TFF Pharmaceuticals, Inc., 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, PhD, 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. 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.”