The Coalition for Epidemic Preparedness Innovations (CEPI) initially provided Novavax with $4m (€3.7m) to progress the clinical development of NVC-CoV2373, the biotech’s vaccine candidate against the novel coronavirus.
The candidate showed enough promise that CEPI is prepared to invest the largest single sum in its investment history, $388m, to accelerate its development.
With this capital in hand, Novavax plans to begin a Phase I clinical trial this month in Australia, while a Phase II trial is expected to follow once the read outs from the Phase I trial are available. Novavax noted that it expects top-line results in July.
Richard Hatchett, CEO of CEPI, explained why the investment in Novavax had been made: “The expansion of our partnership with Novavax represents CEPI’s single biggest investment to date. Our vaccine R&D programs are starting to show progress, so it is vital that we invest now to boost manufacturing capacity, so that our partners have the ability to produce vaccines at a global scale.”
Novavax outlined its plans to use the funding to ‘dramatically increase’ its capacity for large-scale manufacturing of the NVC-CoV2373 antigen and Matrix-M adjuvant.
This has allowed Novavax to project being able to produce up to 100 million doses of the vaccine by the end of 2020. With further expansions allowing the biotech to potentially reach a dose number in excess of one billion during 2021.
Novavax will be aided in this through a partnership made with Emergent Biosolutions, with the contract development and manufacturing organization supplying vaccine product for use in clinical trials.
For Emergent, this follows on from a similar deal agreed with Johnson & Johnson at the end of last month. The two companies will also work on developing a COVID-19 vaccine, with J&J working towards a goal of being able to produce one billion doses and potential commercialization next year.
Foundations in flu
Novavax is already moving towards a potential approval for its flu program. The candidate is NanoFlu, a recombinant quadrivalent seasonal influenza vaccine, which hit its primary endpoints in a Phase III clinical trial and top-line data is expected to be released during this financial quarter.
The biotech stated that the data will be used to support a biologics license application with the US Food and Drug Administration along an accelerated approval pathway.