TFF Pharmaceuticals Announces R&D Collaboration with the University of Georgia for a Universal Influenza Vaccine

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 it has entered into a research collaboration with the University of Georgia’s Center for Vaccines and Immunology (CVI), along with the University of Texas at Austin (UT Austin), to evaluate the immunogenicity and efficacy of universal influenza vaccines following Thin Film Freezing.

Researchers in the University of Georgia’s CVI are world-leaders in vaccine development. In 2019, the National Institutes of Health awarded University of Georgia researchers up to $130 million to develop a new universal flu vaccine designed to protect against multiple strains of influenza virus in a single dose.

Under the terms of the collaboration, TFF Pharmaceuticals, along with UT Austin and the University of Georgia’s CVI will collaborate to investigate TFF-formulated CVI recombinant universal influenza vaccines. As part of this collaboration, UT Austin will formulate hemagglutinin (HA) and neuraminidase (NA) proteins, with and without adjuvant, using the Company’s Thin Film Freezing technology. The University of Georgia’s CVI will then evaluate the ability of these TFF formulated compounds to elicit broadly reactive immune responses and potentially provide longer-lasting protection against a wider variety of influenza viruses, in a pre-clinical challenge model.

Influenza is a contagious viral infection that attacks the respiratory system infecting the nose, throat and sometimes the lungs. According to the U.S. Centers for Disease Control and Prevention (CDC), influenza has resulted in tens of thousands of deaths annually in the US since 2010, and hundreds of thousands of deaths globally.

“Both seasonal and pandemic influenza continue to be major public health threats,” said Glenn Mattes, CEO of TFF Pharmaceuticals. “There is a critical unmet need to develop universal influenza vaccines to address genetic drifting of the virus that can impact the effectiveness of vaccines on patients and address the long production timelines that occur each year.”

“Our goal is to develop vaccines that are broadly protective against most of the versions of influenza that infect humans, and particularly for those most vulnerable people in our population,” said Ted M. Ross, Director of the University of Georgia Center for Vaccines and Immunology. “Ultimately, the vaccines we hope to develop could protect against multiple forms of influenza, even those we don’t know exist yet.”

TFF Pharmaceuticals’ testing confirms that Thin Film Freezing maintains a potential vaccine’s particle size distribution and immunogenicity, is robust for extended periods at room temperature, withstands unintentional freezing, and can be stored and shipped free of cold-chain handling, displays extended stability for stockpiling – dry powder storage over liquid, and provides for needle-free vaccination (nasal or inhalation administration).

“Combining liquid-based compounds to develop more broadly protective vaccines is often problematic,” said Robert O. Williams, Division Head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery. “Thin film freezing these compounds may allow them to be combined more readily into a dry powder, be shelf stable, and be delivered via lung or nasal inhalation.”

TFF Pharmaceuticals continues to engage with various government and defense contracting agencies in an effort to utilize the Company’s TFF technology platform to formulate dry powder vaccines for delivery via reconstitution or lung inhalation or nasal inhalation.

About the University of Georgia’s Center for Vaccines and Immunology

The University of Georgia (UGA) Center for Vaccines and Immunology (CVI) brings together a diverse, world-renowned team of experts in the areas of infectious disease, immunology, virology, microbiology, and public health. The university’s world-class biocontainment research resources are coupled with the expertise of CVI investigators who focus on translational studies to test and assess the efficacy of vaccines and immunotherapies in development by industry, governmental and academic institutions. Dr. Ross, Georgia Research Alliance Eminent Scholar and Professor of Infectious Diseases at the University of Georgia. is also the Project Director of the Collaborative Influenza Vaccine Innovation Center award from the National Institutes of Allergy and Infectious Diseases, which is testing broadly protective influenza vaccine for next generation flu vaccines for people and the models needed to predict their effectiveness.

About the University of Texas at Austin

The University of Texas at Austin College of Pharmacy is one of the premier institutions of pharmaceutical education and research in the country. The Williams’ Lab at the College’s Division of Molecular Pharmaceutics and Drug Delivery, headed by Robert O. Williams III, Ph.D., focuses on the formulation development, optimization, and delivery of small organic compounds, peptides, and proteins by a variety of technologies, including depot drug delivery, oral drug delivery and pulmonary/nasal/ophthalmic drug delivery. Significant effort is devoted to research to enhance drug solubility and dissolution through novel particle engineering technologies, including thin film freezing and precipitation processes, and thermal processes such as hot melt extrusion and KinetiSol Dispersing.

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 39 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 TFF platform and its dry powder versions of influenza vaccines. 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: (1) there can be no assurance that the Company’s research collaboration with University of Georgia’s CVI and UT Austin will lead to a commercial dry powder version of a universal influenza vaccine, (2) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (3) the Company has no current agreements or understandings with any large pharmaceutical companies or others for the development of a drug product or vaccine incorporating the TFF Platform and (4) those other risks disclosed in the section “Risk Factors” included in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 26, 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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