• Canadian biotech Medicago expects to start its Phase 3 COVID-19 vaccine trial in mid-February.
  • The study will go international, particularly to Latin America, to recruit elderly volunteers. 
  • Pivotal data will likely come by May, potentially allowing for an emergency OK in July or August if it works.
  • Visit the Business section of Insider for more stories.

The Canadian biotech Medicago expects to start the final stage of clinical trials for its experimental coronavirus vaccine around the middle of this month, and told Insider that the preliminary results from an ongoing mid-stage trial are encouraging.

The privately held vaccine developer plans to soon start its pivotal Phase 3 study, which was originally set to begin before the end of 2020, Medicago Medical Officer Dr. Brian Ward said in a Wednesday interview. Like other vaccine developers, Medicago has faced challenges in recruiting elderly volunteers for its placebo-controlled study, because authorized COVID-19 vaccines are being rolled out.

The company plans to remedy that by focusing on enrolling volunteers outside the US and Canada for the late-stage study. While the list of countries has not been disclosed, Ward told Insider that the study would recruit in a handful of Latin American countries, the UK, and some Eastern European nations. The study aims to recruit more than 30,000 volunteers, randomizing them to either get two doses of its vaccine candidate or two sham injections of a placebo.

The focus on certain Latin American countries could accelerate the research, Ward said, particularly as countries south of the equator move into their winter months. By contrast, the US, Canada and northern Europe will likely see infection rates start to fall as vaccinations become more widespread and warmer weather arrives. 

Medicago hopes to have late-stage trial results by April or May

“In Latin America, it will be going in the opposite direction,” Ward said, estimating it will take just six weeks to record 160 COVID-19 cases, the study’s primary goal.

Ward hopes to have efficacy results by April or May that, if they show the vaccine works, could allow for emergency authorization in July or August.

The company has already started mass-producing the vaccine before knowing whether or not it works. Medicago’s former CEO Bruce Clark, who was replaced in December, previously estimated to Insider that the company could produce up to 100 million doses in 2021. Ward said he now expects to produce somewhere between 55 million and 75 million doses in 2021.

Canada paid the company about $135 million in October to fund research and development and supply up to 76 million doses.

Medicago’s vaccines are made out of tobacco-like plants

Medicago’s technology is unusual. Rather than relying on massive, stainless-steel cylinders to grow its serum, the company cultivates greenhouses growing a close relative of the tobacco plant. By inserting a part of the coronavirus’ genetic sequence into the plants’ cells, the leafy greens are turned into protein-producing minifactories. 

The plant-based approach is novel, with no approved vaccines yet to come from the platform. But preliminary results with its COVID-19 vaccine candidate showed two doses of the shot generated a robust immune response and was safe in humans. The tobacco industry giant Philip Morris and Japan’s Mitsubishi Tanabe Pharma are major shareholders in Medicago.

In November, Medicago announced data from its first clinical study of 180 healthy adults who were 55 years old and younger. That led them to advance a two-dose regimen using an adjuvant developed by British pharma giant GlaxoSmithKline. 

The Phase 2 portion of the study began in mid-November, designed to recruit nearly 1,000 people. While the study has fully enrolled its target for young people, Ward said that older individuals “are not volunteering their arms as readily.” The hope is by moving the study outside of North America, having a placebo group can remain a viable and ethical path forward.

The early data on Medicago’s vaccine has been encouraging

Medicago has been encouraged by an early look at that ongoing trial, after examining immune responses three weeks out. Those results have yet to be made public, and Ward said they will likely be published as preprints later on. 

“It looks good,” Ward said of the interim data. “It is confirmatory of what we saw in the Phase 1 with the healthy adults. The much more limited data in the elderly adults also looks fairly good.”

Still, Medicago will need to show that its shot can prevent people from becoming sick with COVID-19, not just that it activates the body’s immune responses.

Another critical factor to watch for is the rise of variants that have caused concerns among virologists. Some clinical and lab data suggest variants now spreading in South Africa and Brazil could be at least partially evading vaccine protection. 

Ward compared the situation with influenza vaccines, which typically provide middling rates of protection. Flu shots still help blunt seasonal outbreaks, and Ward said COVID-19 shots will likely also be able to blunt the impact of this pandemic. 

“Everybody’s moaning about loss of efficacy,” he said. “Of course it’s important, but it doesn’t mean these vaccines are useless.”

Medicago is working with labs in Siena, Italy and the UK to learn more about the impact of several virus variants that have caused concern among virologists. 

“We’re very hopeful that our little plant-based vaccine will do well against the historic strains and may actually still do reasonably well against at least some of the variants,” Ward said.

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