TFF Pharmaceuticals Enters into CRADA with the U.S. Army and The Geneva Foundation to Develop Dry Powder Needle-free Medical Countermeasures

AUSTIN, Texas, March 17, 2022 (GLOBE NEWSWIRE) -- 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, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), part of the U.S. Army Medical Research and Development Command and the U.S Army's premier institution and facility for defensive research into countermeasures against biological warfare, and The Geneva Foundation, a non-profit that advances innovative medical research within the U.S. military.

Under the terms of the CRADA, TFF Pharmaceuticals and USAMRIID will evaluate the immune response of a dry powder recombinant Vesicular Stomatitis Virus Severe Acute Respiratory Syndrome Coronavirus-2 Glycoprotein (TFFD-rVSV-SARS2-GP) vaccine formulated using TFF’s Thin Film Freezing technology. Using a well-established preclinical model, USAMRIID will assess the immunogenicity and protective efficacy against SARS-CoV-2 induced by the dry powder formulations when administered intranasally (directly to the site of infection), as compared to the traditional routes of administration (intramuscularly).

“Current medical countermeasures have become less effective in recent months as new COVID-19 variants have emerged,” said Glenn Mattes, President & Chief Executive Officer of TFF Pharmaceuticals. “To slow the emergence of new variants, there is an urgent need for safe, stable, and single-administration vaccines that can be rapidly deployed without the need for cold-chain handling, while maintaining efficacy against variants of concern and other respiratory pathogens.”

TFF Pharmaceuticals announced an initial CRADA with USAMRIID in April 2020 to formulate two different countermeasures using Thin Film Freezing: 1) a monoclonal antibody against alphaviruses (e.g., Venezuelan, Western, and Eastern equine encephalitis viruses) and 2) a recombinant vesicular stomatitis virus (rVSV) vaccine against filoviruses (e.g., Ebola, Marburg). Earlier in 2021, under the existing CRADA, TFF Pharmaceuticals announced positive preclinical data showing the two Thin Film Freezing-formulated biodefense countermeasures maintained efficacy in an in vitro viral neutralization assay. The new study is expected to further validate the approach TFF Pharmaceuticals and USAMRIID are taking to develop broad spectrum countermeasures to protect warfighters against future emerging biological threats.

Andrew Herbert, Ph.D., Branch Chief of Virology at USAMRIID added, “The recombinant vesicular stomatitis virus (rVSV) vaccine platform coupled with TFF’s Thin Film Freezing technology could enable us to develop a single, easily administered and temperature stable countermeasure to protect our warfighters against multiple viral pathogens such as SARS-CoV-2, Ebola, and Marburg.” Dr. Herbert added, “We look forward to continuing our joint exploration into how this novel technology can be used to simplify administration and increase safety and efficacy of biological countermeasures.”

TFF Pharmaceuticals continues to engage with various government and defense contracting agencies to utilize its Thin Film Freezing technology platform to formulate dry powder vaccines and therapeutics for mucosal delivery. TFF’s versatile Thin Film Freezing technology offers an important opportunity to create easy-to-administer and easy-to-deploy needle-free vaccines and therapeutics that could both help maintain broad spectrum biological protection for U.S. warfighters and civilians and enable better preparedness for future pandemics.

“This collaboration reflects our continued commitment to the health and well-being of our service members and global community,” said Geneva’s President & Chief Executive Officer Elise Huszar. “We hope to leverage our expertise in military medical research to accelerate the development of biodefense countermeasures that can be deployed in biologically hostile environments around the globe.”

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 engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety and stability. The company’s versatile Thin Film Freezing (TFF) technology platform has broad applicability to convert any drug, including vaccines, small and large molecules and biologics, into an elegant dry powder ​highly advantageous for inhalation, with improved absorption so drugs can also be delivered to the eyes, nose and topically to the skin. TFF has two lead drug candidates in the clinic: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder, and continues to expand its pipeline by collaborating with a broad array of pharmaceutical companies, academic institutions and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com

About U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
For over 53 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 vaccines, drugs, diagnostics, and training programs that protect both Warfighters and civilians. The Institute's unique science and technology base serves not only to address current threats to our Armed Forces, but is an essential element in the medical response to any future biological threats that may confront our nation. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command. For more information, visit www.usamriid.army.mil.

About The Geneva Foundation
The Geneva Foundation is a 501(c)3 non-profit organization that advances military medicine through innovative scientific research, exceptional program management, and a dedication to U.S. service members and veterans, their families, and the global community. Geneva is proud to have over 25 years of experience in delivering full-spectrum scientific, technical, and program management expertise in the areas of federal grants, federal contracts, industry-sponsored clinical trials, and educational services. http://www.genevaUSA.org.

SAFE HARBOR
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform and its dry powder version of TFFD-rVSV-SARS2-GP, 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 clinical testing or obtain pre-market approval of a dry powder version of TFFD-rVSV-SARS2-GP, (ii) no drug product incorporating the TFF 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 government or defense agencies or large pharmaceutical companies for the development of a drug product incorporating the TFF 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 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.

[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.]

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