Ultimovacs Announces Completed Patient Recruitment in TENDU Phase I Clinical Trial in Prostate Cancer

• First clinical trial based on Ultimovacs’ proprietary TET adjuvant platform technologyFirst clinical trial based on Ultimovacs’ proprietary TET adjuvant platform technology
• 12 patients with prostate cancer treated in TENDU study
• Study provides immune activation and safety data important for future clinical development within the TET technology
  
  
  
  

Oslo, 14 December 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announced that last patient enrollment has been completed in the Phase I TENDU trial in prostate cancer. Patients with relapse after primary radical prostatectomy received four doses of the TENDU vaccine during a 6-week treatment period. Three different dose levels have been explored (40, 400, 960 mcg) and half of the patients were treated at the highest dose level.

“We are pleased to have completed the enrollment of patients in the first clinical trial based on the TET platform technology”, said Carlos de Sousa, Chief Executive Officer at Ultimovacs. “The TET platform represents an innovative approach that can provide the flexibility to incorporate different antigens in vaccines relevant in different tumor types and stages.”

The TENDU clinical trial is the first trial based on the Ultimovacs’ novel vaccine-adjuvant platform, TET (Tetanus-Epitope Targeting). The technology combines the two key components of a vaccine in a single molecule, the cancer-specific antigens and the immune response strengthening adjuvant. The primary objective of TENDU is to evaluate safety and tolerability of different doses of the vaccine in patients with progressive disease after prostatectomy. No safety concerns have emerged in the on-going study. All patients are followed up for 6 months after the last treatment.

“The evidence to date indicates that the TET vaccine-adjuvant platform has the potential to be a highly flexible platform, which can be effectively combined with many therapeutic approaches in oncology,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. “The data from the TENDU trial will be valuable in exploring the opportunities for future development of a clinical program based on the TET platform technology.”

==ENDS==

About TENDU

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 main objectives of the study are to evaluate safety, tolerability and immune response of three different doses of the TENDU vaccine. Patients 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 the TET-platform

Vaccines typically 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. The patent protected TET (Tetanus-Epitope Targeting) platform combines antigens and vaccine adjuvant in the same molecule. Together, the adjuvant and the antigen ensure a specific and effective immune response. This allows a beneficial safety profile and easy administration, offering a promising approach to strengthen and increase T cell responses against cancer-specific peptides. The platform can generate multiple, first-in-class cancer vaccine candidates that harness pre-existing antibody responses against tetanus induced by standard tetanus vaccination. TET vaccine candidates can be tailored to many types of cancer, and potentially to infectious diseases.

About Ultimovacs

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 and draining lymph nodes 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 or contact:

Carlos de Sousa, CEO

Email:

Phone:

Anne Worsøe, Head of IR & Communication

Email:

Phone: +47 906 86815

Mary-Ann Chang, LifeSci Advisors

Email:

Phone:  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 14 December 2022 at 08:00 CET.