Novavax's RSV jab protects infants in PhII, nets $89M Gates Foundation grant

Finding a vaccine for respiratory syncytial virus (RSV) has been a priority for decades, and Novavax ($NVAX) has come one step closer to doing it.

The Maryland-based company reported on Tuesday that top-line results from a Phase II trial in pregnant women showed that the RSV F jab protected infants via maternal immunization. It also announced that it won an $89 million grant from the Bill & Melinda Gates Foundation to get its candidate through Phase III.

The randomized, blinded, placebo-controlled trial involved 50 healthy pregnant women in their third trimester. The aim was to gauge the impact of maternal immunization on infant safety during the first year of life and on RSV-specific antibody levels during the first 6 months of life, Novavax said.

Novavax CEO Stanley Erck

"These data illustrate the promise of our RSV F Vaccine to protect infants via maternal immunization, demonstrating robust immune responses in women with antibody transfer to infants," Novavax CEO Stan Erck said in a statement.

Maternal immunization is an "elegant" way to protect infants in their first few months of life, when they are most vulnerable to RSV, said Dr. Greg Glenn, Novavax's R&D head, in the statement.

Novavax will take RSV F into Phase III in early 2016, the company said. The company had a busy summer, reporting positive data for the Phase I trial of its investigational Ebola vaccine and for the Phase II trial of its quadrivalent seasonal flu candidate. And just last month, the company reported positive top-line results from the Phase II trial of its RSV candidate in older adults.

Novavax won fast-track designation from the FDA for RSV F in November 2014. It was followed by MedImmune's RSV candidate, which was fast-tracked in April this year. No vaccine or specific treatment for RSV exists, but AstraZeneca ($AZN), MedImmune's parent company, markets Synagis, a monoclonal antibody for use in limited cases that will go off patent next month.

- here's the release
- and here's FierceBiotech's take

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