FDA grants orphan drug designation to DF1001 for esophageal cancer
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The FDA granted orphan drug designation to DF1001 for treatment of esophageal cancer.
DF1001 (Dragonfly Therapeutics) is a HER2-targeted natural killer cell engager therapy.
The therapy — developed using Dragonfly’s TriNKET platform — is being evaluated for adults with advanced, HER2-positive solid tumors.
A phase 1/phase 2 trial is underway to assess safety, tolerability, and preliminary biological and clinical activity. Researchers reported no dose-limiting toxicities among the first 40 patients treated.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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