# US 12,076,352 B2 · Immunogenic composition

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- Number: US 12,076,352 B2
- Document ID: US12076352B2
- Status: Granted
- Kind: B2
- Application number: 16/973,471
- Filed: 2019-06-18
- Published: 2021-08-19
- Granted: 2024-09-03
- Earliest claimed: 2018-06-19
- Assignees: Glaxosmithkline Biologicals SA
- Applicants: Glaxosmithkline Biologicals SA
- Inventors: Christiane Marie-Paule Simone Jeanne Feron; Sandra Giannini
- Web page: https://patentgrep.com/patent/US12076352B2

## CPC

- A61K 35/76: Viruses; Subviral particles; Bacteriophages
- C07K 14/195: from bacteria
- C07K 14/285: from Pasteurellaceae (F), e.g. Haemophilus influenza
- C07K 14/33: from Clostridium (G)
- 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
- C07K 2319/02: containing a signal sequence
- C07K 2319/036: targeting to the medium outside of the cell, e.g. type III secretion
- C12N 2795/00034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2795/00043: viral genome or elements thereof as genetic vector
- C12N 2800/24: Vectors characterised by the absence of particular element, e.g. selectable marker, viral origin of replication
- C12N 2820/55: from bacteria
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention discloses an engineered bacteriophage capable of binding to a commensal bacterium and inserting its genome polynucleotide into the commensal bacterium, but incapable of producing progeny, incapable of carrying out a lysogenic cycle and incapable of carrying out a lytic cycle within the commensal bacterium, wherein the engineered bacteriophage comprises a genome polynucleotide including at least one gene encoding at least one heterologous antigen(s) under the control of a promoter.

## Claims

### Claim 1

An engineered bacteriophage capable of binding to a commensal bacterium and inserting its genome polynucleotide into the commensal bacterium, but incapable of producing progeny, incapable of carrying out a lysogenic cycle and incapable of carrying out a lytic cycle within the commensal bacterium, wherein the engineered bacteriophage comprises a genome polynucleotide including at least one gene encoding at least one heterologous antigen(s) under the control of a promoter and the genome polynucleotide is engineered to delete all genes encoding lytic machinery proteins.

### Claim 2 (depends on 1)

The engineered bacteriophage of claim 1 wherein the commensal bacterium is a part of skin, genital, oral or gut microbiome.

### Claim 3 (depends on 2)

The engineered bacteriophage of claim 2 wherein the commensal bacterium is Propionibacterium acnes, Staphylococcus epidermidis, Lactobacillus, Streptococcus gordonii or Escherichia coli.

### Claim 4 (depends on 3)

The engineered bacteriophage of claim 3 wherein the commensal bacterium is a E. coli bacterium and is part of the gut microbiome.

### Claim 5 (depends on 3)

The engineered bacteriophage of claim 3 wherein the commensal bacterium is S. epidermidis or P. acnes and is part of the skin microbiome.

### Claim 6 (depends on 3)

The engineered bacteriophage of claim 3 wherein the commensal bacterium is Lactobacillus and is part of the genital microbiome.

### Claim 7 (depends on 3)

The engineered bacteriophage of claim 3 wherein the commensal bacterium is Streptococcus gordonii and is part of the oral microbiome.

### Claim 8 (depends on 1)

The engineered bacteriophage of claim 1 wherein the genome polynucleotide is engineered to remove at least one gene encoding a capsid protein.

### Claim 9 (depends on 1)

The engineered bacteriophage of claim 1 wherein the genome polynucleotide is engineered to delete at least one gene encoding a lysogeny machinery protein.

### Claim 10 (depends on 1)

The engineered bacteriophage of claim 1 wherein the genome polynucleotide retains the origin of replication.

### Claim 11 (depends on 1)

The engineered bacteriophage of claim 1 wherein the genome polynucleotide retains a phage origin of replication.

### Claim 12 (depends on 1)

The engineered bacteriophage of claim 1 wherein the genome polynucleotide contains a bacterial origin of replication.

### Claim 13

An engineered bacteriophage genome polynucleotide comprising a heterologous antigen gene encoding a heterologous antigen under the control of a promoter wherein the engineered bacteriophage genome polynucleotide is engineered to delete at least one gene encoding a capsid protein, and all genes encoding lytic machinery proteins, and optionally at least one gene encoding a lysogeny machinery protein, wherein when the engineered bacteriophage genome polynucleotide is packaged into a bacteriophage, the resulting bacteriophage is capable of binding to a commensal bacterium and inserting the engineered bacteriophage genome polynucleotide into the commensal bacterium, but is incapable of producing progeny, incapable of carrying out a lysogenic cycle and incapable of carrying out the lytic cycle within a commensal bacterium.

### Claim 14 (depends on 1)

A pharmaceutical composition comprising the engineered bacteriophage claim 1.

### Claim 15 (depends on 1)

An engineered bacteriophage according to claim 1 for use in the prophylactic prevention of disease, optionally infectious disease or cancer.

### Claim 16 (depends on 13)

A pharmaceutical composition comprising the engineered bacteriophage genome polynucleotide of claim 13.

### Claim 17 (depends on 13)

An engineered bacteriophage genomic polynucleotide according to claim 13 for use in the prophylactic prevention of disease, optionally infectious disease or cancer.
