TORONTO —
A Quebec City biopharmaceutical company began clinical trials on humans on Monday for a plant-derived COVID-19 vaccine.
Medicago is the first Canadian company to administer doses of a potential vaccine to volunteers, 180 men and women aged 18 to 55 who will receive two doses 21 days apart. The company expects to have safety and efficacy results for the two doses in October.
“(The) timeline is very aggressive and in fact we’re trying to do in 18 months what normally requires five to six years,” Nathalie Landry, executive vice-president of scientific and medical affairs at Medicago, told CTV News medical correspondent Avis Favaro.
“It’s a race. It is a race to find treatments to be able to vaccinate the population so we can get this COVID-19 under control.”
Unlike traditional vaccine development, Medicago does not use animal products or live viruses to create its products. The company says it uses “virus-like particles (VLPs) that mimic the shape and dimensions of a virus, which allows the body to recognize them and create an immune response in a non-infectious way.”
The company announced on March 12 that it had produced a VLP vaccine, 20 days after obtaining the SARS-CoV-2 gene that is responsible for COVID-19. It said in a news release at the time that it was collaborating with Laval University’s Infectious Disease Research Centre headed by Dr. Gary Kobinger, who helped develop a vaccine and treatment for Ebola.
Medicago says its clinical trial data in developing an influenza vaccine, which is now being reviewed for approval by Health Canada, along with its research into an H1N1 vaccine, shows that “VLPs have a multi-modal mechanism of action that is different from that of inactivated vaccines, activating both arms of the immune system – antibody and cell-mediated responses.”
Landry says its COVID-19 vaccine candidate stimulated a “very high neutralizing antibody response” in mice, along with activating the body’s T-cells, a major component of the immune system.
At least two other vaccine developers are expected to enter candidates into clinical trials in Canada soon.
According to Health Canada’s list of authorized clinical trials to investigate drug treatments and vaccines for the novel coronavirus, Medicago got approval to move forward with Phase 1 clinical trials July 9.
Health Canada has authorized only two potential vaccines to go to clinical trials in this country so far. The other and the first, Ad5-nCoV that was developed by CanSino Biologics and Chinese government scientists, was to be tested in clinical trials conducted by the Canadian Center for Vaccinology (CCV) at Dalhousie University in Halifax.
Health Canada approval came through May 15 and clinical trials were to begin within weeks, but the CCV is now indicating they have been held up because the Chinese government has not approved sending the vaccine candidate to Canada.
Edmonton-based biotechnology firm Entos Pharmaceuticals is working on a relatively new kind of treatment known as a DNA vaccine. Unlike other vaccines, which prompt a body to develop an immunity to a disease, DNA vaccines inject pieces of DNA code into cells, directly instructing them to produce an antibody that stops the virus.
Entos says it has developed two potential “pan-coronavirus” vaccines.
In a June 25 press release, company CEO John Lewis said preclinical results showed the company’s candidates “have the potential to be safe and highly potent vaccines that will provide protection against COVID-19 as well as future coronavirus threats.”
Lewis, a cancer researcher at the University of Alberta, confirmed to CTV News that Entos is on track to begin its clinical trials beginning with 70 to 75 volunteers in August. Entos has partnered with the CCV to carry out the human clinical trials and says it aims to develop a safe and effective vaccine for COVID-19 in one year.
Medicago is evaluating three dosage levels of the vaccine, both alone and in conjunction with two already-approved adjuvants.
“An adjuvant can be of particular importance in a pandemic situation as it may boost the immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and therefore contributing to protect the greatest number of people,” the company said in a news release.
Medicago, named after the Latin word for alfalfa, has its origins in a partnership between Agriculture Canada and Laval University. It was incorporated in 1999, went public in 2006, and was acquired by majority shareholder Mitsubishi Tanabe Pharmaceutical Corp. in 2013. It employs 450 people in Canada and the United States.
The Quebec government has invested $7 million in Medicago’s COVID-19 vaccine development and the company is also the recipient of funding through the Government of Canada’s $192-million COVID-19 research fund.
Landry says Medicago believes it is among the first 20 vaccines to move into clinical trial in the world, among an estimated 150 that are under development.
No one vaccine will provide a global solution to the pandemic, she says, because no manufacturer can produce enough to vaccinate the world’s population and no one formulation will protect everyone from infants to the elderly.
“We need multiple solutions to make sure that we can protect the population in general, with the most effective vaccine,” she said.
Another Canadian company, IMV, tells CTVNews that it plans to begin human tests later this month of a vaccine, called DPX-COVID-19, that officials say may work well in the elderly and those with immune disorders, two high-risk groups.
The tests will be conducted in healthy adults aged 18 to 84. Two dose levels of DPX-COVID-19 will be tested.
Andrew McArthur, an associate professor in biochemistry and biomedical sciences at McMaster University in Hamilton, Ont., says the Canadian pharmaceutical industry is contributing to “a shotgun approach” to finding answers to the pandemic.
He says the key is many different researchers trying many different solutions with the hope “a handful of them will light and do the job.”
“The more the merrier because it just increases our odds that we’ll get a viable vaccine.”
McArthur, who is lead on a lab that develops biological databases and undertakes genomic sequencing, says constant sequencing of the novel coronavirus shows it isn’t changing, meaning what researchers are working on for a vaccine is a “viable target” and improves the odds that it could work long term.
That makes it different from the influenza virus, which mutates rapidly, requiring a new vaccine each year.
Medicago says it expects to be able to manufacture 100 million doses of a COVID-19 vaccine by the end of 2021 in its facility in North Carolina, and another 10 million in a pilot facility in Quebec City. But when the company completes a new manufacturing centre in Quebec City in 2023, it anticipates annual manufacturing capacity of up to 1 billion doses.
Landry says the company is in discussions about distribution with several governments but nothing is official. She said the “expectation” is that if a deal is reached with the Canadian government that it would reserve doses for the Canadian population.
McArthur cautions there is a range of possible outcomes in the hunt for a vaccine. Scientists might be unsuccessful in developing one that effectively wards off COVID-19, but they might also zero in on one that is so effective it provides life-time immunity.
Or the reality could land somewhere in the middle: with a vaccine formulation that requires a booster every six months.
McArthur says all the global capacity in vaccine development that’s being built now is aimed at this pandemic, but will certainly help in the fight in the next one to come.
Canadian researchers are now “starting a massive national sequencing effort” to track every COVID-19 case, to figure out each genome and understand how it moved around, says McArthur. That is going to help prepare for and control future outbreaks of this virus and viruses yet to emerge.
