US 12,150,947 B2
Formulation for administration of RNA
Ugur Sahin, Mainz (DE); Heinrich Haas, Mainz (DE); Annette Vogel, Mainz (DE); Stephanie Erbar, Mainz (DE); Kerstin Walzer, Mainz (DE); Anne Schlegel, Mainz (DE); Sebastian Hörner, Mainz (DE); Jorge Herrero Moreno, Mainz (DE); Thorsten Klamp, Mainz (DE); Sebastian Kreiter, Mainz (DE); Mustafa Diken, Mainz (DE); and Phillip Heller, Mainz (DE)
Assigned to BioNTech SE, Mainz (DE); and TRON—TRANSLATIONALE ONKOLOGIE AN DER UNIVERSITATSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITAT MAINZ, Mainz (DE)
Appl. No. 16/957,898
Filed by BioNTech SE, Mainz (DE); and TRON—TRANSLATIONALE ONKOLOGIE AN DER UNIVERSITATSMEDIZIN DER JOHANNES GUTENBERG-UNIVERSITAT MAINZ GGMBH, Mainz (DE)
PCT Filed Jan. 10, 2019, PCT No. PCT/EP2019/050551
§ 371(c)(1), (2) Date Jun. 25, 2020,
PCT Pub. No. WO2019/137999, PCT Pub. Date Jul. 18, 2019.
Claims priority of application No. PCT/EP2018/050672 (WO), filed on Jan. 11, 2018.
Prior Publication US 2021/0023100 A1, Jan. 28, 2021
Int. Cl. A61K 31/70 (2006.01); A61K 9/00 (2006.01); A61K 35/763 (2015.01); A61K 47/18 (2017.01)
CPC A61K 31/70 (2013.01) [A61K 9/0019 (2013.01); A61K 35/763 (2013.01); A61K 47/183 (2013.01)] 16 Claims
 
1. An injectable pharmaceutical composition comprising:
(a) single stranded, self-replicating RNA encoding a peptide or protein comprising an antigen or epitope, wherein the single stranded, self-replicating RNA is derived from Venezuelan equine encephalitis virus (VEEV) or from Semliki Forest virus (SFV); and
(b) polyethyleneimine
wherein the injectable pharmaceutical is adapted for intramuscular administration, and wherein the single stranded, self-replicating RNA is in an amount effective to elicit an immune response.