DK2145002T3 - Bakterielt afledte, intakte miniceller der omfatter plasmid-fri funktionel nukleinsyre til in vivo-afgivelse til pattedyrceller - Google Patents

Bakterielt afledte, intakte miniceller der omfatter plasmid-fri funktionel nukleinsyre til in vivo-afgivelse til pattedyrceller Download PDF

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DK2145002T3
DK2145002T3 DK08828079.7T DK08828079T DK2145002T3 DK 2145002 T3 DK2145002 T3 DK 2145002T3 DK 08828079 T DK08828079 T DK 08828079T DK 2145002 T3 DK2145002 T3 DK 2145002T3
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minicells
composition
rna
regulatory rna
minicell
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Himanshu Brahmbhatt
Jennifer Macdiarmid
Toby Hulf
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Engeneic Molecular Delivery Pty Ltd
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Claims (32)

1. Sammensætning omfattende (a) en flerhed af intakte, bakterielt afledte miniceller, hvor hver minicelle af flerheden omfatter regulatorisk RNA der er pakket i minicellen, og (b) en farmaceutisk acceptabel bærer derfor, hvor der hos minicellerne er et fravær af et konstrukt til in situ-ekspression af det regulatoriske RNA, hvor det regulatoriske RNA er valgt fra gruppen bestående af siRNA, miRNA og shRNA, og hvor flerheden indeholder en terapeutisk effektiv mængde af det regulatoriske RNA.
2. Sammensætning ifølge krav 1, hvor det regulatoriske RNA er rettet mod det RNA-transkript som koder for et protein der bidrager til lægemiddelresistens, apoptoseresistens eller neoplasticitet.
3. Sammensætning ifølge krav 1, hvor det regulatoriske RNA er rettet mod transkriptet for P-glycoprotein, MDR-2, eller MDR-3.
4. Sammensætning ifølge krav 1, hvor det regulatoriske RNA er rettet mod transkriptet for MRP2, BCR-ABL, STI-571 resistensassocieret protein, lunge-resistens-beslægtet protein, cyclooxygenase-2, nuklear faktor kappa, XRCC1, ERCC1, GSTP1, mutant β-tubulin, eller en vækstfaktor.
5. Sammensætning ifølge krav 1, hvor det regulatoriske RNA er rettet mod et transkript for Bcl-2, Bcl-XL, Al/Bfl 1, fokal adhæsionskinase eller p53-protein.
6. Sammensætning ifølge krav 1, hvor det regulatoriske RNA er rettet mod et transkript for β-Catenin, PKC-α, C-RAF, K-Ras, DP97 Dead box RNA-helikase, cdkl, DNMT1, FLIP, C-Sfc, 53BPI, Polycomb-gruppeprotein EZH2, ErbBl, HPV-16 E5 og E7, Fortilin & MCI1P, KSP, DIP13a, MBD2, p21, KLF4, tpt/TCTP, SPK1 & SPK2, P300, PLK1, Trp53, Ras, ErbBl, VEGF, eller BAG-1.
7. Sammensætning ifølge krav 1, som yderligere omfatter et lægemiddel.
8. Sammensætning ifølge krav 7, hvor det regulatoriske RNA er rettet mod det transkript som koder for et protein der bidrager til resistens mod dette lægemiddel.
9. Sammensætning ifølge krav 8, hvor lægemidlet er pakket i en intakt, bakterielt afledt minicelle.
10. Sammensætning ifølge krav 9, hvor det regulatoriske RNA og lægemidlet er pakket indenfor den samme minicelle.
11. Sammensætning ifølge krav 1, som yderligere omfatter en bispecifik ligand.
12. Sammensætning ifølge krav 11, hvor den bispecifikke ligand omfatter en første arm der bærer specificitet for en minicelle-overfladestruktur og en anden arm der bærer specificitet for en ikke-fagocytisk pattedyrcelle-overfladereceptor.
13. Sammensætning ifølge krav 1 eller krav 12, hvor det regulatoriske RNA er siRNA.
14. Sammensætning ifølge krav 12, hvor pattedyrcelle-overfladereceptoren er i stand til at aktivere receptor-medieret endocytose af denne minicelle.
15. Sammensætning ifølge krav 11, hvor den bispecifikke ligand omfatter et antistof eller antistoffragment.
16. Sammensætning ifølge krav 1, hvor sammensætningen omfatter færre end 1 forurenende forældre-bakteriecelle pr. 109 miniceller.
17. Sammensætning ifølge krav 1, hvor sammensætningen omfatter færre end 1 forurenende forældre-bakteriecelle pr. 1010 miniceller.
18. Sammensætning ifølge krav 1, hvor sammensætningen omfatter færre end 1 forurenende forældre-bakteriecelle pr. 1011 miniceller.
19. Sammensætningen ifølge krav 1 til anvendelse som et medikament.
20. Sammensætning ifølge krav 19, hvor det regulatoriske RNA er shRNA.
21. Sammensætning ifølge krav 19, hvor det regulatoriske RNA er siRNA.
22. Sammensætning ifølge krav 19 til anvendelse i behandlingen af lægemiddelresistens eller apoptoseresistens.
23. Sammensætning ifølge krav 19 til anvendelse i behandlingen af cancer eller neoplasticitet, yderligere omfattende en bispecifik ligand, hvilken bispecifikke ligand omfatter en første arm der bærer specificitet for en minicelleoverfladestruktur og en anden arm der bærer specificitet for en ikke-fagocytisk pattedyrcelle-overfladereceptor.
24. Sammensætning ifølge krav 23, hvor canceren er valgt fra gruppen bestående af mavecancer, urinvejscancer, blærecancer, ovariecancer, brystcancer, tyktarmscancer og tyktarmsepitelcancer.
25. Sammensætning ifølge krav 19, hvor medikamentet er til anvendelse i kombination med et lægemiddel hvor det regulatoriske RNA er rettet mod transkriptet for et protein der bidrager til resistens mod dette lægemiddel.
26. Sammensætning ifølge krav 25, hvor lægemidlet er pakket i en intakt, bakterielt afledt minicelle.
27. Sammensætning ifølge krav 26, hvor det regulatoriske RNA og lægemidlet er pakket indenfor den samme minicelle.
28. Fremgangsmåde til formulering af miniceller i sammensætningen ifølge krav 1, omfattende co-inkubering i en buffer (A) afen flerhed af intakte, bakterielt afledte miniceller med (B) plasmid-frit, regulatorisk RNA, hvorved der opnås miniceller der indeholder det regulatoriske RNA, hvor det regulatoriske RNA er valgt fra gruppen bestående af siRNA, miRNA og shRNA.
29. Fremgangsmåden ifølge krav 28, hvor det regulatoriske RNA er shRNA.
30. Fremgangsmåden ifølge krav 28, hvor det regulatoriske RNA er siRNA.
31. Fremgangsmåden ifølge krav 29, hvor mængden af siRNA til stede i minicellerne der indeholder dette siRNA er således at 1010 miniceller pakker mindst ca. 1,3 pg siRNA.
32. Fremgangsmåden ifølge et hvilket som helst af kravene 28 til 31, hvor inkubationen udføres i bufret saltvand.
DK08828079.7T 2007-03-30 2008-03-26 Bakterielt afledte, intakte miniceller der omfatter plasmid-fri funktionel nukleinsyre til in vivo-afgivelse til pattedyrceller DK2145002T3 (da)

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US90907407P 2007-03-30 2007-03-30
PCT/IB2008/002984 WO2009027830A2 (en) 2007-03-30 2008-03-26 Bacterially-derived, intact minicells that encompass plasmid-free functional nucleic acid for in vivo delivery to mammalian cells

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