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Biotechs Come Back to Earth

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In that time, the company announced each step of a process that revived its longtime immune-system-modulating technology for a potential H1N1 treatment and tested it on blood samples of up to 40 total enrollees at the Johns Hopkins University School of Medicine. The company seized the opportunity to collect more than $20 million in a stock sale to put toward a cancer drug waiting in the wings for years to enter new trials.

But as the number of swine flu patients continues to wane, Cel-Sci’s stock is now trading around 70 cents, and a company official said a much-touted trial remains in a holding pattern with no more than a half-dozen blood samples at hand.

“The H1N1 this year has turned out to be a real enigma—it’s bamboozled everybody,” said Dan Zimmerman, Cel-Sci’s senior vice president of research for cellular immunology, who was rehired full-time last November to head these trials, which he said took “substantial” company financial and personnel resources. “We’re doing what we can, but we have not had the number of patients we really need to be able to evaluate this.”

Novavax perhaps shone most brightly in the swine flu spotlight last year. The company had been working for years on high-tech methods that would lead to faster production of vaccines, and it sped up those efforts last year amid the swine flu hysteria. For much of last year, it trumpeted two major endeavors: the largest clinical trial of its H1N1 vaccine candidate in Mexico and negotiations with Rovi Pharmaceuticals Laboratories of Madrid, Spain, to test and produce its seasonal and pandemic flu vaccine technology in Europe.

The biotech saw its shares swing from its yearly low of 52 cents to its yearly high of $7.79 in a five-month span last spring and summer, and national media from Bloomberg TV to Time magazine were quoting CEO Rahul Singhvi. By year’s end, the previously cash-hungry Novavax was $21 million richer from a major stock sale.

Now, however, the company’s shares are trading below $2.50, and talks with Rovi have ground to a halt.

Yet Novavax remains intent on convincing the U.S. government that its vaccine versions are faster, cheaper, and still effective. The company recently announced that it finished enrollment of its pivotal H1N1 vaccine trials in Mexico, and it hopes the trials will help fine-tune a vaccine-production method that uses only lab-created chunks of a virus rather than a full, live strain.

“There is a need for new technologies in spite of very valiant efforts of companies,” Singhvi said. “If the pandemic was any worse, then it could have been a very tragic situation.”

While Novavax concentrates on using virus-like particles, another small company, Bacilligen Inc., is working on assembling genetic sequences of the flu virus pieces responsible for immunity to draft a vaccine-manufacturing manual of sorts.

Bacilligen CEO Steve Bende describes his company’s chosen method, funded by a National Institutes of Health grant, as even faster than that of purifying virus-like particles, aiming to take 70 days from strain discovery to patient injection.

National experts say that race to fashion newer, faster vaccines is the key to winning future pandemic battles, as the industry mulls options to replace its roughly 70-year-old vaccine-production process: growing each live virus strain in one or two chicken eggs that must also have matured within an all-too-specific time frame. It was that combination that helped lead to delayed deliveries and long patient waiting lines last year.

“It’s not so much about the strain as it is about the platform—how it’s made and what’s in it,” said Lisa Beth Ferstenberg, chief medical officer for Accelovance Inc., a contractor that conducts vaccine clinical trials for other drug developers. “Anything we can do to create an alternative to poultry eggs is helpful.”


Vandana Sinha is a staff reporter for the Washington Business Journal.

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