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– Dragonfly Announces Clinical Collaboration Exploring Combinations of Dragonfly’s DF1001 HER-2 TriNKET® with Gilead’s Trodelvy® in Two Cancer Indications
Trodelvy and HER-2 TriNKET combinations will be in metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC)
WALTHAM, Mass., Feb. 15, 2024 /PRNewswire/ — 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 immune activator -2 developed using Dragonfly’s TriNKET technology platform and Dragonfly’s lead clinical asset, with Trodelvy, Gilead’s Trop-2 targeted antibody-drug conjugate (ADC), in metastatic breast cancer (mBC) and non-cell lung cancer not small (NSCLC).
“DF1001 is the first of eight drugs developed by Dragonfly in the clinic and has demonstrated clinical benefit in mBC, NSCLC and colorectal cancer (CRC) in a heterogeneous Phase 1 population with 22% of patients with RECIST response and 39 % clinical benefit in mBC patients at active dose levels, without DLT, even in a heavily pretreated population,” said Joseph Eid, President of Dragonfly R&D. “It has been shown to be well tolerated at all dose levels in the Phase 1 study as monotherapy, and pharmacodynamic activity was demonstrated in 28/42 (67%) paired biopsies from 0.5 to 15 mg/kg, where increased CD8 and NK cell infiltration was observed consistent with preclinical models and supporting the immunomodulatory MoA TriNKET. Our preclinical work has demonstrated the powerful combinatorial effect of TriNKET with ADC and highlighted the potential patient benefits of using Trodelvy. Gilead in combination with DF1001.”
“We are delighted to further strengthen our partnership with Gilead with the launch of this new clinical-stage collaboration,” said Bill Haney, CEO and co-founder of Dragonfly. “Dragonfly has promising preclinical data that highlights the potential for synergistic efficacy when combining DF1001 with Trodelvy in mBC and NSCLC. We are excited to work with our colleagues at Gilead to bring this combination to patients who need it.”
Dragonfly will have operational control of the study and the first patients are expected to receive this combination in the second quarter of 2024. There are currently open clinical trial sites in the United States, France, Belgium, Denmark and the Netherlands. Additional sites will open in 2024 in North America, Europe and Asia Pacific. Additional information about the trial, including eligibility criteria, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04143711).
About DF1001
DF1001 is a first-in-class investigational drug candidate that targets natural killer (NK) cells and T cell activation signals to coactivate NK receptors, where costimulation of NKG2D and CD16 results in activation potent and distinctive of NK cells. DF1001 is being evaluated in adult patients for the treatment of advanced HER-2-positive solid tumors. DF1001 was discovered and developed using Dragonfly’s TriNKET platform. DF1001 has the potential to stimulate effective antitumor immunity in patients who are ineligible or do not respond adequately to current therapies. DF1001 is the most advanced in a range of TriNKETs that Dragonfly is developing to address large unmet patient needs across a wide range of disease areas.
About Dragonfly
Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel therapies that harness the body’s immune system to deliver innovative treatments to patients. In addition to a suite of advanced programs in the clinic, Dragonfly has a broad pipeline of wholly-owned preclinical candidates discovered using its proprietary platforms that are progressing toward the clinic, as well as productive collaborations with AbbVie, Bristol Myers Squibb, Gilead and Merck in a wide range of disease areas.
For more information visit: www.dragonflytx.com https://www.linkedin.com/company/dragonfly-therapeutics-inc./ https://twitter.com/dragonflytx
DRAGONFLY MEDIA CONTACT:Anne E. Deconinck | anne@dragonflytx.com
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