The new diagnostic assay will support the clinical development of DKN-01, an anti-DKK1 cancer therapy. Credit: National Cancer Institute / Unsplash.

Leica Biosystems and Leap Therapeutics have entered an agreement for the development of a companion diagnostic to detect Dickkopfrelated protein 1 (DKK1), which is often found in cancer.

The protein enables tumour cells to suppress the immune system, which leads to unregulated growth.

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The new diagnostic assay will support the clinical development of Leap Therapeutics’ anti-DKK1 cancer therapy, DKN-01, which is currently being studied in clinical trials.

DKN-01 is a humanised monoclonal antibody that targets DKK1 as a treatment for cancer.

As part of a combination therapy regimen, Leap Therapeutics is now studying DKN-01 in a Phase II clinical trial for gastric or gastroesophageal junction cancer patients.

Leap Therapeutics translational medicine head and vice-president Jason Baum said: “DKK1 is novel and broadly applicable biomarker that is often elevated in patients with poor outcomes.

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“Patients whose tumours express elevated levels of DKK1 have shown compelling clinical responses when treated with DKN-01-based regimens.”

Developed by Leica Biosystems, the diagnostic assay will use Bio-Techne’s RNAscope technology on BOND-III Automated Staining System.

Leica Biosystems said that this system provides high sensitivity and specificity for the detection of the DKK1 protein.

This helps to identify patients who are the most likely to benefit from treatment with DKN-01.

Leica Biosystems pharma partnerships senior director Rachel Skelton said: “Companion Diagnostics are a step toward treating cancer patients based on the biomarker makeup of their disease. We are excited to partner with Leap to advance cancer care.”

In 2020, Leica Biosystems and Bio-Techne introduced the CE-IVD marked RNAscope In Situ Hybridization Detection Kit in Europe for automation on the BOND-III platform.