Ultimovacs Begins Dosing of Second Cohort in Phase I TENDU Study Investigating Prostate Cancer-Specific Therapeutic Vaccine

  • First patient in second cohort dosed with 400 μg of TET vaccine
  • DSMB found no safety concerns for first cohort of three patients at 40 μg dose

Oslo, 1 October 2021: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced it has started dosing of the second cohort in the Phase I TENDU trial, evaluating the Company’s Tetanus-Epitope Targeting (TET)-platform.

The TENDU clinical trial, conducted at the Oslo University Hospital, is a first-in-human, dose-escalation study designed to generate initial safety and immune activation data for a prostate cancer-specific therapeutic TET-based vaccine in prostate cancer patients who have relapsed following radical prostatectomy. Three different and escalating doses of the TET vaccine are being investigated in the study, 40, 400 and 960 μg. Dosing of the 400 μg cohort has now been initiated.

“We are pleased to continue to advance this Phase 1 trial evaluating Ultimovacs’ TET platform in prostate cancer. The 400 μg dose, which we are now investigating, is in a clinically relevant range predicted by preclinical studies,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “We are looking forward to continuing to investigate this new therapeutic prostate cancer vaccine, which has the potential to address a significant medical need by reducing recurrence of the disease. The TENDU study is also important for us as a way of generating initial data on the novel TET platform, as we further expand the Ultimovacs pipeline.”

The TET platform allows for the production of multiple therapeutic cancer vaccines that can 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 trial contains prostate cancer-specific antigens. By combining cancer antigens and the vaccine adjuvant in the same molecule, this unique platform can generate vaccine candidates with a beneficial safety and administration profile, presenting an opportunity to treat patients at an early stage of their disease.


About the TET-platform
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.

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.

About Ultimovacs
Ultimovacs is developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in over 80% 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, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types in combination with other immunotherapies. 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
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
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 Hans Vassgård Eid, CFO at Ultimovacs ASA, on 1 October, 2021 at 12:30 CET.