INOVIO and GeneOne Life Science announced interim data through week 16 from a Phase 1/2a trial of DNA vaccine INO-4700 (also called GLS-5300) for MERS coronavirus (MERS-CoV). Vaccine recipients demonstrated strong antibody and T cell immune responses after 2 or 3 doses with 0.6 mg of INO-4700, a DNA vaccine that targets the MERS-CoV Spike (S) glycoprotein, delivered with intradermal CELLECTRA® device. The vaccination regimen was well-tolerated with no vaccine-associated severe adverse events (SAEs).

The researchers at the Wistar Institute, Seoul National University Hospital, and the International Vaccine Institute (IVI) collaborated on this study with funding from IVI. These results were selected for an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Conference to be held virtually from May 12-15, 2020. Overall, for those receiving 0.6 mg of INO-4700, 88% demonstrated seroconversion after a 2 dose regimen at 0 and 8 weeks, while for those receiving a 3 dose regimen given at 0, 4 and 12 weeks, 84% seroverted after 2 doses and 100% after 3 doses, as measured by a binding antibody assay against the full-length S protein (ELISA).

Additionally, 92% of the vaccine recipients in both groups displayed the ability to neutralize the virus using a neutralization assay (EMC2012-Vero neutralization). Robust T cell responses were observed in 60% of vaccine recipients after the 2 dose regimen and 84% of those in the 3 dose group (ELISpot assay). Interestingly, a single dose of 0.6 mg of INO-4700 intradermal vaccination resulted in 74% binding antibody response rate and 48% neutralization antibody response rate.

This is the 2nd study of INO-4700 (GLS-5300) in a clinical trial, the first being a 75-person study (MERS-001) of vaccine administered intramuscularly and followed by electroporation at either 0.67, 2 or 6 mg. Notably in the MERS-001 study, there was no significant difference between dose levels and vaccine induced immune responses were similar to those seen in recovered patients following natural infection (Lancet Infectious Disease, 2019). INO-4700 vaccination has previously been shown to provide 100% protection against MERS virus disease in a pathogenic monkey challenge model.

INOVIO is planning to advance INO-4700 into a Phase 2 clinical trial in the Middle East with a previously announced funding of $56 million by the Coalition for Epidemic Preparedness Innovations (CEPI). INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, Université Laval, and the University of Texas.

INOVIO has partnered with Beijing Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including VGXI, Inc., Richter-Helm, and Ology Biosciences to produce one million doses of INO-4800 by year-end and seeking additional external funding and partnerships to scale up the manufacturing capacities to satisfy the urgent global demand for a safe and effective vaccine.

To date, CEPI, the Bill & Melinda Gates Foundation, and the US Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800. INO-4800 is INOVIO's DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was designed using INOVIO's proprietary DNA medicine platform rapidly after the publication of the genetic sequence of the coronavirus that causes COVID-19.

INOVIO has deep experience working with coronaviruses and is the only company with a Phase 2a vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).