Novavax COVID-19 vaccine bags record $384m funding from CEPI

The Coalition for Epidemic Preparedness Innovations (CEPI) has earmarked up to $384m in additional funding for a Novavax coronavirus vaccine candidate due to start trials this month.

CEPI had already pledged $4m to the development of NVX-CoV2373 in March, and the scale of the new investment – the highest so far for any CEPI-backed programme – immediately elevates the candidate to the top tier among vaccines against SARS-CoV-2, the virus that causes COVID-19.

Shares in Nasdaq-listed Novavax leaped more than 30% after-hours following the news.

NVX-CoV2373 is a nanoparticle-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2 that includes antigens on the spike protein of the virus and Novavax’ saponin-based Matrix-M adjuvant.

In animal studies it showed efficient binding with receptors targeted by the virus, which the company says is a critical aspect for effective vaccine protection.

In April, Novavax said it had brought forward the start data for its phase 1 trial of the vaccine to the middle of this month. That study in Australia will compare the vaccine to placebo in around 130 healthy volunteers.

The CEPI cash injection means that Novavax can now accelerate plans to expand the study into a phase 1/2 trial, with the phase 2 portion due to get underway in multiple countries if the data from the initial phase – due in July – is positive.

It also means that the company can start scaling-up production of NVX-CoV2373 to allow manufacturing of up to 100 million vaccine doses by end of the year.

“The expansion of our partnership with Novavax represents CEPI’s single biggest investment to date”, said Richard Hatchett, chief executive the public-private partnership, which has so far provided funding for nine coronavirus vaccine projects of up to $446m.

“Our vaccine R&D programmes 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.

According to the World Health Organization’s latest coronavirus vaccine update, dated 5 May, there are eight COVID-19 vaccines in clinical testing and another 100 in preclinical development.

Furthest ahead is an adenovirus type 5-based candidate developed by China’s CanSino Biological and the Beijing Institute of Biotechnology – which is in phase 2, a little ahead of Moderna’s mRNA-based candidate and three Chinese inactivated virus vaccines, all three of which are in phase 1/2 studies.

Another adenoviral vaccine developed by the University of Oxford and partnered with AstraZeneca is in phase 1/2 testing in the UK. Meanwhile, Pfizer/BioNtech’s mRNA-based candidate has started a phase 1/2 trial in Germany and the US, and US biotech Inovio Pharma has a DNA plasmid-based candidate in phase 1.