Medicago, a biopharmaceutical company based in Québec City, and GSK announce the commencement of Phase 2/3 clinical trials to evaluate the efficacy, safety and immunogenicity of Medicago anti-COVID-19 phytotherapeutic vaccine candidate. Based on the positive Phase 1 results and approval from Canadian regulatory authorities, Medicago has decided to commence the Phase 2/3 clinical trial with GSK's pandemic adjuvant.

" The Phase 1 results on our adjuvanted vaccine candidate were very encouraging and fully support further clinical evaluation," said Nathalie Landry, executive vice president of Scientific and Medical Affairs at Medicago.

Thomas Breuer, medical director of GSK Vaccines, said: " This is the first of GSK's many collaborations on the COVID-19 vaccine candidate to move to Phase 2/3 clinical testing, a major step in our contribution to the fight. We are pleased with the very promising Phase 1 results achieved with Medicago's COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant. The proven dose-reducing effect and high immune response achieved thanks to GSK's adjuvant, they make us confident about the possibility of offering, in collaboration with Medicago, an effective vaccine with an acceptable safety profile ".

The CoVLP vaccine candidate (Coronavirus Virus-Like Particle COVID-19) is composed of the recombinant spike glycoprotein (S) expressed as virus-like particles (VLP).

The aim of the study, divided into several phases, is to confirm that the chosen formulation and dosage regimen of CoVLP (two doses of 3.75 µg of CoVLP combined with the GSK pandemic adjuvant and administered 21 days apart) have a acceptable immunogenicity and safety profile in healthy adult patients, aged 18 to 64 years, and in older subjects, aged 65 years or older.

Phase 2 is a randomized, observer-blind, placebo-controlled study aimed at evaluating the safety and immunogenicity of the plant-derived recombinant COVID-19 adjuvanted vaccine candidate in subjects aged 18 years or older. It will be conducted at multiple locations in Canada and, subject to FDA clearance, in the United States, on a population of healthy adults (18-64 years) and healthy seniors (over 65 years of age). Each age group will include over 300 5: 1 randomized subjects to receive the adjuvanted CoVLP vaccine candidate: placebo and 2: 1 stratified in older adults (65-74 and ≥75). All subjects will be followed for a period of 12 months after the last vaccination, to assess the safety and duration of immune responses to the vaccine candidate.

Phase 3 is expected to kick off by the end of 2020. It will be an event-driven, randomized, observer-blind, placebo-controlled, placebo-controlled study. efficacy and safety of the CoVLP formulation, compared to placebo, in over 30,000 subjects in North America, Latin America and / or Europe and compared to the same population or, alternatively, compared to a larger population, subject to pending authorization by of regulatory authorities.