(53) investigation on a treatment option for cervical cancer caused by persisting hpv16 infections: phase 1 dose-escalation study of immunotherapy with delnse6e7 in hpv-16 infected women with normal cytology, cin1 or cin2

Abstract Objectives Assessment Methods randomised, double-blind, 1:3 placebo-controlled, phase 1 dose-escalation study in up to 36 subjects. Results 24 otherwise healthy women with persistent HPV 16 infections were randomised, one was excluded and 17 patients have completed the study. 6 patients are currently in the treatment phase of the clinical trial. The study is still ongoing and open for recruitment. Preliminary results will be presented at the ESSM 2023. Conclusions Introduction/Conclusion: Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Most sexually active individuals are exposed trough lifetime, but 90% of HPV infections usually recover within a few months. A small proportion of infections with high-risk types of HPV virus subtypes can persist and progress to cancer. Thus persistent HPV16 infection cause 55 % of cervical cancer world-wide, which is most often diagnosed between 35 and 44 years. Regardless of HPV vaccination status there is no treatment for persistent HPV16 infections, which causes not only a physiological but also a psychological burden. Immune therapy with delNSE6E7, which has been effective against papilloma virus induced cancer in horses may offer future treatment options for persisting HPV16 infections preventing development of cervical, oropharyngeal or anal cancer in humans. Conflicts of Interest Michaela Bayerle-Eder is involved in patient recruitment for BlueSkyGmbH, which developed delNSE6E7.