15 July 2020

Tobacco vaccine

COVID-19: Plant-based vaccine entered clinical trials

GMP News

Canadian Biopharmaceutical Company Medicago has announced the start of a phase I clinical trial of its plant-based anti-coronavirus vaccine.

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Medicago is supported by the Phillip Morris tobacco company. Medicago also plans to start phase 2/3 in October of this year.

The company is headquartered in Quebec and is privately owned. Phillip Morris owns a 33% stake in Medicago, and the remaining stake belongs to Mitsubishi Tanabe Pharma.

According to the company, the first healthy volunteers were introduced into the study, making it the first Canadian vaccine that, along with more than 20 worldwide, entered the human testing phase. Results on safety and immunogenicity are expected in October.

Phase I of the clinical trial is a randomized, partially blind trial involving 180 healthy volunteers aged 18-55 years. The company will evaluate vaccine doses of 3.75, 7.5 or 15 micrograms with a recombinant virus-Like particle (Coronavirus Virus–Like Particle - CoVLP) or with an adjuvant with a prime booster vaccination regimen. Medicago will test the vaccine with two adjuvants separately – GSK's patented adjuvant technology and Dynavax's CpG 1018™ adjuvant.

Medicago is expected to be able to manufacture approximately 100 million doses of the vaccine by the end of 2021. By the end of 2023, a large-scale enterprise will be built in Quebec, Canada. It is expected that this commercial facility will be able to produce up to 1 billion doses of COVID-19 vaccine per year.

The experimental Medicago vaccine uses the leaves of a tobacco family plant to produce S-protein (Spike protein), one of the three spike proteins of SARS-CoV-2.

Medicago is the only company with plant-based vaccine technology that has completed phase III clinical trials (quadrivalent influenza vaccine VRL) and phase II clinical trials (H1N1 influenza vaccine). The company's first application for a new drug for the seasonal recombinant tetravalent VLP vaccine for active immunization against influenza in adults (18-64 years old) is currently being considered by the Ministry of Health of Canada. The vaccine has passed a clinical safety and efficacy program, with the participation of more than 25,000 people.

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