Entos Pharmaceuticals is one step closer to manufacturing its DNA-based COVID-19 vaccine after the company was granted approval to begin a Phase 2 clinical trial in South Africa.
The trial will be conducted at multiple sites across South Africa for four to six months and it will evaluate the safety, tolerability, and immunogenicity of Covigenix VAX-001.
"Reaching this important milestone gets us one step closer towards helping end this pandemic by providing a potentially effective and safe fridge-stable, single-dose vaccine against COVID-19 to under-vaccinated regions of the world," said Entos CEO Dr. John Lewis.
According to a statement by Entos, approval by the South African Health Products Regulatory Authority (SAHPRA) to start the Phase 2 clinical trial was based on successful pre-clinical and Phase 1 results. Multiple sites across South Africa will be used for the second trial.
"The vaccination rate against COVID-19 in South Africa will allow us to recruit (enough) people," Lewis told Taproot. "Many Albertans have expressed a huge interest in joining our trial, so we are working to open a site here too."
The University of Alberta spinoff company has been developing its vaccine since the beginning of the pandemic. Entos is using a Fusogenix nucleic acid delivery system, which the company said will help provide a robust response against SARS-COV-2, and potentially against future coronavirus threats.
Entos Pharmaceuticals' COVID-19 vaccine candidate has been approved for a Phase 2 clinical trial in South Africa (Courtesy of Entos Pharmaceuticals)
Entos noted that its COVID-19 vaccine candidate "has the key advantage of stability for more than a year at normal refrigerated temperatures, making it more cost-effective to store, transport and deploy worldwide."
The Edmonton-based company recently completed its Phase 1 human trial of its vaccine candidate, which demonstrated that the Fusogenix platform is safe, with the potential to promote positive outcomes at low doses. The trial was conducted at the Canadian Center for Vaccinology in Halifax.