TORONTO —
The Canadian company behind a new plant-derived COVID-19 vaccine candidate has released the results of their Phase 1 clinical trials, saying two doses of their adjuvanted vaccine spurred a significant antibody response in 100 per cent of the trial subjects.
“They’re even better than we had hoped,” Nathalie Landry, executive vice president of scientific and medical affairs at Medicago, said of the results.
“When we talk about neutralizing antibody responses, we say it’s quite remarkable, especially when we compare with a subject that recovered from the disease.”
Those who received the Medicago adjuvanted vaccine in the Phase 1 trial actually had higher antibody levels than the levels found in those who had contracted COVID-19, Landry told CTVNews.ca in a phone interview.
Medicago, a company based in Quebec, launched their first human trials in July.
In Phase 1, they looked at around 180 healthy subjects between the ages of 18 and 55. Participants were given either the vaccine on its own, or the vaccine with one of two adjuvants mixed in: GlaxoSmithKline (GSK)’s pandemic adjuvant or Dynavax’s CpG 1018.
An adjuvant is a substance that is added to vaccines in order to boost the effects and enable a higher immune response. They can be made from a variety of materials, including plants, aluminum and squalene oil, derived largely from sharks. Researchers wanted to measure what difference adding each adjuvant would make for the immune response.
They found that the vaccine candidate on its own did produce antibodies in the subjects, but demanded a much higher dosage level in order to get proper results.
It was the adjuvanted vaccines that really had an effect.
After two doses of adjuvanted vaccine — no matter which adjuvant was used — the antibody response rose significantly. However, subjects developed anti-spike IgG antibodies after a single dose of the vaccine when mixed with the GSK adjuvant, according to the press release.
“[GSK’s was] the adjuvant that provided us with the best immune response at [a] very low dose,” Landry said.
She explained that although they tested three doses at 3.75, 7.5 and 15 micrograms, the antibody response did not increase as the dosage went up.
“We only need 3.75 micrograms to get to a very significant level of antibody and cellular immune responses,” she said.
Being able to spur an immune response at a lower dose means they would be able to manufacture more of the vaccine — if it clears the rest of the phases.
In October, the company announced that they had reached an agreement with the federal government to supply Canada with up to 76 million doses of their vaccine, subject to approval from Health Canada.
The success of the GSK adjuvant means that moving forward, Medicago will be using only their vaccine candidate mixed with GSK’s pandemic adjuvant in further trials.
This phase also proved the safety of the vaccine candidate to proceed to further trials, as no subjects had any severe adverse side-effects, only mild and short-lived side-effects, according to the release.
HOW PLANTS PLAY INTO VACCINE DEVELOPMENT
Medicago’s vaccine candidate is different from many of the others currently in human trials in that it uses “coronavirus virus-like particles” (CoVLP), which mimic the virus to spur an immune response without introducing any form of the actual virus to the human body.
“In general, when developing a vaccine for COVID, you’re looking for two things,” Landry said. “You’re looking for neutralizing antibody responses, and cellular immune responses.”
Their adjuvanted vaccine can trigger both of these, she said.
In order to make their vaccine, Medicago uses plants as, essentially, living factories to produce the antigen in the vaccine that spurs an immune response. This is achieved through recombinant technology: genetic code is transferred to a plant, at which point “the plant will start expressing that antigen like if it was its own,” according to Landry.
The plant they use is called nicotiana benthamiana, a relative of tobacco plants, which grows quickly and can “produce a huge amount of proteins,” she said, making it a prime host for biopharmaceuticals.
“This is 20 years of development, that is behind this innovative manufacturing technology,” Landry said. “And this is something that has been developed in Canada.”
NEXT STEPS
In Phase 2, they will be studying more subjects, as well as those in other age groups not included in the first trial. It will involve around 600 subjects, between the ages of 18 and 64.
“We also evaluate elderly people, make sure that we actually took the right dose, and we have a group safety and immunogenicity profile,” Landry said.
In the final phase of the clinical trials, Medicago hopes to enrol around 30,000 subjects in different regions across the globe.
“Why we need to go global is that to prove the efficacy of the vaccine, you need to go in regions where the virus is circulating,” she explained.
She said they’re on track with their trials so far in terms of timeline. Medicago is aiming to launch Phase 2 soon, pending approval. According to Landry, we could hear the early results from that clinical trial in early 2021, around the same time that they are aiming to launch Phase 3 of the trials.
Phase 3 is when the efficacy of the vaccine really gets tested, she said, so while the results from Phase 1 are promising, and support further trials, they don’t know yet if the vaccine will actively prevent transmission of the virus.
“But that’s the idea,” she said. “You have a high level of antibodies that can neutralize the virus, so you will prevent infection and therefore, hopefully transmission of the virus as well.”
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.
Dollarama Inc.’s food aisles may have expanded far beyond sweet treats or piles of gum by the checkout counter in recent years, but its chief executive maintains his company is “not in the grocery business,” even if it’s keeping an eye on the sector.
“It’s just one small part of our store,” Neil Rossy told analysts on a Wednesday call, where he was questioned about the company’s food merchandise and rivals playing in the same space.
“We will keep an eye on all retailers — like all retailers keep an eye on us — to make sure that we’re competitive and we understand what’s out there.”
Over the last decade and as consumers have more recently sought deals, Dollarama’s food merchandise has expanded to include bread and pantry staples like cereal, rice and pasta sold at prices on par or below supermarkets.
However, the competition in the discount segment of the market Dollarama operates in intensified recently when the country’s biggest grocery chain began piloting a new ultra-discount store.
The No Name stores being tested by Loblaw Cos. Ltd. in Windsor, St. Catharines and Brockville, Ont., are billed as 20 per cent cheaper than discount retail competitors including No Frills. The grocery giant is able to offer such cost savings by relying on a smaller store footprint, fewer chilled products and a hearty range of No Name merchandise.
Though Rossy brushed off notions that his company is a supermarket challenger, grocers aren’t off his radar.
“All retailers in Canada are realistic about the fact that everyone is everyone’s competition on any given item or category,” he said.
Rossy declined to reveal how much of the chain’s sales would overlap with Loblaw or the food category, arguing the vast variety of items Dollarama sells is its strength rather than its grocery products alone.
“What makes Dollarama Dollarama is a very wide assortment of different departments that somewhat represent the old five-and-dime local convenience store,” he said.
The breadth of Dollarama’s offerings helped carry the company to a second-quarter profit of $285.9 million, up from $245.8 million in the same quarter last year as its sales rose 7.4 per cent.
The retailer said Wednesday the profit amounted to $1.02 per diluted share for the 13-week period ended July 28, up from 86 cents per diluted share a year earlier.
The period the quarter covers includes the start of summer, when Rossy said the weather was “terrible.”
“The weather got slightly better towards the end of the summer and our sales certainly increased, but not enough to make up for the season’s horrible start,” he said.
Sales totalled $1.56 billion for the quarter, up from $1.46 billion in the same quarter last year.
Comparable store sales, a key metric for retailers, increased 4.7 per cent, while the average transaction was down2.2 per cent and traffic was up seven per cent, RBC analyst Irene Nattel pointed out.
She told investors in a note that the numbers reflect “solid demand as cautious consumers focus on core consumables and everyday essentials.”
Analysts have attributed such behaviour to interest rates that have been slow to drop and high prices of key consumer goods, which are weighing on household budgets.
To cope, many Canadians have spent more time seeking deals, trading down to more affordable brands and forgoing small luxuries they would treat themselves to in better economic times.
“When people feel squeezed, they tend to shy away from discretionary, focus on the basics,” Rossy said. “When people are feeling good about their wallet, they tend to be more lax about the basics and more willing to spend on discretionary.”
The current economic situation has drawn in not just the average Canadian looking to save a buck or two, but also wealthier consumers.
“When the entire economy is feeling slightly squeezed, we get more consumers who might not have to or want to shop at a Dollarama generally or who enjoy shopping at a Dollarama but have the luxury of not having to worry about the price in some other store that they happen to be standing in that has those goods,” Rossy said.
“Well, when times are tougher, they’ll consider the extra five minutes to go to the store next door.”
This report by The Canadian Press was first published Sept. 11, 2024.
TORONTO – The U.S. Consumer Financial Protection Bureau has ordered TD Bank Group to pay US$28 million for repeatedly sharing inaccurate, negative information about its customers to consumer reporting companies.
The agency says TD has to pay US$7.76 million in total to tens of thousands of victims of its illegal actions, along with a US$20 million civil penalty.
It says TD shared information that contained systemic errors about credit card and bank deposit accounts to consumer reporting companies, which can include credit reports as well as screening reports for tenants and employees and other background checks.
CFPB director Rohit Chopra says in a statement that TD threatened the consumer reports of customers with fraudulent information then “barely lifted a finger to fix it,” and that regulators will need to “focus major attention” on TD Bank to change its course.
TD says in a statement it self-identified these issues and proactively worked to improve its practices, and that it is committed to delivering on its responsibilities to its customers.
The bank also faces scrutiny in the U.S. over its anti-money laundering program where it expects to pay more than US$3 billion in monetary penalties to resolve.
This report by The Canadian Press was first published Sept. 11, 2024.
