With new funding from the International Vaccine Institute (IVI), Inovio plans to ratchet up research on its MERS vaccine, the only candidate against the virus now under testing in humans.
With success in the clinic, the biotech could seek other funding for development and work toward applying for emergency authorizations from regulators.
IVI’s commitment to the Pennsylvania-based biotech comes as part of a $34 million pledge made by the Korea-based Samsung Foundation to the institute last year. The program seeks to “support the development of a MERS vaccine for emergency use in Korea and internationally,” Inovio CEO J. Joseph Kim said in a Tuesday statement.
Since scientists first identified MERS back in 2012, the virus has infected 1,900 people and caused 700 deaths, according to the World Health Organization. An outbreak in South Korea last year caused 38 deaths.
Inovio’s candidate is currently being tested in a phase 1 trial on 75 healthy volunteers through a collaboration with the U.S. Army’s Walter Reed Army Institute of Research. In addition to the funding, IVI will provide the investigators with technical and lab support. Kim serves on IVI's board of trustees.
With data on the candidate’s safety and immunogenicity, Inovio “may be in position to secure additional external funding” and “approach regulators next year to discuss the path to approval via the 'Animal Rule,'" Kim said.
The FDA’s “Animal Rule” allows companies a path to approval when “human efficacy studies are not ethical or feasible,” according to the regulator. Through the pathway, companies may submit data from animal studies under certain circumstances to support their application.
The repeated MERS outbreaks and deaths, plus the fact that scientists know some characteristics of the virus, have left experts upset that there are no vaccines or licensed therapeutics against it. For bigger companies, the market for a potential vaccine isn’t defined enough to jump into the field.
The dearth of ongoing vaccine development in diseases that cause sporadic flare-ups has drawn new attention, in light of Ebola and Zika outbreaks and the research work they spawned. Scientists and industry have jumped from outbreak to outbreak as deadly pathogens have claimed lives, experts say. In an attempt to change the course, GSK recently pledged “biopreparedness” support to stimulate research against potential threats.