The FDA granted Leap Therapeutics’ (NASDAQ:LPTX) DKN-01 fast track designation for gastric and gastroesophageal junction cancer.
Specifically, the designation was granted for patients whose tumors express high Dickkopf-1 protein and who have experienced disease progression on or after chemotherapy and, if appropriate, HER2-targeted therapy.
Leap recently dosed the first patient with gastric or gastroesophageal junction cancer in a combination study of DKN-01 plus tislelizumab, an anti-PD-1 antibody.
“The designation highlights the existing unmet medical need for new and effective treatments for this patient population,” Douglas Onsi, Leap’s president and CEO, said in a statement.
“We believe that DKN-01 shows promise as a novel treatment option for biomarker-selected patients with these cancers, and this designation provides us with earlier and more frequent opportunities to interact with the FDA during the development of DKN-01,” he added.
DKN-01 received FDA orphan drug designation for the treatment of gastric and gastroesophageal junction cancer in June 2020.