Made-in-Edmonton COVID-19 vaccine ready for clinical trials, company says

An Edmonton-based pharmaceutical company say its COVID-19 vaccine is ready for clinical trials. 

Entos Pharmaceuticals says it expects Health Canada approval for a Phase 1 clinical trial is imminent, after it shipped its vaccine for testing to the Canadian Centre for Vaccinology in Halifax.

The company developed a genetic vaccine, similar to those developed by Moderna and Pfizer-BioNTech. But instead of delivering mRNA, the Entos’ vaccine is DNA-based. 

The company says the expected single-dose vaccine can be stored at room temperature for a month or in a fridge for a year. The two-dose mRNA vaccines, meanwhile, need to be stored at either freezer or ultra-cold temperatures.

The company says it applied its cancer-fighting medical technology at the outset of the pandemic to develop the vaccine. 

“If I told you five years ago that a small company that started out with a dozen people brought a new vaccine from concept to phase one trials in ten months, you’d say it couldn’t happen,” said John Lewis, Entos CEO and associate professor in the department of oncology at the University of Alberta. 

“I think what we’ve accomplished so far with a relatively modest budget has been really remarkable.” 

If approved, Entos would join Calgary’s Providence Therapeutics on the list of Alberta-based COVID-19 vaccine developers to enter clinical trials. It comes as the provincial government announced plans Tuesday to build out its local vaccine manufacturing capacity as new variants of the coronavirus emerge. 

Entos hopes to receive emergency authorization for the vaccine by the end of the year, if it can secure the funding for future trial phases and it progresses as planned.

While most Canadians are expected to have access to vaccines by then, the global inoculation effort will be far from over. A study by a Johns Hopkins University public health researcher estimated a quarter of the global population would not have access to a COVID-19 vaccine until at least 2022.

“The real challenge to vaccines as we’re finding is not whether they work or not, which luckily they do, but actually making enough of them and getting them to everybody is a monumental challenge,” Lewis said. 

Manufactured at UofA facility

Entos partnered with the Alberta Cell Therapy Manufacturing (ACTM) facility out of the University of Alberta to manufacture the first batch of the vaccine. It then worked with an Ottawa-based centre to fill the order and send it off to the Canadian Centre for Vaccinology.

There, the Phase 1 clinical trial will test the safety of the vaccine in 72 trial participants, with the aim of moving to a larger 100-person Phase 2 trial by late spring.

“We’re not a commercial manufacturer, but you need a place like us so that it’s ready to go commercial,” said Gayle Piat, operators manager at the ACTM. 

Prime Minister Justin Trudeau admitted on NBC’s Meet the Press that Canada’s vaccine response has been slow. But he also said with new vaccines being approved, ‘we’re going to have everyone vaccinated probably by the end of the summer.’ 3:50

Funding remains a looming question for Entos. The company has received $9.2 million in support since the summer, including $5 million from the National Research Council and $4.2 million from Canadian Institutes of Health Research.

But it’s a shoestring budget, Lewis says, considering he expects it will cost upwards of $250 million to bring the vaccine to market. 

‘Not too late’ for vaccine manufacturing: Entos

The lack of domestic vaccine manufacturing capacity has been blamed for Canada’s sluggish vaccine rollout, when compared to countries such as the U.K. and U.S.

“I think Canada has been a little bit behind in its decision making and its funding of vaccine efforts,” Lewis said. 

“It’s not too late. I think if we invest in the continued development of internal vaccine programs will not only feed this innovation in biotechnology that is really going to grow and could be a really substantial part of Canada’s industry, but also provide better vaccine security.” 

The company is also optimistic that, after showing the safety and efficacy of its first vaccine candidate, it will secure funding for a second vaccine candidate. The company says its second vaccine was developed with machine learning that identified 34 distinct proteins that are similar not only in SARS-COV-2, but other coronaviruses.

“Our hope here is that it will protect against all these variants, hopefully future emerging variants and other coronaviruses as well.”

View original article here Source