Inovio Pharmaceuticals, Inc. announced the dosing of the first subject in its multi-center phase I trial to evaluate Inovio’s Zika DNA vaccine (GLS-5700). In addition to the previously announced US FDA approval for the conduct of the study, Health Canada’s Health Products and Food Branch has also approved this study, which will be conducted at clinical sites in Miami, Philadelphia, and Quebec City.

This phase I, open-label, dose-ranging study of 40 healthy adult volunteers is evaluating the safety, tolerability and immunogenicity of GLS-5700 administered with the CELLECTRA-3P device, Inovio’s proprietary intradermal DNA delivery device. In preclinical testing, this synthetic vaccine induced robust antibody and T cell responses - the immune responses necessary to fight viral infections - in small and large animal models.

Dr. J. Joseph Kim, Inovio’s president & CEO, said, “The WHO declared Zika a public health emergency in February 2016 and every week new insights suggest that, similarly to dengue and Chikungunya, its medical and economic impact may be significant, pervasive and long-lasting. The US Centers for Disease Control (CDC) estimates that there are 30 to 40 million U.S. travelers to Zika-affected areas annually. The resident population in the Americas at higher risk of Zika exposure has been estimated at nearly 300 million. It is easy to see the potentially harmful effect Zika could have and why a safe and effective vaccine, brought to market as quickly as possible, is critical for public health. Inovio’s synthetic vaccine technology allows rapid development of new products to stimulate effective immune responses against targeted infectious diseases and cancers. Our Zika product has established a record as the fastest-ever vaccine development from conceptualization through human application, demonstrating the potential of our SynCon platform to respond rapidly to global health emergencies. With enrollment now started, we expect to complete subject dosing and report interim phase I results later this year.”

Inovio is developing its Zika vaccine, GLS-5700, with GeneOne Life Science, Inc. and academic collaborators from the US and Canada who are also working to advance Inovio’s Ebola and MERS vaccines into clinical development.

First identified in Uganda, Zika virus subsequently spread to equatorial Asia and over the past two years has rapidly spread through the South Pacific, Hawaii, 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. As of July 2016, 65 countries and territories reported continuing mosquito-borne transmission of the Zika virus, compared to 33 countries stated by WHO in their first Zika situation report in February 2016. Zika can also be sexually transmitted.

The most common symptoms of Zika virus are fever, rash, joint pain, and conjunctivitis. Zika has been linked to a severe birth defect called microcephaly which arises from infection during pregnancy. Microcephaly is 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 prevention or treatment of infection with the Zika virus.