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Medicago, a Quebec-based biopharmaceutical company, yesterday began phase 1 clinical trials for its plant-derived COVID-19 vaccine candidate and started administering healthy human subjects the first doses. Medicago is also planning a phase 2/3 trial to begin in October this year.
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A volunteer receives an injection as part of Medicago’s Phase I clinical trial for its COVID-19 vaccine candidate. (Photo: Business Wire)
“We are very excited to start the Phase 1 trial for our COVID-19 vaccine candidate and look forward to the safety and immunogenicity results that will be available in October,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs, Medicago. “Our advances underscore the potential of Medicago’s unique plant-based vaccine technology.”
The phase 1 clinical trial is a randomized, partially blinded study in 180 healthy subjects of male and female sex between the ages of 18 and 55. Dosages of 3.75, 7.5 and 15 micrograms of the recombinant CoVLP vaccine candidate (Coronavirus Virus-Like Particle) alone or in conjunction with an adjuvant as part of a prime boost scheme are being investigated. Medicago will test its vaccine candidate separately with two adjuvants: the proprietary GSK pandemic adjuvant technology and Dynavax
CpG 1018 ™. In a pandemic situation, an adjuvant can be particularly important because it can increase the immune response and reduce the amount of antigen needed per dose, so that more doses of vaccine can be produced and thus help to protect as many people as possible.
Medicago’s innovative platform and plant-based manufacturing technology diversify the pool of COVID-19 vaccines under development.
“Establishing a sufficient supply of COVID-19 vaccines within a year is a challenge that will require several approaches with different technologies,” reports Dr. Bruce Clark, President and CEO at Medicago. “Our proven plant-based technology can make an important contribution to tackling this healthcare crisis collectively.”
Medicago expects to be able to produce around 100 million cans by the end of 2021. Construction of the extensive Medicago production site in Quebec (Canada) will be completed by the end of 2023. This commercial facility is expected to provide sufficient capacity for up to 1 billion doses of the COVID-19 vaccine per year.
Medicago is the only company with plant-based manufacturing technology that has completed Phase III clinical trials (for the tetravalent VLP influenza vaccine candidate) and pandemic Phase II clinical trials (for the H1N1 pandemic vaccine candidate). The Company’s first regulatory filing for its seasonal recombinant tetravalent VLP vaccine for active immunization against adult influenza (18-64 years) is currently under review by the Canadian health authority, Health Canada, after robust clinical safety and efficacy studies in over 25,000 subjects have been completed.
In addition to its experience in clinical development, Medicago has also demonstrated its ability to produce large volumes of vaccines in a short period of time. In 2012, Medicago produced 10 million doses of pandemic H1N1 pandemic influenza vaccines for the Defense Advanced Research Projects Agency (DARPA), which is part of the U.S. Department of Defense, within a month.
Medicago’s plant-based platform
The company uses its proprietary plant-based technology to develop protein therapeutics and vaccines. Unlike traditional vaccine development, Medicago does not use animal products or live viruses. Instead, the company uses virus-like particles (VLP) that mimic the shape and size of a virus so that the body recognizes it and triggers an immune response that isn’t infection-based. Data from clinical trials suggest that VLPs have a multimodal mechanism of action that differs from inactivated vaccines and activates both arms of the immune system – antibodies and cell-mediated immune response.
Medicago’s proprietary technology is fast, versatile, and scalable. Once the gene sequence of a virus is available, Medicago can develop a clinical vaccine candidate in just a few weeks. The recombinant technology enables the production of a vaccine that is tailored to the strains in circulation, such as seasonal flu. Since the technology can be scaled effortlessly, Medicago can easily increase the production volume by increasing the number of plants used.
Medicago is based in Quebec, Canada and plans to manufacture COVID-19 vaccines in Durham, North Carolina and its pilot plant in Quebec. A new, state-of-the-art manufacturing facility currently under construction in Quebec is said to have an annual capacity of up to 1 billion COVID-19 vaccinations.
Medicago is a biopharmaceutical company with its headquarters in Quebec (Canada) and production sites in Quebec and Durham, North Carolina, USA. Medicago’s goal is to improve global treatment outcomes using innovative plant-based technologies to respond more quickly to emerging global health system challenges. Medicago aims to advance the development of therapeutics for life-threatening diseases worldwide.
More information at: www.medicago.com
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