Ultimovacs Announces Completion of Exploratory Phase I TENDU Study of TET Vaccine Technology Platform Meeting the Primary Endpoint

• Dose-escalation, first-in-human Phase I trial showed good safety and tolerability across all dose-cohorts, meeting the primary endpoint
• Data included observations of immune activation with vaccine specific T cell responses, meeting the secondary endpoint
• In addition to the trial results, advancements in preclinical research, technology development and product manufacturing provide a valuable foundation for the future development of the TET technology platform and TET-based vaccine candidates  

Oslo, December 18, 2023: Ultimovacs ASA ("Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today 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.

"We value the positive outcome of this exploratory study as well as the results from dedicated efforts in preclinical research, technology development and manufacturing. These advances position us for the future expansion of our proprietary technologies with the potential to develop new vaccine candidates,” said Carlos de Sousa, Chief Executive Officer of Ultimovacs.  "We have an exciting year ahead of us, with important clinical trial readouts and upcoming value-inflection points in our UV1 clinical development program.”

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.

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About TENDU
The TENDU clinical trial (NCT04701021) is an exploratory, first-in-human, phase I study and the first clinical trial of a vaccine from Ultimovacs' Tetanus-Epitope Targeting (TET)-platform. The study was conducted at Oslo University Hospital, Norway, and evaluated the safety of the vaccine in patients with documented progressive disease (radiologically assessed, PSA progression, or both) after radical prostatectomy. The study's primary objective was to evaluate the safety and tolerability of three different dose levels of the vaccine. Patients received the vaccine before obtaining standard-of-care treatment consisting of radiation and antihormone therapy. The patients were followed for six months after the last dose of the vaccine for assessment of immunological responses, including antibody response to the tetanus-derived parts of the vaccine and T cell responses against the vaccine antigens.

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) technology offers an approach to strengthening and increasing T cell responses against tumor cells by conjugating cancer-specific antigens and peptides derived from tetanus into one molecule. The technology harnesses the immune activation function of immune complexes that is formed between the tetanus-derived parts of the TET vaccine molecules and pre-existing antibodies against tetanus resulting from standard tetanus vaccinations.  The strategy thereby allows for targeted delivery of antigens and adjuvant signals to dendritic cells. The TET technology is a platform technology for generation of new, first-in-class cancer vaccine candidates that can be tailored to many types of cancer.

About Ultimovacs

Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine candidate UV1 is directed against human telomerase (hTERT), an antigen present in 85-90% of cancers in all stages of tumor growth. A broad clinical program, with Phase II trials in five cancer indications enrolling more than 670 patients, aims to demonstrate UV1’s impact in combination with other immunotherapies in multiple cancer types expressing telomerase and where patients have unmet medical needs. UV1 is universal, off-the-shelf and easy to use, and is a patented technology owned by Ultimovacs.
In addition, Ultimovacs holds all rights of the proprietary TET technology platform for any possible future use of formulations in various solid tumor indications. The Company is listed on Euronext Oslo Stock Exchange (ULTI.OL).

For further information, please contact:

Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com
Phone: +47 90686815

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 Anne Worsøe, Head of Investor Relations at Ultimovacs ASA, on December 18, 2023 at 07:00 CET.