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

14 Dec 2022 08:00 CET

* 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 www.ultimovacs.com or contact:

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

Anne Worsøe, Head of IR & Communication
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86815

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 Joachim Midttun, Finance
Manager at Ultimovacs ASA, on 14 December 2022 at 08:00 CET.

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