JP2019031571A5 - - Google Patents
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- JP2019031571A5 JP2019031571A5 JP2018222175A JP2018222175A JP2019031571A5 JP 2019031571 A5 JP2019031571 A5 JP 2019031571A5 JP 2018222175 A JP2018222175 A JP 2018222175A JP 2018222175 A JP2018222175 A JP 2018222175A JP 2019031571 A5 JP2019031571 A5 JP 2019031571A5
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- 239000008194 pharmaceutical composition Substances 0.000 claims 32
- 239000002105 nanoparticle Substances 0.000 claims 16
- 239000000427 antigen Substances 0.000 claims 9
- 102000036639 antigens Human genes 0.000 claims 9
- 108091007433 antigens Proteins 0.000 claims 9
- 108091032973 (ribonucleotides)n+m Proteins 0.000 claims 8
- 150000002632 lipids Chemical class 0.000 claims 8
- -1 cationic lipid Chemical class 0.000 claims 7
- LDGWQMRUWMSZIU-LQDDAWAPSA-M 2,3-bis[(z)-octadec-9-enoxy]propyl-trimethylazanium;chloride Chemical compound [Cl-].CCCCCCCC\C=C/CCCCCCCCOCC(C[N+](C)(C)C)OCCCCCCCC\C=C/CCCCCCCC LDGWQMRUWMSZIU-LQDDAWAPSA-M 0.000 claims 6
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 6
- 229910052760 oxygen Inorganic materials 0.000 claims 6
- 239000001301 oxygen Substances 0.000 claims 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 5
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 claims 4
- 201000010099 disease Diseases 0.000 claims 4
- 238000002296 dynamic light scattering Methods 0.000 claims 4
- 125000000956 methoxy group Chemical group [H]C([H])([H])O* 0.000 claims 4
- 229910052717 sulfur Inorganic materials 0.000 claims 4
- 239000011593 sulfur Substances 0.000 claims 4
- 230000028993 immune response Effects 0.000 claims 3
- KWVJHCQQUFDPLU-YEUCEMRASA-N 2,3-bis[[(z)-octadec-9-enoyl]oxy]propyl-trimethylazanium Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC(C[N+](C)(C)C)OC(=O)CCCCCCC\C=C/CCCCCCCC KWVJHCQQUFDPLU-YEUCEMRASA-N 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- ATUOYWHBWRKTHZ-UHFFFAOYSA-N Propane Chemical compound CCC ATUOYWHBWRKTHZ-UHFFFAOYSA-N 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims 2
- 230000007935 neutral effect Effects 0.000 claims 2
- SNKAWJBJQDLSFF-NVKMUCNASA-N 1,2-dioleoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C/CCCCCCCC SNKAWJBJQDLSFF-NVKMUCNASA-N 0.000 claims 1
- MWRBNPKJOOWZPW-NYVOMTAGSA-N 1,2-dioleoyl-sn-glycero-3-phosphoethanolamine zwitterion Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@H](COP(O)(=O)OCCN)OC(=O)CCCCCCC\C=C/CCCCCCCC MWRBNPKJOOWZPW-NYVOMTAGSA-N 0.000 claims 1
- BUGBHKTXTAQXES-UHFFFAOYSA-N Selenium Chemical compound [Se] BUGBHKTXTAQXES-UHFFFAOYSA-N 0.000 claims 1
- 108091036066 Three prime untranslated region Proteins 0.000 claims 1
- 235000012000 cholesterol Nutrition 0.000 claims 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims 1
- 230000001939 inductive effect Effects 0.000 claims 1
- 210000004072 lung Anatomy 0.000 claims 1
- 108020004999 messenger RNA Proteins 0.000 claims 1
- YHHSONZFOIEMCP-UHFFFAOYSA-O phosphocholine Chemical compound C[N+](C)(C)CCOP(O)(O)=O YHHSONZFOIEMCP-UHFFFAOYSA-O 0.000 claims 1
- 239000001294 propane Substances 0.000 claims 1
- 229910052711 selenium Inorganic materials 0.000 claims 1
- 239000011669 selenium Substances 0.000 claims 1
- 210000000952 spleen Anatomy 0.000 claims 1
- 238000007910 systemic administration Methods 0.000 claims 1
Claims (31)
- 少なくとも1つのカチオン性脂質と少なくとも1つの抗原をコードしているRNAを含むナノ粒子を含む医薬組成物であって、生理的なpHにおいて、ナノ粒子が正味の中性電荷又は正味の負電荷を有する、医薬組成物。
- ナノ粒子における正電荷と負電荷との電荷比が1:2から1.9:2の間である、請求項1に記載の医薬組成物。
- ナノ粒子における正電荷と負電荷との電荷比が1:2から1:1.2の間である、請求項1に記載の医薬組成物。
- ナノ粒子における正電荷と負電荷との電荷比が1:2から1.6:2の間である、請求項1に記載の医薬組成物。
- ナノ粒子における正電荷と負電荷との電荷比が1.1:2から1.6:2の間である、請求項1に記載の医薬組成物。
- ナノ粒子における正電荷と負電荷との電荷比が1.3:2である、請求項1に記載の医薬組成物。
- 正電荷が少なくとも1つのカチオン性脂質により寄与され、負電荷がRNAにより寄与される、請求項1から6のいずれか一項に記載の医薬組成物。
- 少なくとも1つのカチオン性脂質が、1,2-ジ-O-オクタデセニル-3-トリメチルアンモニウムプロパン(DOTMA)及び/又は1,2-ジオレオイル-3-トリメチルアンモニウム-プロパン(DOTAP)、好ましくはDOTMAを含む、請求項1から7のいずれか一項に記載の医薬組成物。
- ナノ粒子が少なくとも1つのヘルパー脂質をさらに含み、好ましくはヘルパー脂質が中性脂質である、請求項1から8のいずれか一項に記載の医薬組成物。
- 少なくとも1つのヘルパー脂質が、1,2-ジ-(9Z-オクタデセノイル)-sn-グリセロ-3-ホスホエタノールアミン(DOPE)、コレステロール(Chol)及び/又は1,2-ジオレオイル-sn-グリセロ-3-ホスホコリン(DOPC)、好ましくはDOPEを含む、請求項9に記載の医薬組成物。
- 少なくとも1つのカチオン性脂質がDOTMAであり、少なくとも1つのヘルパー脂質がDOPEである、請求項9に記載の医薬組成物。
- 少なくとも1つのカチオン性脂質と少なくとも1つのヘルパー脂質とのモル比が、4:1から2:3、7:3から1:1、又は2:1から1:1である、請求項9または10に記載の医薬組成物。
- 少なくとも1つのカチオン性脂質と少なくとも1つのヘルパー脂質とのモル比が、約2:1である、請求項9から11のいずれか一項に記載の医薬組成物。
- DOTMAとDOPEとのモル比が約2:1である、請求項11に記載の医薬組成物。
- 動的光散乱により測定されるナノ粒子の多分散指標は、0.5以下、好ましくは0.4以下又はさらにより好ましくは0.3以下である、請求項1から14のいずれか一項に記載の医薬組成物。
- ナノ粒子が、50nmから1000nm、好ましくは、100nmから800nm、好ましくは、200nmから700nm、例えば、300nmから500nmの範囲の、動的光散乱により測定される平均直径を有する、請求項1から15のいずれか一項に記載の医薬組成物。
- ナノ粒子が、250nmから700nmの範囲の平均直径を有する、請求項1から16のいずれか一項に記載の医薬組成物。
- ナノ粒子が、0mVから-50mV、好ましくは、0mVから-40mV又は-10mVから-30mVのゼータ電位を有する、請求項1から17のいずれか一項に記載の医薬組成物。
- RNAがmRNAである、請求項1から18のいずれか一項に記載の医薬組成物。
- 抗原が、疾患関連抗原である、又は疾患関連抗原若しくは疾患関連抗原を発現している細胞に対する免疫応答を誘発する、請求項1から19のいずれか一項に記載の医薬組成物。
- ナノ粒子の全身投与後に、脾臓におけるRNA発現が、肺におけるRNA発現の量の少なくとも5倍である、請求項1から20のいずれか一項に記載の医薬組成物。
- 対象において免疫応答、好ましくはがんに対する免疫応答を誘導するための、請求項1から21のいずれか一項に記載の医薬組成物。
- 対象において抗原が関与する疾患、好ましくはがん疾患を治療する又は予防するための、請求項1から22のいずれか一項に記載の医薬組成物。
- 生理学的pHにおけるナノ粒子の陽性電荷と陰性電荷の全体の電荷比が1.3:2であり、
動的光散乱により測定されるナノ粒子の多分散指標が0.5以下であり、
ナノ粒子が、動的光散乱により測定される約250nmから約700nmの範囲の平均直径を有し、
少なくとも1つのカチオン性脂質がDOTMAであり、少なくとも1つのヘルパー脂質がDOPEであり、かつ
DOTMAとDOPEとのモル比が約2:1である、請求項1から23のいずれか一項に記載の医薬組成物。 - 少なくとも1つの抗原をコードしているRNAが、マスキングされていないポリA配列を含む、請求項1から24のいずれか一項に記載の医薬組成物。
- マスキングされていないポリA配列が約120塩基対の長さを有する、請求項25に記載の医薬組成物。
- 少なくとも1つの抗原をコードしているRNAが、3'非翻訳領域(UTR)を含む、請求項1から26のいずれか一項に記載の医薬組成物。
- 少なくとも1つの抗原をコードしているRNAが、5'-キャップをさらに含む、請求項1から27のいずれか一項に記載の医薬組成物。
- 5'-キャップが、
W - 、X - 及びY - は独立して酸素、硫黄、セレン及びBH 3 からなる群より選択される]
を含む、請求項28に記載の医薬組成物。 - (a) R 1 及びR 2 がOHであり、W - 、X - 及びY - が酸素である、
(b) R 1 及びR 2 の一方がOHであり、他方はメトキシであり、W - 、X - 及びY - が酸素である、
(c) R 1 及びR 2 がOHであり、X - が硫黄であり、W - 及びY - が酸素である、あるいは
(d) R 2 がOHであり、R 1 がメトキシであり、W - 、X - 及びY - の1つが硫黄であり、他の2つは酸素である、
請求項29に記載の医薬組成物。 - R 2 がOHであり、R 1 がメトキシであり、X - が硫黄であり、W - 及びY - が酸素である、請求項29又は30に記載の医薬組成物。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EPPCT/EP2012/001319 | 2012-03-26 | ||
| PCT/EP2012/001319 WO2013143555A1 (en) | 2012-03-26 | 2012-03-26 | Rna formulation for immunotherapy |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017219079A Division JP6596478B2 (ja) | 2012-03-26 | 2017-11-14 | 免疫療法のためのｒｎａ製剤 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020068394A Division JP7096282B2 (ja) | 2012-03-26 | 2020-04-06 | 免疫療法のためのｒｎａ製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019031571A JP2019031571A (ja) | 2019-02-28 |
| JP2019031571A5 true JP2019031571A5 (ja) | 2019-09-05 |
| JP6832904B2 JP6832904B2 (ja) | 2021-02-24 |
Family
ID=48044720
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015502136A Active JP6279545B2 (ja) | 2012-03-26 | 2013-03-25 | 免疫療法のためのｒｎａ製剤 |
| JP2017219079A Active JP6596478B2 (ja) | 2012-03-26 | 2017-11-14 | 免疫療法のためのｒｎａ製剤 |
| JP2018222175A Active JP6832904B2 (ja) | 2012-03-26 | 2018-11-28 | 免疫療法のためのｒｎａ製剤 |
| JP2020068394A Active JP7096282B2 (ja) | 2012-03-26 | 2020-04-06 | 免疫療法のためのｒｎａ製剤 |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2015502136A Active JP6279545B2 (ja) | 2012-03-26 | 2013-03-25 | 免疫療法のためのｒｎａ製剤 |
| JP2017219079A Active JP6596478B2 (ja) | 2012-03-26 | 2017-11-14 | 免疫療法のためのｒｎａ製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020068394A Active JP7096282B2 (ja) | 2012-03-26 | 2020-04-06 | 免疫療法のためのｒｎａ製剤 |
Country Status (20)
| Country | Link |
|---|---|
| US (3) | US10485884B2 (ja) |
| JP (4) | JP6279545B2 (ja) |
| CN (2) | CN104302276A (ja) |
| AU (3) | AU2013242512B2 (ja) |
| BR (1) | BR112014022562A8 (ja) |
| CA (2) | CA3088428C (ja) |
| DK (2) | DK2830593T3 (ja) |
| ES (3) | ES3030907T3 (ja) |
| HR (1) | HRP20201578T1 (ja) |
| HU (2) | HUE052485T2 (ja) |
| LT (2) | LT3427723T (ja) |
| MX (3) | MX377244B (ja) |
| NZ (1) | NZ628328A (ja) |
| PL (1) | PL3777840T3 (ja) |
| PT (2) | PT3427723T (ja) |
| RS (1) | RS61002B1 (ja) |
| SI (1) | SI3427723T1 (ja) |
| SM (1) | SMT202000603T1 (ja) |
| TR (1) | TR201904758T4 (ja) |
| WO (2) | WO2013143555A1 (ja) |
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- 2017-12-18 AU AU2017279565A patent/AU2017279565B2/en active Active
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2018
- 2018-11-28 JP JP2018222175A patent/JP6832904B2/ja active Active
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2019
- 2019-09-23 US US16/578,601 patent/US11559587B2/en active Active
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2020
- 2020-03-26 AU AU2020202152A patent/AU2020202152B2/en active Active
- 2020-04-06 JP JP2020068394A patent/JP7096282B2/ja active Active
- 2020-10-05 HR HRP20201578TT patent/HRP20201578T1/hr unknown
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2022
- 2022-11-30 US US18/071,705 patent/US20230226217A1/en active Pending
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