On Aug. 4, 2021, Inovio Pharma announced that the company had dosed the first Phase 2 trial subject in its quest to develop the first vaccine against the Middle East Respiratory Syndrome (MERS). INOVIO’s Phase 2 trial is designed to evaluate INO-4700, its DNA vaccine candidate for the prevention of MERS, a disease in the coronavirus family for which there are no approved vaccines.

The multi-center Phase 2 trial is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of INO-4700 administered with INOVIO’s smart device, the CELLECTRA^® 2000, in approximately 500 healthy adult volunteers. The study, which is sponsored by INOVIO and fully funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is being conducted at sites in Jordan and Lebanon where MERS cases have been reported.

This trial builds on the positive results of the Phase 1 trial, which were published in a peer-reviewed article in The Lancet Infectious Diseases entitled, “Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: A phase 1, open-label, single-arm, dose-escalation trial.” Results from this first-in-human Phase 1 trial found high levels of binding antibodies in 92% (57 of 62) of evaluated subjects. Significant antigen-specific cytotoxic T-lymphocyte (CTL) responses were also observed. Importantly, 98% (61 of 62) of vaccinated subjects generated an antibody and/or T cell response against the MERS vaccine.

INOVIO’s pursuit of a MERS vaccine is funded by a previously announced $56 million grant from CEPI under which INOVIO is advancing two vaccine candidates through Phase 2 field trials against MERS and Lassa fever, respectively. INOVIO and CEPI plan to make a stockpile of these vaccines available for emergency use as soon as possible following Phase 2 testing.

Despite the continuing threat of MERS outbreaks, there are no licensed vaccines or treatments for MERS. Since the virus was first identified in Saudi Arabia in 2012, the World Health Organization has reported more than 2,500 people with MERS disease globally and approximately 34% of those patients died. Twenty-seven countries have reported cases, including Korea where an outbreak in the summer of 2015 resulted in 186 cases with 20% dying. In contrast, the case-fatality ratio for COVID-19 before population vaccination was approximately 0.3% to 0.5%; while the case-fatality ratio for the 2003 SARS epidemic was 10%. MERS causes a rapidly progressive respiratory illness that may require intensive care treatment and mechanical ventilation in many patients.