ozarlimogene inteplasmid + pembrolizumab

IFx-2.0 + Keytruda is an investigational combination immunotherapy regimen being developed by TuHURA Biosciences. It pairs ozarlimogene inteplasmid (IFx-2.0), an intralesional plasmid DNA-based innate immune agonist, with pembrolizumab (Keytruda), an intravenously administered anti-PD-1 monoclonal antibody. Ozarlimogene inteplasmid encodes a fragment of the highly immunogenic Streptococcus pyogenes Emm55 cell surface protein. Upon intratumoral injection, transfection of tumor cells leads to the expression of Emm55 on the cell surface, mimicking a bacterium. This bacterial 'flag' is recognized by Toll-like receptor 2 (TLR2) on antigen-presenting cells, activating the TLR2-MyD88 pathway to prime and activate tumor-specific CD8+ T cells. When combined with pembrolizumab, this local immune priming is designed to overcome primary resistance to immune checkpoint inhibitors. The combination is currently being evaluated in a Phase 3 registration trial under a Special Protocol Assessment (SPA) with the FDA as a first-line treatment for checkpoint inhibitor-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC).

Brand names

Keytruda Qlex

Other names

IFx-2.0 + KeytrudaIFx-2.0 + pembrolizumabIFx-Hu2.0 + KeytrudaIFx-Hu2.0 + pembrolizumabozarlimogene inteplasmid + KeytrudapAc/emm55 + KeytrudapAc/emm55 + pembrolizumab