100 per cent of subjects who received an adjuvanted vaccine candidate developed significant antibody and cellular immune responses after two doses
QUEBEC CITY, Nov. 10, 2020 /CNW/ - Medicago, a biopharmaceutical company headquartered in Quebec City, is pleased to report interim results of the Phase 1 clinical trial of its plant-derived vaccine for COVID-19. The results of the trial demonstrated that 100 per cent of subjects developed a promising antibody response after two doses of Medicago's COVID-19 adjuvanted vaccine candidate.
"These are very promising results. After two doses, the adjuvanted vaccine candidate induced robust neutralizing antibody and cellular immune responses which is encouraging and support further clinical evaluation," said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago. "We also observed that the antibody levels were higher after vaccination than those observed in convalescent sera from people who recovered from the disease."
There were no severe adverse events reported and reactogenicity events were generally mild to moderate and short in duration.
The Phase 1 clinical trial was a randomized, partially blinded study of 180 healthy subjects, male and female aged 18-55, and evaluated dosages of 3.75, 7.5 or 15 micrograms of the recombinant Coronavirus Virus-Like Particle (CoVLP) vaccine candidate alone or with an adjuvant in a prime-boost regimen. Medicago tested its vaccine candidate with each of the two adjuvants – GSK's proprietary pandemic adjuvant technology and Dynavax's CpG 1018™. An adjuvant can be of particular importance in a pandemic situation as it may boost the immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and therefore allowing immunization of the greatest number of people. Significant humoral and cell-mediated immune responses have been observed with both adjuvants. Based on the Phase 1 data, Medicago plans to proceed with the Phase 2/3 clinical trial for its COVID-19 vaccine candidate, subject to regulatory approval.
"The positive results of our Phase 1 clinical trial are a step forward in the fight against the COVID-19 pandemic and we are confidently moving forward to our Phase 2/3 trial. We're pleased that Medicago's innovative manufacturing technology is helping to diversify the classes of COVID-19 vaccines candidates in development. In addition to supplying up to 76 million doses to the Government of Canada, we are ready to participate globally in the fight against COVID-19," said Dr. Bruce D. Clark, President and CEO of Medicago. "We would like to express our gratitude to the clinical trial participants who have generously dedicated their time to support the advancement of Medicago's COVID-19 vaccine candidate. We also would like to extend our thanks to our partners GSK and Dynavax, as well as the clinical investigators."
The data from the interim analysis have been published on an online preprint server at medRxiv.org.
About Phase 1 results summary
- Side effects were mainly mild to moderate and of short duration with no serious adverse events. Safety follow-up continues.
- Phase 1 immunogenicity results demonstrate that adjuvants have the potential to improve humoral and cellular immune responses compared to the non-adjuvanted formulations.
- All subjects in the group with GSK's pandemic adjuvant developed anti-spike IgG antibodies after a single dose of vaccine – either 3.75, 7.5 and 15 µg.
- 100 per cent of participants who received an adjuvanted formulation developed neutralizing antibody responses after Dose 2 for all dose groups.
- Anti-spike IgG and viral neutralization responses compared favorably to responses from COVID-19 positive patients outside of the study.
- GSK's pandemic adjuvant was dose-sparing, with the lower 3.75 µg dose of CoVLP performing comparably with the 7.5 or the 15 µg doses.
- Cellular Th1 immune responses of participants who received 3.75 or 7.5 µg doses were significantly higher in the adjuvanted formulations.
- CoVLP finished product is a liquid formulation that can be stored at 2°C to 8°C, easing cold chain management with existing vaccine infrastructure.
Medicago is a biopharmaceutical company and pioneer in plant-derived therapeutics. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare.
Our mission is to improve global health outcomes by leveraging innovative plant-based technologies for rapid responses to emerging global healthcare challenges. Medicago is committed to advancing therapeutics against life-threatening diseases worldwide. Our team includes over 450 scientific experts and employees in Canada and the United States and academic affiliations in Europe and South Africa.
Medicago has previously demonstrated its capability to be a first responder in a flu pandemic. In 2009, the company produced a research-grade vaccine candidate against H1N1 in just 19 days. In 2012, Medicago manufactured 10 million doses of a monovalent influenza vaccine candidate within one month for the Defense Advanced Research Projects Agency (DARPA), part of the U.S. Department of Defense. In 2015, Medicago also demonstrated in principle that it could rapidly produce an anti-Ebola monoclonal antibody cocktail for the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.
For more information: www.medicago.com