Phase 1 clinical trial for Alberta-made COVID-19 vaccine candidate ‘imminent’

Click to play video: 'Phase 1 clinical trial for Alberta-made COVID-19 vaccine candidate ‘imminent’'
Phase 1 clinical trial for Alberta-made COVID-19 vaccine candidate ‘imminent’
Edmonton-based Entos Pharmaceuticals, led by University of Alberta researcher Dr. John Lewis, has a COVID-19 vaccine candidate ready to head into Phase 1 of a clinical trial. As Su-Ling Goh explains on the noon news, it's hoped the vaccine will eventually be approved for use by Health Canada – Mar 9, 2021

EDITOR’S NOTE: The University of Alberta originally stated the Alberta-made vaccine was heading into clinical trials. However, Entos later clarified it has not been given the green light yet, but that Phase 1 was “imminent.”

A made-in-Alberta COVID-19 vaccine candidate is ready to head into Phase 1 of a clinical trial in hopes it will eventually be approved for use by Health Canada.

Edmonton-based Entos Pharmaceuticals, led by University of Alberta researcher Dr. John Lewis, has shipped a vaccine for testing to the Canadian Centre of Vaccinology in Halifax.

Entos had a meeting with the centre Tuesday and the company said Phase 1 of the clinical trial is “imminent.”

“Getting the first batch out is a huge milestone,” Lewis said in a media release Tuesday morning.

“The team is exhausted. They’ve been working non-stop since March 2020. It’s a big sigh of relief now that we’ve got that batch out and we’ll be looking on with a lot of optimism toward the clinical trial results.”

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Once given the green light, the trial will test the safety of the DNA-based vaccine in 72 participants. The U of A said participants will include young adults and older Canadians. The goal is to move into Phase 2 of testing with a larger group by late spring.

Lewis said the Entos vaccine has shown a “strong neutralizing antibody response” in pre-clinical testing and is expected to provide protection against the original strain of SARS-CoV-2, as well as its main variants currently circulating worldwide.

Researchers also believe the vaccine will provide protection after a single dose.

The vaccine heading into clinical trials is one of two being developed by the Edmonton company. It is DNA-based, which means it uses engineered DNA to stimulate an immune response against the SARS-CoV-2 virus.

Many of the COVID-19 vaccines already approved for use are mRNA vaccines, which teach people’s cells how to make a protein that will trigger an immune response, according to Health Canada.

Once triggered, the body then makes antibodies which help people fight the infection if the real virus enters the body in the future.

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Lewis said if approved, the DNA-based vaccine could make it easier to get into the arms of Canadians.

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“RNA is an unstable molecule, and those vaccines require minus 80 degree Celsius storage. That is a real challenge to scale the manufacturing and then distribute the vaccines to anywhere but urban areas,” Lewis said.

“We’ve seen those challenges, certainly with the worldwide rollout of these vaccines. People are over the moon about their effectiveness, but then are finding it a huge challenge to actually get the doses in people’s arms.”

Lewis said the Entos vaccine candidate can be kept in the fridge for over a year, and at room temperature for over a month.

“We need to get 16 billion doses worldwide to beat this pandemic, and we believe DNA is the perfect way to approach that,” he said.

The vaccine was not only developed at the University of Alberta, it was manufactured there as well — at the Alberta Cell Therapy Manufacturing facility (ACTM).

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Dr. Ping Yee, a scientist with Entos, helped make 400 clinical grade doses so far, but the ACTM facility could do thousands per day.

“It’s rare to find universities that have this capability, so we’re extremely fortunate,” Yee said Tuesday.

There is one limitation, though: the ACTM doesn’t have the equipment to put the product in vials. It has to be sent to Ottawa for that.

Alberta’s minister of Jobs, Economy and Innovation said Alberta is accepting proposals for the province to expand its vaccine capacity.

“People thought this would be another opportunity in five years, but it’s an opportunity right today to build out a pharmaceutical health sciences space for economic diversification, as well as making sure we take care of the health of Albertans,” Doug Schweitzer said.

He added the pandemic has showcased a need to develop a domestic vaccine strategy.

“Who would have thought vaccine nationalism would be a huge issue in 2021?” Doug Schweitzer said.

“We make sure we have food supply security, we invest in our military for national security as well so it’s really kind of brought to the forefront the need for us to make sure we have a domestic supply when it comes to critical health products.”

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Schweitzer said that while this particular vaccine may not be approved for use in time to vaccinate people right away, there’s still going to be a need to vaccinate billions of people around the world.

“It’s a smart investment for the future as well,” he said, adding the ability to build up the vaccine capacity in Alberta is “another strategic opportunity for us to grow out and diversify the economy in our province.”

“We’re willing to put some of our skin in the game. We’re really excited to see what these proposals are and I think Alberta has a leadership role to play in our country.”

There are currently four vaccines approved for use in Canada: Pfizer-BioNTech, Moderna, Oxford-AstraZeneca and Johnson & Johnson.

The Pfizer, Moderna and AstraZeneca vaccines require two doses, while the J&J vaccine is a single-dose vaccine.

While news of the trial is promising, Lewis said much more funding will be needed for the company to move ahead toward final approval.

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Since last summer, Entos has received $9.2 million in funding to develop its vaccine — $5 from the National Research Council of Canada Industrial Research Assistance Program and $4.2 million from the Canadian Institutes of Health Research.

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Lewis said the cost of developing the vaccine to the point of administering it to people could hit upwards of several hundred million dollars.

“On a shoestring budget, we’re going to be able to get our first candidate through the end of Phase 1. Then we’re hoping that the federal and/or provincial governments can step in and continue the development of our first candidate,” Lewis said.

“They’ve indicated they’ll also fund Phase 2 activities for some Canadian companies, so we’re talking with them now about what the bar is for acquiring that funding.”

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The company also hopes that if its first vaccine candidate is proven to be safe and effective, it can secure additional funding to push its second vaccine candidate forward.

With files from Su-Ling Goh, Global News.

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