Prostate Cancer Vaccine Candidate Phase 1 Study Progresses
Norway-based Ultimovacs ASA today announced it had completed treatment of the second dose cohort in a Phase I clinical study (TENDU) designed to evaluate the Tetanus-Epitope Targeting (TET)-platform in patients with prostate cancer.
A total of six patients have been treated, three in each dose level (40 and 400 μg).
The Drug Safety Monitoring Board (DSMB) found no safety concerns related to the first two dose cohorts.
The conclusion from the DSMB enables the dose-escalation study to proceed with the 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," said Jens Bjørheim, Chief Medical Officer of Ultimovacs, in a press release issued on February 3, 2022.
"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 TET platform, an innovative adjuvant technology, allows for designing and producing multiple therapeutic cancer vaccines.
It can potentially be used to strengthen and increase T cell responses to cancer cells by targeting antigens specific to one type of cancer or common to many tumor types.
The vaccine used in the TENDU study contains prostate cancer-specific antigens.
By combining cancer antigens and the vaccine adjuvant in the same molecule, the TET platform can generate vaccine candidates with a potential beneficial safety and administration profile, including presenting an opportunity to treat patients at an early stage of their disease.
The TENDU study is a first-in-human, dose-escalation study designed to generate initial safety and immune activation data. In addition, this study investigates a prostate cancer-specific therapeutic TET-based vaccine in patients who have relapsed following radical prostatectomy.
Ultimovacs is developing immune-stimulatory vaccines to treat a broad range of cancers.