Pharma Focus Asia

Medicago begins Phase I clinical trials for candidate vaccine against COVID-19

Wednesday, July 15, 2020

Medicago , a biopharmaceutical company headquartered in Quebec City, initiated Phase I clinical trials for the plant-derived candidate vaccine against COVID-19, during which the first doses were administered to healthy human volunteers. Medicago also plans to start a phase 2/3 study in October.

" We are delighted that our candidate vaccine against COVID-19 is entering Phase I research 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 proves how valuable Medicago's unique plant-based vaccine technology is."

The Phase I clinical trial is a randomized, partially-blinded study involving 180 normal healthy subjects, men and women aged 18-55 years. Doses of 3.75, 7.5 or 15 micrograms of the recombinant CoVLP candidate vaccine (Coronavirus Virus-Like Particle, virus-like particle of the coronavirus) are evaluated, alone or with an adjuvant in a prime boost regimen. Medicago will test the candidate vaccine using two adjuvants separately: GSK 's proprietary pandemic adjuvant technology and Dynavax's CpG 1018 ™. An adjuvant may be of particular importance in the event of a pandemic, as it can enhance the immune response and reduce the amount of antigen required per dose, producing more vaccine doses and thus protecting a larger number of people .

Medicago's innovative platform and plant-based production technology contribute to the diversification of the pool of COVID-19 vaccines under development.

" Creating an adequate supply of COVID-19 vaccines within the next year is a challenge that requires multiple approaches, using different technologies," said Dr. Bruce Clark, President and CEO of Medicago. " Our proven plant-based technology can contribute to the collective solution to this public health emergency."

Medicago expects to be able to produce approximately 100 million doses by the end of 2021. Construction of Medicago's large-scale facility in Quebec City, Canada, will be completed in late 2023. This commercial facility is expected to have the capacity to produce up to 1 billion doses of the COVID-19 vaccine annually.

Medicago is the only plant-based manufacturing technology company to complete Phase III clinical trials (with the quadrivalent candidate vaccine for VLP influenza) and Pandemic Phase II clinical trials (with the candidate pandemic H1N1 vaccine). The company's first drug application for the seasonal recombinant quadrivalent VLP seasonal vaccine for active immunization against influenza in adults (18-64 years) is currently under review by Health Canada, following the completion of a robust clinical safety and efficacy program in more than 25,000 subjects.

In addition to its clinical development potential, Medicago has also demonstrated its ability to produce a large amount of vaccines in a short period of time, producing 10 million doses of monovalent vaccines against pandemic influenza H1N1 in one month in 2012 for the Defense Advanced Research Projects Agency (DARPA), part of the United States Department of Defense.

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