(Released 28 January 2016) Plymouth Meeting, PA - Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced the beginning of recruitment for its collaborative vaccine study for MERS (Middle East Respiratory Syndrome). Inovio and GeneOne Life Science Inc. (KSE:011000) are co-developing Inovio’s MERS vaccine (GLS-5300) in partnership with the Walter Reed Army Institute of Research (WRAIR) in Maryland, where the trial is being conducted.
The primary and secondary goals of this first-in-man phase I trial are to obtain safety and immunogenicity data. This trial represents the first MERS vaccine to be tested in humans for this disease that has no approved vaccines or treatments.
Dr. J. Joseph Kim, Inovio President and CEO, said, “After partnering with WRAIR and receiving an IND approval from the FDA late last year, we are pleased to now open this trial with our collaborators. The MERS virus has triggered widespread outbreaks and deaths in the Middle East and Korea and the healthcare community is urgently exploring possible preventive and therapeutic solutions.
“Our broad experience with DNA-based immunotherapies and with MERS specifically suggests we can potentially make an important contribution to developing such a solution. As demonstrated by our recent vaccine development efforts for Ebola, we can readily apply Inovio’s technology to target other threatening infectious threats like MERS and Zika virus as well as other emergent infectious diseases.”
Last year, GLS-5300 induced 100% protection from a live virus challenge in a rhesus macaque non-human primate study. Inovio and its collaborators evaluated its MERS vaccine in mice, camels as well as non-human primates. As published in Science Translational Medicine, the vaccine induced robust immune responses capable of preventing the virus from infecting cells in all three species. In monkeys, all vaccinated animals in the study were protected from symptoms of MERS when challenged with a live MERS virus.
Middle East Respiratory Syndrome is caused by a coronavirus that is related to the severe acute respiratory syndrome (SARS). While SARS infected more than 8,000 people, the disease was short-lived between 2002 and 2004 and had a mortality rate of about 10%. Since 2012, MERS has infected over 1,600 people, with almost 600 deaths, a mortality rate of about 40%, and is still ongoing. Highlighting the global concern for MERS, in the summer of 2015 a single business person returned to South Korea from Saudi Arabia and was the index case for a country-wide epidemic involving 186 persons with a 20% mortality rate.
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 is 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, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.
About GeneOne Life Science GeneOne Life Science Inc. is an international DNA vaccine developer and leading contract manufacturer of DNA plasmid-based agents for pre-clinical 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.