# US 10,765,735 B2 · Adjuvant compositions and methods of use

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- Number: US 10,765,735 B2
- Document ID: US10765735B2
- Status: Granted
- Kind: B2
- Application number: 15/045,986
- Filed: 2016-02-17
- Published: 2016-06-09
- Granted: 2020-09-08
- Earliest claimed: 2009-01-05
- Assignees: EpitoGenesis, Inc.
- Applicants: EpitoGenesis, Inc.
- Inventors: Michael Vajdy; Shohre Golestani
- Web page: https://patentgrep.com/patent/US10765735B2

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/12: Viral antigens
- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/21: Retroviridae, e.g. equine infectious anemia virus
- A61P 31/16: for influenza or rhinoviruses
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/541: {Mucosal route}
- A61K 2039/543: {intranasal}
- A61K 2039/55511: {Organic adjuvants}
- A61K 2039/55588: {Adjuvants of undefined constitution}
- C12N 2740/16034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2740/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2740/16334: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16151: Methods of production or purification of viral material
- 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)

## Abstract

This disclosure provides adjuvant compositions that are capable of modulating the immune response in a subject. These adjuvant compositions may also be used enhance the immunogenicity of antigens. Also provided are methods of making the adjuvant compositions as well as methods of using the adjuvant compositions.

## Claims

### Claim 1

An adjuvant comprising:
(a) a pharmaceutically acceptable oil selected from the group consisting of wintergreen oil, rosemary oil, mustard seed oil, allyl isothiocyanate, and a mixture thereof;
(b) at least one catechin; and
(c) at least one vitamin selected from the group consisting of vitamin A, vitamin E and vitamin D;
wherein the adjuvant does not comprise an antigen.

### Claim 2 (depends on 1)

The adjuvant of claim 1, further comprising one or more emulsifiers.

### Claim 3 (depends on 2)

The adjuvant of claim 2, wherein the one or more emulsifiers are selected from the group consisting of a polysorbate, phospholipids, sorbitan monolaureate, sorbitan monopalmitate, sorbitan monostearate, sorbitan tristearate, sorbitan monooleate, sorbitan trioleate, and a combination thereof.

### Claim 4 (depends on 1)

The adjuvant of claim 1, wherein said catechin is epigallocatechin gallate (EGCG).

### Claim 5 (depends on 1)

The adjuvant of claim 1, wherein said at least one vitamin is vitamin E.

### Claim 6 (depends on 1)

The adjuvant of claim 1, wherein said at least one vitamin is vitamin A.

### Claim 7 (depends on 1)

The adjuvant of claim 1, wherein said at least one vitamin is vitamin D.

### Claim 8 (depends on 1)

The adjuvant of claim 1, wherein the pharmaceutically acceptable oil is mustard seed oil.

### Claim 9 (depends on 1)

The adjuvant of claim 1, wherein the pharmaceutically acceptable oil is allyl isothiocyanate.

### Claim 10 (depends on 1)

The adjuvant of claim 1, wherein the pharmaceutically acceptable oil is wintergreen oil.

### Claim 11 (depends on 1)

The adjuvant of claim 1, wherein the pharmaceutically acceptable oil is rosemary oil.

### Claim 12 (depends on 1)

A method of modulating an immune response in a subject consisting of administering the adjuvant of claim 1 to said subject.

### Claim 13 (depends on 12)

The method of claim 12, wherein the subject is a mammal.

### Claim 14

An immunogenic composition comprising an adjuvant and an antigen, wherein the adjuvant comprises:
(a) a pharmaceutically acceptable oil selected from the group consisting of wintergreen oil, rosemary oil, mustard seed oil, allyl isothiocyanate, and a mixture thereof;
(b) at least one catechin; and
(c) at least one vitamin selected from the group consisting of vitamin A, vitamin E and vitamin D.

### Claim 15 (depends on 14)

The immunogenic composition of claim 14, wherein the antigen is derived from a virus, fungi, bacterium, prion, or cancer cell.

### Claim 16 (depends on 14)

The immunogenic composition of claim 14, wherein the pharmaceutically acceptable oil is mustard seed oil.

### Claim 17 (depends on 14)

The immunogenic composition of claim 14, wherein the pharmaceutically acceptable oil is allyl isothiocyanate.

### Claim 18 (depends on 14)

The immunogenic composition of claim 14, wherein the pharmaceutically acceptable oil is wintergreen oil.

### Claim 19 (depends on 14)

The immunogenic composition of claim 14, wherein the pharmaceutically acceptable oil is rosemary oil.

### Claim 20 (depends on 14)

A method of modulating an immune response in a subject consisting of administering the immunogenic composition of claim 14 to said subject.
