Date: 2015-09-21
Type of information: Grant
Company: Inovio Pharmaceuticals (USA - PA) MedImmune (USA - global biologics arm of AstraZeneca (UK) GeneOne Life Sciences (Republic of Korea)
Investors: Defense Advanced Research Projects Agency (DARPA) (USA)
Amount: $45 million
Funding type: grant
Planned used: This grant from the Defense Advanced Research Projects Agency (DARPA) will be used to develop multiple treatment and prevention approaches against Ebola. Inovio is the prime contractor on the DARPA program. Other collaborators are MedImmune, the global biologics research and development arm of AstraZeneca; GeneOne Life Sciences and its manufacturing subsidiary, VGXI, Inc.; and Professor David B. Weiner, PhD, professor of Pathology and Laboratory Medicine at The Perelman School of Medicine at the University of Pennsylvania, Emory University and Vanderbilt University. The Inovio-led consortium is taking a multi-faceted approach to develop products to prevent and treat Ebola infection. These programs include development and early clinical testing of: - a therapeutic DNA-based monoclonal antibody product dMAb™ against the Ebola virus infection. This promising new technology has properties that best fit a response to the outbreak in that they could be designed and manufactured expediently on a large scale using common 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.
Inovio’s DNA-based vaccine against Ebola, with the first patient expected to be dosed in 2Q 2015. In previously published preclinical testing, Inovio’s DNA-based Ebola vaccine protected 100% of vaccinated animals from death and sickness after being exposed to a lethal dose of the Ebola virus.
The proposed effort will cover pre-clinical development costs for the dMAb products and protein mAb candidates as well as GMP manufacturing costs and the phase I clinical study costs with the three product candidates. MedImmune will manufacture the protein mAbs and the Inovio-GeneOne/VGXI team will manufacture the DNA based products. The academic partners are leading Ebola research and medical centers at the front edge of the discovery efforts for highly potent anti-Ebola mAbs. The funding period is over two years and covers a base award of $21 million and an option award of $24 million. The development proposal includes a second option of $11 million to support additional product supply and clinical development activities. The options are contingent upon the successful completion of certain pre-clinical development milestones. Due to the global concerns and immediacy of need, the consortium has employed an aggressive development timeline for the Ebola products by developing these three options in parallel, resulting in an acceleration of the initial clinical evaluation. None of these products will contain any Ebola virus or viral particles.
Others: * On September 21, 2015, Inovio Pharmaceuticals announced that the U.S. Defense Advanced Research Projects Agency (DARPA) has exercised its option to provide an additional $24 million to support the Inovio-led development of multiple treatment and prevention approaches against Ebola. The option exercise, part of the $45 million Ebola program 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 program 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 Inovio’s Ebola vaccine, INO-4212. Interim safety and immune response data is expected to be reported in 4Q 2015. * On April 8, 2015, Inovio Pharmaceuticals announced that the company has been selected to receive a grant from the Defense Advanced Research Projects Agency (DARPA) to lead a collaborative team to develop multiple treatment and prevention approaches against Ebola. DARPA, an agency of the U.S. 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 program 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 the current or subsequent outbreaks. Inovio and the other participating institutions have a strong history of previous collaborative development efforts having worked together on multi-institutional product development grants and contracts bringing new products to the clinic. Inovio’s previous collaborative Ebola vaccine research efforts with GeneOne Life Sciences have been incorporated into this Inovio-led team.
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.
Therapeutic area: Infectious diseases
