The NIAID has given contracts to Emergent BioSolutions and PharmAthene worth $29.7 million and $83.9 million, respectively, to further their anthrax vaccines. Both company’s vaccine candidates are being designed to have improved efficacy and dosing regimens compared to the approved anthrax vaccine, BioThrax®, which Emergent BioSolutions owns.
Emergent BioSolutions’ contract comes from BARDA and the NIAID and spans three years. It will be used for the development of AV7909, which has so far undergone preclinical testing and one clinical study.
Emergent will initially receive $24.9 million to support nonclinical safety and efficacy studies and the manufacture of clinical lots. The money will also be used to conduct stability studies to demonstrate that the vaccine does not need refrigeration during storage. Additionally, BARDA and the NIAID have the option to provide another $4.8 million for a Phase I trial.
AV7909 comprises BioThrax along with immunostimulatory oligodeoxynucleotide compound VaxImmune®, which was licensed from Coley now owned by Pfizer. A clinical study has shown that this combination increased peak antiprotective antigen titers more than sixfold and reduced the time to reach the peak response from six weeks to three weeks as compared to BioThrax alone, reports Emergent.
PharmAthene, on the other hand, will initially obtain $13.2 million to advance a third-generation recombinant protective antigen (rPA) anthrax vaccine during a base period of performance. During this time the company will be responsible for preclinical activities like developing assays, conducting stability testing and toxicology studies, as well as developing animal models.
During the base period the NIAID retains the option of extending the contract under two separate options with a combined value of up to $9.7 million. If further options covering advanced manufacturing and clinical development are exercised and if certain milestones are met, the value of the contract could reach approximately $83.9 million.
The objective is to develop a rPA anthrax vaccine that can be stored, transported, and used without the need for a conventional cold chain. In particular, the vaccine must maintain stability for three years at 35º C and induce protective immunity in just one or two doses.
“Based on development efforts to date, PharmAthene's third-generation vaccine could offer significant improvements in both stability and storage compared to the current FDA approved vaccine, thereby meeting the government's requirements for civilian deployment in the strategic national stockpile,” according to David P. Wright, president and CEO. “By comparison, the currently available anthrax vaccine, BioThrax Anthrax Vaccine Adsorbed, which was initially licensed by the FDA in 1970, requires six doses over a period of eighteen months to achieve protective immunity and is required to be stored at between two degrees Celsius and eight degrees Celsius.”