Inovio Pharmaceuticals and GeneOne Life Science Receive Approval for First-in-Man Zika Vaccine Clinical Trial July 01, 2016, 16:06

 (NASDAQ:INO) and GeneOne Life Science, Inc. (KSE:011000) today announced that they have received approval to initiate a phase I human trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700) to prevent infection from this concerning virus. In preclinical testing this synthetic vaccine induced robust antibody and T cell responses in small and large animal models, demonstrating the product’s potential to prevent infection from this harmful pathogen in humans.

This phase I, open-label, dose-ranging study with 40 healthy subjects will evaluate the safety, tolerability and immunogenicity of GLS-5700 administered intradermally with CELLECTRA^®, Inovio’s proprietary DNA delivery device.

Dr. J. Joseph Kim, Inovio’s President & CEO, said, «We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers. As of May 2016, 58 countries and territories reported continuing mosquito-borne transmission of the Zika virus; the incidences of viral infection and medical conditions caused by the virus are expanding, not contracting. We plan to dose our first subjects in the next weeks and expect to report phase I interim results later this year.»

Mr. Young K. Park, GeneOne Life Science’s President & CEO, said, «It is an honor for our company to help usher this Zika vaccine through the clinical and regulatory process. We look forward to conducting this trial with the goal of achieving products to combat this dreaded virus.»

Inovio and GeneOne are developing the Zika vaccine, GLS-5700, with academic collaborators from the US and Canada with whom they have previously collaborated to advance Inovio’s Ebola and MERS vaccines into clinical development.

About the Zika Virus

First identified in Uganda, Zika virus subsequently spread to equatorial Asia and over the past two years has rapidly spread through the South Pacific, including Hawaii, and to South America, Central America, and the Caribbean. Zika virus is a flavivirus, a family of viruses including yellow fever, dengue, and West Nile virus, which are introduced to people through mosquito bites. Because the Aedes species of mosquitoes that spreads Zika virus is found throughout the world there is concern that Zika will continue to spread to new countries and regions. Zika can also be sexually transmitted.

The most common symptoms of Zika virus are fever, rash, joint pain, and conjunctivitis. More seriously, Zika has been linked to a severe birth defect called microcephaly which arises from infection during pregnancy. Microcephaly is a rare condition marked by an abnormally small head and incomplete brain development. Zika is also associated with Guillain-Barré syndrome, which causes muscle weakness of the limbs and in severe cases may cause almost total paralysis including the inability to breath. Recent reports suggest Zika may also be linked to other neurological abnormalities.

No vaccine or therapy currently exists for the Zika virus.

About GeneOne Life Science

GeneOne Life Science, Inc. is an international DNA vaccine developer and leading contract manufacturer of DNA plasmid-based agents for preclinical and clinical trials for global companies and institutions. It researches and develops DNA vaccines to prevent and treat incurable diseases in South Korea and internationally. The company is headquartered in Seoul, South Korea. VGXI, Inc., GeneOne’s wholly-owned manufacturing subsidiary located in Texas, is the largest pure-play cGMP DNA plasmid manufacturing facility in the world. VGXI manufactured the Zika vaccine and other emerging disease vaccines including Ebola and MERS.

About Inovio Pharmaceuticals, Inc.

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Roche, The Wistar Institute, University of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U. S. Military HIV Research Program, and University of Manitoba.