New data demonstrates durable protective response for Appili’s vaccine candidate against Francisella tularensis, a Category A pathogen and potential biological weapons threat
Presentation provides additional safety and efficacy data supporting use of ATI-1701 as a medical countermeasure, supports ongoing development under U.S. Food and Drug Administration’s medical countermeasure development guidelines
HALIFAX, Nova Scotia, November 18, 2019 – Appili Therapeutics Inc. (TSXV: APLI) (the Company or Appili), a biopharmaceutical company focused on anti-infective drug development, 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 Chemical and Biological Defense Science & Technology Conference (CBD S&T). The conference is being held from November 18-21 at the Duke Energy Convention Center in Cincinnati, Ohio.
The poster presentation at CBD S&T will summarize the latest 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 time period 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 H1 2020. The U.S. Defense Threat Reduction Agency (DTRA), an arm of the U.S. Department of Defense (DOD), is funding this trial. MRI Global is managing the study under the DTRA contract HDTRA1-16-C-0028.
“Together with our partners at the DOD, MRIGlobal, and the National Research Council of Canada, we are greatly encouraged by results from the 90-day vaccine challenge study,” said Kevin Sullivan, CEO of Appili Therapeutics. “Although results are preliminary, they add to a growing body of evidence supporting advanced development of ATI-1701. We look forward to sharing the 365-day challenge results next year, and working with our biodefense partners to potentially produce the first FDA-approved vaccine for the prevention of tularemia.”
Presentation details are as follows:
Title: Development of Francisella Tularensis SCHU S4 DeltaclpB as a Vaccine for the Prevention of Pneumonic Tularemia in the Warfighter
Session: Medical Countermeasures in the Context of a Layered Medical Defense
Date: Wednesday, November 20, 2019
Time: 4:00 p.m. – 6:00 p.m. ET
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.[i] 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.[ii]
About the Chemical and Biological Defense Science & Technology Conference (CBD S&T)
DTRA will host the 2019 CBD S&T Conference at the Duke Energy Convention Center, in Cincinnati, Ohio, November 18-21, 2019. The conference provides the opportunity to collaborate with more than 1,500 scientists, program managers and leaders from across the globe who are committed to making the world safer by confronting chemical and biological defense challenges. Attendees will also network with DTRA science and technology managers as well as other members of DTRA’s Chemical and Biological Defense team.
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, we perform contract research for government, industry, and academia. Our 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 pipeline of assets designed to address a broad range of significant unmet medical needs in the infectious disease landscape. This diverse pipeline aims to address some of the most urgent threats in global public health. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, being developed to mitigate the risks of a very serious biological weapons threat. ATI-1503 is a drug discovery program aimed at generating 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 metronidazole for the growing number of patients with difficulty swallowing. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, 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.
This news release contains “forward-looking statements” which reflect the current expectations of the Company’s management future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s proposed development plans with respect to its product. Wherever possible, words such as “may “, “would “, “could “, “should”, “will,” “anticipate,” “believe,” “plan,” “expect,” “intend,” “estimate,” “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to adequately fund and implement its development plans and business strategy. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements including, without limitation, those listed in the final prospectus of the Company dated June 12, 2019 and the other filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise, except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
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Investor Relations Contact:
Kimberly Stephens, CFO
Appili Therapeutics
E: [email protected]
[i] PHAC PSDS (2011) Anthrax; PHAC PSDS (2011) Tularemia
ii] Oyston P (2004) Nat Rev Microbiol 2: 967-979
