GSK and CureVac in tie-up to address multiple emerging variants with one COVID-19 vaccine
GSK will also assist in the manufacturing of CureVac’s existing vaccine, CVnCoV, with it pledging to produce up to 100 million doses of that first generation candidate. It will use its established manufacturing network in Belgium to do so. CVnCoV is currently in a Phase 2b/3 clinical trial.
Under the terms of the new collaboration agreement, both parties are to contribute resources and expertise to research, develop, and manufacture a number of novel mRNA vaccine candidates, including multi-valent and monovalent approaches.
GSK will be the marketing authorization holder for the next generation vaccine, except in Switzerland, and will have exclusive rights to develop, manufacture, and commercialize that vaccine in all countries with the exception of Germany, Austria and Switzerland. GSK will make an upfront payment of €75m and a further milestone payment of €75m, conditional on the achievement of specific milestones.
Keeping 'one step ahead' of the pandemic
The aim of this work is to offer "broader protection" against a variety of different SARS-CoV2 variants, and to enable a quick response to new variants potentially emerging in the future. The development program will begin immediately, with the target of introducing the vaccine in 2022, subject to regulatory approval.
The increase in emerging variants with the potential to reduce the efficacy of first generation COVID-19 vaccines requires acceleration of efforts to develop vaccines against new variants "to keep one step ahead" of the pandemic, said the companies.
“CureVac’s platform is uniquely adapted to designing multi-valent vaccines with a balanced immune response and a low dose of mRNA.
“These next generation COVID-19 vaccines may either be used to protect people who have not been vaccinated before, or to serve as boosters in the event that COVID-19 immunity gained from an initial vaccination reduces over time. In addition, the collaboration will assess the development of novel mRNA vaccines to protect against multiple respiratory viruses, including COVID-19.”
Franz-Werner Haas, CEO, CureVac, said: “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.”
In July last year, GSK acquired a 10% stake in CureVac, and agreed with the biotech to partner on mRNA vaccines.
Under that arrangement, the partners would work to discover, develop, manufacture and commercialize up to five mRNA-based vaccines and monoclonal antibodies.
Alongside the deal to collaborate on developing infectious disease targets, GSK will also make an equity investment of £130m (€150m), thus taking an approximate 10% stake in CureVac.
The deal expressly did not contain any of CureVac’s existing COVID-19 mRNA or rabies vaccines research programs.
And, last month, CureVac announced an alliance with Bayer whereby the fellow German company would support CureVac in further development, supply and key territory operations of its COVD-19 vaccine candidate, CVnCoV, including in the areas of clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance.