EnGeneIC Announces Publication of Preclinical Data Highlighting Potential Efficacy of EGFR-Targeted EDV™ Nanocells to Treat Pediatric Neuroblastoma

NEW YORK and SYDNEY, March 1, 2018 /PRNewswire/ -- EnGeneIC Limited, a clinical stage biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for targeted cyto-immunotherapy in cancer, today announced the publication of preclinical findings that highlight the potential of the Company's targeted, bacterially derived nanocells to enhance the delivery of intensive chemotherapy to tumors while limiting toxicity to normal tissues in aggressive pediatric malignancies, including neuroblastoma. The in vitro and in vivo studies, published in the peer-reviewed journal Molecular Cancer Therapeutics, were conducted in collaboration with the Children's Cancer Institute, Lowy Cancer Research Centre, University of New South Wales, Sydney.

EnGeneIC's EDV™ nanocells are able to package a variety of chemotherapeutic agents and target tumor cells via attachment of bispecific proteins to the nanocell surface.

A completed Phase I clinical trial of epidermal growth factor receptor (EGFR)-targeted, doxorubicin-loaded EDVs^TM (^EGFREDV^TM_Dox) in adults with recurrent glioblastoma showed that up to 8 x 10⁹ nanocells given weekly was well tolerated, with no dose limiting toxicities or withdrawals due to adverse effects. 

EnGeneIC and its collaborators, therefore sought to investigate the activity of ^EGFREDV^TM_Dox for the treatment of pediatric neuroblastoma.

The two independent human neuroblastoma xenograft studies completed at Lowy Cancer Research Centre showed that ^EGFREDV^TM_Dox-treated mice exhibited a significant decrease in tumor size after 28 days, compared to doxorubicin alone- and non–EGFR EDV^TM_Dox-treated mice. This enhanced tumor shrinkage using  ^EGFREDV^TM_Dox was also associated with a greater degree of apoptosis compared to the other groups. 

Moreover, median overall survival was significantly increased in neuroblastoma mice treated with ^EGFREDV^TM_Dox compared to groups treated with doxorubicin alone.

Jennifer MacDiarmid, Ph.D., and Himanshu Brahmbhatt, Ph.D, joint-CEOs and Directors of EnGeneIC, stated, "Drug-loaded, bispecific antibody-targeted EDVs^TM offer a highly promising approach for the treatment of aggressive pediatric malignancies. In these studies, we demonstrated for the first time the ability of our bacterially-derived ^EGFREDV^TM_Dox delivery system to enter and kill neuroblastoma cells in vitro and in in vivo models of neuroblastoma.  We look forward to continuing this work, which may lead to an improved standard of care for children with this devastating disease."

Professor Maria Kavallaris, Head of Program, Tumour Biology and Targeting at Children's Cancer Institute, stated, "Doxorubicin clears from the bloodstream very quickly. We know doxorubicin works in killing cancer, however the problem has always been getting the drug to the actual cancer cells, while limiting its toxicity on healthy cells, which can cause short- and long-term side effects.

"These studies show that EnGeneIC's nanocells can deliver drugs directly to the tumour, killing its cells."

EnGeneIC is currently enrolling pediatric patients with advanced neurological tumors in a Phase 1 clinical study of EGFR-targeted, mitoxantrone-loaded EDVs™ (^EGFREDV^TM_mitoxantrone) at the Sydney Children's Hospital, Randwick, and the Children's Hospital Westmead, Sydney, Australia.  In addition, the Company is currently evaluating ^EGFREDV^TM_Dox in adults with recurrent glioma in a Phase 1 clinical study at two major hospitals in the United States.

About Pediatric Neuroblastoma
Pediatric neuroblastoma is a prevalent disease responsible for 6-10% of children's deaths from cancer. The majority of children present with advanced disease at time of diagnosis, necessitating the use of aggressive treatment.  High-dose chemotherapy invariably causes off-target toxicity to normal tissues, which can be dose limiting and potentially life threatening.  Survivors are often left with life-long health issues as a result.  Therefore, there remains a significant unmet need for new approaches that can focus chemotherapy within tumor cells in order to decrease toxicity to normal cells and potentially enhance anti-tumor efficacy. 

About EnGeneIC and the EDV™ Nanocell Technology 
EnGeneIC is a clinical stage biopharmaceutical company focused on developing its proprietary bacterially-derived EDV™ 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™ 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. 
+1-212-375-2664
[email protected] 

SOURCE EnGeneIC Limited

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