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Emergent BioSolutions to develop dry formulation of anthrax vaccine NuThrax

US-based Emergent BioSolutions has signed a contract with the National Institute of Allergy and Infectious Diseases (NIAID) to develop a dry formulation of NuThrax (anthrax vaccine adsorbed with CPG 7909 adjuvant).

NuThrax is also known as AV7909, which is Emergent BioSolutions’ next generation anthrax vaccine candidate.

The five-year, $29m contract provides funding for manufacturing and non-clinical activities through the preparation of an investigational new drug (IND) application to the US Food and Drug Administration (FDA).

The company said that the dry formulation of NuThrax is intended to increase stability of the vaccine candidate at ambient and higher temperatures, with an aim of reducing the need for cold chain during shipping and storage.

Emergent BioSolutions executive vice-president and biodefense division president Adam Havey said the company is happy with NIAID’s continued support of the development of NuThrax, which it anticipates will demonstrate an enhanced product profile that includes requiring fewer doses, eliciting a higher immune response, and dispensing the need for cold chain due to a dry formulation.

"We are committed to responding to the U.S. government’s needs to combat the ongoing threat of bioterrorism," Havey said.

NuThrax is combination of BioThrax (Anthrax Vaccine Adsorbed) and the immunostimulatory oligodeoxynucleotide compound CPG 7909.

Currently, the company is conducting a randomized, parallel-group, active-controlled, double-blind Phase II trial to assess the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using two- and three-dose immunization schedules and two dose levels.