# US 2024/0385192 A1 · Use of a fuc-alpha(1-2)-gal glycan structure as a biomarker for bladder cancer

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- Number: US 2024/0385192 A1
- Document ID: US20240385192A1
- Status: Published application
- Kind: A1
- Application number: 18/261,516
- Filed: 2022-01-24
- Published: 2024-11-21
- Earliest claimed: 2021-01-25
- Assignees: Uniogen Oy
- Applicants: Uniogen Oy
- Inventors: Md Khirul ISLAM; Parvez SYED; Janne LEIVO; Kamlesh GIDWANI
- Web page: https://patentgrep.com/patent/US20240385192A1

## CPC

- G01N 33/575: for cancer
- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- G01N 33/5756: {involving tumour-associated glycolinkage [TAG]}
- 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}
- G01N 33/57585: {involving compounds identifiable in body fluids}
- G01N 2333/70546: Integrin superfamily, e.g. VLAs, leuCAM, GPIIb/GPIIIa, LPAM
- 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)

## Abstract

A non-invasive diagnostics of cancers, such as bladder cancer, on the basis of altered glycosylation patterns of cancer-associated biomarkers, especially integrins.

## Claims

### Claim at position 1

-13. (canceled)

### Claim 14

A method of determining bladder cancer disease state in a subject, the method comprising:
a) assaying a sample of a bodily fluid obtained from said subject for the level of integrin-presenting vesicles comprising a FUCα(1-2)Gal glycan structure, or for the level of integrin antigen comprising a FUCα(1-2)Gal glycan structure,
b) comparing the assayed level obtained in step a) with that of a control sample or a predetermined threshold value, and
c) determining the cancer disease state on the basis of said comparison.

### Claim 15 (depends on 14)

The method according to claim 14, wherein the integrin species is selected from the group consisting of integrin subunit alpha 3 (ITGA3), integrin subunit alpha 1 (ITGA1), integrin subunit alpha 2 (ITGA2), integrin subunit alpha 4 (ITGA4), integrin subunit alpha 5 (ITGA5), integrin subunit alpha 6 (ITGA6), integrin subunit alpha 11 (ITGA11), integrin subunit alpha V (ITGAV), integrin subunit beta 2 (ITGB2), integrin subunit beta 5 (ITGB5), integrin subunit beta 8 (ITGB8), integrin alpha 2 beta 1 (ITGA2B1) and integrin alpha 3 beta 1 (ITGA3B1).

### Claim 16 (depends on 14)

The method according to claim 14, wherein increased level of said integrin antigen or said integrin-presenting vesicle comprising the FUCα(1-2)Gal glycan structure as compared with that of the control sample or predetermined threshold value indicates that said subject has or is at risk of having bladder cancer.

### Claim 17 (depends on 14)

The method according to claim 14, wherein said assaying is carried out by using a binder molecule specific for a FUCα(1-2)Gal glycan structure or by using mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, electrophoresis, chromatography or a combination thereof.

### Claim 18 (depends on 17)

The method according to claim 17, wherein the binder molecule is Ulex europaeus agglutinin-I (UEA-I) or an antibody specific for the FUCα(1-2)Gal glycan structure.

### Claim 19 (depends on 14)

The method according to claim 14, further comprising assaying said sample for mucin 1 (MUC1) capable of binding to wheat germ agglutinin (WGA) (MUC1WGA), MUC1 capable of binding to anti-Tn antigen antibody (Tn-AB) (MUC1Tn-AB), and/or MUC1 capable of binding to Helix pomatia agglutinin (HPA) (MUC1HPA).