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Dragonfly Therapeutics Initiates Phase 1/2 Study of DF1001 in Patients with Advanced Solid Tumors

WALTHAM, Mass., Nov. 12, 2019 /PRNewswire/ -- Dragonfly Therapeutics, Inc. ("Dragonfly"), a biotechnology company developing novel immunotherapies that harness the innate immune system to treat disease, today announced that the first patient was dosed in a Phase 1/2 study of DF1001 at The University of Texas MD Anderson Cancer Center in Houston. Dragonfly's DF 1001 clinical trial is currently recruiting patients with various types of advanced solid tumors that express human epidermal growth factor receptor 2 (HER2).

"DF1001 is the first candidate from our TriNKET™ Platform to enter the clinic and marks our transition to a clinical-stage company," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "We are pleased to collaborate with the immunotherapy experts at MD Anderson as we explore the differentiated safety profile that our NK-cell engagers may offer over existing immuno-oncology options. We look forward to advancing other assets in our portfolio with the same purpose and focus that allowed us to advance DF1001 to patients."

"Clinical candidates derived from Dragonfly's TriNKET platform have the potential for extraordinary therapeutic performance," said Jean-Marie Cuillerot, Chief Medical Officer at Dragonfly Therapeutics. "We look forward to working with our collaborators at MD Anderson to advance DF1001 to a wide range of patients who are not adequately treated by currently available therapies."

"This is a big day for Dragonfly, which was founded less than four years ago. It is very exciting that our first clinical candidate from our TriNKETs™ pipeline is now in the clinic," said Tyler Jacks, Director of the Koch Institute at MIT and co-founder of the company. "In addition to our DF1001 program and our extensive work building drug candidates for Celgene and Merck, Dragonfly has a deep pipeline of other internal programs rapidly advancing toward the clinic, with our second IND on an internal program targeted for Q2 2020. This remarkable progress and pace underscore the urgency with which Dragonfly has pursued its goal of bringing potential new treatment options to patients with cancer."

Dragonfly Therapeutics received investigational new drug approval for their immunotherapy agent DF1001 from the U.S. Food and Drug Administration (FDA) earlier this year. The company's Phase I/II clinical trial is a first-in-human, multi-part, open-label, non-randomized, multiple-ascending dose study to investigate the safety, tolerability, pharmacokinetics, biological, and clinical activity of DF1001 in patients with locally advanced or metastatic solid tumors who express HER2, followed by expansion in selected Indications.

Additional information about the trial, including eligibility criteria, can be found at: ( Identifier: NCT04143711).

About DF1001 DF1001 is an investigational first-in-class drug candidate 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 or not adequately responding to current therapies. DF1001 is the most advanced in a pipeline of TriNKET™ that Dragonfly is developing to address high unmet needs for patients with different types of cancers.

About Dragonfly's TriNKET™ Platform Dragonfly's TriNKET™ Platform is the basis for a portfolio of novel therapeutics that are tri-specific natural killer cell engagement therapies designed to activate and redirect Natural Killer (NK) cells of the innate and adaptive immune system to eliminate cancers.

About Dragonfly Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel TriNKET™ technology to harness the body's innate immune system to bring breakthrough cancer treatments to patients. Dragonfly has a deep pipeline of wholly-owned TriNKETs™ discovered using its TriNKET Platform that are progressing towards the clinic, as well as productive collaborations with Celgene and Merck.



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