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Flagship Biosciences, Leap Therapeutics Partner on Biomarker Screening for DKN-01 Clinical Trial

NEW YORK – Flagship Biosciences this week said it will use its RNAscope assay to select gastric cancer patients for a study exploring the activity of Leap Therapeutics' anti-DKK1 agent DKN-01.

Specifically, Flagship will use its chromogenic in situ hybridization (CISH) assay, in combination with tissue image analysis, to identify advanced gastric or gastroesophageal cancer patients with elevated tumoral expression of DKK1 RNA, and determine their eligibility for Leap's Phase II DisTinGuish clinical trial. In that study, LEAP is evaluating the combination of DKN-01 and BeiGene's PD-L1 inhibitor tislelizumab with and without chemotherapy.

Investigators will send patients' samples from trial recruitment sites in the US and Korea to Flagship's central lab in Westminster, Colorado. There, the company will perform the RNAscope assay and conduct image analysis, as well as pathologist review of patients' samples to assess their trial eligibility.

Michael Kagey, Leap's senior director of translational medicine, said in a statement that Flagship's laboratory-developed test is "superior to traditional DKK1 immunohistochemistry in its specificity and sensitivity, [and] the use of the digital image analysis algorithm to quantify DKK1 signal and support pathologist interpretation is a novel approach that reduces the risk of scoring bias."