TFF Pharmaceuticals Announces Positive Preclinical Results with Two Biodefense Countermeasures for the United States Army Med...
February 19 2021 - 8:30AM
Business Wire
Company’s Thin Film Freezing maintained
efficacy for two different biodefense countermeasures against
Alphaviruses and Filoviruses
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative drug products based on its patented thin-film
freeze-drying (TFFD) technology platform, today announced that, in
collaboration with the United States Army Medical Research
Institute of Infectious Diseases (USAMRIID), the Company obtained
positive preclinical in vitro efficacy data from TFF formulated
biodefense countermeasures.
In April of 2020, TFF Pharmaceuticals and USAMRIID, part of the
U.S. Army Medical Research and Development Command, the U.S. Army’s
premier institution and facility for defensive research into
countermeasures against biological warfare, entered into a 3-year
Cooperative Research and Development Agreement (CRADA) to
investigate TFFD of various biodefense countermeasures to
demonstrate the use of these formulations as needle-free, inhaled
treatments that are temperature-insensitive. The first two
countermeasures, a monoclonal antibody (mAbs) against Ebolavirus
Zaire (EBOV) and a recombinant vesicular stomatitis virus (rVSV)
vaccine candidate against Venezuelan equine encephalitis virus
(VEEV), were TFFD formulated and tested for efficacy in a
well-established in vitro neutralization assay. Data showed that
the activity of the mAbs and rVSV vaccines were preserved after
TFFD. Formulation optimization and long-term stability testing are
ongoing. Next steps will be in vivo testing in appropriate animal
models.
“This data utilizing our TFFD technology to reformulate
currently developed and characterized medical countermeasures
against EBOV and VEEV is an important milestone,” said Glenn
Mattes, CEO of TFF Pharmaceuticals. “Most countermeasures are
parenterally delivered, require trained personnel for
administration and are temperature sensitive. There is an urgent
need to develop technologies to improve biodefense countermeasures
to better protect the warfighter.”
“Great strides have been made to develop licensed
countermeasures against Department of Defense (DoD) select agents
of interest, such as Ebolavirus Zaire (EBOV) and Venezuelan equine
encephalitis (VEEV),” said John M. Dye, Jr., Viral Immunology
branch chief, USAMRIID. “An alternate route of administration that
bypasses the need for cold chain control and administration by
specialized personnel could be critical in the protection of our
defense forces in biologically hostile environments around the
globe.”
TFF continues to engage and collaborate with various government
and defense contracting agencies in an effort to utilize the
Company’s TFFD technology platform to formulate dry powder vaccines
and therapeutics for delivery via reconstitution, or for lung or
nasal inhalation.
About the U.S. Army Medical Research Institute of Infectious
Diseases:
For over 50 years, USAMRIID has provided leading edge medical
capabilities to deter and defend against current and emerging
biological threat agents. The Institute is the only laboratory in
the Department of Defense equipped to safely study highly hazardous
viruses requiring maximum containment at Biosafety Level 4.
Research conducted at USAMRIID leads to medical solutions –
vaccines, drugs, diagnostics, information, and training programs –
that benefit both military personnel and civilians. Established in
1969, the Institute plays a key role as the lead military medical
research laboratory for the Defense Threat Reduction Agency’s Joint
Science and Technology Office for Chemical and Biological Defense.
USAMRIID is a subordinate laboratory of the U.S. Army Medical
Research and Development Command. For more information, visit
www.usamriid.army.mil. The information contained in this press
release does not necessarily reflect the position or the policy of
the Government and no official endorsement should be inferred.
About TFF Pharmaceuticals’ Thin Film Freezing technology
platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was
designed to improve the solubility and absorption of poorly
water-soluble drugs and is particularly suited to generate dry
powder particles with properties targeted for inhalation delivery,
especially to the deep lung, an area of extreme interest in
respiratory medicine. The TFF process results in a “Brittle Matrix
Particle,” which possesses low bulk density, high surface area, and
typically an amorphous morphology, allowing the particles to
supersaturate when contacting the target site, such as lung tissue.
Based upon laboratory experiments, the aerodynamic properties of
the particles are such that the portion of a drug deposited to the
deep lung has the potential to reach as high as 75 percent.
About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company focused on developing and commercializing innovative drug
products based on its patented Thin Film Freezing, or TFF,
technology platform. Early testing confirms that the TFF platform
can significantly improve the solubility and absorption of poorly
water-soluble drugs, a class of drugs that comprises approximately
one-third of the major pharmaceuticals worldwide, thereby improving
their pharmacokinetics. TFF Pharmaceuticals has two lead drug
candidates: Voriconazole Inhalation Powder and Tacrolimus
Inhalation Powder. The Company plans to add to this pipeline by
collaborating with large pharmaceutical partners. The TFF Platform
is protected by 42 patents issued or pending in the US and
internationally. To learn more about TFF Pharmaceuticals and its
product candidates, visit the Company’s website at
https://tffpharma.com
SAFE HARBOR
This press release contains forward-looking statements regarding
TFF Pharmaceuticals, Inc., including the benefits of the Company’s
TFFD platform and its dry powder versions of voriconazole and the
Company’s plans to add to its existing pipeline of product
candidates. Those forward-looking statements involve known and
unknown risks, uncertainties and other factors that could cause
actual results to differ materially. Among those factors are: (i)
the risk that the Company may not be able to successfully conclude
preclinical testing of its EBOV mAbs or rVSV vaccine or obtain
pre-market approval of either product candidate, (ii) no drug
product incorporating the TFFD platform has received FDA pre-market
approval or otherwise been incorporated into a commercial drug
product, (iii) the Company has no current agreements or
understandings with any large pharmaceutical companies for the
development of a drug product incorporating the TFFD Platform, (iv)
the risk that the Company will not be able to conclude a long-term
commercial agreement with any third-party, and (v) those other
risks disclosed in the section “Risk Factors” included in the
Company’s prospectus supplement filed with the SEC on December 8,
2020. TFF Pharmaceuticals cautions readers not to place undue
reliance on any forward-looking statements. TFF Pharmaceuticals
does not undertake, and specifically disclaims, any obligation to
update or revise such statements to reflect new circumstances or
unanticipated events as they occur, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210219005285/en/
Company: Glenn Mattes President and CEO TFF
Pharmaceuticals, Inc. gmattes@tffpharma.com 737-802-1973 Kirk
Coleman Chief Financial Officer TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com 817-989-6358 Investor Relations and
Media: Paul Sagan LaVoieHealthScience
psagan@lavoiehealthscience.com 617-953-4779
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