Inovio Pharmaceuticals (Nasdaq: INO) reported recent preclinical data summaries for their COVID-19 DNA vaccine called INO-4800 demonstrating promising information. Namely, the sponsor’s tests demonstrated robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The study was published in a peer-reviewed journal Nature Communications and titled “Immunogenicity of a DNA vaccine candidate for COVID-19.” The preclinical study was authored by scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University and Advaccine.
TrialSite News provides a breakdown of this recent announcement. But first a brief background.
Inovio has made significant progress with their COVID-19 vaccine development due to their DNA medicine platform’s suitability for vaccine development targeting emerging viruses with pandemic potential. Inovio claimed in their recent press release that they were the first to advance its DNA vaccine (INO-4700) against MERS-CoV, a related coronavirus from the Middle East, into evaluation in humans in collaboration with GeneOne Life Science and the Walter Reed Army Institute of Research. According to this biotech sponsor, their vaccine—INO-4700—is the only MERS-CoV vaccine with positive data from a Phase I/IIa clinical trial, and Inovio is currently preparing to initiate a larger Phase II vaccine trial for INO-4700 in the Middle East where most Viral outbreaks have occurred. These are being funded by CEPI.
What is INO-4800?
It is Inovio’s COVID-19 vaccine candidate. INO-4800 targets the major surface antigen Spike of SARS-CoV-2 virus, which causes COVID-19.
Where was the study published?
What did the study demonstrate?
This study showed that vaccination with INO-4800 generated what the company describes as robust binding and neutralizing antibody as well as T cell responses in mice and guinea pigs. Importantly, they conducted tests in three separate neutralization assays testing the vaccine’s ability to generate antibodies which can block virus infection.
What were the three assays evidencing the virus’ ability to block the virus?
The vaccine demonstrated this via 1) an assay using live SARS-CoV-2 viruses; 2) an assay using a pseudo-virus assay, where another virus displays the SARS-CoV-2 Spike protein; and 3) a novel high-throughput surrogate neutralization assay measuring the ability of INO-4800-induced antibodies to block SARS-CoV-2 Spike binding to the host ACE2 receptor.
Did the researchers observe antibodies in the lungs of the vaccinated animals?
Yes, and Inovio commented in their recent press release that this could be important in providing additional protection from SARS-CoV-2.
What were the levels of Spike-specific T cell responses?
According to the Inovio press release, there were high levels of Spike-specific T responses observed but they don’t offer any quantitative details. They do not that this observation could be important in mediating protection from the virus.
What will the company do with this data?
According to President & CEO Dr. J. Joseph Kim they will incorporate these preclinical observations along with some additional forthcoming “animal challenge data” as well as “safety and immune response data” from their Phase I studies “to support rapidly advancing this summer to a large, randomized Phase II/III clinical trial.
What is the makeup of the global coalition advancing this vaccine?
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, the University of Texas, Fudan University and the Laval University. The company has partnered with Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively. The sponsor 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 BioLogics, and Ology Biosciences to produce INO-4800 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, the Coalition for Epidemic Preparedness Innovations (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). Traditionally a near penny stock, the company’s shares are now trading at $14.45 for an over $2 billion market capitalization. Blackrock Fund Advisors owns the largest stake of equity at 5.30%.