HHS funds work on new anthrax antitoxin

Sep 9, 2008 (CIDRAP News) – Emergent BioSolutions Inc. recently announced that it won a federal contract worth $24.3 million to develop a monoclonal antibody treatment to block the effects of anthrax toxin.

Emergent, based in Rockville, Md., said in a Sep 3 press release that the 4-year contract from the US Department of Health and Human Services (HHS) for an anthrax monoclonal antibody called AVP-21D9 will cover manufacturing, nonclinical studies, and a phase 1 clinical trial.

The contract will be jointly administered by the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

AVP-21D9 is a fully human monoclonal antibody that binds the anthrax toxin's protective antigen component and inhibits the formation of pores that enable toxin enzymes to enter host cells, according to the news release. Emergent said studies in mice, rats, and rabbits have shown that AVP-21D9 is highly protective, even in animals that had clinical symptoms of anthrax infection.

Emergent, which makes the only US-licensed anthrax vaccine, acquired the anthrax monoclonal antibody treatment from Avanir Pharmaceuticals, based in Aliso Viejo, Calif., in March, according to the statement. Avanir had developed AVP-21D9 with support from the NIAID.

No product for blocking anthrax toxin is currently available. Anthrax infection can be prevented with a vaccine and treated with antibiotics. But antibiotic treatment for inhalational anthrax must begin fairly early in the course of illness, because antibiotics are not effective after Bacillus anthracis has released its toxin into the blood.

AVP-21D9 is one of three investigational monoclonal antibody treatments for anthrax exposure that have received support over the past year from federal biodefense authorities. In September 2007, Elusys Therapeutics, based in Pine Brook, N.J., announced it had been awarded a $12 million contract to continue developing Anthrim for use as prophylaxis and postexposure treatment of inhalational anthrax.

The US Food and Drug Administration (FDA) has granted Anthrim fast-track approval status and designated it an orphan drug, Elusys has said.

According to background material on Elusys' Web site, Anthrim targets anthrax protective antigen to neutralize the toxin. The company said its monoclonal antibody therapy is produced with an "affinity enhancement" process that was developed by researchers at the University of Texas, Austin.

Also last September, PharmaAthene, based in Annapolis, Md., announced that it had won a $13.9 contract to develop Valortim, an anthrax monoclonal antibody treatment. The company was working on the product  with Medarex, a biopharmaceutical firm based in Princeton, N.J.

See also:

Sep 3 Emergent BioSolutions press release

Apr 22 Elusys press release

Elusys backgrounder on Anthrim
http://www.elusys.com/anthim-anthrax.html

Oct 3, 2007, CIDRAP News story "Federal grants support new anthrax countermeasures"

Oct 16, 2007, CIDRAP News story "US funds work on drugs for plague, tularemia, and anthrax"

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