After Years of Red Ink, Vical Says DNA-Based Vaccines ‘Ready for Prime Time.’

6/9/09

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$90 million, much closer to earth for a company with no products.

Samant took charge of Vical in late 2000 after a stint as head of Merck’s vaunted vaccine group. He immediately faced numerous challenges. One was perception. Regulators considered Vical’s vaccines a form of gene therapy, a technology largely focused on using healthy genes to cure inherited disorders. Gene therapy companies typically use viruses to deliver genes, and face added regulatory scrutiny.

“It took us a long time, three or four years, to get out from under that gene therapy label,” Samant said.

Another was finding a way to intensify the immune response to Vical’s vaccines, which are designed to stimulate production of T cells in addition to antibodies. The solution was an adjuvant made of lipids, fatty molecules that naturally incite the immune system.

What other steps got Vical to this point? Samant shared some insights that offer useful tips to other innovation companies:

— Pick a market you can win. At least one Big Pharma player is working on a vaccine to prevent cytomegalovirus infections in healthy women; the virus can cause congenital disabilities when passed from pregnant women to fetuses. Lacking the resources to compete head-to-head, Vical targeted infections in bone marrow transplant patients, a narrow segment worth perhaps $100 million a year – too small to interest traditional vaccine makers. Successful results in transplant patients will position Vical to go after the larger market with a deep-pocketed partner.

— Validate your technology on someone else’s dime. Vical obtained government support for high-profile work on vaccines against avian flu and the H1N1 swine flu. The experimental avian flu vaccine promoted a robust immune response in nearly 70 percent of healthy volunteers; Vical is now looking for government money so it can move its swine flu vaccine from animal studies into human trials. Yet Samant was circumspect, even though Vical’s work on sequencing the swine flu virus was attention-grabbing. ”My goal is to demonstrate the value of our technology against a very difficult target,” he said. “If we’re lucky and the government places an order, that’s an upside.”

With its shares trading in penny stock territory, Vical clearly is not out of the woods. Last year, it closed a San Diego research facility and cut 29 jobs to save cash. And as with any vaccine, there is always concern about a strong or uncontrolled immune system response. A patient death in a mid-stage trial was classified as “probably related” to Vical’s melanoma vaccine, Allovectin-7, because the possibility could not be ruled out. The company does not believe the vaccine, which is injected directly into tumors, was a significant factor in the death.

Samant expressed confidence in the company’s science, which suggests a final bullet point—Believe. “We are close to validation on a variety of fronts,” he said. “We are ready for prime time.”

Denise Gellene is a former Los Angeles Times science writer and regular contributor to Xconomy. You can reach her at dgellene@xconomy.com Follow @

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