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- The study will provide randomized data on the benefit of UV1 vaccination as
add-on to standard pembrolizumab treatment
- Topline results, including overall survival, will be provided to the Company
by the Principal Investigator 12 months after the last patient received
first dose, expected in second half of 2024
Oslo, 3 August 2023 - Ultimovacs ASA (https://ultimovacs.com/) (“Ultimovacs”)
(OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines, today announced the completion of enrollment of 75 patients and
that the last patient has received the first dose in the FOCUS study
(NCT05075122 (Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab - Full Text View - ClinicalTrials.gov)).
FOCUS is an investigator-initiated Phase II randomized clinical trial sponsored
by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs. The
study investigates Ultimovacs’ therapeutic cancer vaccine, UV1, in combination
with pembrolizumab versus pembrolizumab alone, as first-line treatment for
patients with recurrent or metastatic PD-L1 positive head and neck squamous cell
carcinoma (HNSCC). For these patients, pembrolizumab is a standard of care
treatment.
The FOCUS trial is being conducted at ten sites across Germany and is led by
Principal Investigator Mascha Binder, M.D., Professor of Medical Oncology at the
Faculty of Medicine, University Hospital of Basel. Professor Binder is a
renowned oncology clinician and researcher specializing in the analysis of
immune-oncology treatments and their interaction with tumor tissues.
The topline results will include overall survival (OS) with minimum 12 months of
follow-up in addition to progression-free survival (PFS), enabling a full
assessment of the study outcomes. These data will be analyzed 12 months after
the last patient was enrolled and is expected to be disclosed in the second half
of 2024. The results will be announced through a press release followed by an
in-depth presentation of the data at a medical conference and in a peer-reviewed
journal.
“Metastatic or recurrent head and neck cancer is a highly aggressive disease,
and there is a significant need for improved treatment options. The successful
enrollment of patients in the FOCUS study marks a key milestone as we evaluate
novel immunotherapy approaches such as UV1 in combination with checkpoint
inhibitors. By advancing our understanding of these novel therapies, we hope to
bring about a positive impact on the lives of patients battling this devastating
disease,” said Professor Mascha Binder, M.D., Principal Investigator of the
FOCUS trial.
“We are pleased to announce the completion of patient enrollment in the FOCUS
trial, the third of five randomized Phase II clinical trials evaluating UV1 in
different cancer indications and in combination with various checkpoint
inhibitors,” added Carlos de Sousa, Chief Executive Officer at Ultimovacs. “We
look forward to learning the impact of UV1, particularly in terms of overall
survival, the most important efficacy measurement in cancer treatment. We expect
to provide topline data in the second half of 2023 for the Phase II trial in
malignant melanoma, INITIUM. For the Phase II trial in pleural mesothelioma,
NIPU, we expect the full data, including overall survival, to be presented at a
medical conference in the fall of this year. The results from these studies will
increase our understanding of how UV1 can potentially improve outcomes for
cancer patients and provide a foundation for our future pivotal clinical
studies.”
Head and neck cancer is the seventh most common type of cancer worldwide, and
squamous cell carcinoma (HNSCC) represents about 90 percent of these patients.
HNSCC occurs in the head and neck region, including the throat, mouth, sinuses
and nose. Despite advances in treatment strategies, the prognosis for these
patients is poor.
UV1 is a therapeutic cancer vaccine used to generate an immune response against
the enzyme human telomerase (hTERT). The enzyme is essential for the ability of
cancer cells to proliferate. Telomerase is present in 85-90% of all cancers
across the stages of the disease. UV1 is a patented, proprietary technology
owned by Ultimovacs.
Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical
development program across various cancer indications with different biologies
and disease stages, in combination with different checkpoint inhibitors. In
addition to head and neck cancer, Phase II studies are ongoing in patients with
malignant melanoma, pleural mesothelioma, ovarian cancer, and non-small cell
lung cancer.
The FOCUS Phase II trial is partially supported through an innovation grant of
up to NOK 16 million from the Norwegian Research Council.
==ENDS==
About FOCUS
The FOCUS trial (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor
UV1 Study) is an investigator-sponsored, randomized, open-label Phase II
clinical trial. The primary objective of this study is to determine the clinical
performance of UV1 vaccination as add-on to standard pembrolizumab treatment in
patients with recurrent or metastatic PD-L1 positive head and neck squamous cell
carcinoma. Professor Mascha Binder is the principal investigator for the trial,
which is sponsored by the Medical Faculty, University of Halle-Wittenberg in
Germany. The first patient in the FOCUS trial was enrolled in August 2021, and
patients have been treated at ten sites across Germany. The trial is
investigating the tolerability and efficacy addition of UV1 to the standard of
care treatment with programmed death receptor-1 (PD 1)-blocking antibody
pembrolizumab versus pembrolizumab monotherapy. The 75 patients indicated for
treatment with pembrolizumab have been randomized 2-to-1, so 50 patients will
receive UV1 and pembrolizumab, and 25 patients will receive pembrolizumab alone.
The primary endpoint is PFS rate at 6 months after the first administration of
study medication. Secondary endpoints include PFS and OS (overall survival, by
Kaplan-Meier estimate), objective response rate (ORR), duration of response
(DOR), and safety, with a minimum 12 months follow-up. As OS is recognized as
the determining efficacy measure in guiding further development in this cancer
indication, the topline results will be disclosed 12 months after enrollment of
the last patient, allowing simultaneous disclosure of both PFS and OS.
Ultimovacs expects to report the topline readout in the second half of 2024 when
the Principal Investigator discloses the data. The full analysis will be
presented thereafter at a medical meeting and published in a peer-reviewed
journal.
About Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and neck cancer is the term used to describe different malignant tumors
that develop in or around the throat, larynx, nose, sinuses, and mouth. Squamous
cell carcinoma represents about 90 percent of head and neck cancer patients.
Overall survival of patients with metastatic or recurrent HNSCC has improved
over the past decade, but remains poor overall. Median overall survival is
limited to less than 15 months, with the current standard of care (immune
checkpoint blockade with or without chemotherapy). Many patients with HNSCC are
frail and therefore cannot tolerate chemotherapy, reducing their treatment
options to checkpoint inhibitors. Therefore, developing effective and tolerable
combination regimens is urgently needed, especially in first-line therapy.
About 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 puts Ultimovacs in an
advantageous position to capture the cancer vaccine’s potential broad
applicability when combined with checkpoint inhibitors, for further clinical
development:
- INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as
first-line treatment for patients with advanced or metastatic malignant
melanoma. Enrollment of 156 patients completed. Expected readout H2 2023.
Sponsored by Ultimovacs.
- NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-
line treatment for patients with advanced malignant pleural mesothelioma.
Enrollment of 118 patients completed. Topline results announced June 2023,
and detailed data including overall survival expected H2 2023. Investigator-
initiated study led by Oslo University Hospital, supported by Bristol-Myers
Squibb and Ultimovacs.
- FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line
treatment for patients with metastatic or recurrent head and neck cancer.
Recruitment of 75 patients completed, expected topline readout on PFS and OS
in H2 2024. Investigator-initiated study 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 Q1 2023 reporting, expected
readout H2 2024. Investigator-initiated study led by NSGO-CTU, supported by
ENGOT, AstraZeneca, and Ultimovacs.
- LUNGVAC: Evaluating UV1 in combination with cemiplimab as first-line
treatment of patients with advanced or metastatic non-small cell lung
cancer. <10% of 138 patients recruited as of Q1 2023 reporting, expected
readout H2 2025. Investigator-initiated study led by Vestre Viken (Drammen
Hospital), 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 that is
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 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: [email protected]
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ZronmxixcvCgTKXDmb7Iz3vyFeJEo0KK8oTHidt2UbiZXzpyZfujhYyyFd5fA2uzw)
Phone: +47 908 92507
Anne Worsøe, Head of Investor Relations
Email: [email protected]
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Phone: +47 906 86815
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 IR at
Ultimovacs ASA, on 3 August, 2023 at 08:00 CEST.
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