P7 Containing Nucleoside-modified mRNA-lipid Nanoparticle Lineage Vaccine for Hepatitis C Virus

Patent metadata

Field	Value
Publication number	US-2024358821-A1
Application number	US-202218577550-A
Country	US
Kind code	A1
Filing date	Jul 6, 2022
Priority date	Jul 6, 2021
Publication date	Oct 31, 2024
Grant date	—

Abstract

Described are compositions comprising a nucleoside-modified RNA molecules encoding a HCV p7 protein in combination with at least one additional HCV antigen, adjuvant, or a combination thereof, and their use for inducing an immune response against HCV.

First claim

What is claimed is:

1 . A composition for inducing an immune response against Hepatitis C virus (HCV) in a subject, the composition comprising at least one nucleoside-modified RNA molecule encoding a p7 viral protein and further encoding at least one HCV antigen.

2 . The composition of claim 1 , wherein the at least one nucleoside-modified RNA molecule comprises one or more pseudouridine or 1-methyl-pseudouridine.

3 . The composition of claim 1 , wherein the at least one nucleoside-modified RNA molecule is a purified mRNA molecule.

4 . The composition of claim 1 , wherein the at least one HCV antigen comprises at least one HCV antigen selected from the group consisting of envelope protein E1 (E1), envelope protein E2 (E2), and core protein (C).

5 . The composition of claim 1 , wherein the nucleoside-modified RNA molecule encodes HCV C, E1, E2 and p7.

6 . The composition of claim 5 , wherein the mRNA molecule is encoded by a DNA sequence selected from the group consisting of: SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and SEQ ID NO: 10.

7 . The composition of claim 1 , wherein the composition further comprises an adjuvant.

8 . The composition of claim 1 , wherein the at least one nucleoside-modified RNA molecule further encodes at least one adjuvant.

9 . The composition of claim 1 , wherein the composition comprises a lipid nanoparticle (LNP) encapsulating the isolated nucleoside-modified RNA molecule.

10 . The composition of claim 1 , wherein the composition is a vaccine.

11 . A lineage vaccine comprising two or more LNPs, wherein each LNP comprises at least one nucleoside-modified RNA molecule encoding a p7 viral protein and further encoding at least one HCV antigen.

12 . The lineage vaccine of claim 11 , wherein each LNP of the lineage vaccine comprises a nucleoside-modified RNA molecule encoding a p7 viral protein and further encoding at least one HCV antigen of a single lineage.

13 . A method of inducing an adaptive immune response against Hepatitis C virus (HCV) in a subject comprising administering to the subject an effective amount of a composition comprising at least one nucleoside-modified RNA molecule encoding a p7 viral protein and further encoding at least one HCV antigen.

14 . The method of claim 13 , wherein the at least one nucleoside-modified RNA molecule comprises one or more pseudouridine or 1-methyl-pseudouridine.

15 . The method of claim 13 , wherein the at least one nucleoside-modified RNA molecule is a purified mRNA molecule.

16 . The method of claim 13 , wherein the at least one HCV antigen comprises at least one HCV antigen selected from the group consisting of envelope protein E1 (E1), envelope protein E2 (E2), and core protein (C).

17 . The method of claim 13 , wherein the nucleoside-modified RNA molecule encodes HCV C, E1, E2 and p7.

18 . The method of claim 13 , wherein the mRNA molecule is encoded by a DNA sequence selected from the group consisting of: SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and SEQ ID NO: 10.

19 . The method of claim 13 , wherein the composition further comprises an adjuvant.

20 . The method of claim 13 , wherein the at least one nucleoside-modified RNA molecule further encodes at least one adjuvant.

21 . The method of claim 13 , wherein the composition comprises a lipid nanoparticle (LNP) encapsulating the isolated nucleoside-modified RNA molecule.

22 . The method of claim 13 , wherein the method further comprises administering to the subject an effective amount of an adjuvant.

23 . The method of claim 13 , wherein the composition is administered by a delivery route selected from the group consisting of intradermal, subcutaneous, inhalation, intranasal, and intramuscualar.

24 . The method of claim 13 , wherein the method comprises a single administration of the composition.

25 . The method of claim 13 , wherein the method comprises multiple administrations of the composition.

28 . The method of claim 13 , wherein the method treats or prevents an infection, disease, or disorder associated with HCV in the subject.

Assignees

• Univ Pennsylvania

Inventors

• Reagan Erin Kathleen
• Weissman Drew

Classifications

• A61K39/12

  Viral antigens · CPC title

• C12N2770/24234

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

• C12N2770/24222

  New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes · 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

• A61K2039/55555

  Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers · CPC title