# US 7,744,900 B2 · Enhancement of the immune response for vaccine and gene therapy applications

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- Number: US 7,744,900 B2
- Document ID: US7744900B2
- Status: Granted
- Kind: B2
- Application number: 12/111,305
- Filed: 2008-04-29
- Published: 2008-11-27
- Granted: 2010-06-29
- Earliest claimed: 1999-04-08
- Assignees: Novartis Vaccines and Diagnostics, Inc.
- Inventors: Thomas W Dubensky, Jr.; John M Polo; Barbara A Belli; Silvia Perri; Timothy C Fong
- Web page: https://patentgrep.com/patent/US7744900B2

## CPC

- C12N 15/79: Vectors or expression systems specially adapted for eukaryotic hosts
- A61P 37/00: Drugs for immunological or allergic disorders
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Expression cassettes are provided comprising a promoter operably linked to a nucleic acid molecule which, when transcribed in vivo, forms double-stranded RNA that induces the production of interferon. Expression cassettes also are provided comprising a promoter operably linked to a ribozyme or antisense nucleic acid molecule which, when transcribed in vivo, forms a ribozyme or antisense RNA molecule that stimulates an immune response. In addition, expression cassettes are provided comprising a promoter operably linked to a ribozyme or antisense nucleic acid molecule which, when transcribed in vivo, stimulates apoptosis. Finally, gene delivery vectors are provided which contain such expression cassettes, host cells containing the gene delivery vectors, and methods of utilizing the expression cassettes, gene delivery vectors, and host cells.

## Claims

### Claim 1

A method of stimulating an immune response to a selected antigen within a desired host, comprising administering to the host a gene delivery vector comprising an expression cassette, wherein the expression cassette comprises:
a promoter operably linked to a first nucleic acid molecule that encodes a ribonucleic acid (RNA) which comprises a sense RNA encoded by SEQ ID NO:7, which, when transcribed in vivo, forms double stranded RNA via self-complementing sequences within the RNA, wherein the double stranded RNA induces the production of interferon; and
an RNA polymerase II promoter operably linked to a second nucleic acid molecule that encodes an antigen from a pathogenic agent or a tumor.

### Claim 2 (depends on 1)

The method of claim 1 wherein the pathogenic agent is a viral agent.

### Claim 3 (depends on 2)

The method of claim 2 wherein the viral agent is selected from the group consisting of HIV, HSV, HBV, HCV, HPV, and FIV.

### Claim 4 (depends on 1)

The method of claim 1 wherein the pathogenic agent is a bacterium, parasite, or fungus.

### Claim 5 (depends on 1)

The method of claim 1 wherein the antigen is from a tumor.

### Claim 6 (depends on 1)

The method of claim 1 wherein the RNA polymerase II promoter is selected from the group consisting of CMV, SV40, MoMLV LTR, and RSV LTR.

### Claim 7 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a plasmid.

### Claim 8 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a recombinant retrovirus.

### Claim 9 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a recombinant herpes virus.

### Claim 10 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a recombinant poxvirus.

### Claim 11 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a recombinant adenovirus.

### Claim 12 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a recombinant parvovirus.

### Claim 13 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a recombinant alphavirus.

### Claim 14 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a recombinant polyoma virus.

### Claim 15 (depends on 1)

The method of claim 1 wherein the gene delivery vector is a eukaryotic layered vector initiation system.