Biontech Se

Tron—translationale Onkologie an Der Universitátsmedizin Der Johannes Gutenberg—universität Mainz Gemeinnützige Gmbh

Biontech Rna Pharmaceuticals Gmbh

Tron—translationale Onkologie an Der Universitatsmedizin Der Johannes Gutenberg-universitat Mainz Ggmbh

Daniel Zucker

Ugur Sahin

Sebastian Kreiter

Heinrich Haas

Mustafa Diken

Kerstin Walzer

Sebastian Hörner

Annette Vogel

Kerstin Reuter

Anne Schlegel

Stephanie Erbar

Jorge Moreno Herrero

The present invention relates to compositions comprising polyplex formulations for delivery of RNA to a target organ or a target cell after parenteral administration, in particular after intramuscular administration. More precisely, the present invention relates to formulations for administration of RNA such as self-replicating RNA, in particular by intramuscular injection. In more detail, the formulations comprise polyplex particles from single stranded RNA and a polyalkyleneimine. The RNA may encode a protein of interest, such as a pharmaceutically active protein. Furthermore, the present invention relates to pharmaceutical products, comprising said RNA polyplex formulations for parenteral application to humans or to animals. The present invention relates as well to manufacturing of such pharmaceutical products, comprising, optionally, steps of sterile filtration, freezing and dehydration.

Formulation for administration of RNA

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Mainz, Germany

Daniel Zucker