Novavax craters after Phase III RSV F vaccine failure; seeks path forward
By Ben AdamsSep 16, 2016 01:41am
Novavax ($NVAX) saw its shares plummet afterhours yesterday when it announced a late-stage test of its infectious respiratory disease vaccine missed all of its marks across the 12,000-strong study.
In top-line data released just after the markets closed, the biotech’s RSV F-protein recombinant nanoparticle vaccine candidate failed to hit both its primary and secondary objectives, and most damning of all, did not demonstrate vaccine efficacy in the Phase III Resolve trial.
The drug was seeking to treat adults with respiratory syncytial virus (RSV), a respiratory infectious disease that causes serious infection of the respiratory tract, similar to influenza. The virus puts more than 200,000 over-65s in the hospital each year, and accounts for around 16,000 deaths in that age range.
Just over a year ago the company had far better newsone which saw its shares surgeafter posting positive data from a large mid-stage study of its vaccine. The Phase II study showed that its vaccine was 46% effective in preventing lower respiratory tract infections and 44% effective against all symptoms of RSV disease.
Cue blockbuster projections and its president and CEO Stan Erck telling Reuters in August of last year that it could be "the largest selling vaccine in the history of vaccines in terms of revenue."
In a far more tempered tone, Erck said yesterday in a conference call that the latest Phase III data were “surprisingly flat.”
But there was no talk of dumping the program altogether, with Erck saying they will “continue to invest in this vaccine,” which he said based on patterns from other trials the vaccine can “stimulate a robust immune response…our vaccine works.”
Novavax is in addition to the adult studies also running mid-stage trials of its RSV F Vaccine to protect infants via maternal immunization. Glenn said on the call he didn’t think the issues with its Phase III in adults could be seen as a negative read-through for this program, which has been given a $89 million grant by the Bill & Melinda Gates Foundation.
There are other companies seeking to get a new RSV vax to market, with AstraZeneca’s ($AZN) MedImmune unit last April gaining an FDA fast track tag for its early-stage candidate MEDI7510.
https://www.fiercebiotech.com/biotech/novavax-craters-after-phase-iii-rsv-f-vaccine-failure-seeks-path-forward