Biontech Se

Biontech Rna Pharmaceuticals Gmbh

Tron-Translationale Onkologie an Der Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz

Medigene Ag

Other

Johannes Gutenberg-Universität Mainz

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

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

Syncore Biotechnology Co., Ltd.

Medigene Oncology Gmbh

Tron

Tron—translationale Onkologie an Der Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Gemeinnuzige Gmbh

Heinrich Haas

Ugur Sahin

Sebastian Kreiter

Mustafa Diken

Sebastian Hörner

Kerstin Reuter

Yves Hüsemann

Gerhard Winter

Michael Teifel

Uwe Michaelis

Thomas Fichert

Kerstin Walzer

Toralf Peymann

Christian Welz

Brita Schulze

Oliver Schramel

Friedrich Gruber

Carsten Mundus

Isaac Hernan Esparza Borquez

Hossam Hefesha

Thomas Michael Hiller

Anne Schlegel

Annette Vogel

Lena Mareen Kranz

Martin Meng

Daniel Fritz

Stephanie Erbar

Ferdia Bates

Thorsten Klamp

Matthias Barz

Jorge Herrero Moreno

Phillip Heller

Ursula Fattler

Benjamin Weber

Philipp Heller

Sara Nogueira

Hossam Hefresha

Jorge Moreno Herrero

Daniel Zucker

Yves Husemann

The present disclosure relates to methods for preparing RNA lipoplex particles for delivery of RNA to target tissues after parenteral administration, in particular after intravenous administration, and compositions comprising such RNA lipoplex particles. The present disclosure also relates to methods which allow preparing RNA lipoplex particles in an industrial GMP-compliant manner. Furthermore, the present disclosure relates to methods and compositions for storing RNA lipoplex particles without substantial loss of the product quality and, in particular, without substantial loss of RNA activity.

Preparation and storage of liposomal RNA formulations suitable for therapy

The present disclosure relates to RNA particles for delivery of RNA to target tissues after administration, in particular after parenteral administration such as intravenous, intramuscular, subcutaneous or intratumoral administration, and compositions comprising such RNA particles. The RNA particles in one embodiment comprise single-stranded RNA such as mRNA which encodes a peptide or protein of interest, such as a pharmaceutically active peptide or protein. The RNA is taken up by cells of a target tissue and the RNA is translated into the encoded peptide or protein, which may exhibit its physiological activity.

RNA particles comprising polysarcosine

The present invention relates to aqueous lipid and/or liposome formulations with an increased chemical stability, to methods of preparing such aqueous formulations as well as to kits comprising them. The present invention further relates to methods of preparing lipid-based pharmaceutical compositions, to pharmaceutical compositions prepared by such methods and to methods of chemically stabilizing aqueous lipid and/or liposome formulations.

Stable formulations of lipids and liposomes

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.

Formulation for administration of RNA

The present invention relates to RNA decorated particles such as RNA decorated lipid particles, preferably to RNA decorated liposomes. Further, the present invention relates to a pharmaceutical composition comprising RNA decorated particles such as RNA decorated lipid particles, preferably RNA decorated liposomes. Said pharmaceutical composition is useful for inducing an immune response. It is also useful in a prophylactic and/or therapeutic treatment of a disease involving an antigen. Furthermore, the present invention relates to a method for producing the RNA decorated particles such as RNA decorated lipid particles, preferably RNA decorated liposomes.

Particles comprising a shell with RNA

The present invention is in the field of immunotherapy, in particular tumor immunotherapy. The present invention provides pharmaceutical formulations for delivering RNA to antigen presenting cells such as dendrite cells (DCs) in the spleen after systemic administration. In particular, the formulations described herein enable to induce an immune response after systemic administration of antigen-coding RNA.

RNA formulation for immunotherapy

The present invention relates to lipid particles comprising at least one cationic lipid, at least one water-soluble therapeutically effective compound and RNA. Further, the present invention relates to a pharmaceutical composition comprising such particles. Said pharmaceutical composition is useful for inducing an immune response. It is also useful in a prophylactic and/or therapeutic treatment of a disease involving an antigen. Furthermore, the present invention relates to a method for producing the particles.

Lipid particle formulations for delivery of RNA and water-soluble therapeutically effective compounds to a target cell

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.

The present invention related to aqueous lipid and/or liposome formulations with an increased chemical stability, to methods of preparing such aqueous formulations as well as to kits comprising them. The present invention further relates to methods of preparing lipid-based pharmaceutical compositions, to pharmaceutical compositions prepared by such methods and to methods of chemically stabilizing aqueous lipid and/or liposome formulations.

The present invention relates to the preparation of liposomes with enhanced loading capacity for pharmaceutically and/or diagnostically active agents and/or cosmetic agents which are substantially solubilized by the liposomal membranes, to liposome dispersions with enhanced stability with respect to release of the active agent and/or cosmetic agent from the liposomes obtainable by the process, and to pharmaceutical or cosmetic compositions comprising said stabilized liposome dispersions. The preparation may involve dehydration and rehydration steps of liposome dispersions which may be carried out by spray drying.

Liposomal formulations of lipophilic compounds

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Mainz, Germany

Heinrich Haas