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

 

-- First patient treated in clinical study testing vaccine generated from the
innovative TET-platform --

-- Ultimovacs will expand its vaccine pipeline through the TET-platform's
ability to generate multiple vaccine candidates -- 

-- Start of TET clinical program supports Ultimovacs' goal of becoming a leader
in cancer vaccine development -- 

Oslo, 18 February 2021: 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 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