Leap granted fast track designation for mAb to treat gastric cancers

By The Science Advisory Board staff writers

September 24, 2020 -- Leap Therapeutics said that its DKN-01 monoclonal antibody (mAb) has received fast track designation by the U.S. Food and Drug Administration (FDA) for treatment of gastric and gastroesophageal junction (G/GEJ) adenocarcinomas.

The humanized mAb is designed for treatment of 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, HER2/neu-targeted therapy. DKN-01 binds to and blocks the activity DKK1, a modulator of Wnt/Beta-catenin signaling.

DKN-01, which is currently being evaluated in clinical trials for gastroesophageal, gynecologic, hepatobiliary, and prostate cancers, has also received an "orphan drug" designation by the FDA for treatment of GE/GEJ cancer, Leap said.

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