24 September 2020 - Leap Therapeutics today announced that the U.S. FDA has granted fast track designation to DKN-01 for the treatment of patients with gastric and gastro-esophageal junction adenocarcinoma whose tumours 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/neu-targeted therapy.
DKN-01 is a humanised monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin signaling.