Medicago, a biopharmaceutical company headquartered in Quebec City, has started Phase I clinical trials for its plant-derived COVID-19 vaccine candidate, administering the first doses in healthy human volunteers. Medicago is also planning a Phase 2/3 trial to be initiated this October.
The Phase I clinical trial is a randomized, partially blinded study of 180 normal healthy subjects, male and female aged 18 to 55, and will evaluate dosages of 3.75, 7.5 or 15 micrograms of the recombinant Coronavirus Virus-Like Particle (CoVLP) vaccine candidate alone or with an adjuvant in a prime-boost regimen. Medicago will be testing its vaccine candidate with two adjuvants separately – GSK’s proprietary pandemic adjuvant technology and Dynavax’s CpG 1018™. 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.
Medicago’s innovative platform and plant-based manufacturing technology is helping to diversify the pool of COVID-19 vaccines in development.
“We are thrilled to see our COVID-19 vaccine candidate enter the Phase 1 trial, and we look forward to obtaining safety and immunogenicity results in October,” said Nathalie Landry, Executive Vice-President, Scientific and Medical Affairs at Medicago. “Our progress continues to demonstrate the value of Medicago’s unique plant-based vaccine technology.”
“Creating a sufficient supply of COVID-19 vaccines within the next year is a challenge which will require multiple approaches, with different technologies,” said Dr. Bruce Clark, President and Chief Executive Officer of Medicago. “Our proven plant-based technology is capable of contributing to the collective solution to this public health emergency.”
Medicago expects to be able to manufacture approximately 100 million doses by the end of 2021. By the end of 2023, the construction of Medicago’s large-scale facility in Quebec City, Canada, will be completed. It is anticipated that this commercial facility will have the capacity to produce up to 1 billion doses of the COVID-19 vaccine annually.
Medicago is the only company with plant-based manufacturing technology that has completed Phase III clinical trials (with its quadrivalent VLP influenza vaccine candidate) and pandemic Phase II clinical trials (with its H1N1 pandemic vaccine candidate). The company’s first New Drug Submission for its seasonal recombinant quadrivalent VLP vaccine for active immunisation against influenza in adults (18 to 64 years), is currently under review by Health Canada following the completion of a robust safety and efficacy clinical program in over 25,000 subjects.
In addition to its clinical development capabilities, Medicago has also demonstrated its capacity to produce a large amount of vaccines in a short period of time, with the production in 2012 of 10 million doses of monovalent pandemic influenza H1N1 vaccines in one month for the Defense Advanced Research Projects Agency (DARPA), part of the U.S. Department of Defense.