First doses administered to human volunteers
Medicago, a biopharmaceutical company headquartered in Quebec City, began Phase I clinical trials for its plant-derived COVID-19 vaccine candidate yesterday, administering the first doses in healthy human volunteers. Medicago is also planning a Phase 2/3 trial to be initiated this October.
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Vial of a vaccine candidate. (Photo: Business Wire)
"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."
The Phase I clinical trial is a randomized, partially blinded study of 180 normal healthy subjects, male and female aged 18-55, 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.
"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 CEO 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 immunization against influenza in adults (18-64 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.
Medicago’s plant-based platform
The company uses a proprietary plant-based technology to develop vaccines and protein-based therapeutics. Unlike traditional vaccination development, Medicago does not use animal products or live viruses to create its products. Instead, 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. Clinical trial data suggest 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.
Medicago’s proprietary technology is rapid, versatile, and scalable. As soon as the genetic sequence of a virus is made available, Medicago can develop a clinical-grade vaccine candidate in only a few weeks. Its recombinant technology allows the production of a vaccine that precisely matches the circulating strains, such as in the case of seasonal influenza. The technology is easily scalable, allowing the company to increase volume of production by simply increasing the number of plants it uses.
Medicago is headquartered in Quebec City, Canada, and plans to produce COVID-19 vaccines in its manufacturing facility in Durham, North Carolina (USA) and in its Quebec pilot plant. A new state-of-the-art manufacturing plant is under construction in Quebec City, and is planned to have the capacity to deliver up to 1 billion COVID-19 vaccines annually.
Medicago is a biopharmaceutical company headquartered in Quebec City with productions sites in Quebec, Canada and Durham, North Carolina, USA. Medicago’s mission is to improve global health outcomes by leveraging innovative plant-based technologies for rapid responses to emerging global health challenges. Medicago is committed to advancing therapeutics against life-threatening diseases worldwide.
For more information: www.medicago.com