In Phase 1 DF1001 was well-tolerated and showed encouraging pharmacodynamic effects and clinical response, with tumor burden reductions across several tumor types including in HER2-low, heavily pre-treated patients.

Dragonfly’s Phase 2 trial to further evaluate DF1001 both as a monotherapy and in combination with Opdivo® or Abraxane®, has dosed the first patients.

WALTHAM, MA, USA I December 6, 2022 I Dragonfly Therapeutics, Inc. (“Dragonfly”), a biotechnology company developing novel therapies that harness the immune system to treat a broad range of diseases, today announced that the first patients have been dosed in the Phase 2 study of its HER2 targeting TriNKET® DF1001. The trial is recruiting patients across a range of advanced solid tumor indications at 34 sites in the United States and Europe.

DF1001 is the first TriNKET to enter Phase 2 trials. Six Dragonfly-developed drugs are now in the clinic.

DF1001 was well-tolerated with no dose limiting toxicities during dose escalation in the Phase 1 study.  The study showed encouraging pharmacodynamic effects including infiltration of NK cells and T cells into tumors.  DF1001 also demonstrated clinical response as a monotherapy and in combination with nivolumab or nab-paclitaxel, with tumor burden reductions across several solid cancer types representing both HER2-low and HER2-high, and heavily pre-treated patients.   

“Having seen the effect of DF1001 in my breast cancer patients, including those heavily pretreated and resistant to multiple anti-cancer treatments, I’m very encouraged by the prospects for DF1001,” said Dr. Emanuela Romano, Director, Center for Cancer Immunotherapy at the Institut Curie in Paris. “These early signs were seen at doses notably below the dose recommended for Phase 2.” 

“DF1001’s Phase 1 study provided encouraging early evidence of safety and clinical activity in adults with advanced solid tumors, as predicted by our preclinical work,” said Dragonfly CMO, Jean-Marie Cuillerot. “For example, we have seen RECIST responses in multiple tumor types from patients receiving DF1001 monotherapy and in combination with Opdivo and Abraxane, starting at very low doses, including in patients with low HER2 expression or in patients with high HER2 expression who had progressed after they received a full series of other treatments including ADCs such as Enhertu®.”

DF1001’s Phase 2 trial will expand development of DF1001 both as monotherapy and in combination with multiple agents, including Opdivo® and Abraxane®.

About DF1001 

DF1001 is an investigational first-in-class drug candidate being evaluated in adult patients for the treatment of advanced solid 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 TriNKETs that Dragonfly is developing to address high unmet needs for patients with different types of cancers. 

About Dragonfly

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 immune system to bring breakthrough treatments to patients. Dragonfly has built a deep pipeline of wholly owned preclinical and clinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas. 

For more information visit:

SOURCE: Dragonfly Therapeutics