The FDA granted Leap Therapeutics’ (NASDAQ:LPTX) DKN-01 orphan drug designation for the treatment of gastric and gastroesophageal junction cancer.
DKN-01 is a humanized monoclonal antibody that targets the Dickkopf-1 protein, which plays a role in tumor cell signaling and immuno-suppressive tumor microenvironment mediation.
“Orphan drug designation for DKN-01 in gastric and gastroesophageal junction cancer is another significant milestone in our DKN-01 development program and underscores the need for new treatment options for these indications,” Douglas Onsi, Leap’s president and CEO, said in a statement.
“We believe DKN-01 has the potential to be an important new therapy for this patient population that remains an area of high unmet medical need,” he added.
DKN-01 is currently being evaluated in Phase 1/2 and Phase 2 clinical trials for gastroesophageal, gynecologic, hepatobiliary, and prostate cancers. Dosing of the first gastric or gastroesophageal junction cancer patients in a combination study of DKN-01 plus tislelizumab, an anti-PD-1 antibody, is expected to begin in the third quarter of 2020.
