Ultimovacs Announces Completed Patient Recruitment in NIPU Phase II Clinical Trial of UV1 in Mesothelioma

23 Jan 2023 08:00 CET

* Full recruitment of 118 patients with mesothelioma in Scandinavia, Spain and
Australia
* The study provides randomized data on impact of UV1 in combination with
checkpoint inhibitors ipilimumab and nivolumab
* Topline progression-free survival data expected H1 2023

Oslo, 23 January 2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces
the completed recruitment of 118 patients with pleural mesothelioma in the NIPU
trial.

NIPU is a randomized, multi-center phase II trial initiated and sponsored by
Oslo University Hospital with support from Bristol-Myers Squibb and Ultimovacs.
UV1 is being evaluated in combination with the checkpoint inhibitors ipilimumab
and nivolumab as second-line treatment for patients with malignant pleural
mesothelioma. The ipilimumab and nivolumab combination is standard-of-care
treatment for patients with malignant pleural mesothelioma in Europe and the
U.S.

"We are pleased to see the NIPU trial fully enrolled. We are dedicated to
advancing the care of patients suffering from mesothelioma, for which current
treatment options are limited," said Åslaug Helland, Principal Investigator in
the NIPU trial and Professor at Oslo University Hospital.

Happening most frequently to people with occupational asbestos exposure risks,
malignant pleural mesothelioma is a cancer of the lining of the lungs and the
internal thoracic wall. Time from exposure to asbestos to diagnosis of disease
usually takes several decades. The life expectancy for most mesothelioma
patients is approximately 12 months after diagnosis, indicating a
high unmet medical need. The treatment combination evaluated in the NIPU trial
represents an innovative approach for treatment of patients with malignant
pleural mesothelioma.

Consistent with NIPU's event-driven design, topline progression-free survival
results will be disclosed after progression of cancer or death has been observed
in a total of 69 patients. Data readout from the trial is expected during the
first half of 2023. The topline results will be disclosed through a press
release followed by a more in-depth presentation of the results in an article
and at a medical conference.

Ultimovacs' universal cancer vaccine, UV1, is being investigated in combination
with checkpoint inhibitors in five comparative phase II clinical trials. NIPU is
the second of these studies to complete recruitment of patients, following the
INITIUM study in metastatic malignant melanoma. Topline readout from both these
studies during is expected during the first half of 2023.

"We are entering a very exciting period for Ultimovacs as we are approaching
topline readouts from the first two of the company's five randomized phase II
clinical studies investigating UV1," said Carlos de Sousa, Chief Executive
Officer at Ultimovacs. "If positive, these results have the potential to be
transformative for the treatment of cancer patients with a severe unmet need,
and for Ultimovacs on our mission to support these patients."

==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,
will be evaluated in combination with Bristol-Myers Squibb's checkpoint
inhibitors, nivolumab and ipilimumab, as second-line treatment in 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 receive 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.

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, pose a high risk. This cancer
usually takes several decades to develop after a person's first exposure to
asbestos. Most people receive a diagnosis 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 illnesses. 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 an attractive
target for therapeutic vaccination.

About Ultimovacs
Ultimovacs is an immunotherapy company developing immune-stimulatory vaccines to
treat a broad range of cancers. Ultimovacs' lead universal cancer vaccine
candidate UV1 targets human telomerase (hTERT), present in 85-90% of cancers in
all stages of tumor growth. By directing the immune system to hTERT antigens,
UV1 drives CD4 helper T cells to the tumor and the draining lymph nodes to
activate an immune system cascade and increase anti-tumor responses. With a
broad Phase II program in five cancer indications enrolling more than 650
patients, Ultimovacs aims to clinically demonstrate UV1's impact in multiple
cancer types, in combination with other immunotherapies, for patients with unmet
needs. Ultimovacs' second technology approach, based on the proprietary Tetanus-
Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant
in the same molecule and entered Phase I studies in 2021.

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 90686815

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284 853

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 Joachim Midttun, Finance
Manager at Ultimovacs ASA, on 23 January, 2023 at 08:00 CET.

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