Leap Therapeutics gets FDA orphan status for DKN-01 for gastric and gastroesophageal junction cancer

US immuno-oncology company Leap Therapeutics has been granted orphan drug designation for DKN-01 from the US Food and Drug Administration (FDA) for the treatment of gastric and gastroesophageal junction cancer.

DKN-01, which is a humanized monoclonal antibody, has been designed to bind to and block the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling.

Douglas E. Onsi – President and CEO of Leap Therapeutics said: “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.

“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.”

The FDA’s orphan drug designation is given to support the development of drugs for underserved patient populations, or rare disorders, that impact less than 200,000 people in the US.

Through the orphan drug designation to DKN-01, Leap Therapeutics will get certain benefits such as market exclusivity upon regulatory approval if secured, exemption of FDA application fees, and also tax credits for qualified clinical trials.

Currently, DKN-01 is being assessed in phase 1/2 and phase 2 clinical trials for gastroesophageal, gynecologic, prostate, and hepatobiliary cancers. Leap Therapeutics said that it is carrying out site initiation activities for its combination study of DKN-01 plus BeiGene’s anti-PD-1 antibody tislelizumab in patients having gastric or gastroesophageal junction cancer with dosing of the first patients likely to take place in Q3 2020.