Ultimovacs Announces Poster Presentation of NIPU Phase II Trial Update at Upcoming ESMO Congress 2024

Ultimovacs Announces Poster Presentation of NIPU Phase II Trial Update at Upcoming ESMO Congress 2024

Issuer

Ultimovacs ASA

Oslo, August 1, 2024: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage
biotechnology company developing immunotherapeutic cancer vaccines, today
announced that an update from the Phase II NIPU trial (NCT04300244
(https://clinicaltrials.gov/study/NCT04300244)) in patients with malignant
mesothelioma will be presented in a poster presentation at the 2024 ESMO
Congress. The conference will be held in Barcelona, Spain from September
13-17, 2024.

Poster Presentation Details:

Title: Updated survival and vaccine response from the NIPU trial; A randomised,
phase II study evaluating nivolumab and ipilimumab with or without UV1
vaccination in patients with pleural mesothelioma
Presentation Number: 1917P
Speaker: Vilde D. Haakensen, MD, PhD, Project Group Leader at the Oslo
University Hospital
Date: Saturday, September 14, 2024

The first comprehensive data from the NIPU Phase II trial was presented at the
ESMO Congress 2023
(https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=4405256&la
ng=en-GB&companycode=no-ulti&v=). While the study did not meet its primary
endpoint, UV1 in combination with the checkpoint inhibitors ipilimumab and
nivolumab demonstrated clinically meaningful overall survival benefit with no
added toxicities, compared to ipilimumab and nivolumab alone, in the second-line
treatment of patients with malignant mesothelioma. The results were also
published in the European Journal of Cancer
(https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=4473662&la
ng=en-GB&companycode=no-ulti&v=) in March 2024.

==ENDS==

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 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 were 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 benefit in patients
with malignant 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 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.

The trial was sized to detect a target PFS HR of 0.6, with 80% power and a 1-
sided alpha of 0.1. Overall survival was calculated using the same method as for
PFS.

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 as eight
intradermal injections together with the immune-modulator GM-CSF.

About Ultimovacs

Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines. The lead cancer vaccine candidate UV1 is an off-the-shelf
vaccine 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
investigate UV1's impact in combination with other immunotherapies in multiple
cancer types. UV1 is a patented technology owned by Ultimovacs. In addition,
Ultimovacs holds all rights of the proprietary TET technology platform for any
possible future use of formulations in various solid tumor indications. The
Company is listed on the Euronext Oslo Stock Exchange (ULTI).

For further information, please contact:

Carlos de Sousa, CEO
Email: [email protected] (mailto:[email protected])
Phone: +47 908 92507

Hans Vassgård Eid, CFO
E-mail: [email protected]

This stock exchange announcement was published by Hans Vassgård Eid, CFO at
Ultimovacs ASA, on August 1, 2024, at 17:20 CET.

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