Providence Therapeutics COVID-19 Vaccine Receives Health Canada Authorization to Begin Clinical Trials

mRNA vaccine is first fully made-in-Canada vaccine to undergo trials

TORONTO and CALGARY, AB, Dec. 23, 2020 /CNW/ - Providence Therapeutics today announced that Health Canada has provided a Notice of Authorization for its Clinical Trial Application. This permits the Canadian biotech company to begin human clinical trials of its COVID-19 vaccine. PTX-COVID19-B is a messenger RNA (mRNA) vaccine and is the first fully made-in-Canada COVID vaccine to reach this stage of development.

Health Canada's authorization means Phase I clinical trials will begin early in the New Year. Later phase clinical trials are expected to proceed in 2021, subject to regulatory approval.

All Canadians can be proud of the successful design and development of a world class COVID-19 vaccine here in Canada. This would not have been possible without two dozen highly dedicated Providence employees that have been working long hours under significant pressure.

Additionally, it is important that the essential contributions of our collaborators are recognized:

Dr. Mario Ostrowski (University of Toronto), Dr. Anne-Claude Gingras (Mt. Sinai Hospital), Dr. Samira Mubareka and Dr. Rob Kozak (Sunnybrook Research Institute), and Dr. Michael Pollanen (Ontario's Chief Forensic Pathologist) all provided significant contributions to robust pre-clinical studies.

PTX-COVID19-B incorporates industry-leading lipid nanoparticle technology licensed from an affiliate of Genevant Sciences Corporation (Vancouver, BC), and the dedicated professionals at Genevant contributed to the vaccine development with valuable technical and manufacturing support.

The Government of Canada, through the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) program is providing financial sponsorship and advice for the Phase 1 trial.

"We welcome Health Canada authorization and are excited to begin clinical trials. This means we can continue our critical work of developing a made-in-Canada solution to address the global COVID-19 pandemic. We are extremely proud that this vaccine will be researched and manufactured here in Canada, prioritizing Canadians," noted Brad Sorenson, CEO of Providence Therapeutics.

"There is a lot of work that still lies ahead, but today's announcement is important as a Canadian company will be positioned to help contribute to the solution, augment domestic security of supply for Canadians, and add to the global supply to meet overwhelming global demand for effective and safe vaccines," Sorenson added.

"The vaccine development thus far has effectively validated mRNA as a vaccine platform. Providence has been working with mRNA for several years. We plan to complete the trials, and simultaneously secure manufacturing capacity to commercially produce vaccines here in Canada," added Dr. Jared Davis, President of Providence Therapeutics.

Preclinical studies supporting robust immunogenicity of PTX-COVID19-B were carried out at the Combined Containment Level 3 Facility at the University of Toronto. The results demonstrated strong antibody responses against the spike (S) protein that were highly effective at neutralizing the virus in multiple assays.

About Providence Therapeutics
Providence Therapeutics is Canada's leading mRNA vaccine company. In response to a worldwide need for a COVID-19 vaccine, Providence has expanded its focus beyond oncology and devoted its energy and resources to develop a world-class mRNA vaccine for COVID-19. Providence Therapeutics is focused on serving the needs of Canada, and other countries that may be underserved by large pharmaceutical programs. For more information, please visit ProvidenceTherapeutics.com.

SOURCE Providence Therapeutics

Andrea Chrysanthou, Global Public Affairs, [email protected], 416-797-8194