Ultimovacs has completed treatment of the second dose cohort in the Phase I TENDU trial.
The study is designed to evaluate the company’s Tetanus-Epitope Targeting (TET)-platform in patients with prostate cancer.
The Drug Safety Monitoring Board (DSMB), a group of experts set up to monitor patient safety during a clinical trial, found no safety concerns related to the first two dose cohorts. A total of six patients have been treated; three in each dose level (40 and 400 μg). The conclusion from the DSMB enables the dose escalation study to proceed with enrollment of patients in the third and last dose cohort (960 μg).
“The continued progress of the Phase 1 safety evaluation of the TET platform is very encouraging,” says Jens Bjørheim, Chief Medical Officer of Ultimovacs. “Our main focus at this stage in the TENDU study is the safety and tolerability of our new therapeutic vaccine candidate for prostate cancer, a cancer type where the unmet medical need is high. This result also feeds into Ultimovacs’ plans for the development of the TET platform more broadly as an extension of the company’s pipeline.”
The TENDU study
The TENDU study is a first-in-human, dose-escalation study designed to generate initial safety and immune activation data. This study is investigating a prostate cancer-specific therapeutic TET-based vaccine in patients who have relapsed following radical prostatectomy.
Photo of Jens Bjørheim, Chief Medical Officer of Ultimovacs