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FDA Accepts EnGeneIC’s IND for EGFR-Targeted Nanocells Carrying Doxorubicin to Treat Recurrent Glioma

EnGeneIC Ltd., a clinical stage biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's investigational new drug (IND) application for using (EGFR)-EDVs loaded with doxorubicin (dox) in patients with recurrent glioma.

With the IND now active, EnGeneIC intends to proceed with a Phase I study designed to evaluate its proprietary (EGFR)-EDV-dox for treating advanced glioma in patients who have exhausted all treatment options. The company expects to begin enrolling patients before the end of 2015.

The primary objective of the Phase I study is to assess the safety of (EGFR)-EDV-dox in this patient population. EnGeneIC will also assess the anti-tumor response according to Response Assessment in Neuro-Oncology (RANO) criteria and overall survival (OS) of patients, as well as measure certain parameters of the adaptive immune response following administration with (EGFR)-EDV-dox.

The Joint-CEO of EnGeneIC, Dr. Himanshu Brahmbhatt, commented, "While we have shown our EDVs to be extremely well tolerated in first-in-man trials and have some recent exciting results in patients with mesothelioma, the FDA's acceptance of our three-component therapeutic, being a drug-loaded nanocell carrying a targeting antibody, is an extremely important step in our overall strategy of proving our cyto-immunotherapy platform has potential in intractable cancers like recurrent glioma. It also validates our tailored medicine approach to develop a pipeline of novel EDV-based therapeutics with different payloads for different cancers, allowing us to kill cancer cells as well as stimulate the immune system to effect dramatic improvements in overall survival."

About Glioma
Glioblastoma multiforme (GBM) is the most common primary malignant brain tumor in adults in the United States, accounting for approximately 16% of all primary brain tumors. Approximately 11,000 new cases are projected for 2015. Despite an aggressive multimodal approach of surgery and chemotherapy and/or radiation, relapse is almost inevitable for patients with GBM (approximately 90% recurrence rate). Outcomes for patients with GBM are poor despite best management and median overall survival for recurrent glioma is less than four months.

About EDV™ Nanocell Technology
EnGeneIC's bacterially-derived EDV™ nanocells are a powerful nanoparticle drug, 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, 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
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, EDV™ 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.

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