Canadian company's COVID-19 vaccine candidate begins clinical trial in Australia
This undated electron microscope image made available by the U.S. National Institutes of Health in February 2020 shows the Novel Coronavirus SARS-CoV-2, orange, emerging from the surface of cells, green, cultured in the lab. (NIAID-RML via AP)
TORONTO -- Canadian company Symvivo Corporation says it has begun clinical trials for its oral COVID-19 vaccine.
The clinical-stage biotechnology company based in Burnaby, B.C. announced on Monday the enrolment and dosing of the first healthy volunteer in its bacTRL-Spike COVID-19 Phase I clinical trial in Australia.
"We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development," Symvivo's chief medical officer Eric Sievers said in a press release.
The company says that bacTRL-Spike has two key advantages over other vaccines: it can be taken orally instead of by injection, and, if proven successful in advanced clinical trials, it could be stored at room temperature, bypassing cold-chain supply logistics.
Symvivo says these elements could change the COVID-19 vaccine landscape to allow for "simple, safe and fast distribution of a vaccine globally," as individuals could self-administer the vaccine rather than requiring a trained medical professional.
"The rapidly advancing pandemic mandates innovative scientific approaches and we believe a safe, protective oral vaccine could transform the landscape of traditional vaccination approaches, eliminating the need for syringes, needles, and trained vaccinators," Sievers said in the release.
The news of the vaccine trial comes after Symvivo said in October it was receiving up to $2.8 million from Canada’s National Research Council to support the clinical advancement of bacTRL-Spike.
According to the press release, the Phase I trial is being conducted in partnership with Nucleus Network in Brisbane, Australia. The study will evaluate safety and preliminary evidence of immunogenicity to SARS CoV-2 -- the virus that causes COVID-19 -- in response to bacTRL-Spike among healthy volunteers.
Symvivo said preliminary data is expected in early 2021.
Symvivo CEO and founder Alexander Graves told CTVNews.ca the vaccine candidate has a scientific and compliance benefit. He explained in a telephone interview on Monday that by taking the vaccine orally, it allows for a mucosal response in the intestine that can trigger signals to eliminate viruses in the body.
He says this gene therapy platform delivers plasmid DNA that enables a patient’s own cells to produce therapeutic proteins that work to clear harmful virus particles from healthy tissues.
"Your mucosal immune response is really the first line of defense against viruses and other infectious diseases, and we have demonstrated the ability in our preclinical models to produce a mucosal response in addition to traditional systemic immune responses that other vaccines can induce," Graves said.
As an oral capsule that can be kept at room temperature, Graves says bacTRL-Spike could actually eliminate supply logistics around a COVID-19 vaccine.
"When you could envision shipping this product [to] everybody's home around the world so that people can take it without medical oversight, we can actually get a viable vaccine solution globally," Graves said.
If the first phase of the clinical trials proves that bacTRL-Spike is safe to use, Graves said the company will then be able to evaluate whether an effective immune response against SARS-CoV-2 is generated.
"We're going to be looking at the ability of the volunteer’s immune system to recognize the spike protein and mount an immune responses against it that we hope in the future can be protected against SARS-CoV-2 infection," he said.