FGI-101-1A6 is a fully human monoclonal antibody that targets a host protein, TSG101, which is uniquely exposed on the surface of virus-infected cells. FGI-101-1A6 targets and eliminates infected cells via induction of normal host defense mechanisms (ADCC and CDC).
Functional Genetics has demonstrated that FGI-101-1A6 can selectively identify and 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), Parainfluenza virus (PIV), Herpes (HSV-1 and HSV-2) and Ebola virus.
FGI has successfully completed a Phase 1A First-in-Human Safety Study of FGI-101-1A6 for an influenza indication. The Phase 1A clinical trial was a single-center, double-blind, placebo-controlled, single-dose escalation study designed to demonstrate safety and determine pharmacokinetics of a single dose in healthy adult volunteers. A total of 48 volunteers were enrolled and randomized to 6 dose level cohorts, ranging from 0.0017 mg/kg to 10 mg/kg (36 received FGI-101-1A6, 12 received placebo). Results of this Phase 1A study indicate that FGI-101-1A6, administered as an intravenous infusion in healthy adult volunteers, was well tolerated at all doses and support continued clinical investigation of FGI-101-1A6. Additionally, FGI-101-1A6’s long half life is consistent with previously reported estimates for other monoclonal antibodies. FGI expects to initiate a Phase 2 proof-of-concept study in the near future, exploring FGI-101-1A6 in a suitable infectious disease population.”
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-101-1A6. Note that the FGI-101-1A6 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-101-1A6. Studies with human blood cells demonstrate that FGI-101-1A6 treatment can eliminate virus-infected cells and prevent the propagation of HIV in cell-based assays.