Medicago Announces Phase 3 Study of VLP Quadrivalent Influenza Vaccine
Pubblicato il: 26/09/2017 13:02
The first plant-based seasonal flu vaccine candidate reaches final clinical stage
Medicago, a Canadian biopharmaceutical company and leader in the development and production of plant-based vaccines and therapeutics, is proud to announce the start of a Phase 3 efficacy study for its seasonal quadrivalent influenza vaccine (QIV) candidate. The trial is currently taking place with 10,000 subjects in seven countries (Canada, U.S., UK, Germany, Finland, Thailand, and the Philippines). This efficacy study is in support of Medicago's flu program and expected launch of the vaccine in time for the 2020 influenza season in Canada, U.S.A and Europe.
"Reaching this critical stage with our QIV flu vaccine is a very exciting time for us as a company," said Bruce D. Clark, President and CEO of Medicago. "We are convinced that bringing this novel vaccine to market will offer many advantages over current vaccines and benefits for those most at risk from the influenza virus."
Medicago's QIV candidate is produced using a novel virus-like particle (VLP) technology. VLPs represent a new approach to vaccine development and production. VLPs mimic the native structure of viruses, allowing them to be easily recognized by the immune system. However they lack the core genetic material, rendering them non-infectious and unable to replicate. In other words, they are safe and highly effective as they induce an immune response similar to a natural infection.
An alternative to egg-based and cell-based production systems, Medicago's manufacturing platform brings many advantages, including much shorter lead time, reliability and versatility. It currently takes only 5-6 weeks for the company to produce a clinical-grade vaccine, compared to 5-6 months using egg-based production methods.
With influenza viruses constantly mutating, Medicago's rapid technology enables the creation of a vaccine that precisely matches the specific strain in circulation. During a Phase 2 study, the antibody and cell-mediated immunity (CMI) responses to Medicago's VLP vaccine were higher than the responses using a comparator vaccine.
"We are excited to demonstrate the efficacy of the VLP vaccine during a large-scale field trial and prove the benefits of the unique immune response induced by this innovative product," said Nathalie Landry, Medicago's Executive Vice President of Scientific and Medical Affairs.
Based in Quebec City, Medicago announced a major expansion project in 2015 for a new headquarters and commercial production facility to meet demand and complement its present production manufacturing plant located in North Carolina.
Medicago is a leading clinical-stage biopharmaceutical company with a mission to improve global health outcomes by leveraging disruptive plant-based technologies. With more than 300 employees in Canada and the U.S., Medicago is developing a novel manufacturing platform to rapidly provide safe and effective vaccines and therapeutic proteins for infectious diseases and other public health challenges.
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