Dragonfly Therapeutics has entered a clinical collaboration with Gilead Sciences to assess the potential of its investigational drug candidate DF1001 with the latter’s Trodelvy for two cancer indications.

The study of the combination regimen will focus on metastatic breast cancer (mBC) and non-small cell lung cancer (NSCLC).

DF1001 is designed to act on natural killer (NK) cells and T-cell activation signals, leveraging co-stimulation of NK receptor NKG2D and CD16 for NK cell activation.

Trodelvy is a Trophoblast cell-surface antigen 2-directed antibody-drug conjugate.

Dragonfly will maintain operational control of the trial, with the first patients receiving the combination treatment in the second quarter of 2024.

Study sites are already operational in the US, Belgium, France, Denmark and the Netherlands.

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The study is set to expand, with additional sites in Europe, North America and Asia Pacific.

Developed using Dragonfly’s TriNKET platform, DF1001 is being evaluated in adult patients for the treatment of advanced solid human epidermal growth factor receptor 2-positive tumours.

It has shown potential to induce anti-tumour immunity in people who are ineligible for or not adequately responding to existing therapies.

DF1001 represents the most advanced candidate in the TriKNETs pipeline that Dragonfly is developing to meet unmet patient needs across several disease areas.

Dragonfly research and development president Joseph Eid stated: “DF1001 is the first of eight Dragonfly-developed drugs in the clinic and has shown clinical benefit in mBC, NSCLC and colorectal cancer in a heterogeneous Phase I population with 22% RECIST [a standard method to show how a cancer patient responds to a therapy] responders and 39% clinical benefit in mBC patients at active dose levels, with no dose-limiting toxicities even in a heavily-pre-treated population.

“It has been demonstrated to be well-tolerated across all dose levels in the Phase I  study as a monotherapy and pharmacodynamic activity was demonstrated in 28 out of 42 (67%) paired biopsies from 0.5mg/kg-15mg/kg, where an increase in CD8 and NK cell infiltration was observed consistent with preclinical models and supporting the TriNKET immune modulating MoA [effect in the body].”