリザベス | 肝疾患及び肝障害を治療するための組成物及び方法 |
BR112015006264A2 (pt) | 2012-09-21 | 2017-07-04 | Mckenna Elizabeth | composições de oligonucleotídeos cpg ocorrendo naturalmente e suas aplicações terapêuticas |
WO2018112223A1 (en) * | 2016-12-14 | 2018-06-21 | Progenity Inc. | Treatment of a disease of the gastrointestinal tract with a tlr modulator |
US20210123057A1 (en) * | 2019-10-29 | 2021-04-29 | Northwestern University | Sequence Multiplicity Within Spherical Nucleic Acids |
CN114515295B (zh) * | 2022-03-31 | 2023-08-29 | 东莞市人民医院 | CpG ODN在制备防治药物性肝损伤的药物中的应用 |
CN115227684B (zh) * | 2022-07-28 | 2023-11-17 | 杭州师范大学 | 靶向M2型巨噬细胞CpG和ELE脂质体及制法和应用 |
CN117180317B (zh) * | 2023-11-02 | 2024-01-26 | 深圳市第二人民医院(深圳市转化医学研究院) | 詹氏乳杆菌来源纳米囊泡在制备防治卵巢早衰治疗药物中的应用 |
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2013
- 2013-09-23 BR BR112015006264A patent/BR112015006264A2/pt not_active Application Discontinuation
- 2013-09-23 WO PCT/US2013/061236 patent/WO2014047588A1/en active Application Filing
- 2013-09-23 US US14/034,044 patent/US20140086849A1/en not_active Abandoned
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2015
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2016
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2017
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US20180369367A1 (en) | 2018-12-27 |
JP2022078078A (ja) | 2022-05-24 |
US20170266277A9 (en) | 2017-09-21 |
IL237865B (en) | 2021-04-29 |
WO2014047588A1 (en) | 2014-03-27 |
US20170087247A1 (en) | 2017-03-30 |
EP2898073A1 (en) | 2015-07-29 |
JP2024105471A (ja) | 2024-08-06 |
JP2015535829A (ja) | 2015-12-17 |
US20140086849A1 (en) | 2014-03-27 |
HK1213017A1 (zh) | 2016-06-24 |
BR112015006264A2 (pt) | 2017-07-04 |
IL237865A0 (en) | 2015-05-31 |
EP2898073A4 (en) | 2016-03-23 |
US9931398B2 (en) | 2018-04-03 |
JP2018076339A (ja) | 2018-05-17 |
US10688177B2 (en) | 2020-06-23 |
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