Inovio Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, announced that the US Defense Advanced Research Projects Agency (DARPA) has exercised its option to provide an additional $24 million to support the company-led development of multiple treatment and prevention approaches against Ebola.
The option exercise, part of the $45 million Ebola programme grant announced in April when Inovio received an initial $21 million award, was contingent upon Inovio successfully leading the completion of certain pre-clinical and clinical development milestones.
DARPA has funded this programme to develop a DNA-based vaccine against Ebola, a therapeutic DNA-based monoclonal antibody product (dMAb) to treat Ebola infection, and a conventional monoclonal antibody to treat Ebola.
In the intervening period from the grant award in April, Inovio and its collaborators have accomplished full enrollment of 75 volunteers for the phase I clinical study for Ebola vaccine, INO-4212. Interim safety and immune response data is expected to be reported in 4Q 2015.
Significant pre-clinical proof-of-concept demonstrated in animal models for the potential of its dMAb technology including with Ebola dMAb constructs. Screening of different Ebola dMAbs in pre-clinical studies is ongoing. Inovio recently reported the publication of its anti-dengue dMAb demonstrating protection against lethal challenge.
Dr. J. Joseph Kim, president and CEO, said, "Inovio is executing all aspects of the Ebola programme as planned. The DARPA programme is funding an accelerated R&D programme that is simultaneously working on three different counter-measures. Access to the full DARPA funding based on the accomplishment of certain programme milestones allows Inovio and its collaborators to carry out all the elements of the proposal as rapidly as possible."
Inovio is leading a world-class collaboration of industry and academic partners in an effort to prevent and treat Ebola including MedImmune, the global biologics research and development arm of AstraZeneca; GeneOne Life Sciences of Korea (KSE: 011000) and its US manufacturing subsidiary, VGXI, Inc.; the Perelman School of Medicine at the University of Pennsylvania; and researchers at Emory University and Vanderbilt University.
DARPA, an agency of the US Department of Defense that creates and supports novel technologies important for national security, has selected Inovio to develop products that if successful can add to the arsenal of rapid response capabilities. Inovio's Ebola programme is initially targeted to treat first responders and Ebola-infected health care workers and patients, but could potentially be widely utilized to stem the spread of an Ebola outbreak.
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 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 US 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 US 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 1 and phase 2 trials to establish safety and immunogenicity for use in humans.