# US 12,109,243 B2 · Bacterial extracellular vesicles

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- Number: US 12,109,243 B2
- Document ID: US12109243B2
- Status: Granted
- Kind: B2
- Application number: 18/074,122
- Filed: 2022-12-02
- Published: 2023-07-06
- Granted: 2024-10-08
- Earliest claimed: 2017-09-08
- Applicants: Evelo Biosciences, Inc.
- Inventors: Brian Goodman; Baundauna Bose; Christopher J. H. Davitt
- Web page: https://patentgrep.com/patent/US12109243B2

## CPC

- A61K 35/74: Bacteria (therapeutic use of a bacterial protein A61K38/00)
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 38/18: Growth factors; Growth regulators
- A61K 38/19: Cytokines; Lymphokines; Interferons
- A61K 39/02: Bacterial antigens
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- A61K 2039/521: {inactivated (killed)}
- A61K 2039/522: {avirulent or attenuated}
- A61K 2039/55594: {from bacteria}
- A61K 2039/585: {wherein the target is cancer}
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Provided herein are methods and compositions related to EVs useful as therapeutic agents.

## Claims

### Claim 1

A method of treating an immune disorder in a subject comprising administering to the subject a pharmaceutical composition comprising isolated bacterial extracellular vesicles (EVs), wherein at least 90% of the total EV and bacteria particles in the pharmaceutical composition are EVs from Prevotella or Veillonella bacteria.

### Claim 2 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered orally.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject is a human.

### Claim 4 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is formulated as a capsule or tablet.

### Claim 5 (depends on 1)

The method of claim 1, wherein the immune disorder is psoriasis or atopic dermatitis.

### Claim 6 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition comprises at least 1×106 isolated bacterial extracellular vesicles (EVs).

### Claim 7 (depends on 1)

The method of claim 1, wherein at least 95% of the total EV and bacteria particles in the pharmaceutical composition are EVs.

### Claim 8 (depends on 1)

The method of claim 1, wherein no more than 1% of the total EV and bacteria particles in the pharmaceutical composition are bacteria.

### Claim 9 (depends on 1)

The method of claim 1, wherein at least 95% of the total protein in the pharmaceutical composition is present in EVs.

### Claim 10 (depends on 1)

The method of claim 1, wherein no more than 1% of the total protein in the pharmaceutical composition is present in bacteria.

### Claim 11 (depends on 1)

The method of claim 1, wherein at least 95% of the total lipids in the pharmaceutical composition is present in EVs.

### Claim 12 (depends on 1)

The method of claim 1, wherein no more than 1% of the total lipids in the pharmaceutical composition is present in bacteria.

### Claim 13 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is free of bacteria.

### Claim 14 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition comprises at least 5×106 isolated EVs.

### Claim 15 (depends on 1)

The method of claim 1, wherein the EVs are from a single strain of bacteria.

### Claim 16 (depends on 1)

The method of claim 1, wherein the EVs are from Prevotella histicola bacteria.

### Claim 17 (depends on 1)

The method of claim 1, wherein the EVs are from Veillonella tobetsuensis bacteria or Veillonella parvula bacteria.

### Claim 18

A method of treating psoriasis or atopic dermatitis in a subject comprising orally administering to the subject a pharmaceutical composition comprising isolated bacterial extracellular vesicles (EVs), wherein at least 90% of the total EV and bacteria particles in the pharmaceutical compositions are EVs from Prevotella histicola bacteria.

### Claim 19

A method of treating psoriasis or atopic dermatitis in a subject comprising orally administering to the subject a pharmaceutical composition comprising isolated bacterial extracellular vesicles (EVs), wherein at least 90% of the total EV and bacteria particles in the pharmaceutical compositions are EVs from Veillonella tobetsuensis bacteria or Veillonella parvula bacteria.