Positive one year challenge data builds on previously reported efficacy observed at 28- and 90-day challenge timepoints
Appili Therapeutics Inc. (TSX:APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced positive one year challenge 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 results reported today are from the final challenge timepoint in a preclinical study evaluating the efficacy of ATI-1701 28 days, 90 days, and one year after vaccination. At each challenge timepoint, cohorts of vaccinated and unvaccinated animals received a lethal exposure of aerosolized Francisella tularensis, the causative agent of tularemia. In January 2020, Appili had reported 90-day efficacy results, with 100% of ATI-1701 vaccinated animals surviving exposure compared to 0% of the controls. Both 28- and 90-day efficacy data have also been presented previously by Appili’s partners MRIGlobal at biodefense conferences in the U.S. The study was funded by the U.S Defense Threat Reduction Agency (“DTRA”) and conducted by MRIGlobal.
“We are excited to see signals of protection and survival benefit as far out as one year post vaccination. Efficacy under these stringent conditions is a compelling differentiator and positions ATI-1701 as a leading candidate to be the first approved vaccine for the prevention of tularemia,” said Dr. Armand Balboni, CEO of Appili Therapeutics. “We are grateful for the support of DTRA and our partners to achieve this significant milestone and look forward to making continued progress on manufacturing and IND-enabling activities to advance ATI-1701 into the clinic.”
The Company also announced today that Josef Vejvoda has resigned from the Company’s Board of Directors to pursue other endeavours.
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 times more infectious than anthrax, experts consider the aerosolized form to have a high potential 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.
About Appili Therapeutics
Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections. By systematically identifying urgent infections with unmet needs, Appili’s goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives. As part of a global consortium, Appili recently sponsored a late-stage clinical trial evaluating the antiviral Avigan/Reeqonus for the treatment of COVID-19. The Company is also advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs. Led by a proven management team, Appili is at the epicenter of the global fight against infection. For more information, visit www.AppiliTherapeutics.com.
Forward looking statements
This news release contains “forward-looking statements”, including with respect to the proposed use of proceeds. 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. Such forward looking statements include statements with respect to the Company’s development plans relating to ATI-1701. These forward-looking statements reflect the current expectations of the Company’s management for future growth, results of operations, performance and business prospects and opportunities and involve significant known and unknown risks, uncertainties and assumptions, including, without limitation, the risks listed in the annual information form of the Company dated June 23, 2021 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. 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.