# US 10,946,080 B2 · Compositions and methods for combination therapy with dengue virus and dendritic cells

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- Number: US 10,946,080 B2
- Document ID: US10946080B2
- Status: Granted
- Kind: B2
- Application number: 16/389,445
- Filed: 2019-04-19
- Published: 2019-08-15
- Granted: 2021-03-16
- Earliest claimed: 2015-07-02
- Assignees: Primevax Immuno-Oncology, Inc.
- Applicants: PrimeVax Immuno-Oncology, Inc.
- Inventors: Bruce W. Lyday
- Web page: https://patentgrep.com/patent/US10946080B2

## CPC

- A61K 39/12: Viral antigens
- A61K 35/76: Viruses; Subviral particles; Bacteriophages
- A61K 40/19: Dendritic cells
- A61K 40/24: Antigen-presenting cells [APC]
- A61K 40/42: Cancer antigens
- A61K 40/428: {Undefined tumor antigens, e.g. tumor lysate or antigens targeted by cells isolated from tumor}
- A61P 13/08: of the prostate
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 17/00: Drugs for dermatological disorders
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 5/0639: {Dendritic cells, e.g. Langherhans cells in the epidermis}
- A61K 2039/572: {cytotoxic response}
- A61K 2039/585: {wherein the target is cancer}
- A61K 2239/31: characterized by the route of administration
- A61K 2239/57: Skin; melanoma
- C12N 2501/998: Proteins not provided for elsewhere
- C12N 2770/24132: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12N 2770/24171: Demonstrated in vivo effect
- 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 cancer through the combination of tumor antigen-pulsed dendritic cells and Dengue Virus. The combination of the two forms of therapeutic intervention provides enhanced tumor cell reduction compared to either alone. The cancer targeted by compositions and methods described herein may be a solid cancer or blood cancer.

## Claims

### Claim 1

A method for reducing or treating cancer, comprising:
(a) subcutaneously administering to a subject an effective amount of Dengue Virus as an adjuvant to an immunotherapy for treatment of cancer, wherein the Dengue Virus is present in a concentration of from 103 pfu/ml to 108 pfu/ml, and wherein the subject has a cancer; and
(b) administering autologous dendritic cells to the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the Dengue Virus is a DENV-1, 2, 3 or 4 serotype.

### Claim 3 (depends on 1)

The method of claim 1, wherein the Dengue Virus is not attenuated.

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

The method of claim 1, wherein the autologous dendritic cells are bone-marrow-derived cells.

### Claim 6 (depends on 1)

The method of claim 1, wherein the autologous dendritic cells are peripheral-blood-derived cells.

### Claim 7 (depends on 1)

The method of claim 1, further comprising obtaining precursors to dendritic cells from the subject, wherein the precursors to dendritic cells comprise CD34+ progenitor cells or CD1+CD14+ immature monocytes.

### Claim 8 (depends on 7)

The method of claim 7, further comprising culturing the precursors in the presence of GM-CSF to obtain dendritic cells.

### Claim 9 (depends on 1)

The method of claim 1, wherein the autologous dendritic cells are primed against at least one peptide tumor cell antigen.

### Claim 10

A method for reducing or treating cancer, comprising:
(a) subcutaneously administering to a subject an effective amount of Dengue Virus as an adjuvant to an immunotherapy for treatment of cancer, wherein the Dengue Virus is present in a concentration of from 103 pfu/ml to 108 pfu/ml, and wherein the subject has a cancer; and
(b) administering allogeneic dendritic cells to the subject.

### Claim 11 (depends on 10)

The method of claim 10, wherein the Dengue Virus is a DENV-1, 2, 3 or 4 serotype.

### Claim 12 (depends on 10)

The method of claim 10, further comprising obtaining precursors to dendritic cells from the subject, wherein the precursors to dendritic cells comprise CD34+ progenitor cells or CD1+CD14+ immature monocytes.

### Claim 13 (depends on 10)

The method of claim 10, wherein the cancer is a solid cancer or a blood cancer.

### Claim 14 (depends on 10)

The method of claim 10, wherein the Dengue Virus is not attenuated.

### Claim 15 (depends on 1)

The method of claim 1, wherein the Dengue Virus is isolated from a Vero cell line.

### Claim 16 (depends on 10)

The method of claim 10, wherein the Dengue Virus is isolated from a Vero cell line.

### Claim 17 (depends on 10)

The method of claim 10, wherein the allogeneic dendritic cells are bone-marrow-derived cells.

### Claim 18 (depends on 10)

The method of claim 10, wherein the allogeneic dendritic cells are peripheral-blood-derived cells.

### Claim 19 (depends on 10)

The method of claim 10, wherein the allogeneic dendritic cells are primed against at least one peptide tumor cell antigen.

### Claim 20 (depends on 12)

The method of claim 12, further comprising culturing the precursors in the presence of GM-C SF to obtain dendritic cells.