Dragonfly also announced this week its first TriNKET, HER2-targeting DF1001, entered Phase 2. In its Phase 1 study DF1001 was well-tolerated and showed encouraging clinical response, with tumor burden reductions across several tumor types including in HER2-low and heavily pre-treated patients.
WALTHAM, MA. December 8, 2022 /PRNewswire/ -- Dragonfly Therapeutics, Inc. ("Dragonfly" or the Company), a clinical stage biotechnology company developing novel immunotherapies, today announced the first patient dosed in a Phase 1/2 study of the Company’s proprietary EGFR-targeting TriNKET.
DF9001is the sixth Dragonfly-developed drug to enter into clinical trials. The Company’s first TriNKET, DF1001, entered Phase 2 trials this month after being well-tolerated in Phase 1 with encouraging clinical responses, including showing tumor burden reductions across several tumor types, including in HER2-low and heavily pre-treated patients.
“Given our positive experience over the last two years with Dragonfly’s DF1001 HER2-targeting TriNKET, we are excited to begin offering patients with an even broader set of solid tumor cancers this new EGFR-targeting therapeutic,” said Howard P. Safran, MD, Chief of Hematology/Oncology at the Lifespan Cancer Institute and Medical Director for the Brown University Oncology Group. “We see an opportunity for Dragonfly’s next generation of NK cell-engaging immune-oncology therapies to attack solid tumor cancers directly, recruit T cells to cold tumor environments, and offer a broadened therapeutic index – helping patients that presently have very few other therapeutic options.”
“Initiating clinical trials with the sixth drug candidate developed by Dragonfly demonstrates how comprehensively we and our Pharma partners are bringing critically-needed new treatment options to patients with cancer,” said Jean-Marie Cuillerot, Dragonfly’s Chief Medical Officer.
Dragonfly Therapeutics’ DF9001 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 DF9001 alone and in combination with a PD-1 checkpoint inhibitor in patients with locally advanced or metastatic solid tumors, followed by expansion in selected indications including Head and Neck Squamous Cell Carcinoma (HNSCC), Colorectal cancer (CRC), and Non-small Cell Lung Cancer (NSCLC).
Additional information about the trial, including eligibility criteria, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05597839).
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 treatments to patients. Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform 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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SOURCE Dragonfly Therapeutics, Inc.