On November 9, 2021 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported 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 (Press release, Dragonfly Therapeutics, NOV 9, 2021, View Source [SID1234594929]).

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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: View Source (ClinicalTrials.gov Identifier: NCT04143711).

Esophageal Cancer

Esophageal cancer is relatively rare and represents 1% of all new cancer cases in the U.S. Esophageal cancer is more common in men than women and is the sixth most common cause of cancer-related death worldwide3. In the U.S., esophageal adenocarcinoma is more common than squamous cell carcinoma, and its incidence has increased more quickly than any other malignancy in many western countries. Current treatment options include surgery, radiation therapy, chemotherapy, and targeted therapy (and combinations thereof), depending on stage and type of disease4. Despite multimodality treatment strategies, survival remains disappointing, with a 5-year survival rate of 47% for localized disease. When disease has spread to surrounding tissues or organs and/or lymph nodes, the 5-year survival rate is only 25%, and when spread to distant parts, prognosis is particularly poor with a survival rate of just 5%. Approximately one in five people with esophageal cancer have increased HER2 protein on the surface of their cells, so-called HER2-positive cancers.

About DF1001

DF1001 is an investigational first-in-class drug candidate that targets natural killer (NK) cells and T-cell activation signals to specific receptors on cancer cells. DF1001 is being evaluated in adult patients for the treatment of advanced solid HER2-positive tumors. DF1001 was discovered and developed using Dragonfly’s TriNKET Platform. DF1001 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible for, or not adequately responding to, current therapies. DF1001 is the most advanced drug candidate in a pipeline of TriNKETs that Dragonfly is developing to address high unmet needs for patients across a broad range of disease areas.

About Dragonfly’s TriNKET Platform

Dragonfly’s TriNKET Platform is the basis for a portfolio of novel therapeutics that are designed to harness Natural Killer cells and other cells of the innate immune system which can provide direct killing of disease promoting cell types and provide a unique therapeutic window beyond current therapies for treatment of cancer and chronic inflammatory diseases.