Date: 2015-03-24
Type of information: Services contract
Compound: NuThrax®
Company: Emergent BioSolutions (USA - MD) Biomedical Advanced Research and Development Authority (BARDA) (USA)
Therapeutic area: Infectious diseases
Type agreement: services contract
Action mechanism: vaccine. NuThrax is comprised of BioThrax® (Anthrax Vaccine Adsorbed) in combination with the immunostimulatory oligodeoxynucleotide compound CPG 7909.
Disease: anthrax
Details: * On March 24, 2015, Emergent BioSolutions announced that it has signed a contract with the Biomedical Advanced Research and Development Authority (BARDA) for the advanced development of NuThrax™ (anthrax vaccine adsorbed with CPG 7909 adjuvant), also known as AV7909, the company\'s next generation anthrax vaccine candidate. The contract, valued at $31 million, consists of a 30-month base period of performance to develop NuThrax for post-exposure prophylaxis of anthrax disease. Activities to be completed under the contract include process validation, consistency lot manufacture, assay validation, non-clinical studies, and start-up activities in preparation for the Phase 3 clinical trial. In 2014, Emergent successfully concluded a randomized, parallel-group, active-controlled, double-blind Phase 2 study, which was designed to evaluate the safety and immunogenicity of NuThrax™ for post-exposure prophylaxis of anthrax infection using two- and three-dose immunization schedules and two dose levels. The study results, which were presented at the ASM Biodefense and Emerging Diseases Research Meeting last month, suggest further study of a two-dose schedule of NuThrax in light of the favorable tolerability profile and immunogenicity response relative to three doses of BioThrax. This contract HHSO100201500004C for the advanced development of NuThrax is funded by BARDA within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS). The Phase 2 clinical trial was conducted with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) of HHS under development contract number HHSN272201000035C. Contract HHSN272201400038C to develop a dry formulation of NuThrax is also administered through NIAID.
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