Ultimovacs Starts Clinical Evaluation of Novel TET-Platform with Phase I TENDU Study Investigating Prostate Cancer-Specific Therapeutic Vaccine

Ultimovacs ASA ("Ultimovacs", ticker ULTI), today announced the treatment of the first patient in the Phase I TENDU trial, representing the start of clinical evaluation for the Company’s Tetanus-Epitope Targeting (TET)-platform. The 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. 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. 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 relapsed prostate cancer patients. The Company expects to provide the first interim, preliminary safety readout from the trial by the end of this year.

"By offering Ultimovacs’ new therapeutic prostate cancer vaccine to patients that have relapsed after radical prostatectomy but prior to their standard radiation and antihormone therapy, we hope to further reduce the risk of recurrence and to take the next step towards a better outcome for these patients,” commented Dr. Wolfgang Lilleby, principal investigator at the Oslo University Hospital. "The design of the study allows us to obtain a range of important insights regarding the activation of the immune system, including following the patients to identify novel biomarkers. I am convinced that the TET-technology has great potential to aid us in our battle against prostate cancer and it is a great pleasure to participate in this trial.”

"Conducting the TENDU study is an important step for us to gain initial data on the novel platform, while continuing to optimize the core TET-molecule and production process. The TET-technology will enable us to expand our pipeline and bring us closer to fulfilling our ultimate ambition of establishing Ultimovacs as a leader in the cancer vaccine field,” added Sara Mangsbo, Chief Innovation Officer at Ultimovacs.

About the TENDU trial

The TENDU clinical trial is a first-in-human, Phase I study and the first clinical trial resulting 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. Patient enrollment is expected to be completed in the first half of 2022. Further details on the study can be found on clinicaltrials.gov identifier NCT04701021.

About the TET-Technology

In addition to its universal vaccine, UV1, Ultimovacs is developing novel vaccine products based on the patent-protected Tetanus-Epitope Targeting (TET)-platform. The TET-platform offers a promising approach to strengthen and increase T cell responses against cancer-specific peptides by combining antigens and the vaccine adjuvant in the same molecule, allowing for a beneficial safety profile and simplifying administration. The platform generates new, first-in-class cancer vaccine candidates that harness the pre-existing antibody response against tetanus resulting from standard tetanus vaccination. These vaccine candidates can be tailored to many types of cancer as well as infectious diseases.

About Ultimovacs

Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 leverages the high prevalence of the human telomerase (hTERT) to be effective across the dynamic stages of the tumor’s growth and its microenvironment. By directing the immune system to hTERT antigens that are present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor with the goal of activating an immune system cascade to increase anti-tumor responses. Ultimovacs’ strategy is to clinically demonstrate UV1’s impact in many cancer types and in combination with other immunotherapies. The Company will expand its pipeline using its novel TET-platform, which is an innovative vaccine technology that can generate multiple vaccine candidates designed to achieve increased T cell responses to a broad range of target antigens.

For further information, please see www.ultimovacs.com

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