Some cynical Europeans might snicker about industry in America profiting from a threatened terrorist siege. Other commentators may marvel instead at company scientists' ability to engineer biodefense weapons. The editorial-page beat goes on.
So does Avant Immunotherapeutics Inc., one of the latest firms tapped by the federal government to help prepare for biological warfare. Specifically, the firm is assigned by the U.S. Department of Defense to come up with a combination vaccine for anthrax (Bacillus anthracis) and plague (Yersinia pestis).
The deal is worth $8 million for Avant - maybe much more eventually - and that cash will be used to underwrite the company's other, peace-related drug development efforts.
"We've a lot popping," said Una Ryan, president and CEO of Avant. One project is an oral cholera vaccine undergoing Phase II trials in Bangladesh, which Ryan said will be used as a "Trojan horse" for the anthrax/plague vaccine.
The existing first-generation anthrax vaccine, which "everyone hates," involves six injections over 18 months, and takes "many months to produce protective immunity," Ryan said.
Avant already has licensed a second-generation anthrax vaccine to DynPort Vaccine Co. LLC. "There's no choice; they're the primary and only contractor" for the U.S. Department of Defense's Joint Vaccine Acquisition Program, Ryan said.
"So we've got at least up to recombinant technology with generation two," she said. "That one is in Phase I trials, and it's definitely an improvement. Before, they were just taking the whole [anthrax] soup, killing it and adding adjuvants."
The idea with generation three, which "I have to think is as close to ideal as you can get," is to create an oral vaccine that provides rapid protection, Ryan said.
"One dose - you just sip and go," she said, comparing the vaccine's administration to "a demitasse of Cuban coffee."
A cholera vaccine in late-stage Phase II trials in Bangladesh works similarly, Ryan said, "and we're going to use that as the Trojan horse. We'll vector in soldiers' to fight anthrax and plague."
Avant represents something of a case study in how companies can use biodefense contracts to further their own ends. About 150 firms are involved in some way in the effort, according to an estimate from the Biotechnology Industry Organization.
"It's not that they dump $8 million in your lap and say, Run away and play,'" Ryan told BioWorld Financial Watch. "This [contract] is for time and materials. We move through a series of tasks and then we bill as we do the work. But we're not worried about it. We're the people who wrote the schedule."
Importantly, the resources deployed are "people we already had," just as Avant already had the basic technology required for the biodefense contract, thanks to its work with cholera and typhoid vaccines. Avant's areas of focus - food safety, travelers' vaccines, endemic diseases in the developing world - will only be helped by the cash boost provided by the biodefense agreement.
"They're exactly the same things you need," Ryan said.
Along with anthrax, the vaccine will target pneumonic plague, not to be confused with the bubonic plague, the scourge that killed 25 million people in Europe between 1347 and 1352, and 137 million in all, during the 6th, 14th and 17th centuries. Pneumonic plague - typically carried by rodents and fleas - is considered more likely to be used by terrorists than bubonic, possibly in aerosol form so that it would (like anthrax) be inhaled, and could then be spread from person to person as happened when the lungs of bubonic victims became infected.
Avant, with two years of cash on hand, has plenty of other areas in which to spend. The company is expected to report data in the fourth quarter of this year from its Phase II trial of Ceti-1, an immunotherapeutic for cholesterol management. Ceti-1 targets endogenous cholesteryl ester transfer protein, an intermediary in the distribution of cholesterol between high-density lipoproteins (often referred to as the "good" cholesterol) and low-density lipoproteins (the "bad").
In the second half of this year, the National Institutes of Health is expected to start Phase I/II trials with Avant's Ty800 vaccine for typhoid fever. And an oral-dose rotavirus vaccine also is expected to enter Phase III at the hands of partner GlaxoSmithKline plc, of London, in the second half of the year.
"I had to testify twice to Congress" to get the biodefense contract, which covers payment for work on the anthrax/plague vaccine through the preclinical stage, Ryan said, adding that "we expect to apply and hope to get funds all the way through to the end. We're a defense contractor and know how to fill out all those forms."
It may seem like a lot of work for $8 million, but in a tight economic climate, well worth the trouble. "I don't know how these big battleship people get the money all at once," Ryan said. "We have to fight every step of the way" - pointing up again the intersecting interests of the federal government (in literal warfare) and biotechnology firms (in the battle to stay afloat).
Thanks in part to the biodefense contract, Avant hasn't "muddied the waters" with such forms of financing as convertible notes, and hopes to continue on its way, developing products through Phase II, "when we believe we've added as much value as we can add," and then looking for partners.
Although still trading comparatively low, Avant's shares jumped more than 18 percent on news of the contract, closing at $1.23.
"People are interested," Ryan said, in products such as the anti-cholesterol drug.
"There's going to be a large promotional piece to that [drug], an educational piece, and we need someone who knows how to do it," she said. "Everybody's talking to us."