# US 11,433,129 B2 · Compositions and methods of manufacturing trivalent filovirus vaccines

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- Number: US 11,433,129 B2
- Document ID: US11433129B2
- Status: Granted
- Kind: B2
- Application number: 16/879,668
- Filed: 2020-05-20
- Published: 2020-12-03
- Granted: 2022-09-06
- Earliest claimed: 2019-05-20
- Assignees: Soligenix, Inc.; University of Hawaii
- Applicants: Soligenix, Inc.; University of Hawaii
- Inventors: Oreola Donini; Axel Lehrer
- Web page: https://patentgrep.com/patent/US11433129B2

## CPC

- A61K 39/12: Viral antigens
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 31/14: for RNA viruses
- 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 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/55572: {Lipopolysaccharides; Lipid A; Monophosphoryl lipid A}
- A61K 2039/55577: {Saponins; Quil A; QS21; ISCOMS}
- A61K 2039/575: {humoral response}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2760/14122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2760/14134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/14222: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2760/14234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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
- 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

Disclosed is a stable immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one antigen consisting of a filovirus glycoprotein and at least one nano-emulsion adjuvant which are co-lyophilized and can be reconstituted immediately prior to use. Also disclosed is a vaccine composition comprising at least two antigens, wherein each antigen is specific to a different genus of filovirus and which also comprises at least one nano-emulsion adjuvant.

## Claims

### Claim 1

A stable, immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one antigen, wherein the at least one antigen comprises a viral glycoprotein, and at least one adjuvant, wherein the at least one adjuvant comprises sucrose fatty acid sulphate esters, and wherein the at least one adjuvant is a nano-emulsion adjuvant that is mixed with the antigen prior to lyophilization.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the composition does not include alum.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the composition comprises two or more antigens, wherein each antigen is specific to a different virus.

### Claim 4 (depends on 1)

A method of eliciting an immune response in a mammal comprising:
(a) providing the composition of claim 1;
(b) reconstituting the composition of (a) prior to use with a pharmaceutically acceptable diluent; and
(c) administering the composition to the mammal in need thereof.

### Claim 5 (depends on 4)

The method of claim 4, wherein the composition is administered up to three separate occasions, resulting in the mammal being protected from subsequent infections by the virus associated with the viral glycoprotein present in the composition.

### Claim 6

A stable immunogenic composition capable of eliciting a robust and durable immune response, comprising at least one nano-emulsion adjuvant, wherein the at least one nano-emulsion adjuvant is lyophilized and can be reconstituted immediately prior to use with an antigen.

### Claim 7

A method of manufacturing a stable immunogenic composition capable of eliciting a robust and durable immune response to more than one virus, comprising at least two antigens, wherein each antigen is specific to a different virus from the same or different families and providing at least one adjuvant, wherein the at least one adjuvant comprises sucrose fatty acid sulphate esters, wherein the at least one adjuvant is a nano-emulsion that is combined with the antigen prior to lyophilization and wherein the at least one adjuvant does not contain alum.