Drug Development

Novavax makes a case for a do-over on its failed RSV vaccine — but it’s an uphill climb

Ten months after Novavax shares $NVAX were routed by the failure of its RSV F vaccine in Phase III in older subjects, the biotech is looking for a do-over. And the executive crew is trying to make a case that it can succeed where before it failed badly.

The company cobbled together topline claims on safety and immunogenicity data from a Phase II trial, some post hoc analysis from other studies, an assertion that an adjuvant approach would work better, and plans for a new mid-stage study to launch in older patients next year as it built its case that it knows now how to move ahead with a new development plan that can succeed in the wake of a nasty flop.

The rehab campaign included a focus on a 61% reduction in hospitalizations in COPD exacerbations found in the old data. And CEO Stanley Erck insists that he has plenty on the table to attract a partner.

Novavax gained significantly just days ago on the hint of Phase II success. But a comeback won’t be easy. This evening its shares dropped 18%.

Gregory Glenn, Novavax

The biotech’s market cap was crushed last fall when the big Phase III involving more than 11,000 people over the age of 60 failed to significantly prevent RSV-associated lower respiratory tract disease or incidents of symptomatic respiratory disease. That failure led the company to restructure soon after.

At the time the biotech’s executive team thought that a mild RSV season may have been to blame, even though they had earlier seen no signs of such problems.

The market hasn’t been in a very forgiving mood over the last two years when it comes to bad data for big studies. And Novavax will have to contend with a group of critics who gleefully dissected the earlier failure.

“Since September, we have worked to confirm that our RSV F Vaccine elicits a broadly neutralizing antibody response. Through our E205 trial, we have demonstrated adjuvant strategies that magnify and enrich the quality of that underlying antibody response. When combined with the COPD data seen in both E301 and E201, we believe protecting individuals from COPD exacerbation presents a very exciting path forward in older adults,” said Gregory Glenn, president of R&D.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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