Ultimovacs ASA announced the conclusion of the exploratory Phase I TENDU study (NCT04701021) of the company?s vaccine technology platform, Tetanus-Epitope Targeting (TET), in patients with prostate cancer. The purpose of the study was to provide an initial safety assessment of a TET vaccine as a basis for future TET platform development. TET is a new therapeutic vaccine concept for activating specific T cells that can target and eradicate cancer cells.

The TENDU trial is a first-in-human, dose-escalation trial with a TET therapeutic cancer vaccine, with the objective of generating initial safety and immune activation data. The trial investigated a prostate cancer-specific therapeutic vaccine in patients experiencing relapse after radical prostatectomy. Twelve patients were enrolled in the trial, which was conducted at the Oslo University Hospital.

Three dose levels were explored. Three patients were treated with each of the two lower doses (40 and 400 microgram), while six patients received the high dose (960 microgram). The dose range investigated in the study was considered safe.

No serious adverse reactions were reported, and there were no indications of systemic risks of cytokine release or complement activation.  No dose-limiting toxicities were observed, indicating a potential for increasing the dose of tetanus-based vaccines in future clinical studies. Vaccine specific T cell responses were observed indicating immune activation. Further results from the study will be presented in a peer-reviewed publication.

In parallel with the TENDU study, Ultimovacs is conducting activities to develop and explore the potential of the TET vaccine technology platform. Preclinical experiments support the TET concept of targeted delivery of antigens and adjuvant signals to antigen presenting cells. The combination of exploratory research using Ultimovacs?

conjugation technology, significant progress made in the manufacturing process and the clinical data provide a valuable basis for potential expansion of Ultimovacs? pipeline. Ultimovacs?

will continue the ongoing TET non-clinical activities. Future development of TET-based vaccine candidates in prostate cancer and other indications will take into consideration the evolution of the therapeutic landscape and medical needs in different tumor types.