BARDA contracts support new anthrax countermeasures

Sep 15, 2011 (CIDRAP News) – Two companies recently received contracts to advance the development of countermeasures against Bacillus anthracis attacks, a next-generation vaccine given as a nasal spray and an injectable antitoxin, the US Department of Health and Human Services (HHS) announced today.

The contracts, awarded by the HHS Biomedical Advanced Research and Development Authority (BARDA), come just weeks before the 10th anniversary of the US anthrax attacks.

Vaxin, Inc., based in Rockville, Md., received a 2-year contract for $14.7 million to study and develop a manufacturing process for the vaccine, called AdVAV, the HHS said in the statement. One goal of the studies will be to determine if the vaccine can protect with fewer doses than the currently licensed vaccine in the nation's Strategic National Stockpile (SNS), which requires 5 doses over 18 months and annual boosters to protect against B anthracis.

The terms of the vaccine contract could be extended for up to 4 years and $21.7 million, the HHS said.

The company's proprietary technology uses nonreplicating adenovirus and bacterial vectors to noninvasively deliver antigens and provoke an immune response, according to background materials on the company's Web site.

The antitoxin contract went to Elusys Therapeutics, Inc., based in Pine Brook, N.J., which received a 2-year $26.5-million grant to study and evaluate the efficacy of its antitoxin Anthim when administered before or after exposure. The company's contract could be extended to 5 years and up to $68.9 million.

Current anthrax antitoxins—there are two in the SNS—must be given intravenously, but the injectable Anthim would allow for faster and easier administration.

The current contract is for pre- and postexposure prophylaxis, Elusys said in a Sep 8 press release. An earlier separate $143-million 5-year contract covers the development of Anthim treatment for symptomatic patients. The US Food and Drug Administration (FDA) has granted the drug fast-track status and orphan-drug designation.

Anthim is a high-affinity, humanized, and deimmunized monoclonal antibody that targets the protective antigen of B anthracis and neutralizes the lethal effects of anthrax toxins, Elusys said in the release.

BARDA director Robin Robinson, PhD, said in the press release that the countermeasure candidates are promising and have attractive attributes. "Through these contracts, we are helping develop new tools to protect the public in an emergency and at the same time helping industry manage the costs of these products over their life cycle," he said.

See also:

Sep 15 HHS press release

Sep 8 Vaxin background information

Sep 8 Elusys press release

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