EnGeneIC begins Phase 1 Tailored-EDV trial for advanced solid tumor

Aug 19 2015

EnGeneIC Ltd., an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics, today announced that the first patient has been dosed in its Phase 1 Tailored-EDV trial. The trial is being conducted at the Northern Cancer Institute in Sydney, Australia.

The Phase 1 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. 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. The therapeutic payload for each patient will be specifically chosen for his or her individual disease. The first patient dosed is suffering from advanced Adrenal Cell Carcinoma (ACC) and received a siRNA that blocks cell division.

Dr. Jennifer MacDiarmid, joint CEO of EnGeneIC, said, "We are currently seeing excellent results in a Phase 1 trial in recurrent mesothelioma. 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 2 trials in the U.S. 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."

Principal investigator Professor Stephen Clarke, added, "We are eager to see the EDV's capability in tumors which are notoriously difficult to treat. The potential to have a tailored treatment for patients who have exhausted treatment options is particularly enticing for an oncologist, as well as the patient."

ACC is a rare and aggressive cancer with poor prognosis and can occur in people of any age, even children. "While surgical resection is the best option, the disease usually reappears and many are non-resectable as is the case with this patient," said Professor Stan Sidhu, an investigator for the study. "These tumors are usually drug-resistant, and we are very interested to see whether a siRNA will have an impact when delivered effectively by the targeted EDV."