Inovio Pharmaceuticals, Inc. announced it will advance its DNA vaccine for Ebola into a phase I clinical trial in a collaboration with GeneOne Life Science Inc., an international DNA vaccine manufacturer in which Inovio holds a minority interest.
In the collaboration Inovio and GeneOne will co-develop Inovio’s DNA-based Ebola vaccine through a phase I clinical trial. The companies are currently conducting pre-IND activities and plan to start the clinical study in the first half of 2015. Upon successful completion of the phase I, the companies will jointly seek additional third party support and resources to further develop and commercialize this product.
Along with the escalating spread of Ebola and related deaths, this virus is also mutating into diverse strains. There are no preventive vaccines or effective therapeutic approaches to Ebola; the ease with which Ebola is generating genetic variations will complicate the process of creating such solutions. In addition, various experimental approaches have already been associated with undesirable side effects and limited ability to scale manufacturing.
Inovio’s SynCon® technology has been the basis for immunotherapy and vaccine products which have demonstrated the ability to activate immune responses against multiple disease-specific antigens and elicit broad protection against diverse unmatched strains of pathogens in humans. These DNA-based immunotherapy products have demonstrated a very favorable safety profile. Furthermore, these synthetic immunotherapies are manufactured using established production processes. Inovio’s Ebola vaccine was designed using the SynCon technology to provide broad protective antibody and T-cell responses against multiple strains of Ebola virus.
In published preclinical testing of its Ebola vaccine, Inovio observed that 100% of vaccinated guinea pigs and mice were protected from death after being exposed to the Ebola virus. Unlike the non-vaccinated animals, vaccinated animals were also protected from weight loss, a measure of morbidity. Researchers found significant increases in neutralizing antibody titers and strong and broad levels of vaccine-induced T-cells, including “killer” T-cells, suggesting that this product could provide both preventive and treatment benefits.
Dr. J. Joseph Kim, President and CEO, said, “Inovio’s SynCon® DNA-based immunotherapy and vaccine technology offers an advantageous set of characteristics and capabilities to generate and direct powerful immune responses against a target disease. There are no proven agents to check the spread of Ebola, which is now becoming a health threat of global concern. We are therefore taking the steps with our collaborator to establish the safety and immunogenicity of our Ebola vaccine in humans and be in a position to further advance these agents to help fight this challenging disease.”
More than 2,622 people have died in the worst outbreak of Ebola virus in history, which has so far infected at least 5,335 people in West Africa, according to the World Health Organization (WHO). In a recent update on the epidemic, which is raging through Guinea, Sierra Leone and Liberia and has spread into Nigeria and Senegal, the WHO said there were no signs yet of it slowing. There is no vaccine or standard of care treatment for people infected with the Ebola virus.