On November 12, 2019 Dragonfly Therapeutics, Inc. ("Dragonfly"), a biotechnology company developing novel immunotherapies that use the innate immune system to treat disease, reported that the first patient in a Phase I / II study of DF1001 at the MD Anderson Cancer Center at the University of Texas, Houston , USA , and the study by Dragonfly on DF1001 is currently recruiting patients with several types of advanced solid tumors, the human epidermal growth factor Receptor 2 (HER2) (Press release, Dragonfly Therapeutics, NOV 12, 2019, View Source [SID1234551024]).
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"DF1001 is the first candidate in our TriNKET platform to reach the clinic, marking our transition to becoming a clinical development company," said Bill Haney , co-founder and CEO of Dragonfly Therapeutics, "We are very excited about working with the MD Anderson’s immunotherapy experts as part of our study of the differential safety profile that our NK cell engages can offer against existing immuno-oncology options, and we also look forward to improving other assets in our portfolio with the same purposefulness that made us possible To further develop DF1001 for patients. "
"Clinical candidates coming from Dragonfly’s TriNKET platform have the potential for exceptional therapeutic performance," said Jean-Marie Cuillerot, Chief Medical Officer of Dragonfly Therapeutics. "We look forward to working with our MD Anderson collaboration partners on DF1001 continue to evolve for a variety of patients who are not receiving adequate treatment from currently available therapies. "
"Today is a big day for Dragonfly, founded less than four years ago. It is very exciting that the first clinical candidate of our TriNKETs pipeline has now reached the clinic, "said Tyler Jacks , director of the Koch Institute at MITand co-founder of the company. "In addition to our DF1001 program and our extensive development of drug candidates for Celgene and Merck, Dragonfly has an extensive pipeline of other internal programs that are rapidly approaching the clinic, including an internal program planned for the second quarter of 2020 for our second new program investigational. This remarkable progress and speed underline the urgency with which Dragonfly has pursued its goal of providing potential new treatment options for cancer patients. "
Dragonfly Therapeutics received an Investigational New Drug approval for its immunotherapy drug DF1001 earlier this year from the US Food and Drug Administration (FDA). The Company’s Phase I / II clinical trial is a sophisticated, open-label, non-randomized, first-in-man, multiple-dose multiple-dose study to evaluate the safety, tolerability, pharmacokinetics, and biological and clinical activity of DF1001 in patients with locally advanced or advanced disease metastatic solid tumors with HER2, with subsequent extension to selected indications.
Further study information, including eligibility criteria, is available at the following link: View Source (ClinicalTrials.gov identifier: NCT04143711).
About DF1001
DF1001 is a novel investigational drug candidate being studied in adult patients for the treatment of advanced solid HER2-positive tumors. DF1001 was discovered and developed by Dragonfly’s TriNKET platform. DF1001 has the potential to stimulate effective anti-tumor immunity in patients who are not suited for or respond to current therapies. DF1001 is the most advanced in the pipeline of TriNKET , which Dragonfly is developing to meet the unmet medical needs of patients with a variety of cancers.
About Dragonfly’s
TriNKET Platform Dragonfly’s TriNKET platform is the foundation of a portfolio of novel therapeutics that are trispecific natural killer cell activation therapies designed to enhance the natural and killer cells (NK) of the innate and adaptive Activate and redirect the immune system so that the cancer is eliminated.