...Leap Therapeutics, Inc a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.

In the study, high levels of tumoral DKK1 expression correlated with improved clinical outcomes in heterogeneous EGC patients treated with DKN-01 as monotherapy or in combination with pembrolizumab or paclitaxel. Pooled data for the 69 patients in the study for whom tumoral DKK1 expression data is available demonstrated that DKK1-high patients experienced higher overall response rates (ORR), a doubling of median progression-free survival (PFS), and longer median overall survival (OS) as compared to DKK1-low patients.