IP Library › Granted Patent US 12,569,549
Granted Patent B2
US 12,569,549 · App. 18/403,883 · Granted Mar 10, 2026

Flavivirus vaccine

Inventors: Patrick Baumhof (Tübingen, DE); Wolfgang Grosse (Tübingen, DE); Edith Jasny (Tübingen, DE); Thomas Kramps (Tübingen, DE); Daniel Voss (Tübingen, DE); Julia Dannenmaier (Tübingen, DE); Valérie Lecouturier (Chazay d'Azergues, FR); Yves Girerd-Chambaz (Messimy, FR)
Assignees: CureVac SE; Sanofi Pasteur
A61K39/12A61P31/14A61K2039/53A61K2039/575A61K2039/6031C12N2770/24134
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Quick Facts
Patent No.
US 12,569,549
App. No.
18/403,883
Granted
Mar 10, 2026
Kind
B2
Abstract

The present invention is directed to an artificial nucleic acid and to a polypeptide suitable for use in the treatment or prophylaxis of an infection with a flavivirus, in particular an infection with yellow fever virus or with dengue virus, or of a disorder related to such an infection. The present invention is also directed to a composition, preferably an immunogenic composition, comprising the artificial nucleic acid or the inventive polypeptide. In particular, the present invention concerns an immunogenic composition against a flavivirus, such as yellow fever virus or dengue virus. Further, the invention concerns a kit, particularly a kit of parts, comprising the artificial nucleic acid, polypeptide or (immunogenic) composition. The invention is further directed to a method of treating or preventing a disorder or a disease, first and second medical uses of the artificial nucleic acid, polypeptide, composition, in particular the first and second medical uses of the immunogenic composition according to the invention.

Claims (28)

1 . A pharmaceutical formulation comprising RNA formulated in a lipid nanoparticle (LNP), said RNA comprising

a) at least one coding region encoding at least one polypeptide comprising a yellow fever virus premembrane protein (prM) and a yellow fever virus envelope protein (E), wherein said at least one coding region is at least 90% identical to the RNA sequence of SEQ ID NO: 155; and

b) an untranslated region (UTR) comprising at least one heterologous UTR element, wherein said LNP comprises: (i) at least one cationic lipid; (ii) a neutral lipid; (iii) a sterol;

and (iv) a PEG-lipid.

2 . The pharmaceutical formulation according to claim 1 , wherein the at least one encoded polypeptide further comprises a yellow fever virus non-structural protein or a flavivirus capsid protein (C).

3 . The pharmaceutical formulation according to claim 2 , wherein the at least one encoded polypeptide further comprises at least one amino acid sequence that promotes self-cleavage of the encoded polypeptide.

4 . The pharmaceutical formulation according to claim 1 , wherein the at least one encoded polypeptide comprises at least one signal sequence, wherein the at least one signal sequence is a signal sequence of a secretory protein or a signal sequence of a membrane protein.

5 . The pharmaceutical formulation according to claim 1 , wherein the at least one encoded polypeptide further comprises at least one amino acid sequence that promotes virus-like particle (VLP) formation.

6 . The pharmaceutical formulation according to claim 5 , wherein the amino acid sequence promoting virus-like particle (VLP) formation is from a hepatitis B virus core antigen.

7 . The pharmaceutical formulation according to claim 1 , wherein the at least one encoded polypeptide further comprises at least one amino acid sequence that promotes antigen clustering.

8 . The pharmaceutical formulation according to claim 1 , wherein the at least one encoded polypeptide comprises a mutated furin cleavage site.

9 . The pharmaceutical formulation according to claim 1 , wherein the RNA is an mRNA.

10 . The pharmaceutical formulation according to claim 1 , further comprising a histone stem-loop, a 3′-UTR element, a 5′-UTR element, a poly (A) sequence, and/or a poly(C) sequence.

11 . The pharmaceutical formulation according to claim 1 , wherein the coding region encodes a polypeptide comprising a sequence that is at least 95% identical to the amino acid sequence of SEQ ID NO: 51.

12 . The pharmaceutical formulation according to claim 1 , wherein the coding region comprises a sequence that is at least 95% identical to the RNA sequence of SEQ ID NO: 155.

13 . The pharmaceutical formulation according to claim 1 , wherein the LNP comprises (i) the cationic lipid; (ii) the neutral lipid; (iii) the sterol; and (iv) the PEG-lipid, in a molar ratio of about 20-60% cationic lipid: 5-25% neutral lipid: 25-55% sterol; and 0.5-15% PEG-lipid.

14 . The pharmaceutical formulation according to claim 13 , wherein the PEG-lipid is PEG-DMG or PEG-cDMA.

15 . A kit or kit of parts comprising the pharmaceutical formulation according to claim 1 , and comprising technical instructions providing information on administration and dosage of the components.

16 . A method for treating or preventing a yellow fever virus infection comprising administering the pharmaceutical formulation of claim 1 to a patient in need thereof.

17 . The method of claim 16 , wherein the composition is administered by intramuscular injection.

18 . A pharmaceutical formulation comprising RNA formulated in a lipid nanoparticle (LNP), said RNA comprising

a) a 5′ Cap;

b) a 5′ untranslated region (UTR);

c) at least one coding region encoding a polypeptide comprising a sequence that is at least 95% identical to the amino acid sequence of SEQ ID NO: 51, wherein said at least one coding region is at least 90% identical to the RNA sequence of SEQ ID NO: 155;

d) a 3′ UTR; and

e) a poly(A) sequence,

wherein said LNP comprises: (i) at least one cationic lipid; (ii) a neutral lipid; (iii) a sterol; and (iv) a PEG-lipid.

19 . A method of inducing an anti-Yellow fever virus (YFV) immune response in a mammalian subject comprising administering to the subject a pharmaceutical formulation of claim 18 , wherein the pharmaceutical formulation is administered by injection and wherein upon administration the pharmaceutical formulation induces a YFV neutralizing antibody response in the subject.

Assignments (1)
CHANGE OF NAME Recorded May 21, 2026
From: SANOFI PASTEUR
To: SANOFI R&D VACCINS
Reel/Frame 075607/0416 →
Priority Claims (1)
EP 17207141 · Dec 13, 2017 · regional
Continuity (2)
Division 16772131
Related Publication 20240131142A1 · Apr 25, 2024
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