# US 2026/0086095 A1 · Methods for detection of prostate cancer, related biomarkers and kits for determining the biomarkers

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- Number: US 2026/0086095 A1
- Document ID: US20260086095A1
- Status: Published application
- Kind: A1
- Application number: 19/107,620
- Filed: 2023-08-31
- Published: 2026-03-26
- Earliest claimed: 2022-09-01
- Assignees: Oy Arctic Partners Ab
- Applicants: Oy Arctic Partners AB
- Inventors: Kamlesh GIDWANI; Henna KEKKI; Kim PETTERSSON
- Web page: https://patentgrep.com/patent/US20260086095A1

## CPC

- G01N 33/57555: of the prostate
- G01N 2333/4724: Lectins
- G01N 2333/96433: Serine endopeptidases (3.4.21)
- 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

The invention relates to non-invasive detection of prostate cancer on the basis of altered glycosylation patterns, and to biomarkers for use in the detection and to kits including reagents for determining levels of the biomarkers in biological samples.

## Claims

### Claim 1

A glycan structure comprised on a carbohydrate antigen 19-9 (CA19-9) bearing molecular entity and capable of specific binding to Mannose binding lectin (MBL) as a biomarker for prostate cancer.

### Claim 2

A method of determining prostate cancer disease state in a subject, the method comprising:
a) assaying a sample obtained from said subject for the level of a CA19-9-bearing entity comprising a glycan structure capable of specific binding to MBL
b) comparing the assayed level obtained in step a) with that of a control sample or a predetermined threshold value, and
c) determining the prostate cancer disease state on the basis of said comparison.

### Claim 3 (depends on 2)

The method according to claim 2, wherein increased level of said CA19-9-bearing entity in the sample as compared with the level said CA19-9-bearing entity in the control sample or as compared with the predetermined threshold value indicates that said subject has or is at risk of having prostate cancer.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the assaying is carried out by using a binder molecule specific for the glycan structure or by using mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, electrophoresis, chromatography or a combination thereof.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the binder molecule is Mannose binding lectin (MBL) or an antibody specific for the glycan structure capable of specific binding to MBL.

### Claim 6 (depends on 2)

The method according to claim 2, further comprising assaying said sample for a CA19-9-bearing entity capable of specific binding to wheat germ agglutinin (WGA) (CA19-9WGA) and/or for CA19-9 antigens or CA19-9-presenting vesicles capable of specific binding to Macrophage galactose-type lectin (MGL) (CA19-9MGL).

### Claim 7 (depends on 2)

The method according to claim 2, further comprising assaying said sample for one or more biomarkers selected from the group consisting of total prostate specific antigen (PSA), free PSA (fPSA), free PSA capable of specific binding to MGL (fPSAMGL), intact PSA, total human kallikrein 2 (hK2) and free hK2.

### Claim 8

A kit for use in determining prostate cancer disease state in a subject, comprising:
a CA19-9-binding agent and a binder molecule specific for a glycan structure capable of specific binding to MBL, wherein either said CA19-9-binding agent or said binder molecule comprises a detectable label.

### Claim 9 (depends on 8)

The kit according to claim 8, wherein the binder molecule is MBL or an antibody specific for the glycan structure capable of specific binding to MBL.

### Claim 10 (depends on 8)

The kit according to claim 8, further comprising at least one binder molecule specific for a glycan structure capable of specific binding to WGA and/or a glycan structure capable of specific binding to MGL.

### Claim 11 (depends on 10)

The kit according to claim 10, wherein the binder molecule is selected from the group consisting of WGA, MGL, antibodies specific for the glycan structure capable of specific binding to WGA, and antibodies specific for the glycan structure capable of specific binding to MGL.

### Claim 12 (depends on 8)

The kit according to claim 8, further comprising reagents for assaying a sample for one or more biomarkers selected from the group consisting of total prostate specific antigen (PSA), free PSA (fPSA), free PSA capable of specific binding to MGL (fPSAMGL), intact PSA, total human kallikrein 2 (hK2) and free hK2.

### Claim 13 (depends on 8)

The kit according to claim 8, further comprising:
i) a multi-well plate comprising one or more wells immobilized with a CA19-9-binding agent and one or more different wells immobilized with a fPSA-binding agent; and
ii) at least two binders, one specific for a glycan structure capable of specific binding to MBL and one capable of specific binding to MGL.

### Claim 14 (depends on 13)

The kit according to claim 13, wherein said CA19-9-binding agent, said fPSA-binding agent or both are immobilized on an area having a diameter smaller than the diameter of the well.

### Claim 15 (depends on 8)

The kit according to claim 8, further comprising:
i) a multi-well plate with one or more wells having a bottom surface comprising at least two distinct areas, one immobilized with a CA19-9-binding agent and one immobilized with a fPSA-binding agent; and
ii) at least two binders, one specific for a glycan structure capable of specific binding to MBL and one capable of specific binding to MGL.

### Claim 16 (depends on 13)

The kit according to claim 13, wherein the fPSA binding agent is an anti-fPSA antibody, preferably an antigen binding fragment thereof, more preferably a Fab fragment, a F(ab)2 fragment or a F(ab′)2 fragment, even more preferably the fragment being a site-specifically biotinylated fragment.

### Claim at position 17

-32. (canceled)
