# US 10,370,417 B2 · Methods for the diagnosis of cancer through detection of human endogenous retrovirus WL (HERV-WL) envelope expression

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- Number: US 10,370,417 B2
- Document ID: US10370417B2
- Status: Granted
- Kind: B2
- Application number: 15/495,627
- Filed: 2017-04-24
- Published: 2017-11-23
- Granted: 2019-08-06
- Earliest claimed: 2011-03-01
- Assignees: Rutgers, The State University of New Jersey
- Applicants: Rutgers, The State University of New Jersey
- Inventors: Vincent K. Tsiagbe; Yu Li
- Web page: https://patentgrep.com/patent/US10370417B2

## CPC

- C07K 14/15: Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus human T-cell leukaemia-lymphoma virus
- C07K 7/08: having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68)
- C07K 14/005: from viruses
- C07K 16/112: Retroviridae (F), e.g. leukemia viruses
- C07K 16/1145: {Env proteins, e.g. gp41, gp110/120, gp160, V3, principal neutralising domain [PND] or CD4-binding site}
- C12Q 1/68: involving nucleic acids
- C12Q 1/702: {for retroviruses}
- G01N 33/575: for cancer
- G01N 33/57505: of the blood, e.g. leukaemia
- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites}
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K 16/30: from tumour cells
- C07K 2317/34: Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
- C07K 2317/55: Fab or Fab'
- C12N 2710/14143: viral genome or elements thereof as genetic vector
- C12N 2740/10022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2740/13022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- G01N 2333/15: Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus, feline leukaemia virus, human T-cell leukaemia-lymphoma virus
- 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)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- 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)
- 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 methods and kits for diagnosis of cancer in a subject by detecting human endogenous retrovirus env (HERV-WL) polypeptides.

## Claims

### Claim 1

A method of detecting cancer cells in a subject comprising:
a. obtaining a biological sample from said subject;
b. detecting whether human endogenous retrovirus env (HERV-WL) is present in said biological sample by contacting the biological sample with an anti-HERV-WL-Env specific antibody that specifically binds to SEQ ID NO: 2, and detecting binding between HERV-WL-Env and the antibody;
c. comparing the level of HERV-WL-Env detected in the biological sample to a standard level in a control sample; and
d. wherein if the level of HERV-WL-Env is greater in the biological sample as compared to the standard level in the control sample, this greater level of HERV-WL-Env is indicative of cancer cells in the subject, wherein the cancer is one of: lymphoma, B cell lymphoma, non-Hodgkin's lymphoma, diffuse large B cell lymphoma, Burkitt's lymphoma, squamous cell carcinoma, mucoepidermoid carcinoma, cervical cancer, prostate cancer, ovarian cancer, ameloblastoma, throat cancer and breast cancer;
wherein the anti-HERV-WL-Env specific antibody is a non-human, mammalian anti-HERV-WL-Env specific antibody.

### Claim 2 (depends on 1)

The method of claim 1, wherein the anti-HERV-WL-Env specific antibody is a monoclonal antibody or antigen-binding fragment thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein the anti-HERV-WL-Env specific antibody is a polyclonal antibody.

### Claim 4 (depends on 3)

The method of claim 3, wherein the anti-HERV-WL-Env specific polyclonal antibody is created by immunizing one of a mouse, a pig, a goat, or a rabbit, with HERV-WL env.

### Claim 5 (depends on 3)

The method of claim 3, wherein the anti-HERV-WL-Env specific polyclonal antibody is created by immunizing one of a mouse, a pig, a goat, or a rabbit, with a peptide consisting of SEQ ID NO: 2.

### Claim 6 (depends on 2)

The method of claim 2, wherein the anti-HERV-WL-Env specific monoclonal antibody or antigen-binding fragment thereof is a murine antibody.

### Claim 7 (depends on 2)

The method of claim 2, wherein the anti-HERV-WL-Env specific monoclonal antibody or antigen-binding fragment thereof is a F(ab′)2 fragment.

### Claim 8 (depends on 1)

The method of claim 1, wherein the biological sample comprises one of blood, plasma, serum, sputum, saliva, stool, tears, mucus, hair, and skin samples.

### Claim 9 (depends on 1)

The method of claim 1, wherein the anti-HERV-WL-Env specific antibody is a polyclonal antibody or antigen-binding fragment thereof.