Dragonfly Therapeutics, a clinical-stage biotechnology company developing novel immunotherapies, has announced a clinical collaboration with Merck to evaluate the potential of DF9001, Dragonfly’s immune-activating therapy targeting EGFR, in combination with Merck’s anti-PD-1 treatment, KEYTRUDA®, in patients with advanced solid tumors expressing EGFR.
“We are excited to partner with Merck on this Phase I investigational trial of DF9001,” said Bill Haney, Co-Founder and CEO of Dragonfly Therapeutics. “In preclinical models, DF9001 has demonstrated strong anti-tumor activity by engaging immune effector cells and inducing PD-L1 expression in tumor cells, sensitizing cold tumors to checkpoint inhibitors. We hope that the combination of DF9001 with KEYTRUDA will lead to a powerful anti-tumor response across a wide range of indications. Our goal is to advance clinical progress for the benefit of patients in need.”
Dragonfly Therapeutics will sponsor the study, and the first patients are expected to receive DF9001 in combination with pembrolizumab in the fourth quarter of 2024. Clinical trial sites are currently open for monotherapy dosing in the United States, with additional sites in North America and Europe set to open in 2024. More information about the trial, including eligibility criteria, can be found at clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05597839).
DF9001 is an experimental, first-in-class, multispecific drug candidate that targets EGFR and potentially redirects natural killer (NK) cells, gamma-delta T cells, and CD8 T cells by engaging the NKG2D and CD16 receptors. Developed using Dragonfly’s TriNKET® platform, DF9001 is being evaluated in adult patients with advanced EGFR-positive solid tumors. The therapy has the potential to stimulate anti-tumor immunity in patients who are not eligible for or do not adequately respond to current therapies.
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing new therapies that harness the body’s immune system to deliver revolutionary treatments to patients. In addition to their advanced clinical programs, Dragonfly has a broad range of proprietary preclinical candidates that have been discovered through their exclusive platforms and are nearing clinical trials. The company has established productive collaborations with AbbVie, Bristol Myers Squibb, Gilead, and Merck, targeting a wide range of disease areas.
For more information, please visit: www.dragonflytx.com
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Dragonfly Therapeutics has formed a clinical collaboration with Merck to evaluate their immune-activating therapy, DF9001, in combination with Merck’s anti-PD-1 treatment, KEYTRUDA®, for advanced solid tumors expressing EGFR. DF9001 has demonstrated strong anti-tumor activity in preclinical models by engaging immune effector cells and inducing PD-L1 expression in tumor cells, making them more susceptible to checkpoint inhibitors like KEYTRUDA.
DF9001 is an experimental drug candidate developed using Dragonfly’s TriNKET® platform. It is a first-in-class, multispecific drug that targets EGFR and potentially redirects natural killer (NK) cells, gamma-delta T cells, and CD8 T cells by engaging the NKG2D and CD16 receptors. This therapy has the potential to stimulate anti-tumor immunity in patients who are not eligible for or do not respond well to current treatments.
The clinical trial, sponsored by Dragonfly Therapeutics, is set to begin in the fourth quarter of 2024, with the first patients receiving DF9001 in combination with pembrolizumab. Clinical trial sites for monotherapy dosing are currently open in the United States, and additional sites in North America and Europe will open in 2024. Further details on the trial, including eligibility criteria, can be found on clinicaltrials.gov.
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies that leverage the body’s immune system for revolutionary treatments. In addition to their collaboration with Merck, Dragonfly has established partnerships with AbbVie, Bristol Myers Squibb, Gilead, and Merck, targeting various disease areas. They also have a range of proprietary preclinical candidates discovered through their exclusive platforms, which are nearing clinical trials.
Current market trends in the field of immunotherapy indicate a growing interest in combination approaches using multiple therapies to enhance treatment efficacy. The collaboration between Dragonfly Therapeutics and Merck aims to explore the potential synergistic effects of DF9001 and KEYTRUDA in patients with advanced solid tumors expressing EGFR. If successful, this combination could open up new treatment options for patients who have limited response to current therapies.
However, there are several challenges and controversies associated with immunotherapy. One key challenge is the development of resistance to treatment over time. Some patients initially respond well to immunotherapy but eventually develop resistance, leading to treatment failure. Researchers are actively working to better understand and address this issue.
Another challenge is the management of immune-related adverse events (irAEs), which can occur as a result of immunotherapy. These irAEs can affect various organs and systems in the body and require close monitoring and prompt intervention to mitigate potential complications.
Advantages of the Dragonfly-Merck collaboration include the potential for improved treatment outcomes through the combination of DF9001 and KEYTRUDA. DF9001’s ability to engage immune effector cells and induce PD-L1 expression in tumor cells could enhance the anti-tumor immune response when combined with KEYTRUDA’s checkpoint inhibition. This collaboration represents a step forward in personalized medicine, as it aims to target patients with specific tumor characteristics (EGFR-positive tumors) who may not respond well to current therapies.
Disadvantages of this collaboration include the uncertainties that come with early-stage clinical trials. While the preclinical data for DF9001 is promising, the clinical trial will provide crucial evidence of its safety and efficacy. There is always a risk that the combination treatment may not yield the desired results, and the timeline for availability of the therapy to patients may be further extended if there are setbacks in the trial.
For more information about Dragonfly Therapeutics and their ongoing programs, you can visit their website at www.dragonflytx.com.