A made-in-Canada vaccine to protect against COVID-19 is to begin human clinical trials Tuesday in Toronto, says the biotechnology company that developed the vaccine.
Toronto-based Providence Therapeutics said three doses of its vaccine, called PTX-COVID19-B, will be given to 60 adult volunteers at a clinical trial site in Toronto in the first phase of the trial on Tuesday.
Fifteen of those volunteers will receive a placebo, and 45 will get the vaccine.
Brad Sorenson, the company’s CEO, said it’s the first time a vaccine designed and manufactured in Canada has begun clinical trials. The company has purchased a site in Calgary to mass produce the vaccine.
The vaccine is an mRNA vaccine — which triggers an immune response in the body — and is similar to the Moderna coronavirus shot being given to people across Canada.
Quebec-based pharmaceutical Medicago began clinical trials last July of its coronavirus vaccine that is based on another technology. Unlike Providence, a large portion of Medicago’s vaccine doses will be manufactured outside the country, in North Carolina.
Medicago’s vaccine is currently in Phase 3 clinical trials — the last stage before it can apply for approval from Health Canada and other regulators to market the product.
Sorenson said Providence designed and built its vaccine last March.
“We reached out to the Canadian government in April and said, ‘Hey, you’ve heard of Moderna. We’re doing the exact same thing,'” Sorenson said in an interview.
“We went from concept into the clinic in under a year without the same level of support as our peers had.”
Purchased Calgary site
The federal government provided financial sponsorship and support for the early phase clinical trial through the National Research Council of Canada’s Industrial Research Assistance Program.
Currently, Canada lacks the capacity to manufacture the millions of doses of coronavirus vaccines needed to immunize people outside of a clinical setting. It’s why the federal government struck deals with Pfizer and Moderna — both manufactured abroad — to obtain the vaccines being rolled out across Canada.
While the company was developing the vaccine in pre-clinical studies, Sorenson said it also started to build the infrastructure to manufacture the vaccine in Canada as well.
The company purchased a 20,000-square-foot facility in Calgary that includes 12,000 square feet of lab space to mass produce the vaccine. The facility will be up and running in two months, Sorensen said.
In the next phase of clinical trials, another 60 volunteers over the age of 65 will receive the vaccine or a placebo.
Initial focus was cancer research
Providence aims to expand and start Phase 3 clinical trials in May.
If the vaccine proves safe and effective in clinical trials and Health Canada approves it, the goal is to have it ready for the global market by January 2022.
Sorenson founded Providence Therapeutics in 2013 to focus on cancer vaccines.
Several scientists contributed to the pre-clinical research on Providence’s vaccine, including those at the lab of Dr. Mario Ostrowski at the University of Toronto, Dr. Anne-Claude Gingras at Mt. Sinai Hospital, Dr. Samira Mubareka and Dr. Rob Kozak at Sunnybrook Research Institute, as well as Dr. Michael Pollanen, Ontario’s chief forensic pathologist.
In August, Ostrowski, whose laboratory performed the animal trials, said results were on par with tests of vaccines from Moderna and Pfizer-BioNTech at that stage.