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IndustriBioteknik
Ultimovacs är ett norskt läkemedelsbolag. Bolagets affärsinriktning är att utveckla immunoterapier mot diverse cancertillstånd. Forskning och utveckling utgår ifrån egenbaserad teknologisk plattform, där produkterna huvudsakligen vidareutvecklas som vaccin. Störst närvaro återfinns inom Europa och Nordamerika. Bolaget grundades under 2011 och har sitt huvudkontor i Oslo, Norge.
2023-10-25 17:50:20
NON-REGULATORY PRESS RELEASE


Oslo, October 25, 2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
announces that the Company will host a webcast presentation and discussion of
the results from the NIPU study presented at the ESMO Congress 2023.

The results from the randomized Phase II trial showed that Ultimovacs' cancer
vaccine UV1, in combination with ipilimumab and nivolumab, demonstrated a
statistically significant and clinically meaningful improvement of overall
survival versus ipilimumab and nivolumab alone, a key secondary endpoint. Twice
as many patients in the UV1 arm responded to treatment. No additional safety
concerns were reported from the UV1 treatment.

The positive outcome from the NIPU study is the first demonstration of a
universal cancer vaccine efficacy in a randomized Phase II clinical trial,
showing Proof of Concept and supporting further clinical development as per
investigators' recommendation.

NIPU (NCT04300244 (https://clinicaltrials.gov/study/NCT04300244)) is an
investigator-initiated, randomized, multi-center, open-label Phase II clinical
trial for second-line treatment in patients with malignant mesothelioma (MPM).
The data from the study was published initially
(https://newsweb.oslobors.no/message/601533) in a late-breaking abstract
(https://www.annalsofoncology.org/article/S0923-7534(23)04266-7/fulltext) at the
ESMO Congress in Madrid. Further details were provided in an oral presentation
by the Principal Investigator at the ESMO Congress and was detailed in a press
release (https://newsweb.oslobors.no/message/601816) announced by the Company on
Monday, October 23, 2023.

This webcast follows the presentation of the NIPU results at ESMO by the
Principal Investigator, Professor Åslaug Helland, MD, PhD. The webcast held in
Madrid on Monday, October 23, 2023, had technical difficulties due to unexpected
bandwidth issues at the premises.

The webcasts will take place on Tuesday, October 31, 2023, at:

9:00 am CET (in Norwegian): Link
(https://channel.royalcast.com/landingpage/hegnarmedia/20231031_2/)

2:00 pm CET/ 8:00 am ET (in English): Link
(https://channel.royalcast.com/landingpage/hegnarmedia/20231031_3/)

The webcasts can be accessed live or as a replay. Questions can be sent during
the webcast, or in advance to IR@ultimovacs.com (mailto:IR@ultimovacs.com)

UV1 is a therapeutic cancer vaccine used to generate an immune response against
the enzyme human telomerase (hTERT).  The enzyme is essential for the ability of
cancer cells to proliferate. Telomerase is present in 85-90% of all cancers,
across the stages of the disease. The vaccine is manufactured as an off-the-
shelf product with a long shelf life. UV1 is easy to use and does not require
sophisticated hospital infrastructure, enabling patient access to therapy also
in community centers, and in rural and underserved communities.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biology and
disease stages, in combination with different checkpoint inhibitors. The topline
data from NIPU are the first results among the five randomized trials in the UV1
Phase II clinical program. In addition to malignant mesothelioma, Phase II
studies are ongoing in patients with malignant melanoma, head and neck cancer,
ovarian cancer, and non-small cell lung cancer. The topline data from the
malignant melanoma and head and neck cancer trials are expected during the first
and second half of 2024. UV1 is a patented, proprietary technology owned by
Ultimovacs.

==ENDS==

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' adjuvant platform, based on the proprietary Tetanus-
Epitope-Targeting (TET) technology, combines tumor-specific antigens and
adjuvant in the same molecule and is in Phase I clinical development. The
Company is listed on Euronext Oslo Stock Exchange (ULTI.OL).

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

This stock exchange announcement was published by Anne Worsøe, Head of IR at
Ultimovacs ASA, on October 25, 2023 at 17:45 CET.