GSK and Medicago announced a collaboration to develop and evaluate a COVID-19 candidate vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. CoVLPs mimic the structure of the virus responsible for COVID-19 disease, allowing them to be recognized by the immune system. The use of 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 contributing to protecting more people.

Pre-clinical results with Medicago’s CoVLP vaccine candidate demonstrated a high level of neutralizing antibodies following a single dose when administered with adjuvant.

Phase 1 clinical testing is planned to start in mid-July and will evaluate the safety and immunogenicity of three different dose levels of antigen combined with GSKs pandemic adjuvant and in parallel with an adjuvant from another company, administered on a one- and two-dose vaccination schedule, given 21 days apart.

Subject to successful clinical development and regulatory considerations, the companies aim to complete development and make the vaccine available, in the first half of 2021. Both companies will also evaluate expanding their collaboration to develop a post-pandemic vaccine COVID-19 candidate, should the need arise based on the further development of COVID-19 after the pandemic, and other infectious diseases.

The companies will use Medicago’s plant-based production platform to manufacture the COVID-19 vaccine antigen. This innovative technology uses the leaves of a plant as bioreactors to produce the S-spike protein which self-assemble into VLPs for use in the CoVLP vaccine candidate. It is highly scalable and can support the production of large amounts of the vaccine in a significantly shortened timeline. Using this technology combined with GSKs proprietary adjuvant system, the companies expect to be able to manufacture approximately 100m doses by the end of 2021. By the end of 2023, a large-scale facility under construction in Quebec City, Canada, is expected to deliver up to 1 billion doses annually. The manufacturing platform has been used to produce a seasonal VLP flu vaccine and the license application is under review with the Canadian regulatory authority.

Dr. Thomas Breuer, Chief Medical Officer, GSK Vaccines, said: “This agreement paves the way for an innovative vaccine option combining a scalable plant-based antigen technology with an adjuvant which has pandemic dose sparing capability. If successful, it will be a meaningful contributor in the fight against COVID-19. We strongly believe that multiple vaccines are needed, including post-pandemic vaccines. This plant-based technology also shows promise beyond COVID-19 and has the potential to help prevent other infectious diseases.”

Dr. Bruce Clark, President and CEO of Medicago, said: “We are about to begin clinical trials with our CoVLP vaccine candidate harnessing GSKs pandemic adjuvant technology against the virus that causes COVID-19. This collaboration with GSK gives us access to a proven adjuvant which could enhance the effectiveness of our candidate vaccine, and also to a depth of scientific experience to support our development efforts.”

GSK and Medicago have entered into a binding agreement to develop and manufacture an adjuvanted COVID-19 vaccine. Medicago is a privately held company jointly owned by Mitsubishi Tanabe Pharma (MTPC) and Philip Morris International (PMI), with a shareholding ratio of 67:33, respectively. PMI has signaled that it is willing to evaluate offers for its shareholding from parties that may be better suited to help Medicago on the next phase of its journey and has initiated a preliminary review to determine the optimal shareholding and governance structure for Medicago’s future success.