TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented thin-film freeze-drying (TFFD) technology platform, today announced positive preclinical in vitro efficacy data from TFF formulated biodefense countermeasures.
The data was collected in collaboration with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) as part of a 3-year Cooperative Research and Development Agreement (CRADA) initiated in April 2020 to investigate TFFD of various biodefense countermeasures to demonstrate the use of these formulations as needle-free, inhaled treatments that are temperature-insensitive.
The first two countermeasures, a monoclonal antibody (mAb) against Ebolavirus Zaire (EBOV) and a recombinant vesicular stomatitis virus (rVSV) vaccine candidate against Venezuelan equine encephalitis virus (VEEV), were TFFD formulated and tested for efficacy in a well-established in vitro neutralization assay. Data showed that the activity of the mAb and rVSV vaccines were preserved after TFFD. Formulation optimization and long-term stability testing are ongoing. Next steps will include in vivo testing in appropriate animal models.
“This data utilizing our TFFD technology to reformulate currently developed and characterized medical countermeasures against EBOV and VEEV is an important milestone,” said Glenn Mattes, CEO of TFF Pharmaceuticals. “Most countermeasures are parenterally delivered, require trained personnel for administration and are temperature sensitive. There is an urgent need to develop technologies to improve biodefense countermeasures to better protect the warfighter.”
“Great strides have been made to develop licensed countermeasures against Department of Defense (DoD) select agents of interest, such as Ebolavirus Zaire (EBOV) and Venezuelan equine encephalitis (VEEV),” said John M. Dye, Jr., Viral Immunology branch chief, USAMRIID. “An alternate route of administration that bypasses the need for cold chain control and administration by specialized personnel could be critical in the protection of our defense forces in biologically hostile environments around the globe.”
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.