Appili Therapeutics Announces Over US$10 Million in New Funding from US Department of Defense for Biodefense Vaccine Candidate ATI-1701
28 Februar 2022 - 1:40PM
Business Wire
Funds to advance ATI-1701 to IND submission
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the
“Company” or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases, today announced that the U.S.
Department of Defense (“DOD”), via the Joint Science and Technology
Office of the Defense Threat Reduction Agency (“DTRA”), has
selected for funding an Appili proposal that would provide over
US$10 million to advance the Company’s biodefense vaccine candidate
ATI-1701, a potential first-in-class vaccine candidate for the
prevention of infection with Francisella tularensis, the causative
agent of tularemia and a top-priority biothreat.
The new funding is designed to replace and expand upon a prior
contract awarded to one of Appili’s development partners. Appili
will serve as prime contractor and oversee a comprehensive
development program for ATI-1701 that includes nonclinical,
manufacturing, and regulatory activities to support an IND
submission to the FDA. The expected total funding amount of over
US$10 million will fund this expanded scope of work. The award is
subject to successful negotiations between the DTRA contracting
division and Appili. The total funding amount will be confirmed
upon contract execution.
Francisella tularensis has been classified as a Category A
pathogen by the U.S. National Institutes of Health due to its high
rates of infectiousness and ability to cause lethal pneumonia and
systemic infection. As the aerosolized form can be more infectious
than anthrax, it is considered to have a high potential for use in
a bioterrorist attack.
“We are grateful for the continued support from DTRA to help us
further develop ATI-1701 and deliver on our mission to address a
variety of urgent unmet needs in infectious disease,” said Dr.
Armand Balboni, CEO of Appili Therapeutics. “Advancing ATI-1701
could have a transformative impact on mitigating this high risk to
national security and public health. We look forward to continuing
to advance this vaccine candidate and further strengthening our
partnerships with government agencies around the world to address
this urgent bioterrorism threat.”
Last month, the Company announced positive one year 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 positive
one-year data built on previously reported efficacy observed at 28-
and 90-day challenge timepoints, including 100% survival of
ATI-1701 vaccinated animals at the 90-day challenge timepoint, and
well positions ATI-1701 to become the first approved vaccine for
the prevention of tularemia. The study was funded by DTRA and
conducted by MRIGlobal.
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-fold more infectious than anthrax, experts consider the
aerosolized form to have a high potential for 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. The Company
is currently 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 expected finalization and execution
of a definitive agreement, the anticipated funding amount and the
Company’s ongoing development plans with respect to ATI-1701.
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. Forward looking
statements contained in this press release are provided in reliance
on certain assumptions, including with respect to finalizing the
definitive funding documentation with DTRA and being in a position
to secure the full anticipated funding. Although the Company
believes that the expectations reflected in these forward-looking
statements are reasonable, the Company cannot give assurance that
these expectations will prove to have been correct.
Forward looking statements involve significant known and unknown
risks, uncertainties and assumptions, including, without
limitation, the risk that final approval for the funding may not be
secured on terms satisfactory to the Company or at all, the final
funding amount may be different than that communicated herein, and
the other risk factors 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/20220225005486/en/
Media Contact: Danielle Raabe/APCO Worldwide T:
1-646-717-9915 E: DRaabe@apcoworldwide.com Investor Relations
Contact: Stéphane Paquette; Vice President, Corporate
Development Appili Therapeutics E: Info@AppiliTherapeutics.com
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