Ultimovacs Expands High Dose Cohort Size in TENDU Phase I Prostate Cancer Trial after Safety Review
- The TENDU interim safety results from nine patients show no safety concerns
- Trial extended to enroll up to three additional patients at the highest dose level
- TENDU designed to evaluate the Tetanus-Epitope Targeting (TET)-platform in patients with prostate cancer
Oslo, 18August 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, has completed treatment of three patients at the highest dose cohort in the phase I TENDU trial without any safety concerns. Based on these results, the company plans to enroll up to three additional patients at the highest dose level.
The Drug Safety Monitoring Board, a group of experts set up to monitor patient safety during a clinical trial, found no safety concerns in any of the three dose cohorts. A total of nine patients have now been treated; three at each dose level (40 mcg, 400 mcg and 960 mcg). Ultimovacs plans to enroll up to three additional patients at the highest dose level (960 mcg) providing a broader base of early safety data for the TET platform.
“We are very encouraged by the continuing progress of the phase I safety evaluation of the TET platform. With no safety concerns at any dose, we have decided to enroll up to three additional patients at the highest dose level, providing extended data from TENDU on the safety and tolerability of TET for prostate cancer patients.” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “The data from TENDU, in turn, may provide insights that are useful in Ultimovacs’ broader plans for the development of the TET platform.”
The TET platform, an innovative adjuvant technology, allows for the design and production of multiple therapeutic cancer vaccines. It can potentially be used to strengthen and increase T cell responses to cancer cells by targeting antigens that are 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 earlier stage of their disease.
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.
About the TET-platform
All vaccines consist of two components, adjuvant and antigen. The adjuvant activates the immune system so that a relevant immune response can occur. The antigen directs the quality of the immune response. Together the adjuvant and the antigen ensure a specific and effective immune response.
The Tetanus-Epitope Targeting (TET)-platform offers an approach to strengthen and increase T cell responses against cancer-specific peptides by combining cancer-specific antigens and vaccine adjuvant in the same conjugated molecule, allowing for a beneficial safety profile and simplifying administration. The platform generates new, first-in-class cancer vaccine candidates that harness pre-existing antibody responses resulting from standard tetanus vaccinations. TET vaccine candidates can be tailored to many types of cancer, and to infectious diseases.
The TENDU clinical trial (NCT04701021) is a first-in-human, phase I study and the first clinical trial of a vaccine from Ultimovacs' Tetanus-Epitope Targeting (TET)-platform. The trial is being conducted at the Oslo University Hospital, Norway, and evaluates the safety of the vaccine in prostate cancer patients who have relapsed after radical prostatectomy. The primary objective of the study is to evaluate the safety and tolerability of three different doses of the vaccine. Patients will receive the vaccine prior to obtaining standard-of-care treatment consisting of radiation and antihormone therapy and will be followed for 6 months after the last dose of the vaccine to assess immunological responses such as the activation of T cells and anti-tumor activity.
Ultimovacs is an immunotherapy company developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in 85-90% of cancers in all stages of tumor growth. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and increase anti-tumor responses. With a broad phase II program in five cancer indications enrolling more than 650 patients, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types, in combination with other immunotherapies, for patients with unmet needs. Ultimovacs’ second technology approach, based on the proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant in the same molecule and entered phase I studies in 2021.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Phone: +47 908 92507
Anne Worsøe, Head of IR & Communication
Phone: +47 90686815
Mary-Ann Chang, LifeSci Advisors
Phone: +44 7483 284 853
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on 18August, 2022 at 08:00 CET.
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