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Human clinical trials begin for Quebec-made COVID-19 vaccine candidate – 680 News

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Canadian trials have just begun for a prospective COVID-19 vaccine but its Quebec-based manufacturer is already downplaying its potential impact.

Dr. Bruce Clark, president and CEO of the biopharmaceutical company Medicago, cautions observers against holding unrealistic expectations that his product — or any of the numerous vaccines in development globally — will bring the pandemic to a screeching halt.

“Whatever vaccine we get in this first round — unless it’s a miracle — it’s not going to be perfect,” says Clark, whose company began trials for its proposed vaccine Monday in Quebec City.

“It’s going to have to undergo development, it’s going to take probably years to come up with an understanding of the right vaccine, the right approach. It’s not the panacea.

“To assume that we can have, in 18 months, the solution to a pandemic that comes around once in a generation, is naive.”

So much is still unknown about COVID-19, notes Clark, including how it may manifest during the flu season later this year.

He suspects a more likely scenario is that a vaccine will offer only part of the solution, along with new therapeutics and ongoing public health interventions.

Medicago’s first phase of clinical trials will test a plant-based product on 180 healthy men and women, aged 18 to 55.

The randomized, partially blinded study uses technology that does not involve animal products or live viruses like traditional methods.

Clark notes that vaccine developers typically use chicken eggs to propagate a virus, but Medicago uses recombinant technology involving the genetic sequence of a virus, with living plants as the host.

The resulting virus-like particles mimic the shape and dimensions of a virus, which allows the body to recognize them and spark an immune response.

Clark says the plant-based approach is significantly faster and offers more consistent results than egg-based or cell-based methods.

While it takes five to six months to propagate a virus in eggs, the plant-based technique requires just five to six weeks, he says.

“In a pandemic, something like COVID, if you’re able to cut that much time off development, you have a substantial impact on public health.”

Meanwhile, Clark says viruses are prone to mutations as they adapt and grow in an egg, which could result in a vaccine that doesn’t exactly match the circulating virus. In contrast, “a plant is a plant,” and that makes production easily scalable.

“One plant behaves like 100,000 plants,” he says.

The trial will evaluate three different dosages alone, or with one of two adjuvants provided by GlaxoSmithKline and Dynavax. An adjuvant can boost the effectiveness of a vaccine for a better immunological response, thereby reducing the required dose, Clark adds.

He hopes to know the effectiveness of the adjuvants and dosing by October, and then kick off a second, more targeted trial phase involving about 1,000 participants.

Clark says the third phase would involve about 15,000 to 20,000 subjects, and may be a global study, depending on circumstances of the pandemic.

If the vaccine is successful, Clark points to another uncertainty.

Because the company’s commercial plant is across the border in Durham, N.C., he says there’s no guarantee of a Canadian supply.

“‘Guarantee’ is a strong word,” says Clark. “Strange things happen to borders in the context of a pandemic.”

Such border complications were made clear to Canadians in April when Prime Minister Justin Trudeau complained about problems with incomplete or non-existent deliveries of critical COVID-19 supplies. At the time, U.S. President Donald Trump ordered U.S. producers to prioritize the domestic market.

Clark suggested similar hurdles could impact vaccine distribution, putting immediate pressure on Medicago to complete construction of a large-scale manufacturing facility in its home base of Quebec City.

“Certainly, we need a facility in Canada,” Clark says.

“There’s no guarantee on the easy flow of materials back and forth across the border should we have a successful vaccine. We have to keep the focus on completing the Canadian facility so that we have domestic capacity. I think this is what most countries are concerned about.”

By the end of 2023, the Quebec City plant is expected to be able to produce up to one billion doses of the COVID-19 vaccine annually.

Until then, Medicago says it expects to be able to make approximately 100 million doses by the end of 2021, assuming its trials are successful.

Clark says countries must temper any nationalist agendas that might emerge with a viable vaccine and acknowledge that the fight against COVID-19 is global.

Meeting that demand would require multiple manufacturers, multiple distribution routes, and lots of co-operation, he says, possibly through the World Health Organization.

“There has to be some ability to share those around and distribute, whether that’s through an entity like the WHO, or something equivalent.”

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Roots sees room for expansion in activewear, reports $5.2M Q2 loss and sales drop

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TORONTO – Roots Corp. may have built its brand on all things comfy and cosy, but its CEO says activewear is now “really becoming a core part” of the brand.

The category, which at Roots spans leggings, tracksuits, sports bras and bike shorts, has seen such sustained double-digit growth that Meghan Roach plans to make it a key part of the business’ future.

“It’s an area … you will see us continue to expand upon,” she told analysts on a Friday call.

The Toronto-based retailer’s push into activewear has taken shape over many years and included several turns as the official designer and supplier of Team Canada’s Olympic uniform.

But consumers have had plenty of choice when it comes to workout gear and other apparel suited to their sporting needs. On top of the slew of athletic brands like Nike and Adidas, shoppers have also gravitated toward Lululemon Athletica Inc., Alo and Vuori, ramping up competition in the activewear category.

Roach feels Roots’ toehold in the category stems from the fit, feel and following its merchandise has cultivated.

“Our product really resonates with (shoppers) because you can wear it through multiple different use cases and occasions,” she said.

“We’ve been seeing customers come back again and again for some of these core products in our activewear collection.”

Her remarks came the same day as Roots revealed it lost $5.2 million in its latest quarter compared with a loss of $5.3 million in the same quarter last year.

The company said the second-quarter loss amounted to 13 cents per diluted share for the quarter ended Aug. 3, the same as a year earlier.

In presenting the results, Roach reminded analysts that the first half of the year is usually “seasonally small,” representing just 30 per cent of the company’s annual sales.

Sales for the second quarter totalled $47.7 million, down from $49.4 million in the same quarter last year.

The move lower came as direct-to-consumer sales amounted to $36.4 million, down from $37.1 million a year earlier, as comparable sales edged down 0.2 per cent.

The numbers reflect the fact that Roots continued to grapple with inventory challenges in the company’s Cooper fleece line that first cropped up in its previous quarter.

Roots recently began to use artificial intelligence to assist with daily inventory replenishments and said more tools helping with allocation will go live in the next quarter.

Beyond that time period, the company intends to keep exploring AI and renovate more of its stores.

It will also re-evaluate its design ranks.

Roots announced Friday that chief product officer Karuna Scheinfeld has stepped down.

Rather than fill the role, the company plans to hire senior level design talent with international experience in the outdoor and activewear sectors who will take on tasks previously done by the chief product officer.

This report by The Canadian Press was first published Sept. 13, 2024.

Companies in this story: (TSX:ROOT)

The Canadian Press. All rights reserved.

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Talks on today over HandyDART strike affecting vulnerable people in Metro Vancouver

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VANCOUVER – Mediated talks between the union representing HandyDART workers in Metro Vancouver and its employer, Transdev, are set to resume today as a strike that has stopped most services drags into a second week.

No timeline has been set for the length of the negotiations, but Joe McCann, president of the Amalgamated Transit Union Local 1724, says they are willing to stay there as long as it takes, even if talks drag on all night.

About 600 employees of the door-to-door transit service for people unable to navigate the conventional transit system have been on strike since last Tuesday, pausing service for all but essential medical trips.

Hundreds of drivers rallied outside TransLink’s head office earlier this week, calling for the transportation provider to intervene in the dispute with Transdev, which was contracted to oversee HandyDART service.

Transdev said earlier this week that it will provide a reply to the union’s latest proposal on Thursday.

A statement from the company said it “strongly believes” that their employees deserve fair wages, and that a fair contract “must balance the needs of their employees, clients and taxpayers.”

This report by The Canadian Press was first published Sept. 12, 2024.

The Canadian Press. All rights reserved.

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Transat AT reports $39.9M Q3 loss compared with $57.3M profit a year earlier

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MONTREAL – Travel company Transat AT Inc. reported a loss in its latest quarter compared with a profit a year earlier as its revenue edged lower.

The parent company of Air Transat says it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31.

The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.

Revenue in what was the company’s third quarter totalled $736.2 million, down from $746.3 million in the same quarter last year.

On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.

Transat chief executive Annick Guérard says demand for leisure travel remains healthy, as evidenced by higher traffic, but consumers are increasingly price conscious given the current economic uncertainty.

This report by The Canadian Press was first published Sept. 12, 2024.

Companies in this story: (TSX:TRZ)

The Canadian Press. All rights reserved.

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