Respiratory syncytial virus (RSV) vaccine

Patent metadata

Field	Value
Publication number	US-11034729-B2
Application number	US-201816168747-A
Country	US
Kind code	B2
Filing date	Oct 23, 2018
Priority date	Aug 21, 2013
Publication date	Jun 15, 2021
Grant date	Jun 15, 2021

Abstract

The present invention relates to an mRNA sequence, comprising a coding region, encoding at least one antigenic peptide or protein of RSV infections Respiratory syncytial virus (RSV) or a fragment, variant or derivative thereof. Additionally the present invention relates to a composition comprising a plurality of mRNA sequences comprising a coding region, encoding at least one antigenic peptide or protein of RSV infections Respiratory syncytial virus (RSV) or a fragment, variant or derivative thereof. Furthermore it also discloses the use of the mRNA sequence or the composition comprising a plurality of mRNA sequences for the preparation of a pharmaceutical composition, especially a vaccine, e.g. for use in the prophylaxis or treatment of RSV infections Respiratory syncytial virus (RSV) infections. The present invention further describes a method of treatment or prophylaxis of RSV infections using the mRNA sequence.

First claim

The invention claimed is:

1. A pharmaceutical composition comprising a mRNA sequence encoding at least one antigenic polypeptide from the fusion protein F, the nucleoprotein N, the M2-1 protein or the M2-2 protein of Respiratory syncytial virus (RSV), said mRNA comprising a sequence at least 90% identical to the polypeptide coding sequence of SEQ ID NO: 31, 32, 33, 34 or 35, wherein the G/C content of the sequence encoding the antigenic polypeptide is increased compared with the G/C content of the coding region of the wild type mRNA encoding the antigenic polypeptide.

2. The composition according to claim 1 , wherein the mRNA further comprises a 5′-cap structure, a poly(A) sequence, and/or a poly(C) sequence.

3. The composition according to claim 2 , wherein the 5′cap structure is m7GpppN.

4. The composition according to claim 2 , wherein the poly(A) sequence comprises a sequence of 25 to 400 adenosine nucleotides.

5. The composition according to claim 1 , wherein the mRNA further comprises at least one histone stem-loop.

6. The composition according to claim 1 , wherein the mRNA sequence further comprises a stabilizing sequence from the alpha globin 3′ UTR, positioned 3′ relative to the polypeptide coding region of the mRNA sequence.

7. The composition according to claim 1 , wherein the mRNA sequence comprises from a 5′ to 3′: a 5′-cap structure, a 5′ UTR sequence, the sequence encoding the at least one antigenic polypeptide, a 3′ UTR, a poly(A) sequence, a poly(C) sequence and a histone stem-loop sequence.

8. The composition according to claim 7 , wherein the mRNA comprises a sequence at least 90% identical to the polypeptide coding sequence of SEQ ID NO: 35.

9. The composition according to claim 1 , wherein the mRNA sequence is complexed with a cationic or polycationic compound.

10. The composition according to claim 9 , wherein the cationic or polycationic compound is protamine, poly-L-lysine (PLL), or poly-arginine.

11. The composition according to claim 9 , wherein the cationic or polycationic compound is protamine.

12. The composition according to claim 9 , wherein the weight ratio of the mRNA sequence to the cationic or polycationic compound is in the range from 6:1 to 0.25:1.

13. The composition of claim 1 , wherein the mRNA sequence is formulated for injection.

14. The composition of claim 1 , wherein the mRNA sequence is formulated in a Ringer's lactate solution.

15. The composition of claim 1 , wherein the mRNA comprises a sequence at least 90% identical to the polypeptide coding sequence of SEQ ID NO: 35 and further comprising at least at least a second different mRNA encoding a second antigenic polypeptide from RSV.

16. The composition according to claim 1 , wherein the mRNA comprises a sequence at least 95% identical to the polypeptide coding sequence of SEQ ID NO: 35.

17. The composition according to claim 1 , wherein the mRNA comprises a sequence at least 98% identical to the polypeptide coding sequence of SEQ ID NO: 35.

18. The composition according to claim 9 , wherein the cationic or polycationic compound comprises a cationic lipid.

19. The composition according to claim 15 , wherein the second different mRNA encoding the second antigenic polypeptide from RSV encodes a RSV F protein or an antigenic fragment thereof.

20. The composition according to claim 7 , wherein the mRNA comprises a sequence at least 95% identical to the polypeptide coding sequence of SEQ ID NO: 35.

Assignees

• Curevac Ag

Inventors

• Kramps Thomas
• Schnee Margit
• Voss Daniel
• Petsch Benjamin

Classifications

• C07K16/11

  Paramyxoviridae (F); Pneumoviridae (F), e.g. respiratory syncytial virus [RSV] · CPC title

• A61K39/12 Primary

  Viral antigens · CPC title

• C12N7/00

  Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) · CPC title

• C12N2760/18534

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• A61K2039/505

  comprising antibodies · CPC title