US-based biotechnology company INOVIO has unveiled positive results from two Phase 1 clinical trial cohorts evaluating its vaccine candidate against novel coronavirus (SARS-CoV-2), dubbed INO-4800.

INO-4800 is a DNA vaccine candidate being developed to protect against the novel coronavirus SARS-CoV-2, which causes Covid-19.

The vaccine has been designed by leveraging the company’s unique DNA medicine platform, following the publication of the genetic sequence of the coronavirus.

The Phase 1 clinical trial of INO-4800 was initiated with funding support from Coalition for Epidemic Preparedness Innovations (CEPI). The study enrolled 40 healthy adult volunteers 18 to 50 years of age at two US sites.

The participants were enrolled into 1.0 mg and 2.0 mg dose cohorts, where each participant received two doses of INO-4800, with a gap of weeks between each dosage.

The company has used its CELLECTRA 2000 device to administer the dose as intradermal injection.

In the study, INO-4800 was generally safe and well-tolerated in all participants in both cohorts, while all ten reported adverse events (AEs) were grade 1 in severity, most of which were local injection site redness, and no serious adverse events (SAEs) were reported.

INOVIO expands Phase 1 trial to add older participants

INOVIO has secured $71m funding from the US Department of Defence to manufacture the CELLECTRA 3PSP smart device and the procurement of CELLECTRA 2000 devices in large scale.

In addition, INO-4800 has also been selected for a non-human primate (NHP) challenge study under Operation Warp Speed, the US government’s new national programme aimed at providing safe and effective vaccine by January 2021.

Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and intends to begin a Phase 2/3 efficacy trial upon regulatory approval.

INOVIO senior vice president Kate Broderick said: “While the pathophysiologic profile of SARS-CoV-2 is not completely understood, research and clinical studies suggest that both T cell and antibody immune responses will be important for protection in both mild and serious infections.

“Leveraging our previous expertise in MERS with INO-4700, where we demonstrated significant antibody and cellular responses, the breadth and profile of the responses observed to date with INO-4800 targeting SARS-CoV-2 provide a promising read towards further development and addressing the existing public health threat.”