HRP20220843T1 - Lipidne nanočestice za isporuku modificirane rnk koja kodira vegf-a polipeptid - Google Patents

Lipidne nanočestice za isporuku modificirane rnk koja kodira vegf-a polipeptid Download PDF

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HRP20220843T1
HRP20220843T1 HRP20220843TT HRP20220843T HRP20220843T1 HR P20220843 T1 HRP20220843 T1 HR P20220843T1 HR P20220843T T HRP20220843T T HR P20220843TT HR P20220843 T HRP20220843 T HR P20220843T HR P20220843 T1 HRP20220843 T1 HR P20220843T1
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glycero
nanoparticle
phosphocholine
peg
seq
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HRP20220843TT
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Kenny Mikael HANSSON
Kerry BENENATO
Maria WÅGBERG
Annika PÅLSSON
Regina FRITSCHE-DANIELSON
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Astrazeneca Ab
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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Claims (15)

1. Nanočestica naznačena time što sadrži (i) lipidnu komponentu koja sadrži spoj koji ima strukturu [image] , i (ii) modificiranu RNK koja sadrži bilo koju od SEQ ID NO: 1 i 3-5, koja kodira VEGF-A polipeptid iz SEQ ID NO: 2.
2. Farmaceutski pripravak naznačen time što sadrži (a) najmanje jednu nanočesticu koja sadrži (i) lipidnu komponentu koja sadrži spoj koji ima strukturu [image] , i (ii) modificiranu RNK koja sadrži bilo koju od SEQ ID NO: 1 i 3-5, koja kodira VEGF-A polipeptid iz SEQ ID NO: 2; i (b) farmaceutski prihvatljivu pomoćnu tvar.
3. Nanočestica prema zahtjevu 1 ili farmaceutski pripravak prema zahtjevu 2, naznačeni time što lipidna komponenta nadalje sadrži fosfolipid, strukturni lipid i/ili PEG lipid; pri čemu je fosfolipid odabran iz skupine koju čine 1,2-distearoil-sn-glicero-3-fosfokolin (DSPC), 1,2-dioleoil-sn-glicero-3-fosfoetanolamin (DOPE), 1,2-dilinoleoil-sn-glicero-3-fosfokolin (DLPC), 1,2-dimiristoil-sn-glicero-fosfokolin (DMPC), 1,2-dioleoil-sn-glicero-3-fosfokolin (DOPC), l,2-dipalmitoil-sn-glicero-3-fosfokolin (DPPC), 1,2-diundekanoil-sn-glicero-fosfokolin (DUPC), 1-palmitoil-2-oleoil-sn-glicero-3-fosfokolin (POPC), 1,2-di-O-octadecenil-sn-glicero-3-fosfokolin (18:0 Dieter PC), 1-oleoil-2-kolesterilhemisukcinoil-sn-glicero-3-fosfokolin (OChemsPC), 1-heksadecil-sn-glicero-3-fosfokolin (C16 Lyso PC), 1,2-dilinolenoil-sn-glicero-3-fosfokolin,1,2-diarachidonoil-sn-glicero-3-fosfokolin, 1,2-didokozaheksaenoil-sn-glicero-3-fosfokolin, 1,2-difitanoil-sn-glicero-3-fosfoetanolamin (ME 16.0 PE), 1,2-distearoil-sn-glicero-3-fosfoetanolamin, 1,2-dilinoleoil-sn-glicero-3-fosfoetanolamin, 1,2-dilinolenoil-sn-glicero-3-fosfoetanolamin, 1,2-diarachidonoil-sn-glicero-3-fosfoetanolamin, 1,2-didokozaheksaenoil-sn-glicero-3-fosfoetanolamin, 1,2-dioleoil-sn-glicero-3-fosfo-rac-(1-glicerol) natrijeva sol (DOPG), sfingomijelin, i njihove smjese; strukturni lipid je odabran iz skupine koju čine kolesterol, fekosterol, sitosterol, ergosterol, kampesterol, stigmasterol, brasikasterol, tomatidin, ursolna kiselina, alfa-tokoferol, i njihove smjese; i/ili PEG lipid je odabran iz skupine koju čine PEG-modificirani fosfatidiletanolamin, PEG-modificirana fosfatidna kiselina, PEG-modificirani ceramid, PEG-modificirani dialkilamin, PEG-modificirani diacilglicerol, PEG-modificirani dialkilglicerol, i njihove smjese.
4. Nanočestica prema patentnom zahtjevu 1, ili farmaceutski pripravak prema zahtjevu 2, naznačeni time što lipidna komponenta nadalje sadrži fosfolipid koji je DSPC, strukturni lipid koji je kolesterol i/ili PEG lipid koji je PEG-DMG.
5. Nanočestica prema bilo kojem od patentnih zahtjeva 1, 3 i 4, ili farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 2-4, naznačeni time što je omjer N:P od oko 2:1 do oko 30:1, izborno oko 5,67:1 ili oko 3:1.
6. Nanočestica prema bilo kojem od patentnih zahtjeva 1 i 3-5, ili farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 2-5, naznačeni time što je omjer mas./mas. lipidne komponente prema modificiranoj RNK od oko 10:1 do oko 100:1, izborno oko 20:1 ili oko 10:1.
7. Nanočestica prema bilo kojem od patentnih zahtjeva 1 i 3-6, ili farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 2-6, naznačeni time što nanočestica ima srednji promjer od oko 50 nm do oko 100 nm.
8. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 2-7, naznačen time što kada se primjenjuje na tkivo sisavca ili subjekta, farmaceutski pripravak rezultira sa (a) maksimalnom promatranom koncentracijom u plazmi i/ili tkivu, Cmax, VEGF-A polipeptida prema SEQ ID NO: 2 do oko 450 pg/ml plazme ili pg/mg tkiva; ili (b) ukupnom površinom plazme i/ili tkiva ispod koncentracijske krivulje, AUC0-t, VEGF-A polipeptida prema SEQ ID NO: 2 do oko 5,500 pg*h/ml plazme ili pg*h/mg tkiva.
9. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 2-7, naznačen time što kada se primjenjuje na tkivo sisavca ili subjekta, farmaceutski pripravak rezultira sa (a) proizvodnjom više od oko 400 pg/mg tkiva VEGF-A polipeptida prema SEQ ID NO: 2 unutar 8 sati; ili (b) proizvodnjom više od oko 1 pg/mg tkiva VEGF-A polipeptida prema SEQ ID NO: 2 tijekom do 6 dana.
10. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 2-9, naznačen time što je farmaceutski prihvatljiva pomoćna tvar odabrana od otapala, disperzijskog medija, razrjeđivača, disperzije, pomoćnog sredstva za suspenziju, površinski aktivnog sredstva, izotoničnog sredstva, sredstva za zgušnjavanje ili emulgiranje, konzervansa, polimera, peptida, proteina, stanice, hijaluronidaze i njihovih smjesa.
11. Nanočestica prema bilo kojem od patentnih zahtjeva 1 i 3-7 ili farmaceutski pripravak prema bilo kojem od zahtjeva 2-10 za upotrebu u postupku za poticanje i/ili poboljšanje zacjeljivanja rana kod subjekta.
12. Nanočestica ili farmaceutski pripravak za upotrebu prema patentnom zahtjevu 11, naznačeni time što postupak uključuje intradermalno davanje nanočestice ili farmaceutskog pripravka.
13. Nanočestica ili farmaceutski pripravak za upotrebu prema patentnom zahtjevu 11, naznačeni time što je koncentracija modificirane RNK od oko 0,01 mg/kg do oko 10 mg/kg.
14. Nanočestica ili farmaceutski pripravak za upotrebu prema patentnom zahtjevu 11, naznačeni time što subjekt boluje od dijabetesa.
15. Nanočestica ili farmaceutski pripravak za upotrebu prema patentnom zahtjevu 11, naznačeni time što je rana kirurška rana, opeklina, abrazivna rana, mjesto biopsije kože, kronična rana, ozljeda (npr. rana od traumatske ozljede), rana zbog presatka, dijabetička rana, dijabetički ulkus (npr. dijabetički ulkus stopala), dekubitus, dekubitus i njihove kombinacije.
HRP20220843TT 2017-10-31 2018-10-31 Lipidne nanočestice za isporuku modificirane rnk koja kodira vegf-a polipeptid HRP20220843T1 (hr)

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US201762579671P 2017-10-31 2017-10-31
PCT/US2018/058541 WO2019089818A1 (en) 2017-10-31 2018-10-31 Lipid nanoparticles for delivering modified rna encoding a vegf-a polypeptide
EP18811407.8A EP3703658B1 (en) 2017-10-31 2018-10-31 Lipid nanoparticles for delivering modified rna encoding a vegf-a polypeptide

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US (1) US11696892B2 (hr)
EP (1) EP3703658B1 (hr)
JP (2) JP7308000B2 (hr)
KR (1) KR20200081420A (hr)
CN (1) CN111356444A (hr)
AU (1) AU2018358049A1 (hr)
BR (1) BR112020008404A2 (hr)
CA (1) CA3080592A1 (hr)
DK (1) DK3703658T3 (hr)
EA (1) EA202090919A1 (hr)
ES (1) ES2922462T3 (hr)
HR (1) HRP20220843T1 (hr)
HU (1) HUE059049T2 (hr)
IL (1) IL274230B2 (hr)
LT (1) LT3703658T (hr)
MA (1) MA50522B1 (hr)
PL (1) PL3703658T3 (hr)
PT (1) PT3703658T (hr)
RS (1) RS63389B1 (hr)
SG (1) SG11202003941XA (hr)
SI (1) SI3703658T1 (hr)
WO (1) WO2019089818A1 (hr)

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