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

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