# US 11,439,702 B2 · Influenza peptides and compositions

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- Number: US 11,439,702 B2
- Document ID: US11439702B2
- Status: Granted
- Kind: B2
- Application number: 17/013,000
- Filed: 2020-09-04
- Published: 2020-12-24
- Granted: 2022-09-13
- Earliest claimed: 2006-02-07
- Assignees: PepTcell Limited
- Applicants: PepTcell Limited
- Inventors: Gregory A. Stoloff; Wilson Romero Caparros-Wanderley
- Web page: https://patentgrep.com/patent/US11439702B2

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/12: Viral antigens
- A61P 31/16: for influenza or rhinoviruses
- A61P 37/02: Immunomodulators
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- C07K 7/08: having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68)
- C07K 14/005: from viruses
- C07K 14/11: Orthomyxoviridae, e.g. influenza virus
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2}
- A61K 2039/572: {cytotoxic response}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2760/16122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16171: Demonstrated in vivo effect
- C12N 2760/16222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2760/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16271: Demonstrated in vivo effect
- 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 specification discloses recombinant nucleic acid constructs encoding an immunogenic multiepitope polypeptide comprising two or more polypeptides, recombinant nucleic acid constructs encoding at least two epitopes from two or more internal proteins of influenza virus, compositions comprising such recombinant nucleic acid constructs and methods of eliciting a T cell immune response against an influenza virus in a vertebrate using such recombinant nucleic acid constructs and compositions.

## Claims

### Claim 1

A polypeptide composition, the composition comprising an adjuvant and one or more isolated polypeptides, each of the one or more isolated polypeptides being from 8 to 50 amino acids in length,
wherein the one or more isolated polypeptides include
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 1 or a fragment of SEQ ID NO: 1 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 1,
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 2 or a fragment of SEQ ID NO: 2 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 2,
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 3 or a fragment of SEQ ID NO: 3 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 3,
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 4 or a fragment of SEQ ID NO: 4 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 4,
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 5 or a fragment of SEQ ID NO: 5 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 5, and
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 6 or a fragment of SEQ ID NO: 6 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 6,
wherein, the one or more polypeptides are immunogenic to one or more influenza strains in a vertebrate expressing a major histocompatibility complex (MHC) allele, and wherein the one or more isolated polypeptides are not a complete influenza virus protein.

### Claim 2 (depends on 1)

The composition according to claim 1, wherein the one or more isolated polypeptides each comprises a cytotoxic T lymphocyte (CTL) epitope.

### Claim 3 (depends on 1)

The composition according to claim 1, wherein the one or more polypeptides comprise
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 1,
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 2,
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 3,
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 4,
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 5, and
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 6.

### Claim 4 (depends on 3)

The composition according to claim 3, wherein the one or more polypeptides comprise
a polypeptide comprising SEQ ID NO: 1,
a polypeptide comprising SEQ ID NO: 2,
a polypeptide comprising SEQ ID NO: 3,
a polypeptide comprising SEQ ID NO: 4,
a polypeptide comprising SEQ ID NO: 5, and
a polypeptide comprising SEQ ID NO: 6.

### Claim 5 (depends on 4)

The composition according to claim 4, wherein the one or more polypeptides comprise a polypeptide of SEQ ID NO: 1, a polypeptide of SEQ ID NO: 2, a polypeptide of SEQ ID NO: 3, a polypeptide of SEQ ID NO: 4, a polypeptide of SEQ ID NO: 5, and a polypeptide of SEQ ID NO: 6.

### Claim 6 (depends on 1)

The composition according to claim 1, wherein each of the one or more isolated polypeptides are in an amount of 1 pg to 100 g.

### Claim 7 (depends on 1)

The composition according to claim 1, wherein the adjuvant in incomplete Freund's adjuvant.

### Claim 8 (depends on 1)

The composition according to claim 1, which is immunogenic to a plurality of influenza virus strains.

### Claim 9 (depends on 1)

The composition according to claim 1, wherein the one or more influenza strains includes an influenza A strain, an influenza B strain, or both an influenza A strain and an influenza B strain.

### Claim 10

A polypeptide composition, the composition comprising an adjuvant and one or more isolated polypeptides, each of the one or more isolated polypeptides being from 8 to 50 amino acids in length,
wherein the one or more isolated polypeptides include
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 1 or a fragment of SEQ ID NO: 1 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 1,
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 3 or a fragment of SEQ ID NO: 3 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 3,
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 4 or a fragment of SEQ ID NO: 4 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 4, and
a polypeptide comprising an amino acid sequence with 95% or more sequence identity to the amino acid sequence of SEQ ID NO: 6 or a fragment of SEQ ID NO: 6 having 8 or more consecutive amino acids from the amino acid sequence of SEQ ID NO: 6,
wherein, the one or more polypeptides are immunogenic to one or more influenza strains in a vertebrate expressing a major histocompatibility complex (MHC) allele, and wherein the one or more isolated polypeptides are not a complete influenza virus protein.

### Claim 11 (depends on 10)

The composition according to claim 10, wherein the one or more polypeptides comprise
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 1,
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 3,
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 4, and
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 6.

### Claim 12 (depends on 11)

The composition according to claim 11, wherein the one or more polypeptides comprise
a polypeptide comprising SEQ ID NO: 1,
a polypeptide comprising SEQ ID NO: 3,
a polypeptide comprising SEQ ID NO: 4, and
a polypeptide comprising SEQ ID NO: 6.

### Claim 13 (depends on 12)

The composition according to claim 12, wherein the one or more polypeptides comprise a polypeptide of SEQ ID NO: 1, a polypeptide of SEQ ID NO: 3, a polypeptide of SEQ ID NO: 4, and a polypeptide of SEQ ID NO: 6.

### Claim 14 (depends on 10)

The composition according to claim 10, further comprising
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 2 or a fragment of SEQ ID NO: 2 having 8 or more consecutive amino acids from SEQ ID NO: 2, and
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 5 or a fragment of SEQ ID NO: 5 having 8 or more consecutive amino acids from SEQ ID NO: 5.

### Claim 15 (depends on 10)

The composition according to claim 10, further comprising
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 2, and
a polypeptide comprising an amino acid sequence with 95% or more amino acid sequence identity to SEQ ID NO: 5.

### Claim 16 (depends on 10)

The composition according to claim 10, further comprising
a polypeptide comprising SEQ ID NO: 2, and
a polypeptide comprising SEQ ID NO: 5.

### Claim 17 (depends on 10)

The composition according to claim 10, further comprising
a polypeptide of SEQ ID NO: 2, and
a polypeptide of SEQ ID NO: 5.

### Claim 18 (depends on 10)

The composition according to claim 10, wherein each of the one or more isolated polypeptides are in an amount of 1 μg to 100 g.

### Claim 19 (depends on 10)

The composition according to claim 10, wherein the adjuvant in incomplete Freund's adjuvant.

### Claim 20 (depends on 10)

The composition according to claim 10, which is immunogenic to a plurality of influenza virus strains.

### Claim 21 (depends on 10)

The composition according to claim 10, wherein the one or more influenza strains includes an influenza A strain, an influenza B strain, or both an influenza A strain and an influenza B strain.
