# US 11,433,108 B2 · Anti-cancer oncolytic virus combination therapies and elite responder selection platforms

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- Number: US 11,433,108 B2
- Document ID: US11433108B2
- Status: Granted
- Kind: B2
- Application number: 15/744,295
- Filed: 2017-03-28
- Published: 2019-01-03
- Granted: 2022-09-06
- Earliest claimed: 2016-03-28
- Assignees: Suzhou Prajna Biotech Co., Ltd.
- Applicants: Minjie Hu; Yu Li; Xiaoling Liu; Rebecca Hu
- Inventors: Minjie Hu; Yu Li; Xiaoling Liu; Rebecca Hu
- Web page: https://patentgrep.com/patent/US11433108B2

## CPC

- A61K 35/768: Oncolytic viruses not provided for in groups A61K35/761 - A61K35/766
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 35/745: Bifidobacteria
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 35/00: Antineoplastic agents
- 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 2039/55594: {from bacteria}
- C12N 2710/24021: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2710/24032: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12N 2710/24121: Viruses as such, e.g. new isolates, mutants or their genomic sequences
- C12N 2710/24132: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- 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

Therapeutic methods for administering gut microbiota and oncolytic viruses to a subject are provided. The gut microbiota serve to pre-condition, the subject's immune system to antitumor responses and augments anticancer activity of the oncolytic vims. Combinations of the gut. microbiota and viruses and uses thereof for treating and preventing cancer are provided. The present disclosure also provides methods for building elite responder selection platforms through hierarchical clustering analysis of genomic profiles for human gut microbiome.

## Claims

### Claim 1

A method of treating cancer comprising:
orally administering to a subject an effective amount of about 109 to 1011 cfu of gut microbiota of the genus Bifidobacterium; and
from about one week to two months after the gut microbiota are administered, intravenously or intratumorally administering to the subject an effective amount of about 105 to 1010 pfu of an oncolytic ORF virus having anticancer activity and that selectively targets tumor cells;
wherein the gut microbiota pre-conditions the subject's immune system to antitumor responses and augments the anticancer activity of the oncolytic ORF virus, and
wherein a platform is created to identify potential elite responders to the oncolytic ORF virus treatment based on an abundance of the subject's particular gut microbiota.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the platform is built through hierarchical clustering analysis of genomic profiles of the human gut microbiome and identifies the gut microbiota that suppress tumor progression.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the identified elite responders are predicted to respond favourably to the oncolytic ORF virus based on the abundance of the subject's particular gut microbiota.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the cancer is melanoma.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the cancer is lung cancer.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the cancer is kidney cancer.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the cancer is glioma.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the cancer is triple negative breast cancer.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the cancer is renal cancer.