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GSK, CureVac to Develop Next Generation mRNA COVID-19 Vaccines
The companies are partnering to develop additional mRNA COVID-19 vaccines that address multiple variants of the disease, including possible strains in the future.
GSK and CureVac recently announced a $180.5 million collaboration to jointly develop next-generation mRNA COVID-19 vaccines.
The companies will contribute resources and expertise to research, develop, and manufacture various novel mRNA vaccine candidates, including multi-valent and monovalent approaches, GSK stated.
The goal is to offer broader protection against different SARS-CoV-2 variants and allow for quick responses to new variants that may emerge in the future. Additionally, the companies aim to address multiple emerging variants with one vaccine.
“We believe that next generation vaccines will be crucial in the continued fight against COVID-19. This new collaboration builds on our existing relationship with CureVac and means that together, we will combine our scientific expertise in mRNA and vaccine development to advance and accelerate the development of new COVID-19 vaccine candidates,” Emma Walmsley, chief executive officer at GSK, said in the announcement.
“At the same time, we will also support the production of CureVac’s first generation vaccines with the manufacture of 100 million doses in 2021,” Walmsley continued.
Emerging variants have the potential to reduce the efficacy of COVID-19 vaccines. This concern requires a boost in efforts to develop vaccines against new strains, GSK noted. This will ensure the companies are one step ahead of the pandemic.
The next-generation vaccines will either protect individuals who have not been yet vaccinated or will be a booster if initial immunity from the first dose of a COVID-19 vaccine decreases over time.
Additionally, the collaboration will assess the development of mRNA vaccines to protect against multiple other respiratory viruses as well.
GSK stated that it will support the manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine candidate, CVnCoV, using its manufacturing network located in Belgium.
Currently, CVnCoV is in Phase 2b/3 trials.
The randomized, placebo-controlled Phase 2b/3 clinical trial, HERALD, will assess the safety and efficacy of CVnCoV in nearly 35,000 adults at a dose of 12 µg.
Specifically, researchers will look at the efficacy of CVnCoV in preventing confirmed COVID-19 of any severity, as well as preventing moderate to severe COVID-19 in participants who have never been infected with SARS-CoV-2.
“We are very pleased to build on our existing relationship with GSK with a new agreement to jointly develop next generation mRNA-based vaccines, in addition to our current candidate CVnCoV. With the help of GSK’s proven vaccine expertise, we are equipping ourselves to tackle future health challenges with novel vaccines,” Franz-Werner Haas, chief executive officer of CureVac, said in the recent announcement.
Under the terms of the new collaboration agreement, GSK stated that it will be the marketing authorization holder for the next generation vaccine and will have exclusive rights to develop, manufacture, and commercialize the vaccine in all countries.
Additionally, the company will make an upfront payment of $89.7 million and a further milestone payment of the same amount, conditional on the achievement of specific milestones.
The development program will begin immediately, with the anticipation of introducing the vaccine in 2022.
GSK and CureVac first entered into a collaboration at the end of July. The companies aimed to research, develop, manufacture, and commercialize five mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens.
GSK tapped CureVac for its mRNA technology and manufacturing capability related to its existing expertise in vaccines. GSK will also fund research and development activities at CureVac related to the development projects covered by the collaboration.
CureVac will be responsible for preclinical and clinical development through Phase 1 trials of these projects, as well as for the GMP manufacturing of the product candidates, including for commercialization. CureVac will retain commercialization rights for selected countries for all product candidates, the July announcement stated.