Background

The unmet need for effective tools to support the early diagnosis of a range of cancers is well recognised. New cancer biomarkers are continuously being identified, but most are specific to a single cancer type or stage, and few have the selectivity and specificity required to succeed as a diagnostic tool.

There is a sialic acid, N-glycolylneuraminic acid (NeuGc), which is not synthesised by humans, but which is understood to be preferentially taken up by a range of human cancerous cells, and secreted into the blood. NeuGc represents a specific biomarker for detection of a range of human cancers.

Currently available reagents cannot readily distinguish between NeuGc and other sialic acids commonly found in the human body, resulting in poor specificity and sensitivity. A highly specific NeuGc-binding ligand will enable early blood based diagnosis of a broad range of tumours including, but not limited to breast, prostate, ovarian, colon and lung.

Technology Overview

Researchers have discovered that mutated forms of the (non-toxic) binding subunit of a novel bacterial toxin (SubB) demonstrate unprecedented binding specificity and affinity for NeuGc, without binding to “normal” human sialic acid forms (such as NeuAc).

Data has been developed using an ELISA based assay using SubB to detect the presence of NeuGc in human serum. The research team have demonstrated clear dose dependent detection of NeuGc in serum, with sensitivity down to a concentration of 2 nM.

The team has also developed a large amount of surface plasmon resonance data for 2 mutant variants of the SubB protein, demonstrating either improved specificity and/or sensitivity in binding to the tumour antigen NeuGc over NeuAc ().

Stage of Development

The next phase of studies are currently underway, utilising earlier stage samples (stage 1-3) for breast and prostate cancer, to validate the tool as an early stage, pan-cancer diagnostic tool, with potential whole-of-population application.

Benefits

This data demonstrates that all stage 4 breast cancer (24 samples) and stages 1, 2, 3 and 4 ovarian cancer (c. 24 samples) show statistically significant elevated levels of Neu5Gc marker when detected by SubB2M in our surface plasmon resonance assay, when compared to the commercially available IgY antibody (stage ¾ cancers), and healthy age and gender matched controls (stage 1-4 ovarian). These results indicate efficacy for use as a serum marker for both early and later-stage disease identification and progression.

Applications

Early stage, pan-cancer diagnostic tool, with potential whole-of-population application.

Opportunity

The university are actively seeking commercial partners to work with us to develop this into a prognostic and diagnostic tool for clinical use.

SubB Mutant for Detection of Cancer

Patents

Seeking