TSG101 is normally is restricted to the inside of cells, where it is regulates the movement of proteins. During viral infection, TSG101 is “hijacked” by viral proteins and sent to the cell surface. In doing so, TSG101 is exposed on the outer cell membrane and FGI has shown that TSG101 can be targeted using monoclonal antibodies.
FGI-101 is a fully-human monoclonal antibody product, which can selectively recognize and eliminate virus-infected cells. The product functions by recruiting normal host defense mechanisms to kill virus-infected cells before they can release virus.
Functional Genetics has demonstrated that FGI-101 can selectively identify or eliminate cells that have been infected with many virus types, including HIV-1 (including drug-resistant HIV), all forms of Influenza (both seasonal and pandemic), Respiratory Syncytial Virus (RSV), Parainfluenza virus (PIV), Herpes (HSV-1 and HSV-2) and Ebola virus.
The Company intends to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) in 1Q10.
Shown is microscopic assessment of TSG101 on cells that have been infected with a circulating strain of pandemic (avian) influenza. The exposure of TSG101 on the surface of infected cells is shown in green. (Blue identifies cell nuclei). TSG101 is only found on infected cells and this can provide a way to selectively eliminated these cells using monoclonal antibodies.
Broad-Spectrum Potential of FGI-101. Note that the FGI-101 monoclonal antibody can selectively identify (and eliminate) cells that have been infected with many different and unrelated virus types.
Elimination of HIV-Infected Cells by FGI-101. Studies with human blood cells demonstrate that FGI-101 treatment can eliminate virus-infected cells and prevent the propagation of HIV in cell-based assays.