The Biomedical Advanced Research and Development Authority (BARDA) has awarded Altimmune, a Maryland-based clinical stage immunotherapeutic biotechnology company, a $120.2 million contract to conduct clinical trials over the next five years on an experimental vaccine against anthrax.
The vaccine candidate, NasoShield, stimulates an immune response with a single intranasal administration. Currently, the only anthrax vaccine approved by the US Food and Drug Administration (FDA) requires several injections over six months to ensure protection, according to Altimmune.
Bill Enright, President and CEO of Altimmune, told Homeland Security Today said the new contract with BARDA will support the development of the NasoShield anthrax vaccine through Phase 1 and Phase 2 clinical studies. Enright said this includes “the necessary process development, manufacturing scale up activities and preclinical work to advance this product candidate towards licensure.”
BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, supports the development of medical countermeasures for chemical, biological, radiological, and nuclear threats.
Altimmune plans to file an Investigational New Drug application with the FDA and commence a Phase 1 trial in the second half of 2017.
Homeland Security Today has reported on multiple occasions that the availability of medical countermeasures before a crisis strikes is critical to effective US public health and emergency preparedness.
The implications of an attack using a dangerous pathogen was highlighted only a week after the tragic September 11, 2001 terrorist attacks when letters laced with anthrax were mailed through the US postal system, killing five people and infecting 17 others.
With few treatments for anthrax available, having a next-generation vaccine for the prevention of anthrax in the nation’s arsenal is vital, particularly in the event of a bioterrorism emergency.
“The development of NasoShield allows the US government to continue to position itself to have the best available counter measures in the event they are needed,” said Enright. “Preclinical data to date have shown some important improvements over the currently licensed vaccine, which include faster time to a protective immune response and a much more stable immune response with a single intranasally administered dose.”
Enright added, “We have early preclinical data that suggests the protective response also lasts longer and that the vaccine is more stable as well. We are hoping to duplicate these promising preclinical results in the upcoming clinical studies.”