Encouraging Results from MesomiR-1 Phase 1 Trial in Late Stage Mesothelioma patients

Dramatic Response with Novel microRNA Replacement Therapy in Malignant Pleural Mesothelioma Published in the American Journal of Respiratory and Critical Care Medicine

EnGeneIC-logoNEW YORK and SYDNEY, June 15, 2015 /PRNewswire/ — EnGeneIC Ltd, an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics, announced today that, together with the Asbestos Diseases Research Institute (ADRI), a patient case study from the MesomiR-1 Phase 1 clinical trial of its EDV™ nanocells packaged with a miR-16-based microRNA for the treatment of malignant pleural mesothelioma (MPM) has been published in the peer-reviewed journal American Journal of Respiratory and Critical Care Medicine.

The case study, titled, “A significant metabolic and radiological response following a novel targeted microRNA-based treatment approach in malignant pleural mesothelioma,” reported on the remarkable results of a 51-year old male who was diagnosed with MPM in May 2013. After eventually failing three chemotherapy regimens, he entered the MesomiR-1 study. The patient was one of the six patients recruited into the first cohort, which received eight weekly infusions of 5×109 EDV™ nanocells packaged with miR-16a, coined TargomiRs for this study.

At the end of the eight-week study period, a near-complete response was evident on the patient’s PET and CT scans, and which was confirmed four weeks later. In addition, the patient had a significant improvement in respiratory function. During the treatment, the patient experienced only minor Grade 1 toxicities, including transient chills, low-grade fever, fatigue and headache.

TargomiRs consist of EnGeneIC’s antibody-guided EDV™ nanocells packaged with miR-16-based microRNAs, which were discovered to be missing in MPM cells by Professors Glen Reid and Nico van Zandwijk of the ADRI. To deliver the missing microRNAs to the cells, the EDV™ nanocells are designed to specifically target the epidermal growth factor receptor found on MPM cells.

Medical oncologist Dr. Steven Kao from Chris O’Brien Lifehouse (Sydney, Australia), said, “It’s an amazing response for this patient. The mesothelioma is now almost invisible and the condition of my patient has also improved. It probably goes without saying that he is very happy.”

Associate Professor Nick Pavlakis from the Northern Cancer Institute and one of the six medical oncologists involved in the trial, added a cautious remark, “While we are all very excited about this result and of course delighted for the patient, we must stress that this is a very early observation and requires confirmation in the next phase of clinical testing.”

Of the five additional patients in the first cohort, four have achieved stable disease and one progressive disease. Overall, TargomiRs were well tolerated during the treatment period, with the majority of patients reporting a period of shivering/rigor 80-90 minutes following infusion with TargomiRs, sometimes associated with a burning/painful sensation in the area of disease.

Dr. Himanshu Brahmbhatt, Joint-CEO of EnGeneIC, said, “In addition to showcasing the potential of TargomiRs in MPM, the results also serve to demonstrate the platform nature and versatility of EnGeneIC’s targeted EDV™ nanocells, as in previous Phase I clinical studies the EDVTM nanocells have been used to also deliver cytotoxic drugs.”

The MesomiR-1 trial is an open-label, exploratory Phase 1 study of TargomiRs administered in escalating doses by intravenous infusion in patients with MPM who failed to respond to standard of care therapy. The primary study objectives are to establish the optimal dose of TargomiRs and to detect early signs of disease stabilization. The study is the first time a targeted nanotherapeutic approach to microRNA replacement is being tested in patients with MPM.

The trial is a cooperative project involving ADRI, EnGeneIC, Chris O’Brien Lifehouse, the Northern Cancer Institute, Royal Prince Alfred Hospital, Concord Repatriation General Hospital and The University of Sydney.

About ADRI
The Asbestos Diseases Research Institute (ADRI) was opened in January 2009 in response to the increasing incidence of malignant mesothelioma in Australia. The Institute focuses on basic and clinical science, as well as epidemiological and psychosocial research into asbestos-related diseases.

About Chris O’Brien Lifehouse
Chris O’Brien Lifehouse is a world-class cancer treatment and research facility providing care and support services to public and private patients. Our mission is to improve the quality of life for cancer patients, carers and their families by advancing the understanding, diagnosis, treatment, cure and prevention of the disease. Lifehouse is an independent not-for-profit institution. Any operating surplus received by the hospital is re-invested in the Lifehouse hospital to continually innovate and improve services.

About Northern Cancer Institute
Northern Cancer Institute, St Leonards is a privately run cancer treatment and clinical research facility (affiliated with North Shore Private Hospital and Sydney University). Its aim is to provide holistic care in an environment that is designed to be as pleasant and as comfortable as possible. It has had longstanding clinical research links with Royal North Shore Hospital, and in 2014 opened its own Clinical Trials Unit, in which clinical trials have since commenced in a variety of tumour types.

About EDV™ Nanocell Technology
EnGeneIC’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. Intravenously injected EDV™ nanocells exit the leaky vascular system only within tumors and attach to cancer cells via a specially designed, targeted bi-specific antibody. Once attached, the nanocell is able to enter the tumor cell and deliver intracellularly a drug or siRNA or miRNA payload. In parallel, the bacterial cell wall of the nanocells stimulates key components of the immune system, which are then activated to seek out and destroy cancer cells.

About EnGeneIC, Ltd.
EnGeneIC is an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutic and other therapeutic molecules.  The company’s lead technology platform, EDV™ utilizes antibody-targeted, bacterially derived, non-living “nanocells” to release high concentrations of chemotherapeutic agents, molecularly targeted drugs, and RNA-interference molecules directly into targeted tumor cells.  In doing so, EDVTM nanocells enable current cancer treatments to be more potent and far less toxic, while also offering a potential new means for treating drug-resistant cancers.  EnGeneIC is currently planning to undertake clinical trials in several cancer indications in Australia and USA.

For more information please visit www.engeneic.com

SOURCE EnGeneIC, Ltd.

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