MOUNTAIN VIEW (February 15, 2023)—Over the last 19 years, four highly distinct respiratory viruses precipitated deadly human epidemics and pandemics—namely, the 2009 H1N1 influenza outbreak and the three COVID-19 waves. The likelihood that a new and equally virulent respiratory virus will spread again is high. Notwithstanding, our existing countermeasures are not suited to prevent similar mass-casualty events. Respiratory viruses can spread rapidly and the risk of infection is heightened in close quarters as well as in unique environments faced by warfighters.
The Defense Innovation Unit (DIU), collaborating with the Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) under the Vaccine Acceleration by Modular Progression (VAMP) program announce the launch of “Project Panacea.” This 18-month project is focused on prototyping a small-molecule nasal spray as prophylaxis for a variety of respiratory diseases, including novel viruses and emerging variants of existing viruses.
“The lessons learned from the COVID-19 pandemic highlighted the need for the biotechnology industry to address viral threats through the application of novel technologies, said LTC Amanda Love, a Joint Product Manager with the JPEO. “We are excited to begin several new efforts under our VAMP portfolio at JPM CBRN Medical to explore medical countermeasures that targets a broad range of viral pathogens. The technology behind these products provide new solutions for the protection of our warfighters in any environment that they may encounter.”
In late 2022 and early 2023, the government selected two companies, Access to Advanced Health Institute (AAHI) and ENA Therapeutics, to develop pan-viral countermeasures to protect the warfighters in close quarters and in deployed settings.
ENA plans to develop a broad-spectrum antiviral immunomodulator for the prevention of respiratory viral infections. AAHI will test the nasal spray against pandemic influenza and Nipah virus in preclinical studies. If successful, the prototype will allow for the rapid initiation of Phase 1 clinical trials in humans.
“As a scientist that works at the nexus of commercial technology, medicine, and national security, and as a practicing physician entrusted to keep our forces ready, we are uniquely positioned to identify and accelerate commercial therapeutics that have an opportunity to make step-function changes to the protection and survivability of our people,” said Niels Olson, MD, Chief Medical Officer of DIU.
These countermeasure prototypes will demonstrate safe, in-vivo, and non-clinical efficacy against multiple respiratory viruses in animal models. They will also chart a course for current good manufacturing practices (cGMP) and processes to scale for mass production and stockpiling. Once in final form, the prototypes will be ready to file and secure a Federal Drug Administration (FDA) Investigational New Drug (IND) application, which will clear the way for Phase 1 and future clinical studies in humans.
This effort will serve as a launching point to evaluate new broad-spectrum medical countermeasures against different types of viral diseases to protect the warfighter. Novel pan-viral countermeasures may provide protection against a diverse panel of highly transmissible respiratory viruses and ultimately provide deployable solutions to 24-hours 7-days-a-week operations in high-risk environments from ships to basic training.