# US 2014/0193447 A1 · Functional influenza virus-like particles (vlps)

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- Number: US 2014/0193447 A1
- Document ID: US20140193447A1
- Status: Published application
- Kind: A1
- Application number: 14/149,365
- Filed: 2014-01-07
- Published: 2014-07-10
- Earliest claimed: 2003-07-11
- Assignees: Novavax, Inc.
- Applicants: Novavax, Inc.
- Inventors: Gale SMITH; Rick BRIGHT; Peter PUSHKO; Jinyou ZHANG; Kutub MAHMOOD
- Web page: https://patentgrep.com/patent/US20140193447A1

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/12: Viral antigens
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/16: for influenza or rhinoviruses
- C07K 14/005: from viruses
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12N 15/86: Viral vectors
- A61K 2039/5258: {Virus-like particles}
- A61K 2039/543: {intranasal}
- A61K 2039/55505: {Inorganic adjuvants}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2710/14143: viral genome or elements thereof as genetic vector
- C12N 2760/16023: Virus like particles [VLP]
- C12N 2760/16034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16071: Demonstrated in vivo effect
- C12N 2760/16122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2760/16123: Virus like particles [VLP]
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention discloses and claims virus like particles (VLPs) that express and/or contains seasonal influenza virus proteins, avian influenza virus proteins and/or influenza virus proteins from viruses with pandemic potential. The invention includes vector constructs comprising said proteins, cells comprising said constructs, formulations and vaccines comprising VLPs of the inventions. The invention also includes methods of making and administrating VLPs to vertebrates, including methods of inducing substantial immunity to either seasonal and avian influenza, or at least one symptom thereof.

## Claims

### Claim 1

A vaccine comprising an influenza virus-like particle (VLP) and a pharmaceutically acceptable carrier or excipient, wherein the VLP comprises influenza M1, HA and NA proteins, wherein the vaccine induces substantial immunity to influenza virus infection in an animal susceptible to influenza,
wherein the M1 protein is derived from the influenza strain A/Indonesia/5/05,
wherein the HA protein is an H7 protein, and
wherein the NA protein is an N9 protein.

### Claim 2 (depends on 1)

The vaccine of claim 1, wherein the HA protein exhibits hemagglutinin activity.

### Claim 3 (depends on 1)

The vaccine of claim 1, wherein the NA protein exhibits neuraminidase activity.

### Claim 4 (depends on 1)

The vaccine of claim 1, wherein the animal is a human.

### Claim 5 (depends on 1)

The vaccine of claim 1, wherein the influenza VLP further comprises an adjuvant.

### Claim 6 (depends on 5)

The vaccine of claim 5, wherein the adjuvant comprises paucilamellar nonphospholipid vesicles.

### Claim 7 (depends on 1)

The vaccine of claim 1, wherein the vaccine further comprises a second VLP, wherein the second VLP comprises a non-H7 HA protein, a non-N9 NA protein, and an M1 protein derived from the influenza strain A/Indonesia/5/05.

### Claim 8 (depends on 1)

The vaccine of claim 1, wherein the VLP proteins consist essentially of influenza M1, HA and NA proteins.

### Claim 9 (depends on 1)

The vaccine of claim 1, wherein the VLP proteins consist of influenza M1, HA and NA proteins.

### Claim 10 (depends on 1)

The vaccine of claim 1 wherein the M1 protein comprises SEQ ID NO: 49.

### Claim 11

A method of formulating a vaccine that induces substantial immunity to influenza virus infection to an animal susceptible to influenza, comprising adding an effective dose of an influenza virus-like particle (VLP) to a pharmaceutically acceptable carrier or excipient, wherein the VLP comprises influenza M1, HA and NA proteins, wherein the vaccine induces substantial immunity to influenza virus infection to the animal
wherein the M1 protein is derived from the influenza strain A/Indonesia/5/05,
wherein the HA protein is an H7 protein, and
wherein the NA protein is an N9 protein.

### Claim 12 (depends on 11)

The method of claim 11, wherein the VLP proteins consist essentially of influenza M1, HA and NA proteins.

### Claim 13 (depends on 11)

The method of claim 11, wherein the VLP proteins consist of influenza M1, HA and NA proteins.

### Claim 14 (depends on 11)

The method of claim 11, wherein the influenza VLP has been treated to inactivate baculovirus.

### Claim 15 (depends on 14)

The method of claim 14, wherein the inactivation treatment comprises incubating a sample comprising VLPs in about 0.2% of β-propyl lactone (BPL) for about 3 hours at about 25° C.

### Claim 16 (depends on 11)

The method of claim 11 wherein the M1 protein comprises SEQ ID NO: 49.

### Claim 17

A virus-like particle (VLP) comprising an influenza virus M1 protein, an influenza virus H7 hemagglutinin protein, and an influenza virus N9 neuraminidase protein, wherein the M1 protein is derived from the influenza strain A/Indonesia/5/05.

### Claim 18 (depends on 17)

The VLP of claim 17, wherein the VLP proteins consist essentially of influenza M1, HA and NA proteins.

### Claim 19 (depends on 17)

The VLP of claim 17, wherein the VLP proteins consist of influenza M1, HA and NA proteins.

### Claim 20 (depends on 17)

The VLP of claim 17, wherein the VLP is expressed from a eukaryotic cell comprising one or more nucleic acids encoding the H7, N9 and M1 proteins under conditions that permit the formation of VLPs.

### Claim 21 (depends on 20)

The VLP of claim 20, wherein the eukaryotic cell is selected from the group consisting of yeast, insect, amphibian, avian and mammalian cells.

### Claim 22 (depends on 20)

The VLP of claim 20, wherein the eukaryotic cell is an insect cell.

### Claim 23 (depends on 22)

The VLP of claim 22, wherein the insect cell is Sf9.

### Claim 24 (depends on 17)

The VLP of claim 17, wherein the VLP elicits neutralizing antibodies in a human or animal that are protective against influenza infection when administered to the human or animal.

### Claim 25 (depends on 17)

The VLP of claim 17, wherein the M1 protein comprises SEQ ID NO: 49.