Appili Therapeutics Inc. (Appili), an anti-infective drug development company, announced today it has signed a licence agreement with the National Research Council of Canada (NRC) to develop ATI-1701, a vaccine to protect against Francisella tularensis, a potential bioterrorism agent that causes tularemia.

The US Centers for Disease Control and Prevention (CDC) ranks F. tularensis, the bacteria that causes tularemia, as a Category A pathogen (i.e., an organism that poses the highest risk to national security and public health). Aerosolized F. tularensis is on this list because it is considered to have high potential as a biological weapon and has been studied prior to and during World War II, and it was also examined for military purposes by the Soviet Union during the Cold War.

“Francisella tularensis is a very infectious bacteria. A small number (approximately 10 to 50 organisms) can cause tularemia disease. If used as a weapon, the bacteria would likely be made airborne for exposure by inhalation. People who inhale an infectious aerosol would generally experience severe respiratory illness, including life-threatening pneumonia and systemic infection, if they are not treated,” said Sean McBride, vice president of business development at Appili Therapeutics.

Although a vaccine was developed in the former Soviet Union that partially protects against respiratory challenges, it may have limited effectiveness when used in a mass casualty, bioterrorism attack and is currently not approved for use by the US Food and Drug Administration (FDA). Various antibiotic regimens are effective as post-exposure prophylaxis and treatment for tularemia and would likely comprise the first line of public health intervention in response to a deliberate release of F. tularensis; however a highly effective vaccine has long been sought after to protect vulnerable populations.

“If an adversary finds a way to make Francisella tularensis resistant to antibiotics and uses it as an aerosolized bioweapon, the results could be devastating,” continued Mr. McBride. “We are proud to be a part of the team working to advance a vaccine to protect civilians and military personnel in the event of an attack.”
ATI-1701 is based on research led by Dr. Wayne Conlan at the NRC. Dr. Conlan’s team used genetic engineering to disable a previously virulent strain of F. tularensis and develop a live attenuated vaccine.  Their research showed the genetically modified bacterium induced a strong immune response that triggers a protective immune response to F. tularensis.

“It is very rewarding to see our team’s research on this vaccine progress from our labs to the next stage of development. We are delighted to partner with Appili on this important program designed to protect the health of Canadians exposed to bioterror threats,” said Dr. Conlan.

Some of the development work for the vaccine is being funded by the Defense Threat Reduction Agency (DTRA), part of the US Department of Defense, which recently announced a $6.2 million, five-year program to develop a tularemia vaccine. Appili will conduct the preclinical and clinical testing required by the FDA to evaluate the safety of the ATI-1701 vaccine and to ensure it offers the desired protection against the bacteria for humans. These pivotal studies could support the regulatory approval of the vaccine under the FDA Animal Rule.

Today’s license agreement with the NRC grants Appili exclusive worldwide rights to develop and commercialize this tularemia vaccine. “This continues to build out our portfolio of products that have dual civilian and military defensive applications,” said Kevin Sullivan, CEO of Appili Therapeutics. “We will continue to identify partnering opportunities to work with defense departments around the world to develop infectious disease solutions for unmet needs in the military and civilian populations alike.”

About Tularemia
Tularemia is a disease of animals and humans. Rabbits, hares, and rodents are especially susceptible to tularemia and often die during outbreaks. Humans can become infected in several ways including tick and deer fly bites; skin contact with infected animals; ingestion of contaminated water; inhalation of contaminated dust or aerosols; and acts of bioterrorism.

About Appili Therapeutics
Appili is a biopharmaceutical company dedicated to identifying, acquiring and advancing novel therapeutics for infectious disease. Its pipeline includes three anti-infective programs: ATI-1501, a novel taste-masking technology applied in an oral suspension for the treatment for anaerobic infections, ATI-1503, a novel antibiotic targeting drug-resistant Gram-negative infections, and ATI-1701, a vaccine reducing the threat of tularemia bioterrorism. For more information visit www.AppiliTherapeutics.com.

For more information, please contact:

(media relations)
Mike Beyer, Sam Brown Inc.
312.961.2502
mikebeyer@sambrown.com

(investor relations)
Kevin Sullivan
CEO, Appili Therapeutics
902.442.4655
info@AppiliTherapeutics.com

January 9, 2018, Halifax, Nova Scotia