Researchers Present Positive Interim Data on Appili Therapeutics’ ATI-1701 Biodefense Program at 2020 ASM Biothreats

ATI-1701 demonstrated durable protective response against Francisella tularensis, a Category A pathogen and potential biological weapons threat

Safety and efficacy data support ongoing development under U.S. Food and Drug Administration’s medical countermeasure guidelines

HALIFAX, Canada I January 28, 2020 I Appili Therapeutics Inc. (TSXV: APLI) (the Company or Appili), a biopharmaceutical company developing anti-infective drug candidates, today announced that Dr. Carl Gelhaus, Senior Program Manager of the Medical Countermeasures Division at MRIGlobal, will present positive interim data on Appili’s ATI-1701 program at the 2020 ASM Biothreats conference. Hosted by the American Society for Microbiology, the conference is being held from January 28–30, 2020 in Arlington, Virginia.

“These interim results add to a growing body of evidence supporting advanced development of ATI-1701 as a medical countermeasure against one of the most significant bioterrorism threats we might face,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We remain very encouraged by these results and look forward to sharing the 365-day challenge study data later this year. We are committed to working with our biodefense partners at the U.S. DOD, MRIGlobal, and the National Research Council of Canada toward the first approved vaccine for the prevention of weaponized tularemia.”

Presentation details are as follows:

Title: A ClpB Mutant of Francisella Tularensis SCHU S4 is an Effective Vaccine in Fisher 344 Rat and Cynomolgus Macaque Models of Pneumonic Tularemia
Poster Number: 083
Date: Tuesday, January 28, 2020
Time: 4:15 - 5:15 p.m. ET
Location: Independence Center, Hyatt Regency Crystal City at Reagan National Airport

The ASM poster presentation summarizes the findings from the ongoing preclinical study of ATI-1701, which showed complete (100%) protection 90 days after vaccination from a lethal exposure to the pathogen Francisca tularensis. This duration is the longest vaccine protection period tested to date in this model. Researchers will conduct an additional evaluation of vaccine efficacy up to 365 days in the same model in the first half of 2020. The U.S. Defense Threat Reduction Agency (DTRA), an arm of the U.S. Department of Defense (DOD), is funding this trial. MRIGlobal is managing the study under the DTRA contract HDTRA1-16-C-0028.

About ATI-1701
Appili is developing ATI-1701 as a vaccine to combat Francisella tularensis, which the U.S. National Institutes of Health (NIH) defines as a Category A pathogen (an organism that poses the highest risk to national security and public health). As it is 1,000 times more infectious than anthrax, experts consider the aerosolized form to have a high potential use in a bioterrorist attack.1 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.2

About ASM Biothreats
ASM Biothreats is the leading annual conference on biodefense, biosecurity and biological threats. Hosted by the American Society for Microbiology, ASM Biothreats offers a unique program that explores the latest developments and emerging technologies in the industry. This unique meeting draws stakeholders from government, academia, and industry for an important exchange of knowledge and ideas that will shape the future of high consequence pathogen research.

About MRIGlobal
Celebrating its 75th year of business, MRIGlobal addresses some of the world’s greatest threats and challenges. Founded in 1944 as an independent, non-profit organization, MRIGlobal performs contract research for government, industry, and academia. It offers customized solutions in national security and defense and health include research and development capabilities in clinical research support, infectious disease and biological threat agent detection, global biological engagement, in vitro diagnostics, and laboratory management and operations. MRIGlobal is one of two partners in the Alliance for Sustainable Energy, LLC, which manages and operates the National Renewable Energy Laboratory (NREL) in Golden, Colo., for the U.S. Department of Energy. For more information, visit www.mriglobal.org.

About Appili Therapeutics

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this challenging disease space. Appili has built a pipeline of assets designed to address a broad range of urgent threats in global public health. ATI-2307, a novel, broad spectrum, clinical stage antifungal, is in development to address severe and difficult-to-treat invasive fungal infections. Via an in-licensing program, Appili is developing ATI-1701, a vaccine for tularemia, to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program developing a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with the antibiotic metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit www.AppiliTherapeutics.com.

1 PHAC PSDS (2011) Anthrax; PHAC PSDS (2011) Tularemia
2 Oyston P (2004) Nat Rev Microbiol 2: 967-979

SOURCE: Appili Therapeutics

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