# US 10,864,265 B2 · Lentiviral vectors for expression of hepatitis B virus (HBV) antigens

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- Number: US 10,864,265 B2
- Document ID: US10864265B2
- Status: Granted
- Kind: B2
- Application number: 16/320,772
- Filed: 2017-07-20
- Published: 2019-05-30
- Granted: 2020-12-15
- Earliest claimed: 2016-07-27
- Assignees: Theravectys
- Applicants: Theravectys
- Inventors: Mohamad Jamiluddin; Ana Bejanariu; Emeline Sarry
- Web page: https://patentgrep.com/patent/US10864265B2

## CPC

- A61K 39/29: Hepatitis virus
- A61K 39/292: {Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen}
- A61P 31/14: for RNA viruses
- C12N 15/86: Viral vectors
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/5258: {Virus-like particles}
- C07K 2319/00: Fusion polypeptide
- C12N 2740/15011: Lentivirus, not HIV, e.g. FIV, SIV
- C12N 2740/15043: viral genome or elements thereof as genetic vector
- C12N 2740/16011: Human Immunodeficiency Virus, HIV
- C12N 2740/16043: viral genome or elements thereof as genetic vector
- C12N 2799/027: where the vector is derived from a retrovirus
- C12N 2840/203: having an IRES
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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)

## Abstract

The invention relates to nucleic acids, including lentiviral vectors and lentiviral vector particles, encoding at least one Hepatitis B virus (HBV) envelop surface of genotypes A and/or C antigen, at least one polymerase of genotypes A and/or C antigen, at least one HBX protein of genotypes A and/or C antigen, at least one HBV consensus core of genotypes A and/or C antigen, and at least one HBV consensus core MHCI and MHCII epitopes of genotypes A and/or C antigen. The invention encompasses these lentiviral vectors and lentiviral vector particles, methods of making the vectors, and their use, including medicinal uses. The lentiviral vectors and lentiviral vector particles are for use in administering to humans to induce immune responses against the HBV antigens.

## Claims

### Claim 1

A lentiviral vector encoding:
at least one Hepatitis B virus (HBV) envelop surface of genotype A antigen, genotype C antigen or genotypes A and C antigen,
at least one polymerase of genotype A antigen, genotype C antigen or genotypes A and C antigen,
at least one HBX protein of genotype A antigen, genotype C antigen or genotypes A and C antigen,
at least one HBV consensus core of genotype A antigen, genotype C antigen or genotypes A and C antigen, and
at least one HBV consensus core MHCI and/or MHCII epitope of genotype A antigen, genotype C antigen or genotypes A and C antigen.

### Claim 2 (depends on 1)

The lentiviral vector of claim 1, wherein the lentiviral vector encodes at least the amino acid sequence of SEQ ID NO:24.

### Claim 3 (depends on 1)

The lentiviral vector of claim 1, wherein the vector encodes at least the amino acid sequence of SEQ ID NO:25.

### Claim 4 (depends on 1)

The lentiviral vector according to claim 1, wherein the lentiviral vector encodes at least the amino acid sequence of SEQ ID NO:24 and at least the amino acid sequence of SEQ ID NO:25.

### Claim 5 (depends on 1)

The lentiviral vector according to claim 1, wherein the lentiviral vector comprises a β2-microglobulin promoter.

### Claim 6 (depends on 1)

The lentiviral vector according to claim 1, wherein the lentiviral vector is a DNA.

### Claim 7

A lentiviral vector particle encoding:
at least one Hepatitis B virus (HBV) envelop surface of genotype A antigen, genotype C antigen or genotypes A and C antigen,
at least one polymerase of genotype A antigen, genotype C antigen or genotypes A and C antigen,
at least one HBX protein of genotype A antigen, genotype C antigen or genotypes A and C antigen,
at least one HBV consensus core of genotype A antigen, genotype C antigen or genotypes A and C antigen, and
at least one HBV consensus core MHCI and/or MHCII epitope of genotype A antigen, genotype C antigen or genotypes A and C antigen.

### Claim 8 (depends on 7)

The lentiviral vector particle according to claim 7, wherein the vector encodes the amino acid sequence of SEQ ID NO:24.

### Claim 9 (depends on 7)

The lentiviral vector particle according to claim 7, wherein the vector encodes the amino acid sequence of SEQ ID NO:25.

### Claim 10 (depends on 7)

The lentiviral vector particle according to claim 7, wherein the vector encodes at least the amino acid sequence of SEQ ID NO:24 and at least the amino acid sequence of SEQ ID NO:25.

### Claim 11 (depends on 7)

The lentiviral vector particle according to claim 7, wherein the lentiviral vector particle comprises a functional lentiviral integrase protein.

### Claim 12 (depends on 7)

The lentiviral vector particle according to claim 7, wherein the lentiviral vector particle comprises a vesicular stomatitis virus glycoprotein.

### Claim 13 (depends on 7)

The lentiviral vector particle according to claim 7, wherein the lentiviral vector particle comprises HIV-1 subtype D Gag and Pol proteins.

### Claim 14 (depends on 1)

An isolated cell comprising the lentiviral vector according to claim 1.

### Claim 15 (depends on 1)

A composition comprising a lentiviral vector according to claim 1.

### Claim 16 (depends on 7)

An isolated cell comprising the lentiviral vector particle according to claim 7.

### Claim 17 (depends on 7)

A composition comprising a lentiviral vector according to claim 7.