Appili Therapeutics Announces Issuance of Patent for ATI-1701 Biodefense Vaccine Candidate to Protect Against Tularemia and Provides Update on Bridge Loan
15 December 2023 - 11:27PM
Business Wire
Patent coverage provides drug market exclusivity through at
least 2039
Pre-IND meeting with the FDA granted to discuss ATI-1701’s
regulatory, CMC, toxicology, and Phase 1 strategies
Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company”
or “Appili”), a biopharmaceutical company focused on drug
development for infectious diseases and biodefense, today announced
that the United States Patent and Trademark Office (“USPTO”) has
published patent claims for ATI-1701 under the U.S. Application No.
16/982,322 filed on September 18, 2020 and titled “A
Method for Lyophilizing Live Vaccine Strains of Francisella
Tularensis”. The patent covers the composition and preparation
methods for the vaccine through 2039.
This patent was issued to our partners, the National Research
Council of Canada (“NRC”) and protects against the unauthorized use
of methods claimed to lyophilize Francisella tularensis strains,
including Appili’s proprietary live vaccine strain ATI-1701. Appili
licensed the biodefense vaccine candidate ATI-1701 from NRC in
December 2017. The license agreement with NRC grants Appili
exclusive worldwide rights to develop and commercialize ATI-1701.
The new patent protects additional manufacturing methods for the
final drug product.
“This patent protects an improvement in the method of
lyophilizing F. tularensis live vaccine strains, such as the Ft
∆clpB mutant (ATI-1701). The patent also protects a special media
which preserves the viability of the vaccine in a manner which is
clinically useful and allows long-term storage,” said Don Cilla,
Pharm.D., M.B.A., President and Chief Executive Officer of Appili
Therapeutics. “This patent strengthens ATI-1701’s position and the
new methods are expected to allow Appili to further develop a
valuable vaccine that is urgently needed on the market.”
Appili’s development program ATI-1701, for the prevention of
tularemia, has received awards totaling US$14 million from the U.S.
Air Force Academy (“USAFA”). This year, as ATI-1701 early-stage
development activities and regulatory activities progressed, the
Company successfully completed a knowledge transfer and executed a
technology transfer to the Phase 1 Contract Manufacturing
Organization (“CMO”). Appili expects the ATI-1701 CMO to
successfully produce engineering batches and GMP batches in
2024.
Additionally, Appili was granted a pre-IND meeting with the FDA
to discuss ATI-1701’s regulatory, CMC, toxicology, and Phase 1
strategies and expects to receive feedback in early 2024. The goal
of the ATI-1701 program is to evaluate the immunogenicity,
efficacy, and safety of the ATI-1701 vaccine and ultimately submit
a Biological License Application.
The Company also announced that the Company and Bloom Burton
& Co. (“Bloom Burton”) have agreed to amend the terms of the
existing $300,000 bridge loan (the “Bridge Loan”) advanced to the
Company by Bloom Burton in June 2023. Under the amended terms, the
Bridge Loan will now mature on March 31, 2024, subject to
acceleration in connection with certain corporate events.
About ATI-1701
ATI-1701 is the Company’s potential first-in-class vaccine
candidate for the prevention of infection with F. tularensis, the
causative agent of tularemia and a top-priority biothreat. Appili
is developing ATI-1701 as a vaccine to combat F. 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 at least
1,000-fold more infectious than anthrax, experts consider the
aerosolized form to have a high potential for use in a bioterrorism
attack.
Appili secured a US$14M funding commitment for ATI-1701 from
USAFA, who is working in partnership with the Defense Threat
Reduction Agency. These funds along with other potential funding
sources, are anticipated to continue to advance the ATI-1701
program toward an IND submission to the FDA in 2025.
About Appili Therapeutics
Appili Therapeutics is a biopharmaceutical company that is
purposefully built, portfolio-driven, and people-focused to fulfill
its mission of solving life-threatening infectious diseases. 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
an FDA approved ready-made suspension of metronidazole for the
treatment of antimicrobial infections, a vaccine candidate to
eliminate a serious biological weapon threat, and a topical
antiparasitic for the treatment of a disfiguring disease. 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 development plans for
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 the FDA
application and approval process for ATI-1701. 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 the New Drug Application for ATI-1701 may
ultimately not be approved by the FDA, and the other risk factors
listed in the annual information form of the Company dated June 23,
2022 and the other filings made by the Company with the Canadian
securities regulatory authorities (which may be viewed at
www.sedarplus.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/20231214085362/en/
Media: Jenna McNeil, Corporate Affairs and Communications
Manager Appili Therapeutics E: JMcNeil@AppiliTherapeutics.com
Investor Relations: Don Cilla, Pharm.D. M.B.A. Appili
Therapeutics E: Info@AppiliTherapeutics.com
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