After a phase 1 study returned positive results, Inovio Pharmaceuticals and GeneOne Life Sciences have started human testing of their vaccine against Middle East respiratory syndrome in South Korea, where the virus took 36 lives in 2015.
Interim data from a phase 1 trial conducted at the Walter Reed Army Institute of Research in Maryland showed that the three-dose DNA vaccine, dubbed GLS-5300, induced high levels of binding antibodies in 92% of evaluated subjects. Investigators found that 61 of the 62 vaccinated subjects generated an immune response against the virus.
Although a full readout from that trial won’t be available until later this year or early 2018, the development team has initiated a phase 1/2a study in Korea. This clinical trial will assess the vaccine—administered intradermally—on at least 60 subjects, compared to intramuscular vaccination in the U.S. study, Jeff Richardson, Inovio’s VP of strategic relations, told FierceVaccines.
Immune data from the Korean trial will be used to support the potential approval of GLS-5300 in the country, Inovio CEO J. Joseph Kim said in a statement. He added that Inovio’s intradermal vaccine delivery device could elicit high immune responses at a lower dose.
After its emergence in the Middle East in 2012, MERS spooked Korean residents in 2015 as the first outbreak outside the middle East infected 186 and killed 36 people in the country.
Though it's a deadly virus, its relatively small reach has not aroused much interest from the biopharma industry, especially after the outbreak died down. Even today, Inovio and GeneOne’s candidate is still the only MERS vaccined being tested on humans. There aren't any approved vaccines or treatments.
To help incentivize vaccine efforts targeting diseases that might not reel in much support financially, top drugmakers and nonprofits including the Bill & Melinda Gates Foundation joined forces early this year to form a preparedness coalition with $460 million in initial funding. Together, they're working on proactive approaches against known threats before deadly outbreaks actually hit; MERS is an initial focus.
The International Vaccine Institute, with a $34 million grant from the Samsung Foundation to support development in the field, is fully funding the Inovio-GeneOne Korean trial.