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Medicago, GSK Report Positive Interim Phase 2 Data For Adjuvanted COVID-19 Vaccine Candidate

Canadian biopharmaceutical company Medicago, Inc. (MDG.TO) and GlaxoSmithKline (GSK,GSK.L) announced Tuesday positive interim Phase 2 clinical trial safety and immunogenicity data for Medicago's plant-derived COVID-19 vaccine candidate, which has been tested in combination with GSK's pandemic adjuvant.

These results are part of the ongoing Phase 2/3 study and reiterate the promising profile observed during Phase 1 testing. Immunogenicity, as measured by the neutralizing antibody titer, was high - about 10 times higher than those in a panel of sera from patients recovering from COVID-19.

The companies noted that 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 g 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 Phase 2 portion of the trial was a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above.

The Phase 3 trial of the vaccine candidate was 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 FDA in the United States, and Health Canada has initiated a review of Medicago's COVID-19 rolling submission under the Interim Order.

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