STATEMENT: Dragonfly Therapeutics begins phase 1/1b study of its immunotherapy with IL-2

(Information sent by the signatory company).

STATEMENT: Dragonfly Therapeutics begins phase 1/1b study of its immunotherapy with IL-2

(Information sent by the signatory company)

-Dragonfly Therapeutics begins phase 1/1b study of its immunotherapy with IL-2 in patients with advanced solid tumors

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

WALTHAM, Mass., Dec. 6, 2023 /PRNewswire/ -- Dragonfly Therapeutics, Inc., a clinical-stage biotechnology company developing novel immunotherapies, today announced that its first patient was recently dosed in a Phase 1 study/ 1b of the company's proprietary investigational IL-2 immunotherapy, DF6215, developed for patients with advanced solid tumors. DF6215 is the second in a series of cytokines that Dragonfly is developing to address the large unmet need in patients with advanced cancer and other diseases.

"The therapeutic potential of DF6215 is particularly compelling," said Benedito A. Carneiro, MD, MS, associate director of the Division of Hematology/Oncology, director of the Lifespan Cancer Institute Phase I program and co-director of the Therapeutics Program. Cancer Center at Brown University Legorreta Cancer Center. "Dragonfly's preclinical IL-2 package shows strong antitumor activity in hot and cold tumor models and a favorable therapeutic window in cyno, with no signs of vascular leak syndrome or cytokine release syndrome, which we believe makes a powerful difference." to DF6215 from historical IL-2 drug candidates."

"Dragonfly's preclinical 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 antitumor activity in patients who are currently ineligible." or do not respond adequately to current therapies."

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

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

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

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

About DragonflyDragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel therapies that harness the body's immune system to provide innovative treatments to patients. In addition to a suite of advanced programs in the clinic, Dragonfly has a broad 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 wide range of disease areas.

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