GlaxoSmithKline Plc - Medicago/GSK COVID-19 Vaccine Positive Ph2 Results
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Medicago and GSK announce positive interim Phase 2 results for adjuvanted COVID-19 vaccine candidate
- Similar antibody response in adults and in the elderly after two doses
- Neutralizing antibody responses were ten times higher than in people recovering from COVID-19
- No related severe adverse events reported
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.