Inovio Pharmaceuticals (INO.Q) announced the publication of the preclinical study data for its COVID-19 DNA vaccine, IN0-4800, demonstrating neutralizing antibody and T-cell immune responses against the coronavirus.
It’s neither a vaccine nor a cure, but it’s a start and it’s better than what we had yesterday. The study was published in Nature Communications, a peer-reviewed journal, and was called “Immunogenicity of a DNA vaccine candidate for COVID-19” by Inovio’s scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University and Advaccine.
“These positive preclinical results from our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our DNA medicines platform, but also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700. The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials,” said Dr. Kate Broderick, senior vice president of research and development and the team lead on the COVID-19 vaccine development for Inovio.
Back when this whole coronavirus thing kicked off, we briefly covered this company in a four company roundup of pharma-companies we liked because of their chances to solve the antibody riddle. We liked them because of their pre-existing work on both Severe Acute Respiratory Syndrome (SARS) and Middle-Eastern Respiratory Syndrome (MERS), which are coronaviruses not unlike COVID-19, so it would seem they have a jump-start on resolving this crisis. The general idea is that whatever company cracks this code and brings a vaccine to market, complete with patent in hand, will make their investors extremely wealthy.
Well, this company has proven to be one of the frontrunners.
If you’re not familiar with the scientific terminology or the process behind how a drug comes to market, a pre-clinical trial is the one they perform on animals (in this case, rats and guinea pigs). We tend to share comparable DNA and the traits that come from the expression of that DNA, and therefore the assumption is that the effects on animal bodies will be duplicated in ours. It’s not always the case, though, and so we have clinical trials on humans, which are both expensive and slow. It’ll be faster than the average new cancer medication or whatever disease these companies regularly spend their time researching, due to the fast-track designation and the obvious overwhelming need, but it’s a process that will still take months. It’s not a process we can or should be expediting either. We need to be patient.
INO-4800 targets the major surface antigen Spike protein of the SARS-CoV-2 virus, which causes COVID-19. The studies demonstrated that vaccination with INO-4800 generated robust binding and neutralizing antibody as well as T-cell responses in mice and guinea pigs. Both of those are responses of our immune system to invaders, and the variety that we’re looking for.
The authors of the study demonstrated virus neutralizing activity using three separate neutralization assays testing the vaccine’s ability to generate antibody which can block infection by:
- an assay using live SARS-CoV-2 viruses;
- an assay using a pseudo-virus assay, where another virus displays the SARS-CoV-2 Spike protein; and,
- 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.
The study’s authors found these antibodies in the lungs of the vaccinated animals, which could be important in providing protection from SARS-CoV-2.
“INOVIO and our collaborators are working diligently to advance INO-4800 to help fight the current pandemic. We are planning to utilize these positive preclinical results along with our upcoming animal challenge data and safety and immune responses data from our Phase 1 studies to support rapidly advancing this summer to a large, randomized Phase 2/3 clinical trial,” said Dr. J. Joseph Kim, INOVIO’s president and CEO.
Collectively, this preclinical dataset demonstrates that INO-4800 is a promising COVID-19 vaccine candidate against this emerging disease threat, and that’s good news if ever there was any.