Staff Writer

Novavax reported positive results from a second Phase II trial of its trivalent seasonal influenza virus-like particle (VLP) vaccine candidate.

The Rockville, Md.-based company has a Spain-based partner, ROVI Pharmaceutical Laboratories SA, that is helping to fund the VLP vaccine studies through Phase III and ultimately toward an anticipated regulatory approval in Europe.

But the company will need additional funding to satisfy FDA requirements, Rahul Singhvi, president and CEO of Novavax, told BioWorld Today.

In the U.S., Novavax has said that it is seeking support from the Health and Human Services Department's Biomedical Advanced Research and Development Authority. The company also is considering a potential partner as it seeks U.S. approval of the VLP product, Singhvi indicated.

In its most recent earnings report, Novavax reported that it had close to $38 million in cash and no long-term debt on its balance sheet.

The latest Phase II study of 221 patients showed that the VLP-based vaccine was well tolerated and induced robust immune responses against the three influenza strains (H3N2, H1N1 and B). The three strains were matched to the strains recommended for influenza vaccines during the past flu season, 2008-2009.

The positive outcome of the second Phase II study supported moving ahead with larger head-to-head trials of VLP and egg-based vaccines, the first of which is scheduled to start this fall in elderly adults, Novavax said. Phase III studies are expected next year.

The previous Phase II study also was positive. While the first Phase II study involved a 2005-2006 formulation, the second study showed that the product worked against strains targeted for the 2008-2009 flu season, Singhvi explained. Novavax has now shown that the VLP vaccine candidate could work in different formulations, he said.

Novavax hopes that its vaccine candidate, which is made in cell cultures, will stand apart from those that are made in egg cultures, which can have a lengthy cultivation period. Novavax's vaccine candidate has the potential to be made faster for annual flu season.

Another distinction is that Novavax's VLP vaccine candidate includes three viral proteins important for inducing a broad immune response: two surface proteins, hemagglutinin (HA) and neuraminidase (NA), and a core matrix protein, M1. Most seasonal vaccines consist almost entirely of HA with little or no NA and M1, according to the company's website.

The HA protein induces an antibody that neutralizes or blocks the growth of the virus; NA induces antibodies that prevent cell-to-cell transmission of virus down the respiratory tract, potentially reducing the severity of influenza disease; and cell-mediated immune responses to M1 may lead to destruction of cells already infected.

VLPs are recombinant structures that mimic the size and shape of a virus. They are incapable of replication but can induce potent immune response, the company said.

Rodman & Renshaw analyst Elemer Piros wrote in a research note that "Novavax's VLP vaccine technology is truly revolutionary compared to the traditional egg-based vaccines."

He added that the company's developing seasonal vaccine business "may be overlooked," noting that it is applying its technology toward developing vaccines for respiratory syncytial virus, shingles, HIV, and severe acute respiratory syndrome as well as pandemic H1N1 vaccine.

Its VLP-based vaccine against the H1N1 flu vaccine is advancing into preclinical development and could enter the clinic later this year. The company's drug candidate for RSV also is expected to be in the clinic next year, Singhvi said.

Shares in the Rockville, Md.-based company (NASDAQ:NVAX) rose 61 cents, to close at $6.65 Tuesday.