DoD funding aims to advance F. tularensis biodefense vaccine candidate to IND submission
Appili Therapeutics Inc. announced this week that the U.S. Department of Defense, via the Joint Science and Technology Office of the Defense Threat Reduction Agency (DTRA), has selected for funding an Appili proposal that would provide over US$10 million to advance the Company’s biodefense vaccine candidate ATI-1701, a potential first-in-class vaccine candidate for the prevention of infection with Francisella tularensis, the causative agent of tularemia and a top-priority biothreat.
The new funding is designed to replace and expand upon a prior contract awarded to one of Appili’s development partners. Appili will serve as prime contractor and oversee a comprehensive development program for ATI-1701 that includes nonclinical, manufacturing, and regulatory activities to support an IND submission to the FDA. The expected total funding amount of over $10 million will fund this expanded scope of work. The award is subject to successful negotiations between the DTRA contracting division and Appili. The total funding amount will be confirmed upon contract execution.
Francisella tularensis has been classified as a Category A pathogen by the U.S. National Institutes of Health due to its high rates of infectiousness and ability to cause lethal pneumonia and systemic infection. As the aerosolized form can be more infectious than anthrax, it is considered to have a high potential for use in a bioterrorist attack.
“We are grateful for the continued support from DTRA to help us further develop ATI-1701 and deliver on our mission to address a variety of urgent unmet needs in infectious disease,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “Advancing ATI-1701 could have a transformative impact on mitigating this high risk to national security and public health. We look forward to continuing to advance this vaccine candidate and further strengthening our partnerships with government agencies around the world to address this urgent bioterrorism threat.”
Last month, Appli announced positive one year results from its preclinical study evaluating the efficacy of biodefense vaccine candidate ATI-1701 in a lethal model of tularemia. A survival rate of 29% (n = 2/7) was reported in the ATI-1701 vaccinated cohort, compared to 0% (n = 0/5) in mock vaccinated controls. The positive one-year data built on previously reported efficacy observed at 28- and 90-day challenge timepoints, including 100% survival of ATI-1701 vaccinated animals at the 90-day challenge timepoint, and well positions ATI-1701 to become the first approved vaccine for the prevention of tularemia. The study was funded by DTRA and conducted by MRIGlobal.
Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which is classified by the U.S. National Institutes of Health (NIH) as a Category A pathogen, an organism that poses the highest risk to national security and public health. Estimated to be 1,000-fold more infectious than anthrax, experts consider the aerosolized form to have a high potential for use in a bioterrorist attack. Several countries may already have operational weapons programs leveraging this pathogen, making the need for a vaccine to counter this biological weapons threat exceedingly important.