Sep 26, 2008 (CIDRAP News) – Emergent BioSolutions announced today that it has received a $29.7 million contract from the federal government to continue work on another of its next-generation anthrax vaccine candidates.
Emergent, based in Rockville, Md., announced the contract from the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) in a press release today. The company makes BioThrax, the nation's only licensed anthrax vaccine, and is also developing a recombinant anthrax vaccine and an anthrax monoclonal antibody to block the anthrax toxin.
Daniel J. Abdun-Nabi, Emergent's president and chief operating officer, said in the statement that the grant is encouraged by federal support for its AV7909 anthrax vaccine candidate. "We look forward to continuing to work with the US government to advance all aspects of AV7909, as it pursues a multi-prong approach in responding to the ongoing threat of bioterrorism," he said.
Of the 3-year contract, $24.9 million will cover the manufacturing of clinical lots, nonclinical safety and efficacy studies, and stability studies to determine if the vaccine can be stored without refrigeration, which is a key requirement for the new vaccine, Emergent said. The remaining $4.8 million would fund a phase 1 clinical trial if the company and the government exercise that option.
Emergent's AV7909 anthrax vaccine consists of BioThrax (also known as Anthrax Vaccine Adsorbed), plus an adjuvant called CPG 7909, licensed from Pfizer, Inc. A clinical trial of CPG 7909 added to BioThrax showed that anti-protective antigen (PA) titers increased sixfold and reduced the time to peak response from 6 weeks to 3 weeks compared with BioThrax alone, Emergent said in its statement. Also, the two doses of AV7909 elicited the same anti-PA antibody levels as three doses of BioThrax.
A next-generation anthrax vaccine would help the US military more easily inoculate troops. Soldiers in high-risk areas such as the Middle East typically receive six doses of BioThrax over 18 months, followed by annual boosters. The military has said a next-generation anthrax vaccine should ideally require fewer doses and have fewer side effects.
On Sep 3, Emergent announced that it had won a $24.3 million federal contract for an anthrax monoclonal antibody treatment called AVP-21D9. In its statement today the company said it was also developing a polyclonal anthrax immunoglobulin candidate for intravenous treatment for patients who have anthrax infections.
Sep 26 Emergent BioSolutions press release
Sep 9 CIDRAP News story "HHS funds work on new anthrax antitoxin"