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Beskrivning

LandNorge
ListaOB Match
SektorHälsovård
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.
2024-03-02 18:41:17
NON-REGULATORY PRESS RELEASE

* The NIPU trial is investigating the effect of adding UV1 vaccine to
immunotherapy as second-line treatment of pleural mesothelioma. The results
were initially presented at the ESMO Conference in October 2023
* The publication outlines the full trial results, including observations on
UV1's positive impact on objective response rate, overall survival, and
additional data on increased efficacy in defined histological subtypes

Oslo, March 2, 2024: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage
biotechnology company developing immunotherapeutic cancer vaccines, today
announced that the results from the randomized controlled Phase II clinical
trial, NIPU, are published in the European Journal of Cancer
(https://www.ejcancer.com/article/S0959-8049(24)00129-1/fulltext). The trial
investigates the effect of adding Ultimovacs' cancer vaccine UV1 to second-line
treatment with ipilimumab and nivolumab for patients with pleural mesothelioma
(NCT04300244).

NIPU is an investigator-initiated, open-label, multi-center Phase II trial
sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and
Ultimovacs. Six university hospitals in Australia, Denmark, Norway, Spain, and
Sweden participated in the trial. 118 patients were randomized between June
2020 and January 2023.

The study did not meet its primary endpoint of improved progression-free
survival (PFS) based on blinded independent central review (BICR). Analyses on
the secondary endpoints, objective response rate (ORR) by BICR and overall
survival (OS), showed a significant benefit of adding the UV1 vaccine to
ipilimumab and nivolumab. Local assessment demonstrated an improved PFS among
patients in the vaccine arm for all histological subtypes combined, and new
subgroup analysis demonstrates further improvement for the epithelioid subtype.
The epithelioid subtype represents approximately 70% of all patients with
mesothelioma.

The safety profile of the combination of UV1 plus ipilimumab and nivolumab
observed in the trial was consistent with that of ipilimumab and nivolumab
alone, confirming the good safety profile for the UV1 vaccine.

==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. UV1 is a patented technology owned by Ultimovacs.

In addition, Ultimovacs holds all rights to the proprietary TET technology
platform for any possible future formulations for the treatment of solid tumor
indications. The Company is listed on the Euronext Oslo Stock Exchange (OSE:
ULTI).

About NIPU
NIPU (Nivolumab and Ipilimumab Plus/minus UV1 vaccination) is a randomized,
multi-center phase II trial in which Ultimovacs' universal cancer vaccine, UV1,
is evaluated in combination with Bristol-Myers Squibb's checkpoint inhibitors,
nivolumab and ipilimumab, as second-line treatment of malignant pleural
mesothelioma. The trial sponsor is Oslo University Hospital, supported in the
preparation and execution of the trial by Ultimovacs and Bristol Myers Squibb.
The 118 patients are randomized 1:1 into two treatment arms. All participants
receive treatment with nivolumab (240 mg every 2 weeks) and ipilimumab (1 mg/kg
every 6 weeks) until disease progression, unacceptable toxicity or for a maximum
of 2 years. Patients randomized to the experimental arm received 8 intradermal
injections of UV1 vaccine during the first three months of treatment. The
objective of the study is to achieve a clinically meaningful progression-free
survival (PFS) benefit in patients with malignant pleural mesothelioma (MPM)
after progression on first-line standard platinum doublet chemotherapy.
Subsequent events emerging in patients in both arms of the NIPU study will
continue to be monitored beyond the read-out of the primary endpoint. The
ipilimumab and nivolumab combination has recently been approved as first-line
treatment for patients with malignant pleural mesothelioma in Europe and the
U.S.

About Mesothelioma
Malignant pleural mesothelioma is a rare and aggressive type of cancer that
occurs in the thin layer of tissue that surrounds the lungs and inside of the
chest. Mesothelioma accounted for 30 870 new cancer cases and 26 278 cancer
deaths worldwide in 2020, according to International Agency for Research on
Cancer (Globocan 2020). Pleural mesothelioma is a disease with a high unmet
medical need, especially in industrialized countries. The median overall
survival is approximately 1 year.  Occupational asbestos exposure is the No. 1
cause of the disease, and several occupations like firefighters, military
veterans, construction, and industry workers, are at risk. This cancer usually
takes several decades to develop after a person's first exposure to asbestos.
Most patients are diagnosed after age 70 because of the long latency period.
Even though the use of asbestos to a large extent is banned in many countries
today, new incidences of mesothelioma will continue to be a medical and public
health challenge because of the long latency period typical of the illness. For
patients with inoperable disease, few treatment options are available after
first-line chemotherapy. The combination of ipilimumab and nivolumab has
recently shown increased survival compared to standard chemotherapy, but most
patients do not respond, and improvements are called for. Telomerase is
expressed in mesothelioma cells and is therefore a relevant target for
therapeutic vaccination.

About UV1

UV1 is a universal cancer vaccine designed to induce a specific T-cell response
against telomerase. UV1 consists of long, synthetic peptides representing a
sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to
induce CD4+ T-cells. These CD4+ T-cells have the potential to provide
inflammatory signals, and T-cell support is believed to be critical for
triggering a strong anti-tumor immune response. Following intradermal injection,
antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides.
These APCs will process the peptides and present vaccine epitopes on Human
Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. Activated
vaccine-specific T-cells will then enter the circulation and search for cells
displaying their cognate antigen in the context of HLA molecules.

The UV1 peptides contain several epitopes, shown to be non-restrictive in terms
of (HLA) alleles for presentation. It is, therefore, not required to perform HLA
pre-screening of patients, which potentially enables broad population
utilization of the vaccine. UV1 is administered over three months with eight
intradermal injections and the immune-modulator GM-CSF.

For further information, please see www.ultimovacs.com or contact:

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

Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com (mailto:anne.worsoe@ultimovacs.com)
Phone: +47 90686815

This stock exchange announcement was published by Anne Worsøe, Head at Investor
Relations at Ultimovacs ASA, on March 2, 2024 at 18:40 CET.