GSK and Medicago have 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.
According to Medicago, CoVLPs mimic the structure of the virus responsible for COVID-19 disease, allowing them to be recognized by the immune system. Use of an adjuvant may boost the immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be produced.
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 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 scalable and can support the production of large amounts of vaccine in a shortened timeline. Using this technology combined with GSKs proprietary adjuvant system, the companies hope 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.
Read the Medicago statement