Ultimovacs Announces Updated Data Analysis on UV1 Phase II NIPU Trial in Mesothelioma at ESMO 2024

09 Sep 2024 00:10 CEST

Oslo, September 9, 2024: Ultimovacs ASA (https://ultimovacs.com/) ("Ultimovacs")
(OSE ULTI), a clinical-stage biotechnology company developing novel
immunotherapies against cancer, announces the presentation of updated data
analysis from the UV1 Phase II NIPU trial (NCT04300244
(https://clinicaltrials.gov/study/NCT04300244)), at the 2024 ESMO Congress
(https://www.esmo.org/meeting-calendar/esmo-congress-2024). The NIPU trial
evaluated the addition of UV1 telomerase vaccine to immunotherapy with
ipilimumab and nivolumab compared with ipilimumab and nivolumab alone, as a
second-line treatment for patients with inoperable malignant pleural
mesothelioma. As presented
(https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=4405256&la
ng=en-GB&companycode=no-ulti&v=) at ESMO 2023, the trial did not meet the
primary endpoint of improved progression-free survival (PFS) by blinded,
independent central review (BICR), however the data showed a meaningful benefit
on the key secondary endpoints including a doubling of objective response rate
(ORR) and a 27% reduction in risk of death. The ESMO 2024 poster presentation
highlights an increased clinical benefit observed for the epithelioid subgroup,
demonstrating an improvement in median PFS of 5.5 months for UV1 in combination
with ipilimumab and nivolumab, versus a median PFS of 2.9 months for
immunotherapy alone. The epithelioid subtype represents approximately 70% of all
patients with mesothelioma. In addition, the ESMO 2024 data presentation
demonstrates a positive difference in overall survival (OS) for UV1 treatment at
the latest patient follow-up, although the degree of benefit is less than
previously reported.

The full results will be presented
(https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal_2/presentation/list
?q=NIPU&r=pt%7E51) in a poster at the congress, held in Barcelona, Spain from
September 13-17, 2024. The abstract is available on the Ultimovacs website
(under the section 'Presentations and publications') and the poster will be
available on the Ultimovacs website after the presentation on Saturday,
September 14.

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

NIPU is an investigator-initiated, randomized, 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. A total of 118 patients were
randomized between June 2020 and January 2023.

"Zooming in on the different subgroup analyses, we see persistent survival signs
especially in the epithelioid mesothelioma patient subgroup, supporting a
rationale for further investigation of UV1 in this indication, which continues
to represent a high unmet medical need," said Jens Bjørheim, Chief Medical
Officer at Ultimovacs. "At Ultimovacs, our goal is to provide new treatment
options for patients that do not benefit from the current standard of care and
we will discuss these data and potential next steps with key stakeholders and
the medical community."

In March 2024
(https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=4473662&la
ng=en-GB&companycode=no-ulti&v=), Ultimovacs announced the publication of the
Phase II NIPU trial results in the European Journal of Cancer. Analyses of
secondary endpoints, objective response rate (ORR) by BICR and overall survival
(OS), showed a benefit of adding the UV1 vaccine to ipilimumab and nivolumab.
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 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 that are 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 company developing novel
immunotherapies against cancer. The product candidate UV1 is an off-the-shelf
therapeutic cancer vaccine designed to enhance the benefits of immunotherapy and
improve cancer treatment efficacy for patients. UV1 triggers an immune response
against the shared cancer antigen telomerase, a target present in 85-90% of all
cancer indications across disease stages.

Ultimovacs is investigating the safety and efficacy of UV1 in a wide-ranging
clinical development program including various cancer indications and different
immunotherapy combinations. The ongoing Phase II program comprises five
randomized clinical trials in melanoma, mesothelioma, head and neck cancer,
ovarian cancer, and non-small cell lung cancer. More than 750 patients in the
U.S., Europe, and Australia are being enrolled in all Phase I and Phase II
trials in the current program.

Furthermore, Ultimovacs is developing a novel conjugation technology, initially
formed to support the expansion of our vaccine pipeline. With the objective of
driving value and future pipeline growth, this flexible conjugation technology
has the potential to be broadly applicable to a variety of therapeutic
modalities, such as innovative drug conjugates with favorable pharmacological
properties, and in multiple disease areas.

Ultimovacs is listed on the Euronext Oslo Stock Exchange (OSE:ULTI).

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

Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com (mailto:hans.eid@ultimovacs.com)
Phone: +47 482 48632

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act. This stock exchange
announcement was published by Hans Vassgård Eid, CFO at Ultimovacs ASA, on
September 9, 2024, at 00:10 CEST.

More information:
Access the news on Oslo Bors NewsWeb site