Friday, Aug. 3, 2007

GenVec’s fortunes may be found in vaccine for FMD

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For more than a decade, GenVec Inc., a biopharma in Gaithersburg, has parlayed funds from partners and contracts to move its unique brand of therapies for human diseases closer and closer to market.

As it turns out, the first patient to get a commercial GenVec therapy may be a cow.

GenVec’s foot and mouth disease vaccine for livestock is a ‘‘short term product” that could be on the market in 18 to 30 months, said Douglas J. Swirsky, CFO.

‘‘Yes, this could be commercially viable and remove some of the hurdles in advance of any outbreak,” said Swirsky.

The company anticipates a $300 to $500 million-a-year market and has been contacted by veterinarian companies as potential partners, said Swirsky.

A USDA report in 2003 revealed that an outbreak of FMD in the United Kingdom in 2001 cost the British economy between $3.6 and $11.6 billion and necessitated the slaughter of about 4 million animals.

The Department of Homeland Security concerned that FMD could threaten food supplies—by bioterrorism or by accident—signed a new three-year, potential $15 million contract with GenVec in February to support the development and manufacture of the vaccine. Basically, the company uses another, harmless virus, to vector or transport a piece of the FMD virus into an animal’s bloodstream to raise an immune response.

The vaccine being developed by GenVec, ARS and DHS would be the first molecular based FMD vaccine for cattle produced in the United States.

FMD is a highly contagious disease affecting cattle, swine, sheep, goats and deer. The cause is a virus that spreads through the air, but is rarely transmitted to humans.

The GenVec vaccine, in cooperation with the U.S. Department of Agriculture’s Agriculture Research Service, has already protected cattle and swine from the devastating disease in experiments at an off shore federal laboratory.

‘‘This signals tremendous promise,” said ARS Administrator Edward B. Knipling in a statement. ‘‘Although this is still an experimental vaccine, it has made significant developmental progress, and we are optimistic about its prospects.”

Robert R. Peters, professor of animal sciences at the University of Maryland, said the vaccine is ‘‘a step in the right direction.” He said, ‘‘since the foot and mouth disease [in the UK] and the mad cow disease outbreaks, there has been more education available to make producers more aware of bio-security to help prevent disasters like what happened in the UK.”

Swirsky said commercializing the foot and mouth vaccine won’t necessarily get GenVec’s fledgling vaccine program off experimental ground, or to validate its human vaccine work. ‘‘I anticipate we will make a lot more progress on our vaccines by then, especially at NIH in the HIV trials.” He said. GenVec‘s experimental HIV vaccine is funded through the National Institutes of Health. It is developing its malaria and influenza vaccines with money from other partners.

Currently, there is no foot and mouth disease vaccine that can be used in advance of an outbreak according to USDA. GenVec’s vaccine ‘‘will change the market dynamics,” predicts Swirsky.

The disease has not surfaced in the United States since 1929, but is of epidemic proportions in other parts of the world including South America.

Virologist Marvin Grubman of ARS and colleagues developed the method using their own adenoviruses in 1999. ARS partnered with GenVec for its patented adenovirus technology to produce the vaccine commercially after Grubman met with company officials at a vaccine conference in 2001.

The adenovector vaccine would also be a diagnostic in that it introduces a genetic marker into vaccinated animals. The marker would be useful to epidemiologists and livestock farmers because some animals don‘t show any symptoms of FMD immediately. Tests by USDA’s Agricultural Research Service at the Plum Island Animal Disease Center [on an island off New York] showed that when vaccinated cattle are then inoculated with the disease, it did not spread to other nearby cattle, as is common with FMD.

Scientists worldwide have been trying to develop an improved FMD vaccine for the past 30 years, said Grubman, who added, ‘‘I think ours is furthest along.”

Siba K. Samal, associate dean of the Va.-Md. Regional College of Veterinary Medicine, said, ‘‘this would mean a lot because this is the number one animal disease in the world and the most feared in the United States.” He said the GenVec vaccine is ‘‘a good choice” because current vaccines are not allow to be used in the U.S. and if there is an outbreak the new vaccine could be used to contain it.

A vaccine currently is made with a killed virus vaccine that virtually eliminated the disease in Europe by the 1990’s, but does not have the protective or diagnostic advantages of the GenVec⁄ARS vaccine, according to GenVec and ARS officials.

Peters cautioned that key to the vaccine’s success could be its coverage, whether it would be effective on different types or subtypes of the virus.

GenVec, while preparing for a current 8,000-patient mid-stage trial of its HIV vaccine with NIH, saw its revenues skid for the past three months. GenVec’s three-month revenues ending March 31, 2007 were $2.9 million, 51 percent less than revenues of $5.9 million for the same period last year.