CoVLP SARS-CoV-2 Vaccine Description
Medicago's CoVLP SARS-CoV-2 vaccine candidate uses living plants as bioreactors to produce non-infectious versions of viruses (called Virus-like Particles, or VLP). VLPs mimic the architecture of a virus but are non-infectious.
The technology Proficia® uses N. benthamiana plants, the most widely used experimental host in plant virology, due mainly to many viruses that can successfully infect it. Its weakened immune system, the result of natural genetic changes over millennia, means genetic material can be successfully hosted by the plant and not rejected.
The VLPs present antigens to the individual's immune system, eliciting a protective and long-lasting immune response. VLPs mimic the native structure of viruses, allowing them to be easily recognized by the immune system. However, they lack core genetic material, which makes them non-infectious and unable to replicate. In other words, they induce an immune response similar to a natural infection but without the inconveniences associated with it. VLPs can also be engineered to have antigens attached for use in vaccines or other immunotherapies, says the company.
On March 16, 2021, Takashi Nagao, CEO, and President of Medicago, stated in a press release, “We are pleased to take the significant step of initiating the Phase 3 clinical trial at sites around the world. This brings us one step closer to delivering an important new COVID-19 vaccine and contributing to the global fight against the pandemic along with our partner GSK.”
“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, irrespectively of age,” stated Nathalie Landry, EVP, Scientific and Medical Affairs at Medicago, in a press statement issued on May 18, 2021. “These results give us confidence as we continue to move forward with our Phase 3 clinical trial."
Located in Quebec City, Canada, Medicago is a biopharmaceutical company and pioneer in plant-based therapeutics technology. It was founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare.
CoVLP SARS-CoV-2 Vaccine Indication
The CoVLP SARS-CoV-2 vaccine is indicated to prevent COVID-19 disease, which is caused by the SARS-CoV-2 virus. No pediatric vaccine efficacy has been disclosed.
CoVLP SARS-CoV-2 Vaccine News
May 18, 2021 - Medicago and GlaxoSmithKline reported 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. As measured by the neutralizing antibody titer, immunogenicity 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.
April 23, 2021 - Medicago announced that Health Canada received for review the first portion of Medicago’s plant-derived adjuvanted COVID-19 vaccine candidate rolling submission on April 19th.
March 16, 2021 - Medicago and GlaxoSmithKline (GSK) announced Phase 3 clinical testing of Medicago's plant-derived COVID-19 vaccine candidate combined with GSK's pandemic adjuvant part of the ongoing Phase 2/3 study. Medicago received approval from Canadian and US regulatory authorities to enroll healthy adults in the Phase 3 portion of the trial based on positive interim Phase 2 results. In parallel, Medicago has also initiated a vaccine candidate's feasibility study to address the emerging COVID-19 variants.
February 17, 2021 - The vaccine candidate, combined with the pandemic adjuvant, was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Fast Track designation allows the FDA to expedite the development and review of new medicines and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
November 12, 2020 - Medicago and GSK announce the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity. Based on the positive Phase 1 results and the approval of Canadian regulatory authorities, Medicago has decided to launch the Phase 2/3 clinical trial with GSK's pandemic adjuvant.
November 10, 2020 - 100 percent of subjects who received an adjuvanted vaccine candidate developed significant antibody and cellular immune responses after two doses.
November 6, 2020 - Non-peer-reviewed study: Phase 1 trial of a Candidate Recombinant Virus-Like Particle Vaccine for Covid-19 Disease Produced in Plants. Conclusion CoVLP ± adjuvants was well-tolerated. Several adjuvanted formulations elicited strong humoral and T cell responses after dose 2. Even at the lowest CoVLP+AS03 dose, NtAb titers were ∼10-times higher than in convalescent serum with a balanced IFNγ and IL-4 response. These findings support the transition of CoVLP (3.75μg+AS03) to further clinical evaluation.
October 23, 2020 - Medicago announced that it had reached an agreement to supply Canada's Government with up to 76 million doses of its vaccine against COVID-19, subject to Health Canada approval. Medicago will also receive $173M in funding support from the Government of Canada for its vaccine research and development and the construction of its Quebec City manufacturing facility.
July 14, 2020 - Medicago began Phase I clinical trials for its plant-derived COVID-19 vaccine candidate yesterday, administering the first doses in healthy human volunteers. Medicago is also planning a Phase 2/3 trial to be initiated in October 2020.
July 8, 2020 - Dynavax Technologies Corporation and Medicago, a biopharmaceutical company creating vaccines and therapeutics by leveraging innovative plant-based technologies, announced their collaboration to investigate an adjuvanted vaccine candidate to protect against COVID-19. The collaboration evaluates the combination of Medicago's Coronavirus Virus-Like Particle (CoVLP) with Dynavax's advanced adjuvant, CpG 1018™. Adding CpG 1018, the adjuvant contained in Dynavax's U.S. FDA-approved adult hepatitis B vaccine is intended to enhance the immune response of Medicago's COVID-19 vaccine decrease the total amount of antigen needed per dose, providing more doses to help protect a greater number of people.
March 12, 2020 - Medicago said it had produced a virus-like particle of the novel coronavirus, a first step towards producing a vaccine, which will now undergo pre-clinical testing for safety and efficacy.
CoVLP SARS-CoV-2 Vaccine Clinical Trials
Medicago and GSK continue to test their CoVLP adjuvanted recombinant COVID-19 plant-derived vaccine candidate in clinical trials. After a successful Phase 2, the product will be moving into a Phase 3 trial.
The Phase 3 portion is an event-driven, randomized, observer-blinded, crossover placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation, compared to placebo, in up to 30,000 subjects in North America, Latin America, and Europe and within the same populations.