Trial to enroll up to 30,000 volunteers worldwide
Fast Track designation granted by US FDA
Feasibility study initiated of a vaccine candidate to address emerging variants
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago's plant-derived COVID-19 vaccine candidate in combination with GSK's pandemic adjuvant, as part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to proceed with enrollment of healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. In parallel, Medicago has also initiated a feasibility study of a vaccine candidate to address the emerging COVID-19 variants.
"We are pleased to take the significant step of initiating the Phase 3 clinical trial at sites around the world," said Takashi Nagao, CEO and President of Medicago. "This brings us one step closer to delivering an important new COVID-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK."
Thomas Breuer, Chief Medical Officer, GSK Vaccines said, "This advance to late stage clinical testing further reinforces our confidence in the adjuvanted vaccine candidate's potential to make a difference in the continued fight against COVID-19. We look forward to sharing results later this year."
Medicago's plant-derived vaccine candidate against COVID-19 uses Coronavirus-Like-Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs) co-administered with GSK's pandemic adjuvant. Two doses of 3.75 micrograms of CoVLP are administered 21 days apart.
The vaccine candidate, in combination with the pandemic adjuvant, was granted Fast Track designation by the US Food and Drug Administration (FDA) on February 17, 2021. Fast Track designation allows the FDA to expedite the development and review of new medicines and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
"The FDA's decision to grant Fast Track designation for Medicago's vaccine candidate will help us expedite our efforts to bring the first plant-derived COVID-19 vaccine to market, subject to regulatory approval," said Carolyn Finkle, Chief Operating Officer of Medicago. "We are grateful to the FDA and look forward to continuing to work with them as we move forward in our clinical trials, planned application for Emergency Use Authorization, and eventual vaccine licensure application process."
The Phase 3 portion of the study is an event-driven, randomized, observer-blinded, placebo-controlled, two-way cross-over design that will evaluate the efficacy and safety of the adjuvanted CoVLP formulation, compared to placebo. The study will enroll up to 30,000 subjects initially composed of healthy adults (18y to 65y), followed by elderly adults (65y+) and adults with comorbidities. The trial will take place in 10 countries pending regulatory approvals, starting with Canada and the United States, and will enroll males and females from ethnically and racially diverse populations.
Information about how to participate in this clinical trial is available at http://www.CoVLPvaccine.com.
The Phase 2 portion of the trial is approaching completion and results are expected to be made publicly available in April 2021.