Ebola update: Novavax testing nanoparticle jab, Glaxo gets EMA's advice
|Ebolavirus under an electron microscope--Courtesy of CDC|
With several companies now expediting Ebola vaccines in an attempt to halt the spread of the deadly virus, Novavax ($NVAX) has jumped in the race, announcing that it's using its nanoparticle vaccine technology to advance a candidate of its own.
In rodents and monkeys, Novavax's recombinant glycoprotein (GP) nanoparticle vaccine was highly effective, generating antibodies against the virus in the blood of animals challenged with the 2014 Guinea Ebola strain, which is responsible for the current Ebola epidemic in West Africa.
Novavax plans to launch a Phase I clinical trial in December to evaluate the safety and immunogenicity of its EBOV GP vaccine in ascending doses, with and without the company's Matrix-M adjuvant, which was shown to boost the vaccine's immune response in animals. The trial will enroll about 150 subjects.
"We are developing our recombinant Ebola GP vaccine using the same platform we used to develop vaccine candidates against several pathogens including respiratory syncytial virus (RSV), seasonal and pandemic influenza, and Middle Eastern Respiratory Syndrome (MERS)," said Novavax CEO Stanley Erck in a statement. "Our proprietary platform allows us to quickly develop, and manufacture an Ebola vaccine candidate at large scale, which we believe can provide a necessary tool to fight this global health crisis."
Meanwhile, GlaxoSmithKline ($GSK) is testing its Ebola vaccine candidate in clinical trials that are running concurrently in the U.S., U.K. and Mali. As Glaxo presses on with its vaccine--the farthest along in the global pipeline--the European Medicines Agency has given the British pharma giant scientific advice on its development.
Drug developers can receive the EMA's advice on clinical trial design and manufacturing-related questions, as well as safety monitoring of medicines, in an accelerated timeframe through a system called "rapid scientific advice." The agency says it will assess any data in a "rolling review" as soon as it becomes available.
- read more from Novavax
- get the EMA statement
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