DE18200782T1 - Modifizierte polynukleotide zur herstellung von proteinen im zusammenhang mit erkrankungen beim menschen - Google Patents

Modifizierte polynukleotide zur herstellung von proteinen im zusammenhang mit erkrankungen beim menschen Download PDF

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Publication number
DE18200782T1
DE18200782T1 DE18200782.3T DE18200782T DE18200782T1 DE 18200782 T1 DE18200782 T1 DE 18200782T1 DE 18200782 T DE18200782 T DE 18200782T DE 18200782 T1 DE18200782 T1 DE 18200782T1
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DE
Germany
Prior art keywords
composition
use according
mrna
lipid
dlin
Prior art date
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Pending
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DE18200782.3T
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English (en)
Inventor
Stephane Bancel
Tirtha Chakraborty
Antonin De Fougerolles
Sayda M. ELBASHIR
Matthias John
Atanu Roy
Susan Whoriskey
Kristy M. WOOD
Paul Hatala
Jason P. SCHRUM
Kenechi Ejebe
Jeff Lynn Ellsworth
Justin Guild
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ModernaTx Inc
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ModernaTx Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49235350&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE18200782(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by ModernaTx Inc filed Critical ModernaTx Inc
Publication of DE18200782T1 publication Critical patent/DE18200782T1/de
Pending legal-status Critical Current

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    • A61K48/0066—Manipulation of the nucleic acid to modify its expression pattern, e.g. enhance its duration of expression, achieved by the presence of particular introns in the delivered nucleic acid
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Abstract

Zusammensetzung, umfassend eine Lipid-Nanopartikel-Formulierung, die eine mRNA umfasst, die für ein Polypeptid von Interesse codiert, zur Verwendung in einem Verfahren zum Behandeln oder Vorbeugen einer Krankheit oder eines Zustands durch Herstellen des Polypeptids in vivo, wobei die mRNA N1-Methylpseudouridin umfasst.

Claims (11)

  1. Zusammensetzung, umfassend eine Lipid-Nanopartikel-Formulierung, die eine mRNA umfasst, die für ein Polypeptid von Interesse codiert, zur Verwendung in einem Verfahren zum Behandeln oder Vorbeugen einer Krankheit oder eines Zustands durch Herstellen des Polypeptids in vivo, wobei die mRNA N1-Methylpseudouridin umfasst.
  2. Zusammensetzung zur Verwendung nach Anspruch 1, wobei die Zusammensetzung eine Vielzahl verschiedener mRNAs, die N1-Methylpseudouridin umfassen, beinhaltet.
  3. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, wobei mindestens eine mRNA eine oder mehrere microRNA-Zielsequenzen in der 3'-UTR umfasst.
  4. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, wobei mindestens eine mRNA eine oder mehrere Zielstellen von miR-122 in der 3'-UTR umfasst.
  5. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, wobei mindestens eine mRNA 100 % N1-Methylpseudouridin gegenüber Uridin enthält.
  6. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, wobei mindestens eine mRNA einen Poly-A-Schwanz von etwa 160 Nukleotiden umfasst.
  7. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, wobei mindestens eine mRNA ein G-Quartett am Ende des Poly-A-Schwanzes umfasst.
  8. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, wobei das Verfahren eine wiederholte Verabreichung der Zusammensetzung umfasst.
  9. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, die eine mittlere Partikelgröße von 80 nm-160 nm, einen Polydispersitätsindex (PDI) zwischen 0,02 und 0,20 und ein Verhältnis von Lipid zu Polynukleotid (Gew./Gew.) zwischen 10-30, optional zwischen 10-20 aufweist.
  10. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, wobei die Zusammensetzung durch ein Verfahren erhältlich ist, das ein schnelles Injizieren einer ersten ethanolischen Lösung in eine zweite wässrige Lösung umfasst, wobei (a) die erste ethanolische Lösung ein Gemisch aus Lipid:DSPC:Cholesterin:PEG-c-DOMG umfasst, um ein Molverhältnis von 50:10:38,5:1,5 zu ergeben, und eine Endlipidkonzentration von ungefähr 25 mM aufweist und (b) die zweite wässrige Lösung eine Natriumcitrat-gepufferte Lösung des Polynukleotids, welches für das Polypeptid von Interesse codiert, umfasst, die eine Konzentration von 1-2 mg/ml und einen pH von ungefähr 3 aufweist, wobei die schnelle Injektion zu einer Suspension, die 33 % Ethanol enthält, und einem Gesamtgewichtsverhältnis von Lipid zu Polynukleotid von mindestens 10:1 führt.
  11. Zusammensetzung zur Verwendung nach einem der vorhergehenden Ansprüche, umfassend ein Lipid, das aus einem von DLin-DMA, DLin-K-DMA, DLin-KC2-DMA, 98N12-5, C12-200 und DLin-MC3-DMA ausgewählt ist.
DE18200782.3T 2012-04-02 2013-03-09 Modifizierte polynukleotide zur herstellung von proteinen im zusammenhang mit erkrankungen beim menschen Pending DE18200782T1 (de)

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US201261618870P 2012-04-02 2012-04-02
US201261618935P 2012-04-02 2012-04-02
US201261618868P 2012-04-02 2012-04-02
US201261618961P 2012-04-02 2012-04-02
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