# US 10,478,489 B2 · Live-attenuated vaccine having mutations in viral polymerase for the treatment and prevention of canine influenza virus

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- Number: US 10,478,489 B2
- Document ID: US10478489B2
- Status: Granted
- Kind: B2
- Application number: 15/753,671
- Filed: 2016-08-19
- Published: 2018-08-30
- Granted: 2019-11-19
- Earliest claimed: 2015-08-20
- Assignees: University of Rochester; Cornell University
- Applicants: University of Rochester; Cornell University
- Inventors: Luis Martinez-Sobrido; Aitor Nogales-Gonzalez; Colin Parrish
- Web page: https://patentgrep.com/patent/US10478489B2

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 39/12: Viral antigens
- A61P 31/16: for influenza or rhinoviruses
- A61K 2039/5254: {avirulent or attenuated}
- A61K 2039/543: {intranasal}
- A61K 2039/552: {Veterinary vaccine}
- A61K 2039/58: {raising an immune response against a target which is not the antigen used for immunisation}
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- 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

The present invention relates to compositions and methods for the treatment and prevention of canine influenza virus (CIV) and CIV-related pathology. The present invention is based in part upon the discovery that various mutations in segment 1 and segment 2 of the CIV genome, thereby encoding mutant PB2 and PB1 protein, render the virus to be temperature-sensitive.

## Claims

### Claim 1

An immunological composition comprising a live-attenuated canine influenza virus (LACIV), wherein the LACIV comprises segment 1 of the viral genome encoding mutant PB2 comprising the amino acid sequence of SEQ ID NO: 3; and segment 2 of the viral genome encoding mutant PB1 comprising the amino acid sequence of SEQ ID NO: 4.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the LACIV temperature sensitive such that the LACIV exhibits reduced viral replication as compared to wildtype canine influenza virus at a temperature selected from the group consisting of normal body temperature and elevated body temperature.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the segment 1 comprises the nucleic acid sequence set forth in SEQ ID NO: 1.

### Claim 4 (depends on 1)

The composition of claim 1, wherein the segment 2 comprises the nucleic acid sequence set forth in SEQ ID NO: 2.

### Claim 5 (depends on 1)

The composition of claim 1 wherein the LACIV is derived from H3N8 subtype of influenza A virus.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the LACIV expresses HA and NA of H3N8.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the LACIV expresses HA and NA of H3N2.

### Claim 8 (depends on 1)

The composition of claim 1 wherein the composition is used for the treatment or prevention of canine influenza in a subject.

### Claim 9 (depends on 1)

A method for treating or preventing canine influenza in a subject, the method comprising administering to the subject the immunological composition of claim 1.

### Claim 10 (depends on 9)

The method of claim 9, wherein the subject does not have canine influenza, and wherein the method induces immunity against one or more of: influenza A virus subtype H3N8 and influenza A virus subtype H3N2.

### Claim 11 (depends on 9)

The method of claim 9, wherein the subject is infected with at least one or more of: influenza A virus subtype H3N8 and influenza A virus subtype H3N2; and wherein the method induces a therapeutic immune response.

### Claim 12 (depends on 9)

The method of claim 9, wherein the immunological composition is administered intranasally, intratracheally, orally, intradermally, intramuscularly, intraperitoneally, intravenously, or subcutaneously.

### Claim 13 (depends on 9)

The method of claim 9, wherein the subject is a dog.