Dragonfly Therapeutics Announces Clinical Trial of DF9001 with KEYTRUDA in Solid Tumor Patients

Dragonfly Therapeutics, Inc., a clinical-stage biotechnology firm focused on creating innovative immunotherapies, has entered into a clinical collaboration with Merck, known as MSD outside the US and Canada, to evaluate the combination of Dragonfly’s DF9001 and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The collaboration aims to treat patients with advanced solid tumors that express EGFR.

Bill Haney, co-founder and CEO of Dragonfly Therapeutics, expressed enthusiasm about this partnership with Merck, highlighting their fruitful collaboration since 2018. He stated that DF9001 has shown promise in preclinical models by engaging various immune effector cells to combat tumor activity and inducing PD-L1 expression in tumor cells, which could make cold tumors more receptive to checkpoint inhibitors. Haney is optimistic that the combination of DF9001 and KEYTRUDA® will exhibit strong anti-tumor activity across multiple indications, ultimately benefiting patients in need.

The clinical trial is sponsored by Dragonfly, with the first patients expected to start receiving the combined treatment in the fourth quarter of 2024. Currently, clinical trial sites in the U.S. are open for monotherapy dosing, with additional sites in North America and Europe anticipated to open throughout 2024.

DF9001 is a first-in-class investigational drug that targets EGFR and redirects natural killer (NK) cells, gamma-delta T cells, and CD8 T cells through the activation of receptors NKG2D and CD16. Developed using Dragonfly's proprietary TriNKET® platform, DF9001 is being assessed for its potential to treat advanced solid EGFR-positive tumors. This drug candidate aims to stimulate anti-tumor immunity in patients who either do not respond adequately to current therapies or are ineligible for them.

Dragonfly Therapeutics is dedicated to discovering, developing, and commercializing therapies that harness the immune system to provide groundbreaking treatments to patients. The company has a robust pipeline of preclinical candidates discovered using its proprietary platforms, which are progressing toward clinical trials. Besides the collaboration with Merck, Dragonfly has productive partnerships with AbbVie, Bristol Myers Squibb, and Gilead across various disease areas.

The clinical trial will specifically focus on evaluating the investigational combination of DF9001 and KEYTRUDA® in second-line treatments for Renal Cell Carcinoma and Head and Neck Squamous Cell Carcinoma. Additional details regarding the trial, including eligibility criteria, are available under the ClinicalTrials.gov identifier NCT 05597839.