HRP20211619T1 - Poboljšana formulacija lipida - Google Patents
Poboljšana formulacija lipida Download PDFInfo
- Publication number
- HRP20211619T1 HRP20211619T1 HRP20211619TT HRP20211619T HRP20211619T1 HR P20211619 T1 HRP20211619 T1 HR P20211619T1 HR P20211619T T HRP20211619T T HR P20211619TT HR P20211619 T HRP20211619 T HR P20211619T HR P20211619 T1 HRP20211619 T1 HR P20211619T1
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- Prior art keywords
- gene
- lipid
- pharmaceutical preparation
- lipid particle
- therapeutic agent
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- 150000002632 lipids Chemical class 0.000 title claims 20
- 239000000203 mixture Substances 0.000 title claims 3
- 238000009472 formulation Methods 0.000 title 1
- 239000002245 particle Substances 0.000 claims 17
- 239000000825 pharmaceutical preparation Substances 0.000 claims 10
- 239000003814 drug Substances 0.000 claims 7
- 238000000034 method Methods 0.000 claims 7
- 108090000623 proteins and genes Proteins 0.000 claims 7
- 229940124597 therapeutic agent Drugs 0.000 claims 7
- 108091034117 Oligonucleotide Proteins 0.000 claims 6
- 108020004707 nucleic acids Proteins 0.000 claims 6
- 102000039446 nucleic acids Human genes 0.000 claims 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 5
- 150000007523 nucleic acids Chemical group 0.000 claims 5
- 229920001184 polypeptide Polymers 0.000 claims 5
- 102000004196 processed proteins & peptides Human genes 0.000 claims 5
- 108090000765 processed proteins & peptides Proteins 0.000 claims 5
- 108020004459 Small interfering RNA Proteins 0.000 claims 4
- 239000002924 silencing RNA Substances 0.000 claims 4
- 108700011259 MicroRNAs Proteins 0.000 claims 3
- 201000010099 disease Diseases 0.000 claims 3
- 230000014509 gene expression Effects 0.000 claims 3
- 239000002679 microRNA Substances 0.000 claims 3
- 239000013612 plasmid Substances 0.000 claims 3
- 102100033270 Cyclin-dependent kinase inhibitor 1 Human genes 0.000 claims 2
- 101150017040 I gene Proteins 0.000 claims 2
- 239000000074 antisense oligonucleotide Substances 0.000 claims 2
- 238000012230 antisense oligonucleotides Methods 0.000 claims 2
- -1 cationic lipid Chemical class 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 230000003308 immunostimulating effect Effects 0.000 claims 2
- 108091033319 polynucleotide Proteins 0.000 claims 2
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- 102100023804 Coagulation factor VII Human genes 0.000 claims 1
- 108010068192 Cyclin A Proteins 0.000 claims 1
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- 108090000257 Cyclin E Proteins 0.000 claims 1
- 102100033233 Cyclin-dependent kinase inhibitor 1B Human genes 0.000 claims 1
- 108090000323 DNA Topoisomerases Proteins 0.000 claims 1
- 101150029707 ERBB2 gene Proteins 0.000 claims 1
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- 101100316840 Enterobacteria phage P4 Beta gene Proteins 0.000 claims 1
- 108010023321 Factor VII Proteins 0.000 claims 1
- 101000944380 Homo sapiens Cyclin-dependent kinase inhibitor 1 Proteins 0.000 claims 1
- 101000944361 Homo sapiens Cyclin-dependent kinase inhibitor 1B Proteins 0.000 claims 1
- 101001008953 Homo sapiens Kinesin-like protein KIF11 Proteins 0.000 claims 1
- 101100464893 Homo sapiens PPM1D gene Proteins 0.000 claims 1
- 101001098868 Homo sapiens Proprotein convertase subtilisin/kexin type 9 Proteins 0.000 claims 1
- 101000830894 Homo sapiens Targeting protein for Xklp2 Proteins 0.000 claims 1
- 101150041215 JNK gene Proteins 0.000 claims 1
- 101150038517 JUN gene Proteins 0.000 claims 1
- 102100027629 Kinesin-like protein KIF11 Human genes 0.000 claims 1
- 108060006687 MAP kinase kinase kinase Proteins 0.000 claims 1
- 101150018665 MAPK3 gene Proteins 0.000 claims 1
- 101150078498 MYB gene Proteins 0.000 claims 1
- 101150008755 PCNA gene Proteins 0.000 claims 1
- 101150109373 PPM1D gene Proteins 0.000 claims 1
- 102100038955 Proprotein convertase subtilisin/kexin type 9 Human genes 0.000 claims 1
- 101150040459 RAS gene Proteins 0.000 claims 1
- 101150062264 Raf gene Proteins 0.000 claims 1
- 108091006627 SLC12A9 Proteins 0.000 claims 1
- 101150099493 STAT3 gene Proteins 0.000 claims 1
- 101710190759 Serum amyloid A protein Proteins 0.000 claims 1
- 102100024813 Targeting protein for Xklp2 Human genes 0.000 claims 1
- 108010091356 Tumor Protein p73 Proteins 0.000 claims 1
- 102000044209 Tumor Suppressor Genes Human genes 0.000 claims 1
- 108700025716 Tumor Suppressor Genes Proteins 0.000 claims 1
- 108010078814 Tumor Suppressor Protein p53 Proteins 0.000 claims 1
- 108010046308 Type II DNA Topoisomerases Proteins 0.000 claims 1
- 108010019530 Vascular Endothelial Growth Factors Proteins 0.000 claims 1
- 101150077398 WNT-1 gene Proteins 0.000 claims 1
- 230000002776 aggregation Effects 0.000 claims 1
- 238000004220 aggregation Methods 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108700041737 bcl-2 Genes Proteins 0.000 claims 1
- 230000000295 complement effect Effects 0.000 claims 1
- 239000003184 complementary RNA Substances 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
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- 108700021358 erbB-1 Genes Proteins 0.000 claims 1
- 108700020302 erbB-2 Genes Proteins 0.000 claims 1
- 229940012413 factor vii Drugs 0.000 claims 1
- 101150078861 fos gene Proteins 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 101150098203 grb2 gene Proteins 0.000 claims 1
- 230000028993 immune response Effects 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 238000001727 in vivo Methods 0.000 claims 1
- 230000001939 inductive effect Effects 0.000 claims 1
- 108020004999 messenger RNA Proteins 0.000 claims 1
- 230000035772 mutation Effects 0.000 claims 1
- 230000007935 neutral effect Effects 0.000 claims 1
- 230000002018 overexpression Effects 0.000 claims 1
- 101150115162 p27 gene Proteins 0.000 claims 1
- 244000052769 pathogen Species 0.000 claims 1
- 230000001717 pathogenic effect Effects 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 108091092562 ribozyme Proteins 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 108700026239 src Genes Proteins 0.000 claims 1
- 230000004083 survival effect Effects 0.000 claims 1
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Classifications
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- A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids
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- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
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- A61K48/0025—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition wherein the non-active part clearly interacts with the delivered nucleic acid
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- C07C229/02—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
- C07C229/04—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated
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- C07C29/58—Preparation of compounds having hydroxy or O-metal groups bound to a carbon atom not belonging to a six-membered aromatic ring by elimination of halogen, e.g. by hydrogenolysis, splitting-off
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- C07D475/02—Heterocyclic compounds containing pteridine ring systems with an oxygen atom directly attached in position 4
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Claims (14)
1. Lipidna čestica, naznačeno time, što sadrži kationski lipid formule I:
[image]
ili njegovu farmaceutski prihvatljivu sol.
2. Lipidna čestica u skladu s patentnim zahtjevom 1, naznačeno time, što lipidna čestica nadalje sadrži neutralni lipid i lipid sposoban smanjiti agregaciju čestica.
3. Lipidna čestica u skladu s patentnim zahtjevom 1 ili patentnim zahtjevom 2, naznačeno time, što nadalje sadrži terapijsko sredstvo.
4. Lipidna čestica u skladu s patentnim zahtjevom 3, naznačeno time, što je terapijsko sredstvo nukleinska kiselina odabrana iz skupine koja se sastoji od plazmida, imunostimulacijskog oligonukleotida, jednolančanog oligonukleotida, dvolančanog oligonukleotida, aptamera ili ribozima.
5. Lipidna čestica u skladu s patentnim zahtjevom 4, naznačeno time, što je terapijsko sredstvo siRNA ili gdje je terapijsko sredstvo sekvenca mRNA koja kodira terapijski koristan polipeptid.
6. Farmaceutski pripravak, naznačeno time, da sadrži lipidnu česticu u skladu s bilo kojim od patentnih zahtjeva 1 do 5 i farmaceutski prihvatljivu pomoćnu tvar, nosač ili razrjeđivač .
7. Postupak in vitro moduliranja ekspresije ciljanog gena u stanici, naznačeno time, što postupak obuhvaća davanje stanici lipidne čestice iz bilo kojeg od patentnih zahtjeva 1 do 5 ili farmaceutskog pripravka u skladu s patentnim zahtjevom 6.
8. Lipidna čestica u skladu s bilo kojim od patentnih zahtjeva 1 do 5 ili farmaceutski pripravak u skladu s patentnim zahtjevom 6, naznačeno time, što je za uporabu u in vivo metodi moduliranja ekspresije ciljanog gena u stanici.
9. Postupak u skladu s patentnim zahtjevom 7, ili lipidna čestica ili farmaceutski pripravak za uporabu u skladu s patentnim zahtjevom 8, naznačeno time, gdje je ciljani gen odabran iz skupine koju čine faktor VII, Eg5, PCSK9, TPX2, apoB, SAA, TTR, RSV, PDGF beta gen, gen Erb-B, gen Src, gen CRK, gen GRB2, gen RAS, gen MEKK, gen JNK, gen RAF, gen Erk1/2, gen PCNA (p21), gen MYB, gen JUN, gen FOS, BCL -2 gen, Cyclin D gen, VEGF gen, EGFR gen, Cyclin A gen, Cyclin E gen, WNT-1 gen, gen beta-katenina, c-MET gen, gen PKC, gen NFKB, gen STAT3, gen za preživljavanje, Her2 /Neu gen, gen topoizomeraze I, alfa gen topoizomeraze II, gen p73, gen p21 (WAF1/CIP1), gen p27 (KIP1), gen PPM1D, gen kaveolin I, gen MIB I, gen MTAI, gen M68, mutacije tumorskih supresorskih gena, p53 tumorski supresorski geni i njihove kombinacije.
10. Lipidna čestica u skladu s patentnim zahtjevom 3 ili farmaceutski pripravak u skladu s patentnim zahtjevom 6, naznačeno time, što je za uporabu u liječenju bolesti ili poremećaja uzrokovanih prekomjernom ekspresijom polipeptida u subjekta, koji obuhvaća davanje subjektu lipidne čestice u skladu s patentnim zahtjevom 3 ili farmaceutskog pripravka u skladu s patentnim zahtjevom 6, gdje je terapijsko sredstvo odabrano od siRNA, mikroRNA, antisens oligonukleotida i plazmida sposobnog za ekspresiju siRNA, mikroRNA ili antisens oligonukleotida, i gdje siRNA, mikroRNA ili antisens RNA sadrži polinukleotid koji se specifično veže na polinukleotid koji kodira polipeptid ili njegov komplement.
11. Farmaceutski pripravak u skladu s patentnim zahtjevom 6, naznačeno time, da je za uporabu u liječenju bolesti ili poremećaja uzrokovanih nedovoljnom ekspresijom polipeptida kod subjekta, koji obuhvaća davanje subjektu farmaceutskog pripravka u skladu s patentnim zahtjevom 6, gdje je terapijsko sredstvo plazmid koji kodira polipeptid ili funkcionalna varijanta ili njezin ulomak.
12. Farmaceutski pripravak u skladu s patentnim zahtjevom 6, naznačeno time, da je za uporabu u postupku izazivanja imunološkog odgovora kod subjekta, pri čemu postupak obuhvaća davanje subjektu farmaceutskog pripravka sukladno patentnom zahtjevu 6, gdje je terapijsko sredstvo imunostimulacijski oligonukleotid.
13. Cjepivo, naznačeno time, što sadrži lipidnu česticu u skladu s bilo kojim od patentnih zahtjeva 1 do 5 i antigen povezan s bolešću ili patogenom.
14. Postupak za pripravu čestica lipida u skladu s patentnim zahtjevima 4 ili 5, naznačeno time, da sadrži korake:
(i) kombiniranja smjese lipida s puferiranom vodenom otopinom nukleinske kiseline za proizvodnju međuprodukta smjesa koja sadrži nukleinsku kiselinu inkapsuliranu u čestice lipida, pri čemu su inkapsulirane nukleinske kiseline prisutne u omjeru nukleinska kiselina/lipid od 3 tež.% do 25 tež.%; i
(ii) povećanja pH vrijednosti radi neutraliziranja barem dijela površinskih naboja na česticama lipidne nukleinske kiseline.
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EP18174274.3A EP3431076B1 (en) | 2009-06-10 | 2010-06-10 | Improved lipid formulation |
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HRP20211619TT HRP20211619T1 (hr) | 2009-06-10 | 2010-06-10 | Poboljšana formulacija lipida |
HRP20181221TT HRP20181221T1 (hr) | 2009-06-10 | 2018-08-01 | Poboljšani lipidni pripravak |
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