# US 10,370,647 B2 · Host regulatory factor that enhances replication and/or propagation of vaccinia virus

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- Number: US 10,370,647 B2
- Document ID: US10370647B2
- Status: Granted
- Kind: B2
- Application number: 15/746,018
- Filed: 2016-07-22
- Published: 2018-07-26
- Granted: 2019-08-06
- Earliest claimed: 2015-07-22
- Assignees: National University Corporation Tottori University
- Applicants: National University Corporation Tottori University
- Inventors: Takafumi Nakamura; Kousuke Horita; Hajime Kurosaki; Motomu Nakatake
- Web page: https://patentgrep.com/patent/US10370647B2

## CPC

- 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 35/76: Viruses; Subviral particles; Bacteriophages
- A61K 35/768: Oncolytic viruses not provided for in groups A61K35/761 - A61K35/766
- A61P 35/00: Antineoplastic agents
- C12N 7/04: Inactivation or attenuation; Producing viral sub-units
- C12N 15/09: Recombinant DNA-technology
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/53: Immunoassay; Biospecific binding assay; Materials therefor
- G01N 33/575: for cancer
- C12N 2710/24132: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/158: Expression markers
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

It is an object of the present invention to provide utilization of a UCA1 gene that is a host regulatory factor that enhances replication and/or propagation of a vaccinia virus, in order to effectively carry out cancer virotherapy using the vaccinia virus. The present invention relates to: a method for predicting and evaluating the cancer therapeutic effects of a vaccinia virus, which comprises measuring the expression of a UCA1 gene in the cancer cells of a cancer patient, and then predicting that a vaccinia virus exhibits cancer therapeutic effects on the patient, when the UCA1 gene has been expressed therein; and a vaccinia virus into which a UCA1 gene has been expressibly introduced.

## Claims

### Claim 1

A method for predicting and evaluating the cancer therapeutic effects of an oncolytic vaccinia virus that replicates in cancer cells, which comprises measuring the expression of a UCA1 gene in the cancer cells of a cancer patient, and then predicting that the oncolytic vaccinia virus exhibits cancer therapeutic effects on the patient, when expression of the UCA1 gene exceeds a determined threshold value.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the vaccinia virus is modified to allow expression of a B5R gene, and wherein the vaccinia virus is an LC16 strain, an LC16mO strain, or an LC16m8 strain.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the expression of the UCA1 gene is measured by RT-PCR.

### Claim 4

An oncolytic vaccinia virus that replicates in cancer cells, into which a UCA1 gene has been expressibly introduced, wherein the vaccinia virus is modified to allow the expression of a B5R gene, and wherein the vaccinia virus is an LC16 strain, an LC16mO strain, or an LC16m8 strain.

### Claim 5 (depends on 4)

The vaccinia virus according to claim 4, which allows the UCA1 gene to express in cancer cells and replicates in the cancer cells by regulation of UCA1.

### Claim 6 (depends on 4)

A pharmaceutical composition for cancer therapy, comprising the vaccinia virus according to claim 4.

### Claim 7

A pharmaceutical composition kit for cancer therapy, comprising an expression vector into which a UCA1 gene has been expressibly introduced, in combination with an oncolytic vaccinia virus that replicates in cancer cells, wherein the vaccinia virus is modified to allow the expression of a B5R gene, and wherein the vaccinia virus is an LC16 strain, an LC16mO strain, or an LC16m8 strain.