Inovio Pharmaceuticals, Inc. this week announced that the company has initiated a phase I trial to evaluate safety, tolerability and immune responses of Inovio’s DNA immunotherapy for Ebola.
In previously published preclinical testing, Inovio’s DNA-based Ebola immunotherapy protected 100% of immunized 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 programs 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.
- 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.
“The Inovio-led partnership is uniquely positioned to create and test methods to both prevent and treat Ebola virus infections,” said Dr. J. Joseph Kim, President and CEO. “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 program.”