EnGeneIC Announces Publication in The Lancet Oncology of First Clinical Study Employing EDV(TM) Nanocell Platform to Enable microRNA Replacement Therapy

NEW YORK and SYDNEY, Sept. 5, 2017 /PRNewswire/ -- EnGeneIC Limited, a clinical stage biopharmaceutical company focused on developing its proprietary EDV(TM) nanocell platform for targeted cyto-immunotherapy in cancer, today announced the publication of clinical data from a 'first-in-man' trial of a novel microRNA (miRNA)-based cancer therapy enabled by the Company's EnGeneIC Dream Vector (EDV(TM)) technology. The results have been published in the prestigious clinical research journal, The Lancet Oncology. The article, co-authored by EnGeneIC, the Asbestos Diseases Research Institute (ADRI), and investigators from Northern Cancer Institute/Royal North Shore Hospital, Lifehouse/Royal Prince Alfred Hospital and Concord Repatriation General Hospital in Sydney, showcases the first time that tumor-targeted EDVs(TM) have been used to deliver a nucleic acid-based therapy to patients with cancer.

Loss of oncogene regulation by miRNA-15/16 is linked to a number of cancers in which expression of these miRNAs is inhibited, including Malignant Pleural Mesothelioma (MPM). In this open-label, dose-finding Phase 1 study, EnGeneIC's EDVs(TM) loaded with a microRNA miR-16 mimic were administered intravenously and targeted with anti-epidermal growth factor receptor for delivery to tumor cells in an attempt to re-establish normal gene regulation and potentially inhibit tumor growth. The results demonstrated that gradual escalation from 1x10(9 )EDV nanocells/week up to 5x10(9 )EDV nanocells/week was well tolerated and accompanied by encouraging early signs of anti-tumour activity (of 22 evaluable patients, one had a prolonged objective tumor response and 15 exhibited disease stabilization; 4.5% and 68.2%, respectively).

Jennifer MacDiarmid, Ph.D., and Himanshu Brahmbhatt, Ph.D, joint-CEOs and Directors of EnGeneIC, stated that, "These results showcase the safety and versatility of our EDV(TM) platform. In previous clinical studies, we demonstrated the targeted delivery of small molecules at therapeutic levels, and we have now shown that EDVs can deliver miRNAs safely to patients' tumors, with promising outcomes. We are pleased that our technology was instrumental in this major advancement for miRNA therapeutics and for all patients whose tumors may respond to miRNA replacement therapy. Based on successful in vitro and animal studies, we would expect these encouraging human results to apply to other nucleic-acid based approaches, including the potential for our EDVs(TM) to deliver functional short interfering RNA (siRNA) to tumors. These studies have also shown that our EDV has the capacity to stimulate the immune system, which has clearly contributed to this encouraging result."

More information regarding the Malignant Pleural Mesothelioma EDV trial can be found at: https://clinicaltrials.gov/ct2/show/NCT02369198

Full Reference: Safety and activity of microRNA-loaded minicells in patients with recurrent malignant pleural mesothelioma: a first-in-man, phase 1, open-label, dose-escalation study. van Zandwijk, Nico et al. The Lancet Oncology. Published Online: 01 September 2017

DOI: http://dx.doi.org/10.1016/S1470-2045(17)30621-6

About EnGeneIC and the EDV(TM) Nanocell Technology

EnGeneIC is a clinical stage biopharmaceutical company focused on developing its proprietary bacterially-derived EDV(TM) nanocells as a powerful nanoparticle drug, siRNA, or miRNA delivery platform designed to directly target and effectively kill tumor cells with minimal toxicity, while simultaneously stimulating the immune system's natural and adaptive anti-tumor response. The EDV(TM) nanocell platform has shown promising results in early clinical studies and EnGeneIC is currently planning to commence further clinical trials in several cancer indications in Australia and USA.

For more information, please visit www.engeneic.com.

U.S. Investor Contact:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.

U.S. Media Contact:
Tiberend Strategic Advisors, Inc.
Janine McCargo

Australia Media Contact:
Felicity Moffatt

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SOURCE EnGeneIC Limited