Dragonfly Therapeutics, Inc., a clinical-stage biotechnology company developing novel immunotherapies, today announced a new clinical collaboration designed to evaluate and combine DF1001, a HER-2 immune activating device developed using Dragonfly’s TriNKET technology platform and Dragonfly’s lead clinical asset, with Trodelvy, Gilead’s Trop-2-directed antibody-drug conjugate in metastatic breast cancer and non-small cell lung cancer (NSCLC).
“DF1001, the first of eight drugs developed at the clinical stage by Dragonfly, has demonstrated clinical benefit in metastatic breast cancer, NSCLC and colorectal cancer in a heterogeneous Phase 1 population. Notably, we observed 22% RECIST (validated tumor response endpoints) respondents and 39% clinical benefit in patients with metastatic breast cancer at active doses, with no dose-limiting toxicity events, even in a heavily pretreated population,” said Joseph Eid, President of R&D at Dragonfly. “DF1001 was shown to be well tolerated at all doses as a monotherapy in the Phase 1 study. In addition, pharmacodynamic activity was demonstrated in 28 of 42 matched biopsies from 0.5 to 15 mg/kg (67%), in which increased CD8 and NK cell infiltration was observed, consistent with preclinical models and supporting the TriNKET immune modulation mechanism. Our preclinical work has demonstrated the potent combinatorial effect between TriNKET and antibody-drug conjugates and has highlighted the potential benefits that patients may receive from using Gilead’s Trodelvy in combination with DF1001. »
“We are thrilled to strengthen our partnership with Gilead by launching this new clinical collaboration,” said Bill Haney, CEO and co-founder of Dragonfly. “Dragonfly has promising preclinical data that highlight the potential synergistic efficacy of the combination of DF1001 and Trodelvy in metastatic breast cancer and NSCLC. We are excited to work with our colleagues at Gilead to bring this combination to patients in need.” »
Dragonfly will have operational control of the study and the first patients are expected to receive the combination in the second quarter of 2024. Clinical trial sites are open in the United States, France, Belgium, Denmark and the Netherlands. Additional locations in North America, Europe, and Asia-Pacific will open in 2024. Additional information about the trial, including eligibility criteria, is available at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04143711).
