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Dragonfly Initiates Phase 1/1b Study of its IL-2 Immunotherapy

The company announces the first patient dosed in a Phase 1/1b clinical trial evaluating its novel IL-2 cytokine, DF6215, the seventh Dragonfly-developed drug to enter into clinical trials.

WALTHAM, Mass., Dec. 5, 2023 /PRNewswire/ -- Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, today announced it recently dosed its first patient in a Phase 1/1b study of the Company's proprietary IL-2 investigational immunotherapy, DF6215, developed for patients with advanced solid tumors. DF6215 is the second in a pipeline of cytokines Dragonfly is developing to address the high unmet need in patients with advanced cancer and other diseases.

"DF6215's therapeutic potential is particularly compelling," said Dr. Benedito A. Carneiro, MD, MS, Associate Director of the Hematology/Oncology Division, Director of the Phase I program at the Lifespan Cancer Institute, and Co-Leader of the Cancer Therapeutics Program at the Legorreta Cancer Center at Brown University. "Dragonfly's IL-2 preclinical package shows strong anti-tumor activity in cold and hot tumor models and a favorable therapeutic window in cyno, with no signs of Vascular Leak Syndrome or Cytokine Release Syndrome – which we believe powerfully differentiates DF6215 from historic IL-2 drug candidates."

"Dragonfly's pre-clinical data package on IL-2 is very promising, and we are eager to demonstrate its effects in cancer patients," said Dr. Joseph Eid, President of Research and Development at Dragonfly. "DF6215 is functionally differentiated from other IL-2s, retaining alpha activity, with an expanded therapeutic window compared to other IL-2s, giving DF6215 the potential to stimulate effective anti-tumor activity in patients who are not currently eligible for or adequately responding to current therapies."

DF6215 is the seventh Dragonfly-developed and fourth Dragonfly-owned drug, in the clinic.

"Initiating clinical trials with our second cytokine and the seventh Dragonfly-developed drug candidate underscores the pace with which our team is advancing the development of important new treatment options for patients with cancer and autoimmune disease, as well as the the breadth of Dragonfly's portfolio of innovative therapeutics," said Bill Haney, CEO and Dragonfly co-founder.

Dragonfly's DF6215 Phase 1/1b clinical trial is a first-in-human, multi-part, open-label study to investigate the safety, tolerability, pharmacokinetics, biological, and clinical activity of DF6215 in patients with advanced (unresectable, recurrent, or metastatic) solid tumors. DF6215-001 is currently recruiting at multiple sites in the U.S., with sites in additional regions scheduled to open in 2024.

Additional information about the trial, including eligibility criteria, can be found at: ( Identifier: NCT06108479).

About Dragonfly Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing novel therapies that harness the body's immune system to bring breakthrough treatments to patients. In addition to a set of advanced programs in the clinic, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platforms that are progressing toward the clinic, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.



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