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news.Emergent BioSolutions has secured a $31m contract from the US Department of Health and Human Services' (HHS') Biomedical Advanced Research and Development Authority (BARDA) to advance the development of its next generation anthrax vaccine candidate, NuThrax.
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NuThrax is a combination of BioThrax (Anthrax Vaccine Adsorbed) and the immunostimulatory oligodeoxynucleotide compound CPG 7909.
The contract includes a 30-month base period of performance to develop NuThrax for post-exposure prophylaxis of anthrax disease.
Under the deal, activities which are to be completed include process validation, consistency lot manufacture, assay validation, non-clinical studies as well as start-up activities in preparation for the Phase III clinical trial.
In 2014, the company concluded a randomized, parallel-group, active-controlled, double-blind Phase II trial, which evaluated the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using two- and three-dose immunization schedules and two dose levels.
Emergent BioSolutions executive vice-president and president biodefense division Adam Havey said: "Emergent looks forward to working with BARDA to advance the development of NuThrax towards a Phase III study.
"We are committed to addressing the U.S. government’s desire for a next generation anthrax vaccine with an enhanced product profile that includes requiring fewer doses, eliciting a higher immune response, and dispensing the need for cold chain with a dry formulation.
"Moving to these final stages of development is also made possible by earlier support from the National Institute of Allergy and Infectious Diseases (NIAID) for the early stage development of NuThrax, which led to the successful completion of our Phase 2 clinical study.
"NIAID is also supporting current efforts to develop a dry formulation for this vaccine candidate."
The US National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NAID) supported early-stage development of NuThrax, including completion of Phase II trials.