# US 11,110,165 B2 · Therapeutic vaccine for the treatment of papillomavirus lesions

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- Number: US 11,110,165 B2
- Document ID: US11110165B2
- Status: Granted
- Kind: B2
- Application number: 16/598,516
- Filed: 2019-10-10
- Published: 2021-04-15
- Granted: 2021-09-07
- Earliest claimed: 2019-10-10
- Assignees: Ricardo Rosales Ledezma
- Applicants: Ricardo Rosales Ledezma
- Inventors: Ricardo Rosales Ledezma
- Web page: https://patentgrep.com/patent/US11110165B2

## CPC

- A61K 39/12: Viral antigens
- A61K 39/285: Vaccinia virus or variola virus
- A61P 31/20: for DNA viruses
- C12N 7/04: Inactivation or attenuation; Producing viral sub-units
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/5254: {avirulent or attenuated}
- A61K 2039/575: {humoral response}
- A61K 2039/58: {raising an immune response against a target which is not the antigen used for immunisation}
- A61K 2039/585: {wherein the target is cancer}
- C12N 2710/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/24134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2710/24143: viral genome or elements thereof as genetic vector
- 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

A novel attenuated vaccinia virus GAB-1 and its use in treatment of papillomavirus lesions. In preferred embodiments, the Lederle-Chorioallantoic strain of vaccinia virus is serially passaged in chicken embryo-fibroblast (CEF) cells by at least 100 passages. Surprisingly, GAB-1 is highly immunogenic after serial passaging, while being less virulent and safe to use without side effects. Experimentation has found that GAB-1 is much more immunogenic than other strains of vaccinia virus, including Western Reserve (WR) and modified Vaccinia Ankara (MVA). GAB-1 can be used safely in humans for treating tumorous lesions caused by human papillomavirus (HPV).

## Claims

### Claim 1

A method of treating a cancer in an individual, comprising:
administering a therapeutically effective amount of a pharmaceutical composition comprising the attenuated Lederle-Chorioallantoic GAB-1 strain of vaccinia virus to the individual, wherein the cancer is caused by human papillomavirus.

### Claim 2 (depends on 1)

The method in claim 1, wherein the pharmaceutical composition comprises between 104 and 106 viral particles of the attenuated Lederle-Chorioallantoic GAB-1 strain of vaccinia virus.

### Claim 3 (depends on 1)

The method in claim 1, wherein the cancer is cervical intraepithelial neoplasia and wherein the therapeutically effective amount of attenuated Lederle-Chorioallantoic GAB-1 strain of vaccinia virus is selected to reduce size of cervical intraepithelial neoplasia by at least 80%.

### Claim 4 (depends on 1)

The method of claim 1, further comprising administration of an adjuvant to the individual.

### Claim 5

A method of treating a lesion caused by human papilloma virus (HPV) in an individual, comprising:
administering a therapeutically effective amount of a pharmaceutical composition comprising the attenuated Lederle-Chorioallantoic GAB-1 strain of vaccinia virus to the individual.

### Claim 6 (depends on 5)

The method of claim 5, wherein the lesion is a wart.

### Claim 7 (depends on 5)

The method of claim 5, wherein the lesion is a pre-cancerous lesion.

### Claim 8 (depends on 5)

The method of claim 5, further comprising administration of an adjuvant to the individual.