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held October 20-24, 2023 in Madrid
- UV1 also received FDA orphan drug designation for treatment of patients with
malignant melanoma in December 2021
Oslo, October 09, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
announced that the U.S. Food and Drug Administration (FDA) has granted Orphan
Drug Designation (ODD) to the company’s therapeutic cancer vaccine UV1 for the
treatment of patients with mesothelioma. The designation was granted based on
the initial data from the Phase II clinical trial, NIPU.
Mesothelioma is a rare and aggressive form of cancer with a high mortality rate
and few therapeutic options. Patients with mesothelioma commonly have a history
of occupationally or environmentally exposure to asbestos, and it typically
takes decades for this specific form of cancer to develop.
The impact of UV1 vaccination in patients with malignant pleural mesothelioma is
being assessed in the randomized Phase II clinical trial, NIPU. In the study,
UV1 was combined with checkpoint inhibitors ipilimumab and nivolumab and
compared to ipilimumab and nivolumab alone as a second-line treatment after
first-line treatment with platinum-based chemotherapy. The randomized, open-
label, multicenter trial with 118 patients was conducted in Australia, Denmark,
Norway, Spain, and Sweden. The first patient in the trial was enrolled in June
2020, and the last patient was enrolled in January 2023. The NIPU study is
sponsored by Oslo University Hospital with support from Bristol-Myers Squibb and
Ultimovacs.
The results from the study will be shared at the ESMO Congress in Madrid, held
October 20-24, in an oral presentation by the Principal Investigator, Åslaug
Helland, MD, Ph.D., Professor at Oslo University Hospital. The presentation
title is “LBA99 - First survival data from the NIPU trial; A randomized, open-
label, phase II study evaluating nivolumab and ipilimumab combined with UV1
vaccination as second-line treatment in patients with malignant mesothelioma”.
“Gaining FDA orphan drug designation for UV1 in mesothelioma highlights UV1’s
potential and the significant need for new treatment options for this patient
population,” said Carlos de Sousa, CEO of Ultimovacs. “We look forward to the
presentation of the NIPU results at the ESMO Congress later this month and to
continue our dialogue with the FDA as we seek to bring UV1 to cancer patients as
quickly as possible.”
The FDA’s Office of Orphan Products Developments grants orphan status to support
the development of medicines for rare disorders that affect fewer than 200,000
people in the U.S. Orphan drug designation provides certain benefits, including
potentially up to seven years of market exclusivity upon regulatory approval,
exemption of FDA application fees, and tax credits for qualified clinical
trials.
UV1 is a therapeutic cancer vaccine that generates an immune response against
the human telomerase (hTERT) enzyme. The enzyme is essential for the ability of
cancer cells to proliferate. Telomerase is present in 85-90% of all cancers
across all stages of the disease.
Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biologies
and disease stages, combined with different checkpoint inhibitors. The topline
data from NIPU are the first results among the currently five randomized trials
in the UV1 Phase II clinical program. In addition to malignant pleural
mesothelioma, Phase II studies are ongoing in patients with malignant melanoma,
head and neck cancer, ovarian cancer, and non-small cell lung cancer. The
topline data from the malignant melanoma and head and neck cancer trials are
also expected within a year. UV1 is a patented, proprietary technology owned by
Ultimovacs.
==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 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 two weeks) and ipilimumab (1
mg/kg every six weeks) until disease progression, unacceptable toxicity or for a
maximum of 2 years. Patients randomized to the experimental arm received eight
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 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 been approved as first-line treatment for patients with malignant pleural
mesothelioma in Europe and the U.S.
About Mesothelioma
Mesothelioma is a rare and aggressive type of cancer that occurs in the thin
layer of tissue surrounding the lungs and inside the chest. Mesothelioma
accounted for 30 870 new cancer cases and 26 278 cancer deaths worldwide in
2020, according to the 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 one 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. Few
treatment options are available after first-line chemotherapy for patients with
inoperable disease. 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 the UV1 Phase II program
The immunotherapeutic cancer vaccine UV1 is investigated in combination with
checkpoint inhibitors in patients with various cancer indications with diverse
tumor biology. The diversity of the UV1 Phase II program places Ultimovacs in a
favorable position to capture the cancer vaccine’s potential broad
applicability when combined with checkpoint inhibitors:
- INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as
first-line treatment for patients with malignant melanoma. Enrollment of
156 patients completed. Expected readout H1 2024. Sponsored by Ultimovacs.
- NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-
line treatment for patients with malignant pleural mesothelioma. Enrollment
of 118 patients completed; results will be presented at the ESMO Congress in
October 2023. The investigator-initiated study is led by Oslo University
Hospital and supported by Bristol-Myers Squibb and Ultimovacs.
- FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line
treatment for patients with head and neck cancer. Enrollment of 75 patients
completed, expected readout H2 2024. The investigator-initiated study is led
by Halle University in Germany, supported by Ultimovacs.
- DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as
maintenance therapy in non-BRCA mutated patients with advanced ovarian
cancer. >20% of 184 patients recruited as of Q2 2023 reporting, expected
readout H2 2024. The investigator-initiated study is led by NSGO-CTU and
supported by ENGOT, AstraZeneca, and Ultimovacs.
- LUNGVAC: Evaluating UV1 combined with cemiplimab as first-line treatment of
non-small cell lung cancer patients. <10% of 138 patients recruited as of Q2
2023 reporting, expected readout H2 2025. The investigator-initiated study
is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.
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, and is a patented technology owned by Ultimovacs.
In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-
Epitope-Targeting (TET) technology, combines tumor-specific antigens and
adjuvant in the same molecule and is in Phase I clinical development.
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.
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 IR
Email: anne.worsoe@ultimovacs.com (mailto:anne.worsoe@ultimovacs.com)
Phone: +47 90686815
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 Anne Worsøe, Head of Investor
Relations at Ultimovacs ASA, on October 9, 2023 at 07:00 CET.
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