Plant-Derived COVID-19 Vaccine Candidate Found Effective

Quebec City-based Medicago and GlaxoSmithKline (GSK) reported positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago's plant-derived, refrigerator-stable COVID-19 vaccine candidate known as CoVLP, which has been tested in combination with GSK's pandemic adjuvant.

As measured by the neutralizing antibody titer, immunogenicity was found about 10 times higher than those in a panel of sera from patients recovering from COVID-19.

No related severe adverse events were reported, and reactogenicity was generally mild to moderate and short in duration.

The Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP (two doses of 3.75 µg CoVLP combined with GSK's pandemic adjuvant given 21 days apart) has an acceptable immunogenicity and safety profile in healthy adults 18-64 years of age, elderly subjects aged 65 and over and adults with comorbidities. The interim data from the Phase 2 study was published at MedRxiv on May 17, 2021.

“After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespectively of age,” said Nathalie Landry, EVP, Scientific, and Medical Affairs at Medicago, in a related press statement.

“These results give us confidence as we continue to move forward with our Phase 3 clinical trial."

The Phase 3 trial of the vaccine candidate launched on March 16, 2021. Trial sites are currently enrolling subjects in Canada, the United States, the United Kingdom, and Brazil, with additional sites expected to be added in the coming weeks. The vaccine candidate has received Fast Track designation by the U.S. FDA, and Health Canada has initiated a review of Medicago's COVID-19 rolling submission under the Interim Order.

Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare, Medicago is a pioneer in plant-derived therapeutics.