Appili Therapeutics Announces Positive One Year Challenge Results from Preclinical Study Evaluating Biodefense Vaccine Candidate ATI-1701 and Change to Board of Directors
19 Novembre 2021 - 01:42PM
Business Wire
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.
About ATI-1701
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211119005423/en/
Media:
Danielle Raabe/APCO Worldwide T: 1-646-717-9915 E:
DRaabe@apcoworldwide.com
Investor Relations: Stéphane Paquette; Senior Director, Corporate
Development Appili Therapeutics E: Info@AppiliTherapeutics.com
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