Two Calgary companies are receiving $5 million from the Next Generation Manufacturing (NGen) supercluster to tackle two of the biggest impediments to Canada's vaccine supply: the ability to mass produce vaccines domestically and ensuring a supply of raw materials to do so.
Providence Therapeutics, a biotechnology company, and partner Northern RNA, which manufactures vaccine ingredients, will use the NGen funding in a $10-million project to establish a facility in Calgary to manufacture Providence's COVID-19 vaccine and build a raw material supply chain to produce tens of millions of doses.
“We are already seeing supply issues with COVID-19 vaccines that entered Canada in the past month,” Brad Sorenson, CEO of Providence Therapeutics, said in an email to Research Money.
“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,” said Sorenson.
Related story: Precision NanoSystems receives federal support to build $50 million biomanufacturing facility in Vancouver
Providence Therapeutics was founded as a cancer research company by Sorenson, whose 13-year-old son Adam was diagnosed with Stage 4 brain cancer in 2013 (he survived).
Providence’s work was focused on an messenger RNA (mRNA)-based cancer vaccine, like the mRNA technology used in the Pfizer-BioNTech and Moderna COVID vaccines. That enabled Providence to quickly pivot in 2020 in trying to find a vaccine for COVID-19.
The company’s mRNA vaccine, called PTX-COVID19-B, is the first fully made-in-Canada COVID vaccine to reach this stage of development.
The vaccine uses mRNA to send a message to the body’s cells to build a harmless piece of the “spike protein” found on the surface of the COVID-19 virus. The body can then build an immune response to the virus.
Pre-clinical studies of PTX-COVID19-B showed the vaccine is as effective as the Pfizer-BioNTech and Moderna COVID-19 vaccines. PTX-COVID19-B supported robust antibody responses against the spike protein of COVID-19 that were highly effective at neutralizing the virus in multiple assays, Providence said.
Providence announced last Wednesday it has begun dosing 60 healthy volunteers with its COVID-19 vaccine in Phase 1 human clinical trials in Toronto. 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 Health Canada approval.
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 at the end of 2021 or in early 2022.
However, Sorenson said the company could have been further along had it received the $35 million it requested from the federal government in April 2020, to support development of its vaccine. The company would by now be moving into Phase 3 clinical trials (rather than just starting Phase 1), and have plans to roll out vaccines to Canadians this summer, he said.
It wasn’t until October 2020 that the National Research Council of Canada (NRC) awarded Providence funding of up to $4.7 million from the NRC’s Industrial Research Assistance Program.
Sorenson said while he’s grateful for the funding, his company needs more federal support if it’s to compete against international companies like Moderna and Pfizer-BioNTech which received hundreds of millions of dollars for vaccine development from, respectively, the U.S. government and the European Union.
Alberta Health Minister Tyler Shandro and Doug Schweitzer, provincial minister of economy, innovation and jobs, sent a letter on January 19 to their federal counterparts, Patty Hadju in health and François-Philippe Champagne in innovation and science, seeking support to improve domestic vaccine manufacturing capacity.
Alberta has world-class virology institutions that can play a leadership role in building stronger international supply chains, the Alberta ministers noted.
NGen providing $27 million for 12 COVID-related projects
The funding for the two Calgary companies is part of $27 million awarded by NGen for advanced manufacturing projects that can supply critical products to combat COVID-19.
Announced last week, the funding is from the supercluster’s “Strategic Supply Challenge” competition, which ran last summer. The money supports 12 projects by Canadian companies and their partners, for a total combined investment with industry of more than $60 million.
"NGen has built an extensive network across the country which helped mobilize a powerful response from industry to our challenge to stand up sustainable and globally competitive manufacturing of critical health care products in Canada,” Jayson Myers, NGen’s CEO, said in an email to Research Money.”
“The challenge also shows the importance of collaboration in building resilience across our domestic supply networks,” he said. “By supporting a series of business-led consortia with complementary capabilities, NGen enabled project teams to distribute risk and develop and deploy advanced manufacturing technologies in ways that allowed them to tackle big problems that no single company could accomplish on its own.”
NGen’s investment will help meet the immediate needs created by COVID-19, “while also developing a sustainable, globally competitive and cost-effective domestic supply that can be applied to industry needs beyond the pandemic,” Myers said.
Other projects funded by NGen’s Strategic Supply Challenge involve partnerships between companies in Ontario, Alberta, Saskatchewan and British Columbia, to produce a wide range of COVID-19-related products and equipment.
R$