Providence Therapeutics announces first subject has been dosed in COVID-19 vaccine trial

mRNA vaccine maker has begun first human trial of a fully made-in-Canada vaccine

TORONTO and CALGARY, AB, Jan. 26, 2021 /CNW/ - Providence Therapeutics has announced today that it has begun dosing of volunteers in 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.

Subjects will be monitored for a total of 13 months from the beginning of the trial. However, there will be enough data accumulated by April 2021 to move into Phase 2 in May 2021, pending regulatory approval. 

The clinical study of PTX-COVID19-B will be carried out in Toronto, ON. Sixty volunteers between the ages of 18-65 will be enrolled in the Phase 1 study and divided into three groups of 20. Three different dose levels of PTX-COVID19-B will be administered together with a placebo in each group.

The study will test the immunogenicity of the vaccine, as well as its safety for human use. Pending positive results, commercialization is estimated to begin end of 2021 or early 2022.

"We are thrilled to begin human clinical trials of PTX-COVID19-B. Having a made-in-Canada solution to address the global COVID-19 pandemic will augment the reliability of vaccine supply for Canadians, contribute to the global vaccine supply and position a Canadian company on the global stage as a contributor to the solution," says Brad Sorenson, CEO of Providence Therapeutics. "We would also like to extend our gratitude to the volunteers who have stepped forward to take part in this important clinical trial."

Preclinical studies of PTX-COVID19-B supported robust antibody responses against the spike (S) protein of COVID-19 that were highly effective at neutralizing the virus in multiple assays.

Providence Therapeutics has relied on the essential contributions of our collaborators to reach this Phase of vaccine development:

• 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.
• The laboratories of 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.

About Providence Therapeutics
Providence Therapeutics Holdings Inc., a clinical stage company, 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

For further information: Media Contact: Andrea Chrysanthou, Global Public Affairs, [email protected], 416-797-8194