Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, today announced that its wholly-owned HER2-targeted NK cell engager therapy, DF1001, has been granted Orphan Drug Designation (ODD) in the US for treatment of esophageal cancer.
An estimated 19,260 new cases of esophageal cancer will be diagnosed this year and the disease could lead to more than 15,500 deaths in the US in 2021.1 The Food and Drug Administration (FDA) grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. HER2 is expressed in a large subset of esophageal cancers, even in patients without amplification of erbb2.
An ongoing Phase 1/2 clinical trial for the DF1001 TriNKET is a first-in-human study exploring the safety, tolerability and preliminary biological and clinical activity of DF1001. Dragonfly has treated 40 patients with DF1001, with no DLTs to date. Clinical trial sites are open in the U.S., France, Belgium, Denmark and The Netherlands. Additional information about the trial, including eligibility criteria, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04143711).
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