# US 12,059,443 B2 · Method for treating cancer using dengue virus serotype 1 (DENV-1)

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- Number: US 12,059,443 B2
- Document ID: US12059443B2
- Status: Granted
- Kind: B2
- Application number: 17/130,349
- Filed: 2020-12-22
- Published: 2021-08-05
- Granted: 2024-08-13
- Earliest claimed: 2018-01-04
- Assignees: Prime Vax Immuno-Oncology, Inc.
- Applicants: PrimeVax Immuno-Oncology, Inc.
- Inventors: Bruce W. Lyday
- Web page: https://patentgrep.com/patent/US12059443B2

## CPC

- A61K 35/76: Viruses; Subviral particles; Bacteriophages
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61P 35/00: Antineoplastic agents
- 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 2770/24121: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2770/24132: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- 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

Described herein are compositions and methods for treating a disease, particularly a cancer, with a Dengue Virus and, optionally, primed dendritic cells recognizing a tumor antigen. Lysis protocols are described where the lysis does not result in complete or less than complete lysis of cells in order to provide cell surface molecules maintained in a cell surface-embedded state. Non-lethal Dengue virus strains are also provided for therapeutic purposes.

## Claims

### Claim 1

A method of treating a solid cancer, comprising administering to a solid cancer an effective amount of a Dengue virus serotype 1 strain, wherein the solid cancer is a melanoma, wherein the Dengue virus serotype 1 strain is 45AZ5, wherein the administering reduces a level of cancer cells, and wherein the Dengue virus serotype 1 strain is present in an amount up to about 90,000 PFU.

### Claim 2 (depends on 1)

The method of claim 1, wherein the Dengue virus serotype 1 strain is present in an amount of about 30,000 PFU.

### Claim 3 (depends on 1)

The method of claim 1, wherein the melanoma is V600E positive.

### Claim 4 (depends on 1)

The method of claim 1, wherein the solid cancer is a refractory cancer.

### Claim 5 (depends on 1)

The method of claim 1, wherein the solid cancer is reduced in size by at least about 60% as measured by computed tomography (CT) scan.

### Claim 6 (depends on 1)

The method of claim 1, wherein the solid cancer is reduced in size by at least about 80% as measured by computed tomography (CT) scan.

### Claim 7 (depends on 1)

The method of claim 1, wherein the solid cancer is reduced in size by at least about 90% as measured by computed tomography (CT) scan.

### Claim 8 (depends on 1)

The method of claim 1, wherein the Dengue virus serotype 1 strain is in a volume of about 0.01 ml to 0.1 ml.

### Claim 9 (depends on 1)

The method of claim 1, wherein the administering of the Dengue virus serotype 1 strain comprises a subcutaneous injection to the subject.

### Claim 10 (depends on 1)

The method of claim 1, wherein the Dengue virus serotype 1 strain is in liquid form, lyophilized form or freeze-dried form.

### Claim 11 (depends on 1)

The method of claim 1, wherein the Dengue virus serotype 1 strain is stored in a container.

### Claim 12 (depends on 11)

The method of claim 11, wherein the container is a syringe, vial, bottle, flask, or bag.