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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.


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2021-06-01 08:31:28
Oslo, 1 June 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage
leader in immune stimulatory vaccines for cancer, today announced that a
peer-reviewed article on the ongoing NIPU Phase II trial of the Company's
universal cancer vaccine, UV1, in malignant pleural mesothelioma (MPM) has been
published. The article in The Journal of Translational Medicine outlines the
mechanistic rationale for the use of the combination of UV1 with two checkpoint
inhibitors, ipilimumab and nivolumab.

The dual use of ipilimumab and nivolumab was recently approved as a first-line
therapy in MPM where few therapeutic options are currently available. However,
as Haakensen et al explain in the article, observed response rates with
checkpoint inhibitors have been moderate in MPM compared to documented
performance for the combination of checkpoint inhibitors in other cancers,
suggesting that checkpoint inhibitors alone may be insufficient to trigger an
immune response.

Earlier phase I/II studies have shown that UV1 is safe on its own and when used
in combination with checkpoint inhibitors, and that it induces vaccine-specific
immune response associated with survival.

"The NIPU trial is important in understanding the potentially synergistic
activities of checkpoint inhibitors and our universal cancer vaccine, UV1."
stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "Malignant pleural
mesothelioma is a challenging disease to treat even with checkpoint inhibitors
that have been effective in other types of cancer. The article published today
explains how we think UV1 may help in meeting that challenge. "

NIPU is a randomized, multi-centre, open-label, proof of concept study comparing
the efficacy and safety of nivolumab and ipilimumab with or without UV1 in
patients with inoperable malignant pleural mesothelioma after first-line
platinum-based chemotherapy (NCT04300244 -

Article details
Haakensen, V.D., Nowak, A.K., Ellingsen, E.B. et al. NIPU: a randomised,
open-label, phase II study evaluating nivolumab and ipilimumab combined with UV1
vaccination as second line treatment in patients with malignant mesothelioma. J
Transl Med 19,232(2

About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the
universal cancer antigen telomerase. UV1 is being developed as an
"off-the-shelf" therapeutic cancer vaccine which may serve as a platform for use
in combination with other immunotherapy which requires an ongoing T cell
response for their mode of action. To date, UV1 has been tested in four phase I
clinical trials in a total of 82 patients and maintained a positive safety and
tolerability profile as well as encouraging signals of efficacy.

About UV1 Clinical Programs
As a universal cancer vaccine, UV1's unique mechanism of action has the
potential to be applicable across most cancer types. The clinical development of
the UV1 vaccine includes four randomized, multinational, Phase II combination
trials: INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 patients in total.
The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154
patients with metastatic malignant melanoma to evaluate UV1 in combination with
ipilimumab and nivolumab as first-line treatment. The NIPU study is testing UV1
in combination with checkpoint inhibitors ipilimumab and nivolumab as
second-line treatment in 118 patients with advanced malignant pleural
mesothelioma, a rare lung cancer. The study is sponsored by Oslo University
Hospital and Bristol-Myers Squibb is providing the checkpoint inhibitors for
this study. The DOVACC study is sponsored by the Nordic Society of
Gynaecological Oncology. In total, 184 patients with high-grade ovarian cancer
will be enrolled to evaluate UV1 in combination with durvalumab and olaparib,
both provided by AstraZeneca. FOCUS is an investigator-sponsored, randomized
clinical trial enrolling 75 patients with metastatic head and neck cancer
receiving pembrolizumab as standard of care, and will evaluate the impact of
adding UV1 to this regimen. Ultimovacs anticipates announcing data on the
primary endpoints for the NIPU and INITIUM studies in 2H2022 and for the DOVACC
and FOCUS studies in 2023.

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, Chief Executive Officer
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Hans Vassgård Eid, Chief Financial Officer
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632