FDA grants orphan drug designation to DF1001 for esophageal cancer

FDA grants orphan drug designation to DF1001 for esophageal cancer

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 drugRead More

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