GSK, Medicago Forge Agreement to Develop Novel Adjuvanted COVID-19 Vaccine
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This morning, the pharma giant announced a partnership with Canada’s Medicago 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. 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 protect more people.
In March, Medicago announced it produced a Virus-Like Particle (VLP) of the coronavirus just 20 days after obtaining the SARS-CoV-2 gene and began to develop its vaccine candidate. The companies will use Medicago’s plant-based production platform to manufacture the COVID-19 vaccine antigen. The 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 vaccine in a significantly shortened timeline.
Pre-clinical results with Medicago’s CoVLP vaccine candidate demonstrated a high level of neutralizing antibodies following a single dose when administered with adjuvant, the companies announced this morning. A Phase I clinical study is expected to begin within the next few weeks. During the Phase I study, the researchers will evaluate three different dose levels of the 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.
“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,” Bruce Clark, president and chief executive officer of Medicago said in a statement.
Thomas Breuer, chief medical officer of GSK Vaccines, said the agreement with Medicago paves the way for an innovative vaccine options that combines a scalable plant-based antigen technology with an adjuvant which has pandemic dose sparing capability. If the program is successful, Breuer said the vaccine will become 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,” Breuer said in a statement.
In May, GSK pledged to manufacture 1 billion doses of its adjuvant technology as part of its commitment to boosting efforts to develop vaccine candidates against COVID-19. This year, GSK has struck several deals to provide its adjuvant for COVID-19 vaccines. Among the most significant deals are with Sanofi, Vir Biotechnology and China’s Innovax. The company has also struck deals with Clover Biopharmaceuticals and the University of Queensland in Australia.
If the trial is successful and rapidly moves through the clinic like other vaccine candidates have done, the companies hope to have a potential vaccine available for use against the novel coronavirus in the first half of 2021. As it looks to the potential success of the vaccine candidate, Medicago is scaling up its manufacturing efforts. The company said it should be able to manufacture about 100 million doses by the end of 2021 and up to 1 billion doses by the end of 2023.
In addition to assessing the combination of GSK’s adjuvant with Medicago’s Virus Like Particle program against COVID-19, the companies said they could expand the 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. Medicago is no stranger to responding to pandemics. In 2009, the company produced a research-grade vaccine candidate against H1N1 in just 19 days. Three years later, Medicago manufactured 10 million doses of a monovalent influenza vaccine within one months’ time. Then, in 2015, Medicago also demonstrated that it could rapidly produce an anti-Ebola monoclonal antibody treatment to respond to the crisis in Africa.