Leica Biosystems, a cancer diagnostics company, has entered into an agreement with Leap Therapeutics (NASDAQ: LPTX), a biotechnology company, to develop a companion diagnostic to detect Dickkopf-related protein 1 (DKK1). The assay will be used to support clinical development of Leap Therapeutics' anti-DKK1 cancer therapy, DKN-01, currently being studied in clinical trials.

DKK1 is a protein often implicated in cancer, enabling tumor cells to suppress the immune system and lead to unregulated growth. Overexpression of DKK1 is associated with poor survival in cancer patients.

Leap Therapeutics is currently advancing the development of DKN-01, a humanized monoclonal antibody that targets DKK1, to treat cancer. The company is currently studying the drug as part of a combination therapy regimen in a Phase 2 clinical trial in patients with gastric or gastroesophageal junction cancer.

The assay developed by Leica Biosystems will utilize RNAscope™ technology from Bio-Techne on the BOND-III Automated Staining System, which allows for detection of DKK1 with high sensitivity and specificity, to help identify patients most likely to benefit from DKN-01 treatment.

"Companion Diagnostics are a step toward treating cancer patients based on the biomarker makeup of their disease," said Rachel Skelton, Senior Director of Pharma Partnerships at Leica Biosystems. "We are excited to partner with Leap to advance cancer care."

Companion Diagnostics are tests that may be used to determine if a patient's tumor has the biomarker that will predict the outcome of a treatment with a specific therapy. With expertise in assay development, regulatory approval and commercialization, the Leica Biosystems Companion Diagnostics team partners with pharmaceutical companies to develop assays for a diverse range of technologies. Our flexible approach to partnerships, along with the robust capabilities of the BOND Advance Staining Solutions, supports our mission of Advancing Cancer Diagnostics, Improving Lives.

"DKK1 is novel and broadly applicable biomarker that is often elevated in patients with poor outcomes," said Jason Baum, Vice President and Head of Translational Medicine at Leap Therapeutics. "Patients whose tumors express elevated levels of DKK1 have shown compelling clinical responses when treated with DKN-01-based regimens. We are pleased to partner with Leica to advance the clinical development of our therapy and improve patient lives."