Takashi Nagao, Medicago’s chief executive, said: "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.”
Canada-based Medicago said its candidate uses Coronavirus-Like-Particle (CoVLP) technology co-administered with GSK's pandemic adjuvant. Two doses of 3.75μg of CoVLP are administered 21 days apart.
Thomas Breuer, chief medical officer of 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."
Medicago's candidate, in combination with Glaxo's pandemic adjuvant, was granted Fast Track designation by the US Food and Drug Administration (FDA) on 17 February 2021.
The phase III study will enrol up to 30,000 subjects initially composed of healthy adults (18y to 65y) followed by elderly adults (65y+) and adults with comorbidities.
Ten countries will host the trial pending regulatory approvals, starting with Canada and the United States, and will enrol males and females from ethnically and racially diverse populations.
A Phase 2 portion of the trial is approaching completion and results are expected to be made publicly available in April 2021.
A collaboration with French giant Sanofi on an adjuvanted, protein-based vaccine candidate has had to be reworked after it had no benefit on the elderly
An earlier stage collaboration with SK Bioscience is also ongoing, while Glaxo is working with mRNA specialist, CureVac, to develop multi-valent mRNA vaccines.
On treatments, Glaxo is working with Vir on new anti-viral antibodies that could be used as therapeutic or preventive options.