EnGeneIC begins Phase I tailored-EDV clinical trial in solid tumors

The first patient dosed is suffering from advanced adrenal cell carcinoma (ACC) and received a siRNA that blocks cell division. The company is focused on developing its proprietary EDV nanocell platform for the targeted delivery of cancer therapeutics.

The Phase I Tailored-EDV trial is an open-label feasibility study of a single delivery agent (EGFR)-EDVs packaged with the clinician’s chosen therapy in subjects with advanced solid tumors who have no further curative treatment options.

In the trial, eligible patients with a variety of intractable tumor indications, including triple-negative breast cancer, non-small cell lung cancer and metastatic colorectal cancer, will be dosed intravenously, receiving a combination of (EGFR)-EDVs, chemotherapy and functional nucleic acids, such as siRNA, which may address issues of chemotherapy resistance.

EnGeneIC joint CEO Dr Jennifer MacDiarmid said: "The Tailored-EDV trial is designed to hopefully expand the library of favorable data involving our EDV nanocell technology, while informing us of what indications and payloads are best to pursue in Phase II trials in the US and Australia.

"Equally important, the trial design will enable us to investigate the platform potential of our EDV nanocell technology by assessing its safety and efficacy in multiple, difficult-to-treat cancer indications.

"Additionally, we will be monitoring adaptive immune responses in these patients since it is likely that the EDV works as an immunotherapeutic agent as well as a cytotoxic."

The company’s bacterially-derived EDV nanocells are a powerful nanoparticle drug or siRNA or miRNA delivery system designed to directly target and effectively kill tumor cells with minimal toxicity, while at the same time stimulate the immune system’s natural anti-tumor response.