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Medicago and GSK Announce Positive Interim Phase 2 Results for Adjuvanted Covid-19 Vaccine Candidate

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Medicago and GSK Announce Positive Interim Phase 2 Results for Adjuvanted Covid-19 Vaccine Candidate | Pharmtech Focus

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to report 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 neutralising antibody titer, was high: 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.

“We are very excited to see such positive results from the Phase 2 data. After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses in all subjects, irrespective of age,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago. “These results give us confidence as we continue to move forward with our Phase 3 clinical trial. We hope to add another tool in the global fight against COVID-19, particularly as cross-protection emerges as an important consideration in vaccination efforts worldwide.”

Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “We are delighted to see that the results suggest a very strong immune response. Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant was also well tolerated, reinforcing its potential benefits. We now look forward to the outcome of the ongoing Phase 3 trial of this refrigerator-stable vaccine candidate as the next step forward in our contribution to the global response to the pandemic.”

The Phase 3 trial of the vaccine candidate launched on 16 March 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.

About Phase 2: Results Summary

The interim data from Phase 2 in adults and in the elderly have been published on an online preprint server at MedRxiv.

  • This publication focuses on presenting safety and tolerability results, and immunogenicity, as measured by neutralizing antibody (NAb) and cell mediated immunity (IFN-γ and IL-4 ELISpot) responses, in adults aged 18-64 (adults) and older adults aged 65+ (older adults).
  • Medicago’s vaccine candidate with GSK’s pandemic adjuvant exhibited an acceptable safety profile and adverse events (AEs) were primarily mild or moderate and of transient duration.
  • AEs in older adults were more limited than those observed in the adult population.
  • Medicago ’s vaccine candidate with GSK’s pandemic adjuvant induced a significant humoral immune response of similar strength in both age cohorts after two doses.
  • The vaccine candidate induced a greater humoral response in adults than older adults after a single dose but after the second dose both age cohorts responded with NAb titers that were about 10 times higher than those in a panel of sera from patients recovering from COVID-19.
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