February 19, 2021 -- TFF Pharmaceuticals, in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRID), has announced positive preclinical in vitro efficacy data from TFF-formulated biodefense countermeasures utilizing its thin-film freeze-drying (TFFD) technology platform.
In April 2020, the company entered into a three-year cooperative research and development agreement with the USAMRID to investigate TFFD of various biodefense countermeasures against biological warfare to demonstrate the use of needle-free, inhaled treatments that are temperature-insensitive. TFF technology is 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.
The first two countermeasures were TFFD formulated and tested for efficacy with in vitro neutralization assays; they include monoclonal antibodies (mAbs) against filovirus zaire ebolavirus (EBOV) and a recombinant vesicular stomatitis virus (rVSV) vaccine candidate against the alphavirus Venezuelan equine encephalitis virus.
The data showed that the activity of the mAbs and rVSV vaccine candidate were preserved after TFFD; formulation optimization and long-term stability testing are ongoing. The next steps will be in vivo testing in appropriate animal models, according to the company.