# US 2014/0193484 A1 · Influenza virus immunogenic compositions and uses thereof

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- Number: US 2014/0193484 A1
- Document ID: US20140193484A1
- Status: Published application
- Kind: A1
- Application number: 14/152,397
- Filed: 2014-01-10
- Published: 2014-07-10
- Earliest claimed: 2013-01-10
- Inventors: Sylvie Carine Bertholet Girardin; Andrew Geall
- Web page: https://patentgrep.com/patent/US20140193484A1

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A01K 67/0278: Knock-in vertebrates, e.g. humanised vertebrates
- A61K 9/127: Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
- A61P 31/16: for influenza or rhinoviruses
- A61P 37/04: Immunostimulants
- C12N 15/86: Viral vectors
- A01K 2217/072: maintaining or altering function, i.e. knock in
- C12N 2760/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16334: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/36143: viral genome or elements thereof as genetic vector
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A01K: ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Immunogenic compositions comprise a RNA component and a polypeptide component. The RNA component is a self-replicating RNA. The polypeptide component comprises an epitope from an influenza virus antigen (the first epitope), and the RNA component encodes a polypeptide which also comprises an epitope from an influenza virus antigen (the second epitope). Delivery of epitopes in these two different manners can enhance the immune response to influenza virus as compared to immunization with the RNA or the polypeptide alone.

## Claims

### Claim 1

An immunogenic composition comprising: (i) a self-replicating RNA molecule that encodes a first polypeptide antigen comprising a first epitope from an influenza virus antigen; and (ii) a second polypeptide antigen comprising a second epitope from an influenza virus antigen; wherein:
(a) the first and second epitopes are both from influenza hemagglutinin;
(b) the first and second epitopes are both from influenza A virus; and/or
(c) the first epitope and the second epitope are both from influenza B virus.

### Claim 2 (depends on 1)

The immunogenic composition of claim 1, wherein said first and second epitopes are both from an influenza A virus hemagglutinin.

### Claim 3 (depends on 2)

The immunogenic composition of claim 2, wherein said first and second epitopes are both from the same subtype of an influenza A virus hemagglutinin.

### Claim 4 (depends on 2)

The immunogenic composition of claim 2, wherein said first and second epitopes are both from influenza A virus H5 hemagglutinin.

### Claim 5 (depends on 3)

The immunogenic composition of claim 3, wherein said first and second epitopes are both from the same influenza A virus hemagglutinin.

### Claim 6 (depends on 1)

The immunogenic composition of claim 1, wherein said first and second epitopes are both from an influenza B virus hemagglutinin.

### Claim 7 (depends on 6)

The immunogenic composition of claim 6, wherein said first and second epitopes are both from the same lineage of an influenza B virus hemagglutinin.

### Claim 8 (depends on 7)

The immunogenic composition of claim 7, wherein said first and second epitopes are both from the same influenza B virus hemagglutinin.

### Claim 9 (depends on 1)

The immunogenic composition of claim 1, wherein said first and second epitopes are the same.

### Claim 10 (depends on 1)

The immunogenic composition of claim 1, wherein said first and second polypeptide antigens share at least two B-cell epitopes.

### Claim 11 (depends on 1)

The immunogenic composition of claim 1, wherein (a) said first and second polypeptide antigens share a common amino acid sequence which includes multiple epitopes and is 80 amino acids or longer e.g. 120 amino acids or longer, and/or (b) said first and second polypeptide antigens have at least 80% amino acid sequence identity to each other.

### Claim 12 (depends on 1)

The immunogenic composition of claim 1, wherein the self-replicating RNA is an alphavirus-derived RNA replicon.

### Claim 13 (depends on 1)

The immunogenic composition of claim 1, wherein the self-replicating RNA molecule comprises one or more modified nucleotides.

### Claim 14 (depends on 1)

The immunogenic composition of claim 1, including (i) liposomes (ii) non-toxic and biodegradable polymer microparticles or (iii) a cationic submicron oil-in-water emulsion.

### Claim 15 (depends on 1)

A method for treating or preventing influenza disease and/or infection, comprising administering to a subject in need thereof a therapeutically effective amount of a composition of claim 1.

### Claim 16 (depends on 1)

A method for inducing an immune response in a subject comprising administering to a subject in need thereof a therapeutically effective amount of the composition of claim 1.

### Claim 17

A kit comprising (a) a first kit component comprising a polypeptide that comprises an epitope from an influenza virus antigen, and (b) a second kit component comprising a self-replicating RNA which encodes a polypeptide that comprises an epitope from an influenza virus antigen.
