# US 2021/0330786 A1 · Compositions comprising bacterial strains

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- Number: US 2021/0330786 A1
- Document ID: US20210330786A1
- Status: Published application
- Kind: A1
- Application number: 17/176,791
- Filed: 2021-02-16
- Published: 2021-10-28
- Earliest claimed: 2018-08-17
- Assignees: 4D Pharma Research Limited
- Applicants: 4D Pharma Research Limited
- Inventors: IMKE ELISABETH MULDER; MARSILIO ADRIANI; AMY BETH HOLT; MARIA CHRISTOFI; PHILIP COWIE; EMMA RAFTIS; DELPHINE LOUISE CLAUDETTE LAUTE-CALY; EMMA ELIZABETH CLARE HENNESSY; SUAAD AHMED; ANNA ETTORRE
- Web page: https://patentgrep.com/patent/US20210330786A1

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 35/745: Bifidobacteria
- A61P 37/04: Immunostimulants
- A61K 2035/115: {Probiotics}
- A61K 2039/55594: {from bacteria}
- 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

## Abstract

The invention provides a composition comprising a bacterial strain for use in stimulating the immune system in a subject.

## Claims

### Claim at position 1

-30. (canceled)

### Claim 31

A method of enhancing an immune response to an antigen in a subject in need thereof comprising administering to the subject a composition comprising a bacterial strain of the species Bifidobacterium breve, wherein the bacterial strain comprises a 16s rRNA gene sequence having at least 95% sequence identity to the sequence of SEQ ID NO: 1.

### Claim 32 (depends on 31)

The method of claim 31, wherein the antigen comprises a viral antigen, a bacterial antigen, a fungal antigen, a parasite antigen, or a tumor antigen.

### Claim 33 (depends on 32)

The method of claim 32, wherein the viral antigen is an antigen of a virus selected from the group consisting of influenza virus, human immunodeficiency virus (HIV), hepatitis B virus, herpes simplex virus, rabies, respiratory syncytial virus, cytomegalovirus, a coronavirus, varicella zoster virus, Epstein Barr virus, and human papillomavirus.

### Claim 34 (depends on 31)

The method of claim 31, wherein the subject has a disease caused by a pathogen from which the antigen is derived.

### Claim 35 (depends on 31)

The method of claim 31, wherein the subject has a disease caused by a coronavirus.

### Claim 36 (depends on 31)

The method of claim 31, wherein the bacterial strain expresses EPS on its surface.

### Claim 37 (depends on 31)

The method of claim 31, wherein the bacterial strain expresses pullulanase.

### Claim 38 (depends on 31)

The method of claim 31, wherein the bacterial strain has a biochemical profile that is positive for fermentation of one or more of α-galactosidase, β-galactosidase, α-glucosidase and β-glucosidase, α-arabinose, mannose, and raffinose as determined by an Analytical Profile Index test.

### Claim 39 (depends on 31)

The method of claim 31, wherein the immune response comprises an immune response to a vaccine comprising the antigen.

### Claim 40 (depends on 31)

The method of claim 31, wherein the bacterial strain stimulates TLR2 or NFκB and/or increases the expression level and/or activity of IL-12p70, IL-12p70, IFNγ, IL-4, TNF-α and/or IL-17α.

### Claim 41 (depends on 31)

The method of claim 31, wherein the bacterial strain comprises a 16s rRNA gene sequence having at least 98% sequence identity to the sequence of SEQ ID NO: 1, as determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12 and a gap extension penalty of 2.

### Claim 42 (depends on 31)

The method of claim 31, wherein the bacterial strain comprises a 16s rRNA gene sequence of SEQ ID NO: 1.

### Claim 43 (depends on 31)

The method of claim 31, wherein the bacterial strain is the strain deposited under accession number 42380 at NCIMB.

### Claim 44 (depends on 31)

The method of claim 31, wherein the sequence identity is determined by a Smith-Waterman homology search algorithm using an affine gap search with a gap open penalty of 12 and a gap extension penalty of 2.

### Claim 45

A method of treating an immunodeficiency in a subject in need thereof comprising administering to the subject a composition comprising a bacterial strain of the species Bifidobacterium breve, wherein the bacterial strain comprises a 16s rRNA gene sequence having at least 95% sequence identity to the sequence of SEQ ID NO: 1.

### Claim 46 (depends on 45)

The method of claim 45, wherein the immunodeficiency comprises a primary immunodeficiency disease or a secondary immunodeficiency disease.

### Claim 47 (depends on 46)

The method of claim 46, wherein the primary immunodeficiency disease comprises X linked agammaglobulinemia (XLA), chronic granulomatous disease (CGD), common variable immunodeficiency (CVID), or severe combined immunodeficiency (SCID).

### Claim 48 (depends on 46)

The method of claim 46, wherein the secondary immunodeficiency disease comprises AIDS, a cancer of the immune system, or an immune-complex disease.

### Claim 49

A method of stimulating the immune system in a subject in need thereof comprising administering to the subject a composition comprising a bacterial strain of the species Bifidobacterium breve, wherein the bacterial strain comprises a 16s rRNA gene sequence having at least 95% sequence identity to the sequence of SEQ ID NO: 1, wherein the subject has a disease or a condition that is treatable by stimulating the immune system.

### Claim 50 (depends on 49)

The method of claim 49, wherein the disease or the condition is caused by a coronavirus.