After winning a small grant for early vaccine work in March, Novavax just won the largest-ever investment from CEPI, a global coalition aiding COVID-19 vaccine development.
The grant of up to $384 million from the Coalition for Epidemic Preparedness Innovations will fund Novavax’s COVID-19 vaccine testing through phase 2, plus early work to scale-up manufacturing. The funding follows a $4 million award back in March.
The Maryland biotech will use the funds to conduct a phase 1/2 trial on its candidate, NVX-COV2373, starting with the phase 1 portion in Australia this month. After phase 1 results—expected in July—the phase 2 portion is slated for multiple countries, Novavax said.
Beyond testing, the company intends to use part of the funds to scale up production to make up to 100 million doses by the end of 2020. The company aims to make more than 1 billion doses in 2021.
Novavax’s COVID-19 candidate is a recombinant nanoparticle vaccine combined with the company’s Matrix-M adjuvant. The platform recently succeeded in a phase 3 trial for NanoFlu, a quadrivalent influenza shot, in adults 65 and older.
Aside from Novavax, CEPI has awarded COVID-19 vaccine R&D funds to Moderna, Inovio and Curevac, plus the University of Hong Kong, the University of Oxford, the University of Queensland and a group led by Institut Pasteur.
“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,” CEPI CEO Richard Hatchett said in a statement. “We still have a long way to go, but we’re making important steps forward to deliver a safe, effective, and globally accessible vaccine as quickly as possible.”
In recent days, some of the leading companies involved in the COVID-19 vaccine race have talked up their progress and timelines. On Monday, Pfizer said it’s planning to work with contract manufacturers to establish U.S.- and Europe-based supply chains to make some of its existing meds, including sterile injectables. That effort is necessary as the company dedicates considerable resources to a potential COVID-19 vaccine rollout.
Last week, Moderna said it aims to launch a phase 3 study for its mRNA vaccine candidate in the “early summer.” Under that timeline, the company could score a full FDA nod next year.
Aside from those companies, Johnson & Johnson is involved in the COVID-19 vaccine R&D effort, as are partners Sanofi and GlaxoSmithKline. AstraZeneca has signed on to produce vaccines for the University of Oxford project. In all, the World Health Organization is tracking eight programs in human testing and more than 100 programs in preclinical testing.
By: Eric Sagonowsky
Source: Fierce Pharma
The Serum Institute of India (SII) expects to soon receive World Health Organisation (WHO) emergency use authorisation for the Oxford University/AstraZeneca Covid-19 vaccine, produced for mid and low-income countries.
According to the deal, Sanofi will gain full global rights to Kymab’s fully human monoclonal antibody, KY1005 that attaches to OX40-Ligand and can potentially treat various immune-mediated diseases and inflammatory ailments.
Moderna tapped veteran Amgen executive Corinne Le Goff to spearhead that effort as chief commercial officer.