WALTHAM, Massachusetts, July 21, 2020
The company announces its first patient enrolled and dosed in a Phase 1/2 clinical trial evaluating its novel IL12 cytokine, DF6002.
WALTHAM, Massachusetts, July 21, 2020 /PRNewswire/ -- Dragonfly Therapeutics, Inc. ("Dragonfly" or the "Company"), a clinical stage biotechnology company developing novel immunotherapies, today announced it has dosed its first patient in a Phase 1/2 study of the Company's proprietary IL12 investigational immunotherapy, DF6002. Dragonfly's DF6002 clinical trial is currently recruiting patients with advanced solid tumors at Lifespan Cancer Institute at Rhode Island Hospital, the principal teaching hospital of Brown University, with additional sites scheduled to open shortly. DF6002 will be Dragonfly's second drug in the clinic, with its NK cell engager therapy DF1001 having started clinical testing in the fall of 2019.
"DF6002's therapeutic potential is particularly exciting," said Dr. Mario Sznol, Dragonfly Clinical Advisory Board member and Professor of Medicine & Co-Leader, Cancer Immunology, Yale Cancer Center. "Dragonfly's extended half-life IL12 with retained potency and remarkable in vivo anti-tumor data may help fulfill the long-awaited potential of this cytokine in a broad population of cancer patients."
"Dragonfly's pre-clinical data package on IL12 is extraordinary, and we are eager to demonstrate its effects in cancer patients"," said said Dr. Tyler Jacks, Director of the Koch Institute at MIT and Chairman of the Company's Scientific Advisory Board. "DF6002 is Dragonfly's first cytokine and has demonstrated preclinically superior efficacy to native IL12 combined with a compelling preclinical safety profile and wide therapeutic window."
Dragonfly Therapeutics received investigational new drug approval for DF6002 from the U.S. Food and Drug Administration (FDA) in late May. The company's Phase 1/2 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 DF6002 alone and in combination with PD-1 inhibition in patients with locally advanced or metastatic solid tumors, followed by expansion in selected indications.
Initiating clinical trials with our first cytokine underscores both the breadth of Dragonfly's portfolio of innovative therapeutics, and the pace with which our team is bringing important new treatment options to patients with cancer and autoimmune disease," said Bill Haney, CEO and Dragonfly co-founder. "In addition to DF6002, our productive collaborations building drugs for BMS, Merck, and Abbvie, and our DF1001 TriNKET presently advancing in the clinic, we're already racing to bring our second TriNKET to IND in 2021."
Additional information about the trial, including eligibility criteria, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04423029).
DF6002, Dragonfly's extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines that Dragonfly is developing to address the high unmet need in patients with advanced cancer.
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel bispecific antibody technology to harness the body's innate immune system to bring breakthrough cancer treatments to patients. Dragonfly has a deep pipeline of wholly-owned preclinical candidates discovered using its platform that are progressing toward the clinic, as well as productive collaborations with BMS, Merck and Abbvie in a broad range of disease areas.
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