# US 11,896,635 B2 · Oncolytic virus (oncolytic immunotherapy) capable of effectively treating even metastatic cancer while ensuring safety, with expression control system providing optimal expression level of mounted immunogenic gene

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- Number: US 11,896,635 B2
- Document ID: US11896635B2
- Status: Granted
- Kind: B2
- Application number: 16/758,019
- Filed: 2018-11-08
- Published: 2021-01-14
- Granted: 2024-02-13
- Earliest claimed: 2017-11-08
- Assignees: Kagoshima University
- Applicants: Kagoshima University
- Inventors: Ken-ichiro Kosai; Nobuhiro Ijichi
- Web page: https://patentgrep.com/patent/US11896635B2

## CPC

- A61K 35/761: Adenovirus
- A61K 48/005: {characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered}
- A61P 35/00: Antineoplastic agents
- A61P 35/04: specific for metastasis
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 14/52: Cytokines; Lymphokines; Interferons
- C12N 15/86: Viral vectors
- C12N 15/861: Adenoviral vectors
- C12N 2710/10332: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2830/008: cell type or tissue specific enhancer/promoter combination
- 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
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- 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

The present invention is based on a novel concept for finding the optimum expression level of a therapeutic gene for inducing the largest therapeutic effect without any adverse reaction. An object of the present invention is to develop an immuno-viral therapeutic vector exerting the optimal therapeutic effect while ensuring high safety. The present invention provides, for example, an oncolytic virus comprising an immunity-inducing gene operably linked to the downstream of E2F promoter or a promoter having an activity equivalent thereto, wherein at least one promoter for nucleic acids encoding an element essential for viral replication or assembly is replaced with a promoter for an organ specific highly expressed factor or with a promoter for a cancer cell specific highly expressed factor.

## Claims

### Claim 1

An oncolytic virus comprising an immunity-inducing gene operably linked to and downstream of an E2F promoter (E2Fp),
and at least one viral promoter operably linked to a nucleic acid encoding an element essential for viral replication or assembly, wherein said viral promoter is replaced with a survivin promoter, and wherein the immunity-inducing gene comprises GM-SCF.

### Claim 2 (depends on 1)

The oncolytic virus of claim 1, wherein the oncolytic virus is adenovirus.

### Claim 3 (depends on 2)

The oncolytic virus of claim 2, wherein the element essential for viral replication or assembly is selected from a group consisting of E1A, El AΔ24, E1B and E1BΔ55K.

### Claim 4 (depends on 2)

The oncolytic virus of claim 2, wherein the at least one element essential for viral replication or assembly is E1A.

### Claim 5 (depends on 1)

The oncolytic virus of claim 1, which further comprises an expression cassette including nucleic acids encoding a cytotoxic factor or a therapeutic factor operably linked to an exogeneous promoter.

### Claim 6 (depends on 1)

A therapeutic agent for cancer, comprising the oncolytic virus of claim 1.

### Claim 7 (depends on 1)

A method of treatment of cancer, comprising administration of the oncolytic virus of claim 1, wherein the method results in less damage to non-targeted cells.