Drug intelligence / Profile preview

IFx-Hu2.0 + pembrolizumab

Development stage
Unknown
Lead developer
TuHURA Biosciences
Modality
DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Prophylactic Vaccines → Vaccines & Immunotherapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intratumoral, Intravenous
01

Overview

**IFx-Hu2.0 + pembrolizumab** is an investigational combination therapy comprising IFx-Hu2.0, a personalized in situ cancer vaccine, with pembrolizumab (Keytruda), an anti-PD-1 monoclonal antibody checkpoint inhibitor. IFx-Hu2.0 consists of a plasmid DNA encoding an immunogenic bacterial protein (Emm55 segment) that is delivered intratumorally, causing tumor cells to express this foreign antigen and thereby activating the innate and adaptive immune responses against tumor cells. Pembrolizumab blocks the PD-1 immune checkpoint pathway, releasing T cell inhibition to promote anti-tumor activity. This combination is under study primarily for its ability to overcome primary resistance to checkpoint inhibitors, particularly in advanced or metastatic Merkel cell carcinoma (MCC), and potentially in cutaneous squamous cell carcinoma (cSCC) and melanoma. Early-phase clinical data indicate that IFx-Hu2.0 can stimulate both B and T cell antitumor responses, and the combination is being evaluated in a Phase 3 trial as first-line therapy in checkpoint inhibitor–naïve advanced MCC patients[2][4][6][8].

Other names
IFx-Hu2.0 and pembrolizumabIFx-Hu-2.0 and pembrolizumabIFx-Hu 2.0 and pembrolizumabIFx-2.0 and pembrolizumabIFx2.0 and pembrolizumabIFx 2.0 and pembrolizumabIFx-Hu2.0 plus pembrolizumabIFx-Hu-2.0 plus pembrolizumabIFx-Hu 2.0 plus pembrolizumab
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)

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