TFF Pharmaceuticals Awarded Contract under DARPA’s Next-Generation Personalized Protective Biosystems Program for U.S. Warf...
April 13 2021 - 9:00AM
Business Wire
Company’s Thin Film Freezing platform to be
developed for use in rapidly neutralizing chemical and biological
threats at vulnerable tissue barriers to increase soldier
protection and decrease operational burden
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative drug products based on its patented Thin Film Freezing
(TFF) technology platform, today announced that Leidos, a leading
Fortune 500 information technology, engineering and science
solutions and services leader, has awarded the Company a
subcontract to participate in the Personalized Protective
Biosystems (PPB) Program to develop next-generation chemical and
biological protection for U.S warfighters and stability
operators.
The PPB research program, overseen by the Defense Advanced
Research Projects Agency (DARPA), will develop an integrated system
that simultaneously reduces protective equipment needs while
increasing protection for the individual against existing and
future chemical and biological (CB) threats. This will be achieved
through lightweight materials that protect the warfighter or
stability operator from exposure to CB threats, while
simultaneously providing a second layer of protection, at the
tissue barrier, with bio-molecular, commensal organisms, or other
technologies that protect the skin, eyes, and airway from CB
threats. Successful PPB technologies could change how the military
and public health communities perform in unpredictable threat
environments.
Under the 60-month, three-phase subcontract with Leidos, TFF
Pharmaceuticals will utilize its Thin Film Freezing platform to
formulate a series of countermeasures designed to neutralize
chemical and biological agents at the site of vulnerable tissue
barriers, including the skin, the eyes and the respiratory system.
Phase I of the program will include the development and validation
of methods to quantify countermeasures and the formulation of
countermeasures for delivery to the various tissue. Phase II will
include the scale up manufacturing of countermeasure formulations
for preclinical studies, demonstration of the deliverability of
countermeasure products and meeting with the FDA to determine a
path to GMP production of the countermeasure formulations,
nonclinical safety testing, and a pathway to human clinical
testing. Phase III will include plans for scale-up manufacturing
for human safety trials.
“We are very pleased that Leidos selected our Thin Film Freezing
platform to help develop the next generation of chemical and
biological protective technologies for our frontline warfighters
and stability operators,” said Glenn Mattes, President and CEO of
TFF Pharmaceuticals. “The Personalized Protective Biosystems
program will develop groundbreaking technology and we are proud to
be able to play a role in this program that will have strategic
impact to this country for years to come.”
About Leidos
Leidos is a Fortune 500® information technology, engineering,
and science solutions and services leader working to solve the
world's toughest challenges in the defense, intelligence, homeland
security, civil, and health markets. The company's 37,000 employees
support vital missions for government and commercial customers.
Headquartered in Reston, Va., Leidos reported annual revenues of
approximately $11.09 billion for the fiscal year ended January 3,
2020. For more information, visit www.leidos.com.
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 Tac-Lac 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 Company’s participation in
the Personalized Protective Biosystems (PPB) Program and the
benefits of the Company’s TFF platform. 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 PPB not successfully develop
the proposed countermeasures utilizing the Company’s TFF platform,
(ii) the risk that Leidos and the Company may not be able to
successfully conclude clinical testing or obtain pre-market
approval of the proposed countermeasures utilizing the Company’s
TFF platform, (iii) no drug product incorporating the TFF platform
has received FDA pre-market approval or otherwise been incorporated
into a commercial drug product, and (iv) those other risks
disclosed in the section “Risk Factors” included in the Company’s
2020 Annual Report on Form 10-K filed with the SEC on March 10,
2021. 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.
“This Press Release was cleared by DARPA under Distribution
Statement "A" (Approved for Public Release, Distribution
Unlimited).”
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210413005710/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 617-865-0041
TFF Pharmaceuticals (NASDAQ:TFFP)
Historical Stock Chart
From Mar 2024 to Apr 2024
TFF Pharmaceuticals (NASDAQ:TFFP)
Historical Stock Chart
From Apr 2023 to Apr 2024