# US 2010/0166790 A1 · Preventive cancer vaccine based on brother of regulator of imprinted sites molecule (boris)

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- Number: US 2010/0166790 A1
- Document ID: US20100166790A1
- Status: Published application
- Kind: A1
- Application number: 12/546,561
- Filed: 2009-08-24
- Published: 2010-07-01
- Earliest claimed: 2003-08-25
- Assignees: UniVax, LLC
- Inventors: Michael G. Agadjanyan; Anahit Ghochikyan
- Web page: https://patentgrep.com/patent/US20100166790A1

## CPC

- C07K 14/4748: {Tumour specific antigens; Tumour rejection antigen precursors [TRAP], e.g. MAGE}
- A61K 40/19: Dendritic cells
- A61K 40/24: Antigen-presenting cells [APC]
- A61K 40/4267: {Cancer testis antigens, e.g. SSX, BAGE, GAGE or SAGE}
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- C12N 5/0639: {Dendritic cells, e.g. Langherhans cells in the epidermis}
- A61K 2039/5258: {Virus-like particles}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/55516: {Proteins; Peptides}
- A61K 2039/6075: {Viral proteins}
- A61K 2239/31: characterized by the route of administration
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- 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

Polynucleotides encoding a nonfunctional mutant form of the Brother of Regulator of Imprinted Sites (BORIS) molecule, nonfunctional mutated BORIS protein, polypeptide or peptide and modified protein forms of BORIS are described. These molecules are used as a therapeutic vaccine against cancer.

## Claims

### Claim 1

An immunogenic composition comprising nonfunctional Brother of Regulator of Imprinted Sites (BORIS) protein, polypeptide or peptide, wherein said nonfunctional protein, polypeptide or peptide does not bind DNA.

### Claim 2 (depends on 1)

The composition according to claim 1, wherein said nonfunctional BORIS protein, polypeptide or peptide comprises SEQ ID NO:2, lacking all zinc finger domains.

### Claim 3

(canceled)

### Claim 4 (depends on 1)

The composition according to claim 1, wherein said nonfunctional BORIS protein, polypeptide or peptide is attached to a pharmaceutically accepted carrier.

### Claim 5 (depends on 1)

The composition according to claim 1, wherein said nonfunctional BORIS protein, polypeptide or peptide is attached to a protein transducing domain.

### Claim 6 (depends on 1)

The composition according to claim 1, wherein said BORIS protein, polypeptide or peptide is attached to a peptide that enhances said nonfunctional BORIS protein, polypeptide or peptide antigenicity or immunogenicity.

### Claim 7 (depends on 1)

The composition according to claim 1, further comprising a bacterial, mammalian or yeast cell, or virus.

### Claim 8

(canceled)

### Claim 9

(canceled)

### Claim 10 (depends on 1)

The composition according to claim 1, further comprising an adjuvant.

### Claim 11 (depends on 10)

The composition according to claim 10, wherein said adjuvant is mixed with or fused to said nonfunctional BORIS protein, polypeptide or peptide.

### Claim 12 (depends on 10)

The composition according to claim 10, wherein said adjuvant is selected from the group consisting of a cytokine, a chemokine and a costimulatory molecule.

### Claim 13

(canceled)

### Claim 14

(canceled)

### Claim 15

(canceled)

### Claim 16 (depends on 7)

The composition according to claim 7, wherein said mammalian cell is a dendritic cell.

### Claim 17

An antibody comprising a binding site that recognizes an epitope from a nonfunctional Brother of Regulator of Imprinted Sites (BORIS) protein, polypeptide or peptide.

### Claim 18

A immunotherapeutic composition against cancer comprising a nonfunctional Brother of Regulator of Imprinted Sites (BORIS) protein, polypeptide or peptide wherein said nonfunctional BORIS protein, polypeptide or peptide does not bind DNA.

### Claim 19

(canceled)

### Claim 20 (depends on 18)

The immunotherapeutic composition according to claim 18, wherein said nonfunctional BORIS protein, polypeptide or peptide comprises SEQ ID NO:2, lacking all zinc finger domains.

### Claim 21 (depends on 18)

The immunotherapeutic composition according to claim 18, further comprising an adjuvant.

### Claim 22 (depends on 18)

The immunotherapeutic composition according to claim 18, further comprising a pharmaceutically acceptable carrier.

### Claim 23

A method of immunizing a mammalian subject which comprises administering to a patient in need thereof an effective amount of a nonfunctional Brother of Regulator of Imprinted Sites (BORIS) protein, polypeptide or peptide, wherein said nonfunctional BORIS protein, polypeptide or peptide lacks all zinc finger domains.

### Claim 24 (depends on 23)

The method of claim 23, wherein said a nonfunctional BORIS protein, polypeptide or peptide is mixed or fused with a molecular adjuvant.

### Claim 25 (depends on 24)

The method of claim 24, wherein said molecular adjuvant is a molecule that increases cellular immune response and/or antibody responses.

### Claim 26 (depends on 24)

The method of claim 24, wherein said molecular adjuvant is selected from the group consisting of any cytokine, chemokine, and costimulatory molecule.

### Claim 27 (depends on 23)

The method of claim 23, wherein said nonfunctional BORIS protein, polypeptide or peptide is mixed with any conventional or molecular adjuvant.

### Claim 28 (depends on 23)

The method of claim 23, wherein said nonfunctional BORIS protein, polypeptide or peptide is attached to a pharmaceutically accepted carrier.

### Claim 29 (depends on 23)

The method of claim 23, wherein said nonfunctional BORIS protein, polypeptide or peptide is attached to a peptide that enhances its antigenic or immunogenic property.

### Claim 30 (depends on 23)

The method of claim 23, wherein said nonfunctional BORIS protein, polypeptide or peptide further comprises a protein transducing domain (PTD).

### Claim 31 (depends on 46)

The method of claim 46, wherein said dendritic cell presents the nonfunctional BORIS protein, polypeptide or peptide after being transfected with DNA encoding the BORIS molecule which comprises SEQ ID NO:2, lacking all zinc finger domains.

### Claim 32 (depends on 46)

The method of claim 46, wherein said dendritic cell presents the nonfunctional BORIS protein, polypeptide or peptide after being infected with a viral vector encoding the nonfunctional BORIS molecule which comprises SEQ ID NO:2, lacking all zinc finger domains.

### Claim 33 (depends on 46)

The method of claim 46, wherein said dendritic cell presents the nonfunctional BORIS protein, polypeptide or peptide after being loaded with the BORIS protein, polypeptide, or peptide which comprises SEQ ID NO:2, lacking all zinc finger domains, or any modified protein form of BORIS.

### Claim 34 (depends on 23)

The method of claim 23, wherein said administration occurs intramuscularly, subcutaneously, intradermally, intravenously, nasally, rectally, vaginally or peritoneally.

### Claim 35 (depends on 23)

The method according to claim 23, wherein said patient has more than one type of cancer.

### Claim 36 (depends on 23)

The method of claim 23, wherein said patient has cancer.

### Claim 37

(canceled)

### Claim 38 (depends on 23)

The method according to claim 23, wherein said patient has a genetic susceptibility to cancer.

### Claim 39

(canceled)

### Claim 40 (depends on 23)

The method according to claim 23, wherein said immunization results from mounting a cellular immune response comprising T cells that recognize an epitope from a nonfunctional BORIS peptide, polypeptide, protein.

### Claim 41

A dendritic cell expressing a nonfunctional BORIS peptide, polypeptide, or protein.

### Claim 42

A dendritic cell loaded with a nonfunctional mutant BORIS peptide, polypeptide, or protein.

### Claim 43 (depends on 41)

The dendritic cell according to claim 41, wherein said cell is infected with a viral vector encoding a nonfunctional BORIS protein, polypeptide or peptide.

### Claim 44 (depends on 18)

A method of treating cancer comprising administering to a patient in need thereof an effective amount of an immunotherapeutic composition according to claim 18.

### Claim 45 (depends on 18)

The immunotherapeutic composition according to claim 18, further comprising a dendritic cell.

### Claim 46 (depends on 23)

The method of claim 23, further comprising a dendritic cell.

### Claim 47 (depends on 23)

The method of claim 23, wherein said cancer is breast or prostate cancer.
