JPWO2019239144A5 - - Google Patents

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JPWO2019239144A5
JPWO2019239144A5 JP2020570030A JP2020570030A JPWO2019239144A5 JP WO2019239144 A5 JPWO2019239144 A5 JP WO2019239144A5 JP 2020570030 A JP2020570030 A JP 2020570030A JP 2020570030 A JP2020570030 A JP 2020570030A JP WO2019239144 A5 JPWO2019239144 A5 JP WO2019239144A5
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Priority claimed from PCT/GB2019/051654 external-priority patent/WO2019239144A1/en
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単離された合成ｓａＲＮＡと少なくとも１つの追加の活性剤とからなる医薬組成物であって、前記ｓａＲＮＡがＣ／ＥＢＰα遺伝子の発現をアップレギュレートし、前記ｓａＲＮＡが配列番号３の領域に対して少なくとも８０％相補的である鎖を含み、前記鎖が１４～３０ヌクレオチドを有する、医薬組成物。 A pharmaceutical composition comprising an isolated synthetic saRNA and at least one additional activator, wherein the saRNA upregulates the expression of the C / EBPα gene and the saRNA is relative to the region of SEQ ID NO: 3. A pharmaceutical composition comprising a chain that is at least 80% complementary, wherein the chain has 14-30 nucleotides. 前記ｓａＲＮＡが二本鎖であり、アンチセンス鎖およびセンス鎖を含む、請求項１に記載の医薬組成物。 The pharmaceutical composition according to claim 1, wherein the saRNA is double-stranded and comprises an antisense strand and a sense strand. 前記ｓａＲＮＡのアンチセンス鎖が配列番号１（ＣＥＢＰＡ－５１）の配列を含む、請求項２に記載の医薬組成物。 The pharmaceutical composition according to claim 2, wherein the antisense strand of the saRNA comprises the sequence of SEQ ID NO: 1 (CEBPA-51). 前記ｓａＲＮＡのセンス鎖が配列番号２（ＣＥＢＰＡ－５１）の配列を含む、請求項３に記載の医薬組成物。 The pharmaceutical composition according to claim 3, wherein the sense strand of the saRNA comprises the sequence of SEQ ID NO: 2 (CEBPA-51). 前記追加の活性剤がＦＧＦＲ４シグナル伝達に影響を与える、請求項１～４のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 4, wherein the additional activator affects FGFR4 signaling. 前記追加の活性剤がＦＧＦＲ４阻害剤である、請求項５に記載の医薬組成物。 The pharmaceutical composition according to claim 5, wherein the additional activator is an FGFR4 inhibitor. 前記追加の活性剤が、低分子阻害ＲＮＡ（ＦＧＦＲ４－ｓｉＲＮＡ）、ＦＧＦＲ４アンタゴニスト抗体、または低分子ＦＧＦＲ４阻害剤である、請求項６に記載の医薬組成物。 The pharmaceutical composition according to claim 6, wherein the additional activator is a small molecule inhibitory RNA (FGFR4-siRNA), a FGFR4 antagonist antibody, or a small molecule FGFR4 inhibitor. 前記追加の活性剤がＣＥＢＰＢ発現を減少させる、請求項１～４のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 4, wherein the additional activator reduces CEBPB expression. 前記追加の活性剤が低分子阻害ＲＮＡ（ＣＥＢＰＢ－ｓｉＲＮＡ）である、請求項８に記載の医薬組成物。 The pharmaceutical composition according to claim 8, wherein the additional activator is a small molecule inhibitory RNA (CEBPB-siRNA). 前記追加の活性剤がチェックポイント阻害剤または免疫チェックポイント遮断剤である、請求項１～４のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 4, wherein the additional activator is a checkpoint inhibitor or an immune checkpoint blocker. 前記追加の活性剤がＣＴＬＡ４、ＰＤ－１またはＰＤ－Ｌ１の阻害剤である、請求項１０に記載の医薬組成物。 The pharmaceutical composition according to claim 10, wherein the additional activator is an inhibitor of CTLA4, PD-1 or PD-L1. 前記活性剤がＰＤ－１抗体である、請求項１１に記載の医薬組成物。 The pharmaceutical composition according to claim 11, wherein the activator is a PD-1 antibody. 前記追加の活性剤がチロシンキナーゼ阻害剤である、請求項１～４のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 4, wherein the additional activator is a tyrosine kinase inhibitor. 前記チロシンキナーゼ阻害剤がソラフェニブまたはレンバチニブまたはそれらの組み合わせである、請求項１３に記載の医薬組成物。 The pharmaceutical composition according to claim 13, wherein the tyrosine kinase inhibitor is sorafenib or lenvatinib or a combination thereof. 前記チロシンキナーゼ阻害剤がソラフェニブである、請求項１３に記載の医薬組成物。 The pharmaceutical composition according to claim 13, wherein the tyrosine kinase inhibitor is sorafenib. 前記医薬組成物が、チロシンキナーゼ阻害剤およびチェックポイント阻害剤をさらに含む、請求項１～４のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 4, wherein the pharmaceutical composition further comprises a tyrosine kinase inhibitor and a checkpoint inhibitor. 前記チロシンキナーゼ阻害剤がソラフェニブであり、前記チェックポイント阻害剤がＰＤ－１阻害剤である、請求項１６記載の医薬組成物。 The pharmaceutical composition according to claim 16, wherein the tyrosine kinase inhibitor is sorafenib and the checkpoint inhibitor is a PD-1 inhibitor. 細胞内のＣ／ＥＢＰα遺伝子の発現をアップレギュレートするための医薬組成物であって、前記医薬組成物は単離された合成ｓａＲＮＡと少なくとも１つの追加の活性剤とを含み、前記医薬組成物は細胞内のＣ／ＥＢＰα遺伝子の発現をアップレギュレートすることを必要とする対象に投与されるものであり、前記ｓａＲＮＡが前記Ｃ／ＥＢＰα遺伝子の発現をアップレギュレートし、前記ｓａＲＮＡが配列番号３の領域に対して少なくとも８０％相補的である鎖を含み、前記鎖が１４～３０ヌクレオチドを有する医薬組成物。 A pharmaceutical composition for upregulating the expression of the C / EBPα gene in cells, wherein the pharmaceutical composition comprises an isolated synthetic saRNA and at least one additional activator. The substance is administered to a subject who needs to upregulate the expression of the C / EBPα gene in the cell, the saRNA upregulates the expression of the C / EBPα gene, and the saRNA is sequenced. A pharmaceutical composition comprising a chain that is at least 80% complementary to the region of number 3, wherein the chain has 14-30 nucleotides. 前記ｓａＲＮＡが二本鎖であり、アンチセンス鎖およびセンス鎖を含む、請求項１８に記載の医薬組成物。 The pharmaceutical composition of claim 18, wherein the saRNA is double-stranded and comprises an antisense strand and a sense strand. 前記ｓａＲＮＡのアンチセンス鎖が配列番号１（ＣＥＢＰＡ－５１）の配列を含む、請求項１９に記載の医薬組成物。 19. The pharmaceutical composition of claim 19, wherein the antisense strand of the saRNA comprises the sequence of SEQ ID NO: 1 (CEBPA-51). 前記ｓａＲＮＡのセンス鎖が、配列番号２（ＣＥＢＰＡ－５１）の配列を含む、請求項２０に記載の医薬組成物。 20. The pharmaceutical composition of claim 20, wherein the sense strand of the saRNA comprises the sequence of SEQ ID NO: 2 (CEBPA-51). 前記追加の活性剤がＦＧＦＲ４レベルを低下させる、請求項１８に記載の医薬組成物。 The pharmaceutical composition of claim 18, wherein the additional activator reduces FGFR4 levels. 前記追加の活性剤がＦＧＦＲ４阻害剤である、請求項２２に記載の医薬組成物。 22. The pharmaceutical composition of claim 22, wherein the additional activator is an FGFR4 inhibitor. 前記追加の活性剤が、低分子阻害ＲＮＡ（ＦＧＦＲ４－ｓｉＲＮＡ）、ＦＧＦＲ４アンタゴニスト抗体、または低分子ＦＧＦＲ４阻害剤である、請求項２３に記載の医薬組成物。 23. The pharmaceutical composition of claim 23, wherein the additional activator is a small molecule inhibitory RNA (FGFR4-siRNA), a FGFR4 antagonist antibody, or a small molecule FGFR4 inhibitor. 前記ｓａＲＮＡは、前記追加の活性剤と同時にまたは順次に投与されるものである、請求項１８に記載の医薬組成物。 The pharmaceutical composition of claim 18 , wherein the saRNA is administered simultaneously or sequentially with the additional activator. 前記追加の活性剤がＣＥＢＰＢ発現を減少させる、請求項１８に記載の医薬組成物。 The pharmaceutical composition of claim 18, wherein the additional activator reduces CEBPB expression. 前記追加の活性剤が低分子阻害ＲＮＡ（ＣＥＢＰＢ－ｓｉＲＮＡ）である、請求項２６に記載の医薬組成物。 26. The pharmaceutical composition of claim 26, wherein the additional activator is a small molecule inhibitory RNA (CEBPB-siRNA). 前記Ｃ／ＥＢＰα遺伝子の発現が、少なくとも２０％、５０％、１００％、２倍、３倍、３倍、４倍または５倍アップレギュレートされる、請求項１８に記載の医薬組成物。 The pharmaceutical composition according to claim 18, wherein the expression of the C / EBPα gene is upregulated by at least 20%, 50%, 100%, 2-fold, 3-fold, 3-fold, 4-fold or 5-fold. それを必要とする対象の癌、肝線維症、肝不全、または非アルコール性脂肪肝炎（ＮＡＳＨ）を治療するための医薬組成物であって、前記医薬組成物は、単離された合成ｓａＲＮＡと少なくとも１つの追加の活性剤とを含み、前記医薬組成物は前記対象に投与されるものであり、前記ｓａＲＮＡがＣ／ＥＢＰα遺伝子の発現をアップレギュレートし、前記ｓａＲＮＡが配列番号３の領域に対して少なくとも８０％相補的である鎖を含み、前記鎖が１４～３０ヌクレオチドを有する医薬組成物。 A pharmaceutical composition for treating cancer, liver fibrosis, liver failure, or nonalcoholic steatohepatitis (NASH) in a subject in need thereof, wherein the pharmaceutical composition comprises an isolated synthetic saRNA. The pharmaceutical composition comprises at least one additional activator, wherein the saRNA upregulates the expression of the C / EBPα gene and the saRNA is the region of SEQ ID NO: 3. A pharmaceutical composition comprising a chain that is at least 80% complementary to the chain, wherein the chain has 14-30 nucleotides. 前記ｓａＲＮＡが二本鎖であり、アンチセンス鎖およびセンス鎖を含む、請求項２９に記載の医薬組成物。 29. The pharmaceutical composition of claim 29, wherein the saRNA is double-stranded and comprises an antisense strand and a sense strand. 前記ｓａＲＮＡのアンチセンス鎖が配列番号１（ＣＥＢＰＡ－５１）の配列を含む、請求項３０に記載の医薬組成物。 30. The pharmaceutical composition of claim 30, wherein the antisense strand of the saRNA comprises the sequence of SEQ ID NO: 1 (CEBPA-51). 前記ｓａＲＮＡのセンス鎖が、配列番号２（ＣＥＢＰＡ－５１）の配列を含む、請求項３０に記載の医薬組成物。 30. The pharmaceutical composition of claim 30, wherein the sense strand of the saRNA comprises the sequence of SEQ ID NO: 2 (CEBPA-51). 前記ｓａＲＮＡがＭＴＬ－ＣＥＢＰＡとして投与される、請求項２９に記載の医薬組成物。 29. The pharmaceutical composition of claim 29, wherein the saRNA is administered as MTL-CEBPA. 前記ｓａＲＮＡは、前記追加の活性剤と同時にまたは順次に投与されるものである、請求項２９～３３のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 29 to 33, wherein the saRNA is administered simultaneously or sequentially with the additional activator. 前記追加の活性剤がＦＧＦＲ４レベルを低下させる、請求項２９～３３のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 29 to 33, wherein the additional activator reduces FGFR4 levels. 前記追加の活性剤がＦＧＦＲ４阻害剤である、請求項３５に記載の医薬組成物。 35. The pharmaceutical composition of claim 35, wherein the additional activator is an FGFR4 inhibitor. 前記追加の活性剤が、低分子阻害ＲＮＡ（ＦＧＦＲ４－ｓｉＲＮＡ）、ＦＧＦＲ４アンタゴニスト抗体、または低分子ＦＧＦＲ４阻害剤である、請求項３６に記載の医薬組成物。 36. The pharmaceutical composition of claim 36, wherein the additional activator is a small molecule inhibitory RNA (FGFR4-siRNA), a FGFR4 antagonist antibody, or a small molecule FGFR4 inhibitor. 前記追加の活性剤がＣＥＢＰＢ発現を減少させる、請求項２９～３３のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 29 to 33, wherein the additional activator reduces CEBPB expression. 前記追加の活性剤が低分子阻害ＲＮＡ（ＣＥＢＰＢ－ｓｉＲＮＡ）である、請求項３８に記載の医薬組成物。 38. The pharmaceutical composition of claim 38, wherein the additional activator is a small molecule inhibitory RNA (CEBPB-siRNA). 前記追加の活性剤がチェックポイント阻害剤または免疫チェックポイント遮断剤である、請求項２９～３３のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 29 to 33, wherein the additional activator is a checkpoint inhibitor or an immune checkpoint blocker. 前記追加の活性剤がＣＴＬＡ４、ＰＤ－１またはＰＤ－Ｌ１の阻害剤である、請求項４０に記載の医薬組成物。 40. The pharmaceutical composition of claim 40, wherein the additional activator is an inhibitor of CTLA4, PD-1 or PD-L1. 前記追加の活性剤がＰＤ－１抗体である、請求項４１に記載の医薬組成物。 The pharmaceutical composition according to claim 41, wherein the additional activator is a PD-1 antibody. 前記追加の活性剤がチロシンキナーゼ阻害剤である、請求項２９～３３のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 29 to 33, wherein the additional activator is a tyrosine kinase inhibitor. 前記チロシンキナーゼ阻害剤がソラフェニブまたはレンバチニブまたはそれらの組み合わせである、請求項４３に記載の医薬組成物。 The pharmaceutical composition according to claim 43, wherein the tyrosine kinase inhibitor is sorafenib or lenvatinib or a combination thereof . 前記チロシンキナーゼ阻害剤がソラフェニブである、請求項４３に記載の医薬組成物。 The pharmaceutical composition according to claim 43, wherein the tyrosine kinase inhibitor is sorafenib. 前記ソラフェニブは、ｓａＲＮＡ治療と併用して、またはｓａＲＮＡ治療後に投与されるものである、請求項４５に記載の医薬組成物。 The pharmaceutical composition of claim 45, wherein the sorafenib is administered in combination with or after saRNA treatment. 前記対象がさらに高周波アブレーション（ＲＦＡ）治療を受ける、請求項２９～４６のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 29 to 46, wherein the subject is further treated with radio frequency ablation (RFA). 前記対象がｓａＲＮＡ治療の前にＲＦＡ治療を受ける、請求項４７に記載の医薬組成物。 47. The pharmaceutical composition of claim 47, wherein the subject receives RFA treatment prior to saRNA treatment. 前記対象がさらにチロシンキナーゼ阻害剤の治療およびチェックポイント阻害剤の治療を受ける、請求項２９に記載の医薬組成物。 29. The pharmaceutical composition of claim 29, wherein the subject is further treated with a tyrosine kinase inhibitor and a checkpoint inhibitor. 前記チロシンキナーゼ阻害剤がソラフェニブであり、前記チェックポイント阻害剤がＰＤ－１阻害剤である、請求項４９に記載の医薬組成物。 The pharmaceutical composition according to claim 49, wherein the tyrosine kinase inhibitor is sorafenib and the checkpoint inhibitor is a PD-1 inhibitor. 前記対象が癌を有する、請求項２９～５０のいずれか一項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 29 to 50, wherein the subject has cancer. 前記癌が、肝細胞癌（ＨＣＣ）、大腸癌、胃癌、皮膚癌、膵臓癌、頭頸部癌、子宮頸癌、および前立腺癌から選択される、請求項５１に記載の医薬組成物。 The pharmaceutical composition according to claim 51, wherein the cancer is selected from hepatocellular carcinoma (HCC), colon cancer, gastric cancer, skin cancer, pancreatic cancer, head and neck cancer, cervical cancer, and prostate cancer.
JP2020570030A 2018-06-15 2019-06-14 Combination therapy with C / EBP alpha saRNA Pending JP2021527651A (en)

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US201962821533P 2019-03-21 2019-03-21
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