Biopharmaceutical firm EnGeneIC has commenced the Phase I Tailored-EDV trial at the Northern Cancer Institute in Sydney, Australia.
The 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 tumours who have no further curative treatment options.
The firm’s bacterially-derived EDV nanocells are claimed to be powerful nanoparticle drug or siRNA or miRNA delivery system designed to directly target and effectively kill tumour cells with minimal toxicity and at the same time stimulate the immune system’s natural anti-tumour response.
EnGeneIC joint CEO Dr Jennifer MacDiarmid said: "The Tailored-EDV trial is designed to hopefully expand the library of favourable 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."
In the trial, patients with a variety of intractable tumour indications, including triple-negative breast cancer, non-small cell lung cancer, and metastatic colorectal cancer, will be dosed intravenously with a combination of (EGFR)-EDVs, chemotherapy and functional nucleic acids, such as siRNA.
The therapeutic payload for each patient will be specifically selected based on his or her individual disease, while the first patient dosed in the study is suffering from advanced Adrenal Cell Carcinoma (ACC) and received a siRNA that blocks cell division.
Intravenously injected EDV nanocells leave the leaky vascular system only within tumours and attach to cancer cells through a specially designed, targeted bi-specific antibody.
Once attached, the nanocell can enter the tumour cell and deliver intracellularly a drug or siRNA or miRNA payload and the bacterial cell wall of the nanocells stimulates key components of the immune system in parallel, which are then activated to seek out and destroy cancer cells.