DE12722942T1 - Freisetzung und formulierung von manipulierten nukleinsäuren - Google Patents

Freisetzung und formulierung von manipulierten nukleinsäuren Download PDF

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DE12722942T1
DE12722942T1 DE12722942.5T DE12722942T DE12722942T1 DE 12722942 T1 DE12722942 T1 DE 12722942T1 DE 12722942 T DE12722942 T DE 12722942T DE 12722942 T1 DE12722942 T1 DE 12722942T1
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thio
procedure according
fluid
deaza
methyl
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Jason P. SCHRUM
Noubar B. Afeyan
Gregory J. Sieczkiewicz
Stephane Bancel
Antonin De Fougerolles
Sayda M. ELBASHIR
Kenechi Ejebe
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ModernaTx Inc
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Abstract

Verfahren zum Herstellen eines Polypeptids von Interesse in einer Zelle, einem Gewebe oder einer Körperflüssigkeit eines Säuger-Subjekts, das dessen bedarf, umfassend ein Verabreichen einer pharmazeutischen Zusammensetzung, die ein Polynukleotid umfasst, an das Subjekt, wobei das Polynukleotid eine Sequenz umfasst, die aus der Gruppe bestehend aus SEQ ID NO: 4, 7, 8 und 12 ausgewählt ist.

Claims (26)

  1. Verfahren zum Herstellen eines Polypeptids von Interesse in einer Zelle, einem Gewebe oder einer Körperflüssigkeit eines Säuger-Subjekts, das dessen bedarf, umfassend ein Verabreichen einer pharmazeutischen Zusammensetzung, die ein Polynukleotid umfasst, an das Subjekt, wobei das Polynukleotid eine Sequenz umfasst, die aus der Gruppe bestehend aus SEQ ID NO: 4, 7, 8 und 12 ausgewählt ist.
  2. Verfahren nach Anspruch 1, wobei das Polynukleotid ferner eine 5'-Cap1-Struktur und einen ungefähr 160 Nukleotide langen PolyA-Schwanz umfasst.
  3. Verfahren nach Anspruch 2, wobei die pharmazeutische Zusammensetzung formuliert wird.
  4. Verfahren nach Anspruch 3, wobei die Formulierung aus Kochsalzlösung oder einer Lipidformulierung ausgewählt wird.
  5. Verfahren nach Anspruch 4, wobei die Formulierung eine Kochsalzlösungsformulierung ist und auf einem Weg verabreicht wird, der aus der Gruppe bestehend aus intravenös, intramuskulär, subkutan und lokal ausgewählt ist.
  6. Verfahren nach Anspruch 4, wobei die Formulierung eine Lipidformulierung ist und auf einem Weg verabreicht wird, der aus der Gruppe bestehend aus intravenös, intramuskulär, subkutan und lokal ausgewählt ist.
  7. Verfahren nach Anspruch 4, wobei die Formulierung eine Lipidformulierung ist und aus der Gruppe bestehend aus Liposomen, Lipoplexen und Lipid-Nanopartikeln ausgewählt wird.
  8. Verfahren nach Anspruch 6, wobei der Verabreichungsweg entweder intramuskulär oder subkutan ist und die Lipidformulierung ein Copolymer umfasst.
  9. Verfahren nach Anspruch 8, wobei das Copolymer PLGA ist.
  10. Verfahren nach Anspruch 2, wobei die Verabreichung lokal erfolgt.
  11. Verfahren nach Anspruch 1, wobei die pharmazeutische Zusammensetzung in einer Gesamtdosis von etwa 0,1 mg/kg bis etwa 40 mg/kg verabreicht wird.
  12. Verfahren nach Anspruch 11, wobei eine Verabreichung nach einem Zeitplan erfolgt, der aus der Gruppe bestehend aus dreimal täglich, zweimal täglich, einmal täglich, jeden zweiten Tag, jeden dritten Tag, wöchentlich, zweiwöchentlich, alle drei Wochen, alle vier Wochen und monatlich ausgewählt ist.
  13. Verfahren nach Anspruch 11, wobei die Gesamtdosis durch Mehrfachverabreichungen verabreicht wird.
  14. Verfahren nach Anspruch 13, wobei die Mehrfachverabreichungen nach einem Zeitplan erfolgen, der aus der Gruppe bestehend aus dreimal täglich, zweimal täglich, einmal täglich, jeden zweiten Tag, jeden dritten Tag, wöchentlich, zweiwöchentlich, alle drei Wochen, alle vier Wochen und monatlich ausgewählt ist.
  15. Verfahren nach Anspruch 1, wobei ein Anstieg des Spiegels des Polypeptids von Interesse in Gewebe oder Körperflüssigkeit innerhalb von 8 Stunden beobachtet wird.
  16. Verfahren nach Anspruch 1, wobei ein Anstieg des Spiegels des Polypeptids von Interesse in Gewebe oder Körperflüssigkeit innerhalb von 2 Stunden beobachtet wird.
  17. Verfahren nach Anspruch 15, wobei der erhöhte Spiegel des Polypeptids von Interesse in einem Gewebe beobachtet wird, das aus der Gruppe bestehend aus Leber, Milz, Niere, Lunge, Herz, perirenalem Fettgewebe, Thymus und Muskel ausgewählt ist.
  18. Verfahren nach Anspruch 2, wobei die Körperflüssigkeit aus der Gruppe bestehend aus peripherem Blut, Serum, Plasma, Aszites, Urin, Zerebrospinalflüssigkeit (CSF), Sputum, Speichel, Knochenmark, Gelenksflüssigkeit, Kammerwasser, Fruchtwasser, Cerumen, Muttermilch, bronchoalveolärer Lavage-Flüssigkeit, Sperma, Prostataflüssigkeit, Cowper-Fluid oder Präejakulationsflüssigkeit, Schweiß, Fäkalien, Haaren, Tränen, Zystenflüssigkeit, Pleura- und Peritonealflüssigkeit, Perikardflüssigkeit, Lymphe, Chymus, Chylus, Galle, interstitieller Flüssigkeit, Menstruationsflüssigkeit, Eiter, Talg, Erbrochenem, Vaginalsekreten, Schleimhautsekret, Stuhlwasser, Pankreassaft, Lavage-Flüssigkeiten aus Nebenhöhlen, bronchopulmonalen Aspiraten, Blastocylhöhlenflüssigkeit und Nabelschnurblut ausgewählt ist.
  19. Verfahren nach Anspruch 2, wobei das Polynukleotid eine oder mehrere Modifikationen umfasst, die aus der Gruppe bestehend aus Pyridin-4-onribonukleosid, 5-Azauridin, 2-Thio-5-azauridin, 2-Thiouridin, 4-Thiopseudouridin, 2-Thiopseudouridin, 5-Hydroxyuridin, 3-Methyluridin, 5-Carboxymethyluridin, 1-Carboxymethylpseudouridin, 5-Propinyluridin, 1-Propinylpseudouridin, 5-Taurinomethyluridin, 1-Taurinomethylpseudouridin, 5-Taurinomethyl-2-thiouridin, 1-Taurinomethyl-4-thiouridin, 5-Methyluridin, 1-Methylpseudouridin, 4-Thio-1-methylpseudouridin, 2-Thio-1-methylpseudouridin, 1-Methyl-1-deazapseudouridin, 2-Thio-1-methyl-1-deazapseudouridin, Dihydrouridin, Dihydropseudouridin, 2-Thiodihydrouridin, 2-Thiodihydropseudouridin, 2-Methoxyuridin, 2-Methoxy-4-thiouridin, 4-Methoxypseudouridin, 4-Methoxy-2-thiopseudouridin, 5-Azacytidin, Pseudoisocytidin, 3-Methylcytidin, N4-Acetylcytidin, 5-Formylcytidin, N4-Methylcytidin, 5-Hydroxymethylcytidin, 1-Methylpseudoisocytidin, Pyrrolocytidin, Pyrrolopseudoisocytidin, 2-Thiocytidin, 2-Thio-5-methylcytidin, 4-Thiopseudoisocytidin, 4-Thio-1-methylpseudoisocytidin, 4-Thio-1-methyl-1-deazapseudoisocytidin, 1-Methyl-1-deazapseudoisocytidin, Zebularin, 5-Azazebularin, 5-Methylzebularin, 5-Aza-2-thiozebularin, 2-Thiozebularin, 2-Methoxycytidin, 2-Methoxy-5-methylcytidin, 4-Methoxypseudoisocytidin, 4-Methoxy-1-methylpseudoisocytidin, 2-Aminopurin, 2,6-Diaminopurin, 7-Deazaadenin, 7-Deaza-8-azaadenin, 7-Deaza-2-aminopurin, 7-Deaza-8-aza-2-aminopurin, 7-Deaza-2,6-diaminopurin, 7-Deaza-8-aza-2,6-diaminopurin, 1-Methyladenosin, N6-Methyladenosin, N6-Isopentenyladenosin, N6-(cis-Hydroxyisopentenyl)adenosin, 2-Methylthio-N6-(cishydroxyisopentenyl)adenosin, N6-Glycinylcarbamoyladenosin, N6-Threonylcarbamoyladenosin, 2-Methylthio-N6-threonylcarbamoyladenosin, N6,N6-Dimethyladenosin, 7-Methyladenin, 2-Methylthioadenin und 2-Methoxyadenin, Inosin, 1-Methylinosin, Wyosin, Wybutosin, 7-Deazaguanosin, 7-Deaza-8-azaguanosin, 6-Thioguanosin, 6-Thio-7-deazaguanosin, 6-Thio-7-deaza-8-azaguanosin, 7-Methylguanosin, 6-Thio-7-methylguanosin, 7-Methylinosin, 6-Methoxyguanosin, 1-Methylguanosin, N2-Methylguanosin, N2,N2-Dimethylguanosin, 8-Oxoguanosin, 7-Methyl-8-oxoguanosin, 1-Methyl-6-thioguanosin, N2-Methyl-6-thioguanosin und N2,N2-Dimethyl-6-thioguanosin und Kombinationen davon ausgewählt sind.
  20. Verfahren nach Anspruch 19, wobei der Spiegel des modifizierten Polynukleotids in einer Körperflüssigkeit aus dem Spiegel des modifizierten Polynukleotids in einem Exosom bestimmt wird.
  21. Isoliertes Polynukleotid, wobei das Polynukleotid eine Sequenz umfasst, die aus der Gruppe bestehend aus SEQ ID NO: 4, 7, 8 und 12 ausgewählt ist.
  22. Polynukleotid nach Anspruch 21, ferner umfassend eine 5'-Cap1-Struktur und einen ungefähr 160 Nukleotide langen PolyA-Schwanz.
  23. Pharmazeutische Zusammensetzung, umfassend das Polynukleotid nach Anspruch 22.
  24. Pharmazeutische Zusammensetzung nach Anspruch 23, die formuliert ist und wobei die Formulierung aus Kochsalzlösung oder einer Lipidformulierung ausgewählt ist.
  25. Pharmazeutische Zusammensetzung nach Anspruch 24, wobei die Formulierung eine Lipidformulierung ist und aus der Gruppe bestehend aus Liposomen, Lipoplexen und Lipid-Nanopartikeln ausgewählt ist.
  26. Polynukleotid nach Anspruch 22, wobei das Polynukleotid eine oder mehrere Modifikationen umfasst, die aus der Gruppe bestehend aus Pyridin-4-onribonukleosid, 5-Azauridin, 2-Thio-5-azauridin, 2-Thiouridin, 4-Thiopseudouridin, 2-Thiopseudouridin, 5-Hydroxyuridin, 3-Methyluridin, 5-Carboxymethyluridin, 1-Carboxymethylpseudouridin, 5-Propinyluridin, 1-Propinylpseudouridin, 5-Taurinomethyluridin, 1-Taurinomethylpseudouridin, 5-Taurinomethyl-2-thiouridin, 1-Taurinomethyl-4-thiouridin, 5-Methyluridin, 1-Methylpseudouridin, 4-Thio-1-methylpseudouridin, 2-Thio-1-methylpseudouridin, 1-Methyl-1-deazapseudouridin, 2-Thio-1-methyl-1-deazapseudouridin, Dihydrouridin, Dihydropseudouridin, 2-Thiodihydrouridin, 2-Thiodihydropseudouridin, 2-Methoxyuridin, 2-Methoxy-4-thiouridin, 4-Methoxypseudouridin, 4-Methoxy-2-thiopseudouridin, 5-Azacytidin, Pseudoisocytidin, 3-Methylcytidin, N4-Acetylcytidin, 5-Formylcytidin, N4-Methylcytidin, 5-Hydroxymethylcytidin, 1-Methylpseudoisocytidin, Pyrrolocytidin, Pyrrolopseudoisocytidin, 2-Thiocytidin, 2-Thio-5-methylcytidin, 4-Thiopseudoisocytidin, 4-Thio-1-methylpseudoisocytidin, 4-Thio-1-methyl-1-deazapseudoisocytidin, 1-Methyl-1-deazapseudoisocytidin, Zebularin, 5-Azazebularin, 5-Methylzebularin, 5-Aza-2-thiozebularin, 2-Thiozebularin, 2-Methoxycytidin, 2-Methoxy-5-methylcytidin, 4-Methoxypseudoisocytidin, 4-Methoxy-1-methylpseudoisocytidin, 2-Aminopurin, 2,6-Diaminopurin, 7-Deazaadenin, 7-Deaza-8-azaadenin, 7-Deaza-2-aminopurin, 7-Deaza-8-aza-2-aminopurin, 7-Deaza-2,6-diaminopurin, 7-Deaza-8-aza-2,6-diaminopurin, 1-Methyladenosin, N6-Methyladenosin, N6-Isopentenyladenosin, N6-(cis-Hydroxyisopentenyl)adenosin, 2-Methylthio-N6-(cishydroxyisopentenyl)adenosin, N6-Glycinylcarbamoyladenosin, N6-Threonylcarbamoyladenosin, 2-Methylthio-N6-threonylcarbamoyladenosin, N6,N6-Dimethyladenosin, 7-Methyladenin, 2-Methylthioadenin und 2-Methoxyadenin, Inosin, 1-Methylinosin, Wyosin, Wybutosin, 7-Deazaguanosin, 7-Deaza-8-azaguanosin, 6-Thioguanosin, 6-Thio-7-deazaguanosin, 6-Thio-7-deaza-8-azaguanosin, 7-Methylguanosin, 6-Thio-7-methylguanosin, 7-Methylinosin, 6-Methoxyguanosin, 1-Methylguanosin, N2-Methylguanosin, N2,N2-Dimethylguanosin, 8-Oxoguanosin, 7-Methyl-8-oxoguanosin, 1-Methyl-6-thioguanosin, N2-Methyl-6-thioguanosin und N2,N2-Dimethyl-6-thioguanosin und Kombinationen davon ausgewählt sind.
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