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Pennsylvania-based Inovio announced today that the company has dosed the first Phase 2 trial subject in its quest to develop the first vaccine against the Middle East Respiratory Syndrome (MERS).

Middle East respiratory syndrome coronavirus
Image/National Institute of Allergy and Infectious Diseases (NIAID)

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.

Investigational MERS vaccine receives approval for Phase I trial in South Korea

Dr. J. Joseph Kim, President and CEO of INOVIO, said, “We are pleased to collaborate with CEPI to combat one of the most virulent pathogens of the coronavirus family for which there is no approved vaccine. This advancement not only complements our late-stage efforts with COVID-19, but it also represents an important milestone for INOVIO’s infectious disease platform. We look forward to continuing our collaboration with CEPI and moving another step closer to providing patients with a safe and effective preventive vaccine against MERS.”

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.

Richard Hatchett, CEO of CEPI, said, “I’m delighted to see the progress made by INOVIO in its MERS vaccine program. As we’ve seen with COVID-19, coronaviruses pose a significant threat to global health. Prior to the COVID-19 pandemic, CEPI had identified the MERS coronavirus, in particular, as an epidemic threat and partnered with INOVIO in 2018 to advance its promising vaccine candidate. This Phase 2 trial is the first of its kind to assess a vaccine candidate against MERS and represents an important step towards combatting this deadly coronavirus.”

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.