# US 2008/0159957 A1 · Anti-Cancer and Anti-Infectious Disease Compositions and Methods for Using Same

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- Number: US 2008/0159957 A1
- Document ID: US20080159957A1
- Status: Published application
- Kind: A1
- Application number: 10/530,000
- Filed: 2003-10-01
- Published: 2008-07-03
- Earliest claimed: 2002-10-01
- Inventors: W Michael Kavanaugh; Mary Lee MacKichan; David L. Sloane
- Web page: https://patentgrep.com/patent/US20080159957A1

## CPC

- A61K 39/12: Viral antigens
- A61K 35/768: Oncolytic viruses not provided for in groups A61K35/761 - A61K35/766
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 40/10: characterised by the cell type used
- A61K 40/42: Cancer antigens
- A61K 40/46: Viral antigens
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 31/12: Antivirals
- A61P 31/14: for RNA viruses
- A61P 31/16: for influenza or rhinoviruses
- A61P 31/18: for HIV
- A61P 31/20: for DNA viruses
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12N 15/86: Viral vectors
- A61K 2039/5252: {inactivated (killed)}
- A61K 2039/5256: {expressing foreign proteins}
- A61K 2039/5258: {Virus-like particles}
- A61K 2039/55555: {Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers}
- C12N 2710/10332: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12N 2710/14122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2710/14132: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12N 2710/14143: viral genome or elements thereof as genetic vector
- C12N 2760/20234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention provides methods and compositions for treating and/or preventing cancer in a subject via administration of a non-pathogenic virus. The present invention also provides methods and compositions for treating and/or preventing infectious diseases in a subject via administration of a non-pathogenic.

## Claims

### Claim at position 1

1-148. (canceled)

### Claim 149

A method of treating or preventing a disease or a symptom of a disease in an animal comprising administering to said animal an amount of a composition comprising a non-pathogenic, insect-specific virus effective to treat or prevent the disease or disease symptom in said animal.

### Claim 150 (depends on 149)

The method of claim 149, wherein the composition comprising a non-pathogenic, insect-specific virus is effective at a concentration of less than about 500,000 PFU or about 500,000 PFU Equivalents to cause cell death in greater than about 50% of the contacted cells in an in vitro assay.

### Claim 151 (depends on 149)

The method of claim 149, wherein the insect-specific virus is a virus of the Baculaviridae family.

### Claim 152 (depends on 151)

The method of claim 151, wherein the Baculaviridae virus is a granulosis virus or a nucleopolyhedrosis virus.

### Claim 153 (depends on 152)

The method of claim 152, wherein the nucleopolyhedrosis virus is Autographa californica nucleopolyhedrosis virus.

### Claim 154 (depends on 149)

The method of claim 149 wherein the disease is cancer or an infectious disease, or a symptom of cancer or an infectious disease.

### Claim 155 (depends on 154)

The method of claim 154 wherein the cancer is selected from the group consisting of lung, breast, prostate, colon, gastric, pancreatic, renal, or skin cancer.

### Claim 156 (depends on 154)

The method of claim 154 wherein the infectious disease is selected from the group consisting of HIV, West Nile virus, hepatitis A, B, C, small pox, tuberculosis, Vesicular Stomatitis Virus, Respiratory Syncytial Virus, human papilloma virus, SARS, influenza, Ebola, viral meningitis, herpes, anthrax or lyme disease.

### Claim 157 (depends on 154)

The method of claim 154 wherein the symptom of cancer is selected from the group consisting of tumor growth, abnormal cell growth, metastasis, angiogenesis, cell death, cell invasiveness, weight loss, bleeding, difficulty in breathing, bone fractures, compromised immune system or fatigue.

### Claim 158 (depends on 149)

The method of claim 149 further comprising:
(a) inactivating the non-pathogenic, insect-specific virus by adding trioxalen to the non-pathogenic virus at a concentration between about 5-10 μg/ml and illuminating said non-pathogenic, insect-specific virus with UV at about 365 nm and about 6 W for about 15 minutes;
(b) formulating the inactivated non-pathogenic, insect-specific virus into a pharmaceutical composition; and
(c) administering the pharmaceutical composition to the subject.

### Claim 159 (depends on 149)

The method of claim 149 wherein the non-pathogenic, insect-specific virus is a virus of the Baculaviridae family.

### Claim 160 (depends on 149)

The method of claim 149, wherein said composition comprising a non-pathogenic, insect-specific virus is effective at a concentration of less than about 500,000 PFU or about 500,000 PFU equivalents to prevent cell growth in greater than about 50% of the contacted cells in an in vitro assay.

### Claim 161 (depends on 149)

The method of claim 149, wherein the composition is administered intratumorally and/or peritumorally.

### Claim 162 (depends on 149)

The method of claim 149, wherein the animal is a human.

### Claim 163 (depends on 149)

The method of claim 149, wherein the non-pathogenic, insect-specific virus is an inactivated virus, a viral particle, a virosome, a Virus Like Particle, a viral occlusion body, or a viral component.

### Claim 164 (depends on 163)

The method of claim 163, wherein the viral component comprises at least two viral proteins.

### Claim 165 (depends on 149)

The method of claim 149, wherein the non-pathogenic, insect-specific virus comprises gp64.

### Claim 166 (depends on 163)

The method of claim 163, wherein the viral component comprises one or more of a nucleic acid, a lipid or a carbohydrate.

### Claim 167 (depends on 149)

The method of claim 149, wherein the non-pathogenic, insect-specific virus is an inactivated virus.

### Claim 168 (depends on 167)

The method of claim 167, wherein the inactivation is heat-inactivation, chemical inactivation, or UV inactivation, or a combination thereof.

### Claim 169 (depends on 167)

The method of claim 167 wherein said inactivation is psoralen inactivation, UV inactivation, or a combination thereof.

### Claim 170 (depends on 149)

The method of claim 149, wherein the composition is co-administered with another agent, wherein said agent is a chemotherapeutic, an anti-cancer drug, a vaccine, or combinations thereof.

### Claim 171

A method of inducing an immune response in an animal comprising administering to said animal an amount of a composition comprising an inactive non-pathogenic, insect-specific virus effective to induce an immune response in said animal.

### Claim 172 (depends on 171)

The method of claim 171, wherein said immune response protects against infectious disease.

### Claim 173 (depends on 171)

The method of claim 171, wherein said immune response protects against cancer.

### Claim 174 (depends on 171)

The method of claim 171, wherein said immune response induces a T-cell memory response.

### Claim 175 (depends on 171)

The method of claim 171, wherein said immune response promotes dendritic cell maturation.

### Claim 176

A method of causing cell death in a cell comprising administering a composition comprising an amount of a non-pathogenic, insect-specific virus to said cell effective to cause cell death in said cell.

### Claim 177 (depends on 176)

The method of claim 176, wherein said composition comprising a non-pathogenic, insect-specific virus is effective at a concentration of less than about 500,000 PFU or about 500,000 PFU Equivalents to cause cell death in greater than about 50% of the contacted cells in an in vitro assay.

### Claim 178

A method of causing cell death in a population of cells comprising contacting a composition comprising an amount of a non-pathogenic, insect-specific virus to a portion of said population of cells effective to cause cell death in said population of cells.

### Claim 179 (depends on 178)

The method of claim 178 wherein said portion of said population of cells is no more than about 20% of said population.

### Claim 180 (depends on 178)

The method of claim 178 wherein the population of cells comprises peripheral blood cells, tumor cells, NK cells or macrophages.

### Claim 181 (depends on 171)

The method of claim 171, wherein the insect-specific virus is a virus of Baculaviridae family.

### Claim 182 (depends on 171)

The method of claim 171, wherein the non-pathogenic, insect-specific virus is an inactivated virus.

### Claim 183

A method of predicting in vivo anti-tumor activity of a compound comprising:
a) contacting the compound with tumor cells and peripheral blood mononuclear cells; and
b) measuring cell death of said tumor cells;
wherein compounds that cause cell death of contacted tumor cells are predicted in be active in vivo.

### Claim 184 (depends on 183)

The method of claim 183 wherein said compound is an inactivated virus, a viral particle, a virosome, a Virus Like Particle, a viral occlusion body, or a viral component.

### Claim 185 (depends on 183)

The method of claim 183 wherein said compound is derived from the Baculoviridae family.

### Claim 186 (depends on 183)

The method of claim 183 wherein said compound is an insect specific virus.

### Claim 187 (depends on 183)

The method of claim 183, wherein said tumor cells are A549 cells, 3LL-HM cells, 4T1 cells, MT901 cells, MAT BIII cells, B16 melanoma cells or MG-63 cells.

### Claim 188

A composition comprising a non-pathogenic, insect-specific virus and a pharmaceutically acceptable carrier.

### Claim 189 (depends on 188)

The composition of claim 188, wherein said non-pathogenic, insect-specific virus is inactivated using two or more methods selected from the group consisting of genetic inactivation, chemical inactivation, photochemical inactivation, UV-light inactivation, heat inactivation, or radiological inactivation, further comprising at least one PBMC.

### Claim 190

A composition comprising an inactivated non-pathogenic, insect-specific virus, at least one antigen, wherein the antigen is distinct from the inactivated non-pathogenic, insect-specific virus, at least one adjuvant, and a pharmaceutically acceptable carrier.

### Claim 191

A composition comprising an adjuvant composition, said adjuvant composition comprising an inactivated non-pathogenic, insect-specific virus, at least one antigen, wherein said antigen is distinct from the adjuvant composition, and further wherein said immunostimulating composition is capable of increasing the immune response to the antigen.

### Claim 192

A composition comprising a non-pathogenic, insect-specific virus, one or more peripheral blood mononuclear cells (PBMCs), and a pharmaceutically acceptable carrier.

### Claim 193 (depends on 188)

The composition of claim 188, wherein the insect-specific virus is a virus of Baculaviridae family.

### Claim 194 (depends on 188)

The composition of claim 188, wherein the non-pathogenic, insect-specific virus is an inactivated virus.

### Claim 195

A process for preparing an anticancer or anti-infectious disease composition comprising a non-pathogenic, insect-specific virus, said process comprising:
(a) exposing the non-pathogenic, insect-specific virus to a first inactivator effective to inactivate an active virus;
(b) exposing the non-pathogenic, insect-specific virus to a second inactivator effective to inactivate an active virus;
(c) combining said non-pathogenic, insect-specific virus with one or more pharmaceutically acceptable carriers or excipients; and
(d) confirming inactivity of non-pathogenic, insect-specific virus in an in vitro assay.

### Claim 196 (depends on 195)

The process of claim 195, wherein the insect-specific virus is a virus of the Baculaviridae family.