Novavax hopes to revive RSV vaccine with a new phase 2 trial

Novavax has started a new phase 2 trial on its previously failed RSV vaccine.

Novavax has started a new phase 2 trial on its key respiratory syncytial virus vaccine candidate in an effort to breathe new life into a program that was hit hard last fall with disheartening late stage data.

The placebo-controlled trial will enroll up to 300 adults aged 60 or older, testing the RSV F-protein nanoparticle vaccine candidate in one or two doses with or without Novavax’s Matrix-M adjuvant. This time, subjects are to be enrolled and vaccinated in the southern hemisphere, outside of the RSV season, “to best assess immunogenicity,” the company said in a release.


Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

Last September, when the vaccine posted a phase 3 failure that decimated Novavax’s stock, R&D chief Gregory Glenn cited a sluggish RSV season as a potential reason behind the failure. Even though EvaluatePharma downgraded 2022 sales prediction for the candidate from $845 million before the failure to the most recent $549 million, the game-changing sales still make the candidate too big a temptation for Novavax to let it go without a fight.

“We expect the results from this trial … would ensure we maintain our leadership position in this very attractive market opportunity,” CEO Stanley Erck said in a statement.

The FDA fast-tracked Novavax’s candidate last May as a potential means to satisfy a “significant unmet medical need,” an RSV vaccine for the elderly. With a $89 million grant from the Bill & Melinda Gates Foundation, the candidate is also in a phase 3 trial that tests its ability to protect infants through maternal immunization.

After the previous phase 3 misstep, the company responded with a 30% workforce reduction as part of a restructuring plan announced with its third quarter financial results last November.

Elsewhere in RSV, AstraZeneca’s MedImmune has gained an FDA fast track for its RSV candidate, a monoclonal antibody currently being tested in phase 2 in healthy preterm infants. Bavarian Nordic also has an RSV vaccine candidate currently in phase 2, whose readout is expected in the middle of this year. In a recent interview with FiercePharma, CEO Paul Chaplin said BN's version utilizes a “differentiated approach” and “will be successful in the long run.”

Novavax is also developing vaccines against flu and intends to start phase 1 trial of its Zika vaccine candidate this year. A 2016 World Preview report by EP put 2022 sales of the biotech’s influenza and RSV combo respiratory vaccine at more than $1 billion. That program is still in preclinical stages.

Editor's Note: This story has been updated with the most recent estimate for the candidate's 2022 sales from EvaluatePharma.

Suggested Articles

At one point, Novartis even offered up $90 apiece for the inclisiran developer but would later say even $85 was too much, a securities filing shows.

Sanofi spent months hyping its Tuesday investor event, and new CEO Paul Hudson certainly laid out a different vision for the drugmaker at the confab.

After more than 10 years as partners, Sanofi and Regeneron are splitting up their deal to comarket PCSK9 med Praluent and immunology drug Kevzara.