TFF Pharmaceuticals Announces Positive Preclinical Results with University of Georgia Universal Influenza Vaccines

·8 min read

Company’s Thin Film Freezing dry powder was equivalent to the liquid universal influenza formulated vaccine in preclinical immunogenicity and efficacy testing

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 in collaboration with the University of Georgia’s (UGA) Center for Vaccines and Immunology (CVI) obtained positive preclinical immunogenicity and efficacy data from TFF formulated UGA universal Influenza hemagglutinin (HA) recombinant vaccines.

In April of 2020, TFFP and the University of Georgia’s CVI entered into a Research and Development Agreement to test the immunogenicity and efficacy of universal influenza HA recombinant vaccines following the TFF process. Animals were vaccinated with HA vaccines with or without adjuvants and challenged with H1N1 and H3N2 influenza viruses. The TFF HA vaccines elicited equivalent neutralizing antibodies and protection against influenza virus infection compared to liquid formulations. Currently, the level of neutralizing antibodies and amount of virus in the lung are being analyzed, in addition to long term stability testing of the TFF HA vaccine.

Researchers in the University of Georgia’s CVI are world-leaders in vaccine development. In 2019, the National Institutes of Health awarded UGA 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.

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 results in tens of thousands of deaths annually in the US since 2010 and hundreds of thousands of deaths globally.

"Based on these results, we believe the TFF process and resulting dry powder allows protein vaccines to be more stable and long-lasting than in liquid solution, therefore improving stability and removing logistical cold chain challenges," said Glenn Mattes, CEO of TFF Pharmaceuticals. "Unfortunately, there is a significant financial burden considering that cold-chain storage alone accounts for most of the vaccination cost. There is an urgent need to develop technologies that would eliminate the cold-chain and allow for better drug delivery options."

"Our goal is to identify vaccines that are broadly protective against most variants of the influenza virus that infect humans, particularly for those populations that are most vulnerable and susceptible to the virus," said Ted M. Ross, Director of the University of Georgia Center for Vaccines and Immunology. "Hand-in-hand with that goal is to develop a delivery mechanism that can make the vaccine easier to ship, store and administer to this population around the globe. The results observed with Thin Film Freezing converting our liquid influenza HA vaccine to a dry powder can bring us closer to achieving this goal."

TFF Pharmaceuticals’ testing suggests 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).

"These results further add supporting evidence that Thin Film Freezing indeed provides a method to convert liquid forms of vaccines that require cold chain storage into a much more stable dry powder form for ultimate use," said Robert O. Williams III, Division Head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery. "Being able to overcome the challenges of liquid vaccine storage and provide a more stable dry powder form of both traditional vaccines and the newer breakthrough biologics-based vaccines is essential for their worldwide distribution."

TFF Pharmaceuticals is in discussions with various government and defense contracting agencies in an effort to utilize the Company’s TFF technology platform to formulate dry powder vaccines including COVID-19 and other countermeasures in development for delivery via reconstitution or mucosal (lung 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 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 TFF platform and its dry powder versions of UGA’s universal Influenza hemagglutinin (HA) recombinant vaccines and the Company’s plans to formulate other dry powder 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: (i) the risk that results obtained in preclinical studies of the HA vaccines may not be indicative of results obtained in future clinical trials; (ii) the risk that the Company’s dry powder formulation of the HA vaccines may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iii) the risk that the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of the HA vaccines, (v) no drug or vaccine product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug or vaccine product incorporating the TFF Platform, (vii) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (viii) 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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Contacts

Company Contacts:
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 Contact:
Paul Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-953-4779