# US 10,369,218 B2 · Immunostimulator and method for producing the same

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- Number: US 10,369,218 B2
- Document ID: US10369218B2
- Status: Granted
- Kind: B2
- Application number: 15/387,951
- Filed: 2016-12-22
- Published: 2017-06-29
- Granted: 2019-08-06
- Earliest claimed: 2015-12-25
- Assignees: Hiroshi Handa; Saitama Medical University; Sysmex Corporation
- Applicants: Saitama Medical University; Sysmex Corporation
- Inventors: Hiroshi Handa; Masaaki Kawano; Masahiko Kato
- Web page: https://patentgrep.com/patent/US10369218B2

## CPC

- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- A61P 37/04: Immunostimulants
- A61K 2039/5258: {Virus-like particles}
- A61K 2039/555: {characterised by a specific combination antigen/adjuvant}
- C12N 2710/14043: viral genome or elements thereof as genetic vectore
- C12N 2710/22023: Virus like particles [VLP]
- 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)

## Abstract

Disclosed is an immunostimulator containing virus-like particles, in which the virus-like particles contain an outer coat protein containing an amino acid sequence selected from the group consisting of SEQ ID No. 1, SEQ ID No. 26, SEQ ID No. 33, SEQ ID No. 35, SEQ ID No. 37, SEQ ID No. 39, SEQ ID No. 41, SEQ ID No. 43 and SEQ ID No. 45; the outer coat protein constitutes an outer coat of the virus-like particles; and the virus-like particles do not substantially contain a genome DNA of SV40.

## Claims

### Claim 1

A method for potentiating an immune effect of a living body, comprising administering an adjuvant and a vaccine comprising an exogenous antigen to a living body and inducing production of CD86+ lymphocytes in the living body, the adjuvant comprising a pharmacologically effective amount of virus-like particles,
wherein the virus-like particles comprise an outer coat protein comprising the amino acid sequence of SEQ ID NO: 1;
wherein the outer coat protein constitutes an outer coat of the virus-like particles;
wherein the virus-like particles do not substantially comprise a genome DNA of SV40; and
wherein the virus-like particles do not substantially comprise the exogenous antigen.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the virus-like particles do not substantially comprise VP2, VP3, or both of them.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the administrating step is conducted by oral administration, transmucosal administration, parenteral administration, or transdermal administration.

### Claim 4

A method for potentiating an immune effect of a living body, comprising administering an adjuvant and a vaccine comprising an exogenous antigen to a living body, the adjuvant comprising a pharmacologically effective amount of virus-like particles;
wherein the virus-like particles comprise an outer coat protein comprising the amino acid sequence of SEQ ID NO: 1;
wherein the virus-like particles do not substantially comprise a genome DNA of SV40; and
wherein the virus-like particles do not substantially comprise the exogenous antigen.