The clinical trial is a randomised, double-blind, placebo-controlled phase 1 dose-escalation study of delNS/E6E7 in up to 20 women. The trial’s primary endpoint is to evaluate safety and to determine the dosage for the subsequent phase 2. First results obtained in the clinical trial have now confirmed the tolerability of the delNS-based vector delNS/E6E7 after subcutaneous administration. In the course of the study, secondary endpoints such as the removal of the HPV 16 infection and the elimination of already existing tumours and tumour cells will also be assessed.

“The elimination of HPV 16 infections mediated by the delNS vector delNS/E6E7 could prevent millions of conisations of precancerous lesions and up to 150,000 deaths due to cervical cancer annually. HPV 16 infection is highly prevalent and persistent, and no early-stage treatment is available. We want to change this,” explains Thomas Muster, CEO of BlueSky Immunotherapies