Sask. vaccine developer locks in Canadian manufacturers for human clinical trials

The University of Saskatchewan's VIDO-InterVachas contracted two Canadian pharmaceutical companies to manufacture ingredients for its potentialCOVID-19 vaccine to be used inthe first stages of human clinical trials.

Toronto-based Dalton Pharma Services announced in a news release Tuesday it will be making parts of the vaccine being developed by the Vaccine and Infectious Disease Organization-International Vaccine Centre, or VIDO-InterVac, team in Saskatoon.

Biodextris, a company based near Montreal, has also confirmed it will manufacture part of the vaccine for early-stage human clinical trials planned to begin later this year, pending approval.That company is working with the National Research Council to prepare some of the materials needed.

Dr. Paul Hodgson, associate director of business development at VIDO-InterVac, said the fact both companies are in Canada was a factor in VIDO-InterVac's decision to work with them.

"One of the things the world has become much more cognizant of is potential limitations in borders and what can happen if a nationality decides to clamp down on anything," he said.

"But they are also world-leading companies.We've worked with Dalton for probably the better part of two decades. Biodextris has roots in major pharmaceutical companies, so these guys are well-established companies."

Manufacturing has become a key part of the discussion about access to a COVID-19 vaccine inCanada, amid concerns about a lack of capacity to serve the population once a vaccine is developed. There isalso the possibilitygovernments in other countries could refuse to share a vaccine that is manufactured on their soil.

The Saskatchewan-based team is working toward human clinical trials by conducting trials with animals to establish its vaccine is effective and safe.

Manufacturing spike protein

The VIDO-InterVac vaccine uses a modified version of the spike protein of SARS-CoV-2 the novel coronavirus that causes COVID-19 to stimulate an immune response that would in turn produce protective antibodies and T-cells.

The spike protein iswhat the virus uses to latch on to human cells and infect them.

Biodextris is preparing a part of the vaccine known as the antigen in this case part of the spike protein which is grown in human kidney cells.The spike protein alone is not infectious and cannot replicate to cause the disease.

The company is essentially growing non-virus cells researchers can "tell" to grow a spike protein by introducing the right genetic material, said Biodextris president and CEO Joseph Zimmermann.

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The company specializes in pharmaceuticals for clinical trials but is also working towardcommercial manufacturing an area whereCanada is expected to need more capacityduring the pandemic.

"As a scientistit's nice to be able to try to help in such an important issue. I think that's kind of why most of the peoplego intothe field," saidZimmermann.

"It's terrible when the issue comes upfor sure it's a bad situation right now but I think now we're happy to be part of trying to resolve it."

Positive results from 1st round of trials

Dalton Pharma Services will be manufacturing a different part of the vaccine known as an adjuvant, which works alongside the spike protein to provoke a broader activation of the immune system.

In late May, the VIDO-InterVac team reported positive results from its first round of pre-clinical trials in ferrets.

It is now working with hamsters to attempt toshow the effect of the vaccine andbolster the evidence it needs before human clinical trials can be approved.

Vaccines need to go through three phases of human clinical trials before they can be approved by Health Canada, a process that usually takes five to 10 years.

In an emergency situation like a pandemic, some phases can be done in tandem and emergency authorizations can be used to speed up the process.

VIDO-InterVac is working toward approvalin 2021.