Pandemic gives Vical H1N1 vaccine a shot

CHICAGO Thu Sep 10, 2009 5:54pm EDT

CHICAGO (Reuters) - For biotechnology company Vical Inc, the swine flu pandemic came along at the right time.

The San Diego-based company had done early stage testing on its pandemic vaccine for H5N1 avian flu, but was having trouble getting funding.

"Then along came H1N1. It has reinvigorated interest in pandemic vaccines," said Alan Engbring, a company spokesman.

Since April, Vical's shares have more than doubled in price and the company has landed a contract to test its vaccine with the U.S. Navy. Vical expects to get that funding soon and then it will begin clinical trials of its swine flu vaccine.

"We should get the money very shortly. We have tested the vaccine. We know it produces an immune response which is effective. We're in the active process of manufacturing the vaccine," Vijay Samant, Vical's president and chief executive, said in a telephone interview.

He said clinical tests should start within four to six weeks. "If we start the trial by mid-October, the data should be in our hands by early next year."

Meanwhile, the company is looking outside the United States. "We are in discussions with other foreign governments," he said.

Samant said he only plans to spend government grant money on swine flu vaccine development because the U.S. government is not stockpiling vaccine using any new technologies.

But he said the pandemic does offer a great opportunity to test its DNA-based vaccine technology.

Unlike conventional methods of making flu vaccines, which incubate a virus in specially bred chicken eggs and take six months to produce, Vical just needs the virus's genetic code to make a vaccine.

"The conventional flu vaccines require the handling of pathogens. Our technology does not," Samant said.

HEAD START

"As a result, we got a head start, ahead of anybody in terms of doing animal studies. All we need is the gene sequence or the recipe for the pathogen."

From there, the company makes a plasmid -- a small ring of DNA -- and ferments that with bacteria to make it multiply.

The bacteria is killed and what is left is a portion of genetic code for the virus. When injected into a person's arm, the DNA takes over the cell's machinery.

"The nucleus of the muscle cell is actually a manufacturing factory. It takes the recipe, makes multiple copies and releases them. The immune system recognizes them, trains against them and creates a memory, so that when the real (virus) comes along, it will recognize it," Samant said.

"Whether we make a product for cancer, as we're doing with Merck, or we're doing an Ebola vaccine, the manufacturing process is always the same."

Samant, who once led Merck & Co Inc's vaccine business and did early work on the Gardasil vaccine for human papillomavirus or HPV, is passionate about the technology's potential.

"I love my business. I've been involved in three vaccine approvals in the last 15 years," he said, noting that only 15 vaccines have won U.S. approval in the past 75 years.

He said while Vical's H1N1 vaccine has not been tested in humans, the technology has been widely tested in human clinical studies.

The company has several other vaccine programs in the works, including a late-stage study of a vaccine for advanced melanoma and a vaccine to prevent cytomegalovirus infections in phase 2 testing in people undergoing stem cell transplants.

Samant said whether his H1N1 vaccine will be used in the current pandemic is not clear. In an emergency, he said the U.S. Food and Drug Administration can approve a vaccine based on animal data. Should the pandemic prove mild, Vical might need to run tests in thousands of people.

(Editing by Maggie Fox and Gerald E. McCormick)

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