HiFiBiO Therapeutics has announced that the first patient has been dosed with HFB200301, a monoclonal antibody in combination with tislelizumab for the treatment of advanced solid tumor indications preselected by HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform. The Phase 1a/b study will investigate the safety and tolerability of this combination therapy, and data from the trial will inform combination dose and dosing regimen, further indication selection, and biomarker strategy.
HiFiBiO is applying a biomarker strategy by leveraging its DIS® platform to select indications that may benefit the most from HFB200301 as a monotherapy as well as combination therapy. Tislelizumab is an investigational humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages. In pre-clinical studies, binding to Fcγ receptors on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.