Edmonton-based Entos Pharmaceuticals has partnered with Alberta Cell Therapy Manufacturing (ACTM) and The Ottawa Hospital's Biotherapeutics Manufacturing Centre (BMC) to manufacture and prepare its COVID-19 DNA vaccine for clinical trials.
Entos Pharmaceuticals CEO Dr. John Lewis said that his company has partnered with ACTM, which is based at the University of Alberta, to manufacture enough Covigenix VAX-001 to fill the 400 vials required for Phase 1 of its clinical trials, as well as the safety testing that needs to be done before vaccination can occur.
"We have already completed the manufacturing of our Covigenix VAX-001 vaccine for the adaptive Phase 1/2 trial starting at the (Canadian Centre of Vaccinology) in Halifax," Lewis told Taproot.According to a statement by Entos, Covigenix VAX-001 is a single-dose COVID-19 DNA vaccine. It is similar to the recently approved mRNA vaccines, but with the advantage of stability at room temperature for up to a month and in a fridge for a year. Covigenix VAX-001 is also designed as a pan-coronavirus vaccine and incorporates all of the variants.
Entos Pharmaceuticals has partnered with Alberta Cell Therapy Manufacturing and the Ottawa Hospital Research Institute to manufacture and ready its COVID-19 vaccine. (Courtesy of ACTM)
Entos has also partnered with The Ottawa Hospital’s BMC to fill vials with Covigenix VAX-001.
"Finding a facility in Canada that could ready our DNA vaccine in vials time for the Phase 1 trials was extremely challenging because the few that we have here are all in high demand right now," noted Lewis.
He told Taproot that the vials were shipped to a Canadian-based pharmaceutical services company in Ottawa to be labelled.
"(The vials) will stay at the labelling company pending approval by Health Canada," said Lewis. "We hope to hear back sometime in the next two weeks.”
Once Health Canada's approval is granted, the vials will be shipped to the Canadian Centre for Vaccinology in Halifax.
"If everything goes well, we will start Phase 2 in mid-June and complete it during the summer. Phase 3 will start shortly after and is more of an unknown as the requirements are changing almost daily," Lewis said.Entos' vaccine could still get emergency use authorization before the end of the year if the company secures sufficient funding to advance through Phase 2 and 3 clinical trials.
Entos received grants from the Canadian Institutes of Health Research (CIHR) and the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) for Phase 1 trial manufacturing.