Inovio Pharmaceuticals, Inc, a developmental stage DNA vaccine maker, has initiated a phase I trial to evaluate safety, tolerability and immune responses of its DNA immunotherapy for Ebola.
In previously published preclinical testing, Inovio's DNA-based Ebola immunotherapy protected 100 per cent of immunised animals from death and sickness after being exposed to a lethal dose of the Ebola virus.
This is the first step in the Inovio-led consortium selected by the U.S. Defense Advanced Research Projects Agency (DARPA) to take a multi-faceted approach to develop products to both prevent and treat Ebola infection.
These programmes include development and early clinical testing of
Inovio's DNA-based vaccine against Ebola, for which the first study was initiated this week.
Inovio's therapeutic DNA-based monoclonal antibody product dMAb against Ebola virus infection. This promising new technology has properties that are best suited to respond to an Ebola outbreak in that they could be designed and manufactured expediently on a large scale using proven fermentation technology, are thermal-stable, and may provide more rapid therapeutic benefit; and a highly potent conventional protein-based therapeutic monoclonal antibody (mAb) product against Ebola virus infection.
This initial trial will evaluate Inovio's Ebola immunotherapy (INO-4212) in five groups of healthy subjects receiving INO-4212 and its components (INO-4201 and INO-4202) alone or in combination with INO-9012, delivered into muscle or skin using Inovio's proprietary DNA delivery technology.
Dr. J. Joseph Kim, president and chief executive officer, said "The Inovio-led partnership is uniquely positioned to create and test methods to both prevent and treat Ebola virus infections. The global product development experts we have brought together coupled with Inovio's DNA-based vaccines and immunotherapies should meet and exceed the expected outcomes. Demonstrating our commitment and speed, we have begun our first trial just a few weeks after being selected by DARPA to advance this promising programme."
The Ebola virus causes periodic outbreaks of a highly contagious and lethal human infectious disease marked by severe hemorrhagic fever, with a mortality rate that ranges between 50 per cent and 90 per cent. The infection typically affects multiple organs in the body and is often accompanied by severe bleeding.
The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission. At present, there are no FDA-approved pre- or post-exposure interventions available in the event of an outbreak, laboratory accident, or deliberate misuse. The Ebola virus is classified as a category A priority pathogen by the Centers for Disease Control and Prevention. This designation prescribes an accelerated development pathway for FDA approval that determines efficacy based on two different validated animal studies followed by clinical evaluation in phase I and phase II trials to establish safety and immunogenicity for use in humans.