# US 5,700,649 A · Method of detection of urinary tumor associated antigen

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- Number: US 5,700,649 A
- Document ID: US5700649A
- Status: Granted
- Kind: A
- Application number: 08/462,264
- Filed: 1995-06-05
- Granted: 1997-12-23
- Earliest claimed: 1989-11-03
- Inventors: Donald L. Morton; Rishab K. Gupta; David M. Euhus
- Web page: https://patentgrep.com/patent/US5700649A

## CPC

- 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 47/6851: {the antibody targeting a determinant of a tumour cell}
- A61K 47/6873: {the antibody targeting an immunoglobulin; the antibody being an anti-idiotypic antibody}
- A61K 49/00: Preparations for testing in vivo
- A61P 35/00: Antineoplastic agents
- C07K 14/4748: {Tumour specific antigens; Tumour rejection antigen precursors [TRAP], e.g. MAGE}
- C07K 16/30: from tumour cells
- C07K 16/4266: {against anti-tumor receptor Ig}
- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- 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)
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- C07K 2317/734: Complement-dependent cytotoxicity [CDC]
- Y10S 530/828: Cancer
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

The present invention describes Urinary Tumor Associated Antigen (UTAA), its isolation and use in diagnostic assays. In particular, UTAA has been identified in samples from cancer patients, in some cases as part of an immune complex of UTAA and UTAA-specific immunoglobulin. Isolated UTAA also may be formulated as a pharmaceutical for production of antibodies or as a vaccine.

## Claims

### Claim 1

A method of detecting a cancer in a subject having a naturally occurring immune complex of Urinary Tumor Associated Antigen (UTAA) and a first anti-UTAA antibody comprising
(i) contacting a sample from said subject with a second anti-UTAA antibody; and
(ii) detecting said complexes bound to said second anti-UTAA antibody with an antibody reactive with said first anti-UTAA antibody,
wherein said first and said second anti-UTAA antibodies recognized different epitopes on UTAA.

### Claim 2 (depends on 1)

The method of claim 1, wherein the cancer is subclinical.

### Claim 3 (depends on 1)

The method of claim 1, wherein the sample is blood or urine.

### Claim 4

A method for monitoring a malignancy in a subject having a naturally occurring immune complex of Urinary Tumor Associated Antigen (UTAA) and a first anti-UTAA antibody comprising
(i) contacting a sample from said subject with a second anti-UTAA antibody;
(ii) detecting said complexes bound to said second anti-UTAA antibody with an antibody reactive with said first anti-UTAA antibody, wherein said first and said second anti-UTAA antibodies recognize different epitopes on UTAA;
(iii) determining the amount of UTAA per a given unit of body fluid; and
(iv) comparing the amount with an amount previously determined for an equivalent sample,
wherein the variation in UTAA amount indicates a variation in the state of the malignancy.

### Claim 5 (depends on 4)

The method of claim 4, wherein the sample is blood or urine.

### Claim 6

A method of detecting Urinary Tumor Associated Antigen in a sample comprising:
(1) contacting the sample with a first reagent which binds to a first epitope on Urinary Tumor Associated Antigen;
(2) contacting the sample with a second reagent which binds to a second epitope on Urinary Tumor Associated Antigen; and
(3) detecting the presence of the first or second bound reagent, thereby detecting the presence of Urinary Tumor Associated Antigen.

### Claim 7 (depends on 6)

The method of claim 6, wherein both of the reagents are antibodies.

### Claim 8 (depends on 7)

The method of claim 7, wherein said at least one of said first and second antibodies is a murine antibody.

### Claim 9 (depends on 7)

The method of claim 7, wherein said second reagent is labeled.

### Claim 10 (depends on 7)

The method of claim 7, wherein the antibodies are polyclonal and isolated from a baboon.

### Claim 11 (depends on 6)

The method of claim 6, wherein either the first or second reagent is bound to the solid support prior to binding to an epitope on UTAA.

### Claim 12 (depends on 6)

The method of claim 6, wherein said sample is a biopsy sample.

### Claim 13

A method of detecting Urinary Tumor Associated Antigen (UTAA) in a sample comprising:
(1) contacting the sample with a first reagent which binds to an epitope on UTAA selected from the group consisting of the epitope on the 45, 65, 90-100 and 120 kD subunit as identified after reduction by .beta.-mercaptoethanol and separation by SDS-polyacrylamide gel electrophoresis;
(2) contacting the sample with a second reagent which binds to a second epitope on UTAA selected from the group consisting of the epitope on the 45, 65, 90-100 and 120 kD subunit as identified after reduction by .beta.-mercaptoethanol and separation by SDS-polyacrylamide gel electrophoresis; and
(3) detecting said second reagent bound to said sample.

### Claim 14 (depends on 13)

The method of claim 13, wherein said first reagent is bound to a solid support prior to binding an epitope on UTAA.

### Claim 15 (depends on 13)

The method of claim 13, wherein the sample is a biopsy sample.

### Claim 16

A method for detecting a naturally-occurring immune complex of a urinary tumor associated antigen (UTAA) and a first anti-UTAA antibody in a sample comprising the steps of:
(i) contacting said sample with a second anti-UTAA antibody; and
(ii) detecting said complexes bound to said second anti-UTAA antibody with an antibody reactive with said first anti-UTAA antibody, wherein said first and said second anti-UTAA antibodies recognize different epitopes on UTAA.

### Claim 17 (depends on 16)

A method according to claim 16, further comprising a step, before step (i), of providing a surface on which said second anti-UTAA antibody is immobilized.

### Claim 18 (depends on 17)

The method of claim 17, wherein said first anti-UTAA antibody is a human antibody.

### Claim 19 (depends on 18)

The method of claim 18, wherein said second anti-UTAA antibody is a murine antibody.

### Claim 20 (depends on 19)

The method of claim 19, wherein said detecting comprises the steps of:
(a) contacting said surface with an anti-human Ig antibody; and
(b) detecting anti-human Ig antibody bound to said surface.

### Claim 21 (depends on 20)

The method of claim 20, wherein said anti-human Ig is specific for a particular isotype.

### Claim 22 (depends on 21)

The method of claim 21, wherein said anti-human Ig antibody is labeled with a detectable marker.

### Claim 23 (depends on 16)

The method of claim 16, wherein the second anti-UTAA antibody is a polyclonal baboon antibody.

### Claim 24 (depends on 16)

The method of claim 16, wherein the sample is blood or urine.