Vis børsmeldingen
- As of today, the 70 events have not yet occurred, but the 18-month follow-up
for the last patient has now been reached. The Company expects to announce
topline results from the INITIUM trial in March 2024.
- The randomized Phase II clinical trial results will provide comparative data
on efficacy and safety for UV1 vaccination added to standard-of-care
immunotherapy, ipilimumab and nivolumab, in patients with unresectable or
metastatic malignant melanoma.
Oslo, January 16, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-
stage biotechnology leader in novel immunotherapeutic cancer vaccines, today
announced that the last patient enrolled in the INITIUM trial has now been
followed for 18 months, thereby enabling readout of the primary endpoint. The
Company expects to announce topline results from the randomized Phase II
clinical trial in March this year.
The first patient was enrolled in INITIUM in June 2020, and the trial completed
enrollment of 156 patients in July 2022. As per the original study protocol,
data analysis was planned to be initiated after disease progression or death had
been verified in 70 patients, which was initially estimated to occur by the
first half of 2023. It has taken longer than anticipated for the participants in
INITIUM to experience disease progression or death compared with the historical
reference data.
The INITIUM protocol was therefore amended
(https://ultimovacs.com/investors/news/Ultimovacs-Announces-Protocol-Amendment-
in-UV1-Phase-II-Study-INITIUM-in-Malignant-Melanoma,-Enabling-Data-Readout-in-
First-Half-of-2024) late 2023 to allow data readout based on a minimum of 18
months of follow-up of all evaluable patients. The amendment was agreed to by
the relevant regulatory authorities in the countries where the trial has been
conducted. The protocol amendment will maintain the integrity of the study
statistics without materially affecting the scientific value of the clinical
trial.
The patients in the INITIUM trial have been followed for a range of 18 to 42
months with an expected median observation time of approximately 24 months. The
patients will continue being followed for survival for an additional two years.
“The initiation of the process for the INITIUM readout marks a noteworthy
milestone in Ultimovacs’ clinical development program for UV1. We look forward
to announcing the topline results in March this year and plan to present the
full data thereafter at a medical conference and in a publication in a peer-
reviewed medical journal,” said Carlos de Sousa, CEO of Ultimovacs. “There
remains an unmet need in the treatment of metastatic melanoma, and UV1 has shown
significant potential to be a therapeutic option for these advanced-stage
patients. The INITIUM results and additional upcoming Phase II data readouts
will be the basis for our next steps in advancing UV1, as we seek to bring UV1
to the patients as quickly as possible.”
The INITIUM clinical trial (NCT04382664
(ClinicalTrials.gov)) evaluates
Ultimovacs’ universal cancer vaccine, UV1, as first-line treatment in
unresectable or metastatic malignant melanoma in combination with PD-1
checkpoint inhibitor nivolumab and CTLA-4 checkpoint inhibitor ipilimumab.
Nivolumab and ipilimumab are considered the “gold standard” treatment for
patients with unresectable or metastatic melanoma who can tolerate the potential
toxicity.
The randomized Phase II clinical trial results will provide comparative data on
the efficacy and safety of UV1 vaccination added to the standard-of-care
immunotherapy. The primary endpoint of the INITIUM trial is progression-free
survival (PFS) as per RECIST 1.1. Secondary endpoints include overall survival
(OS), objective response rate (ORR), duration of response (DOR), and safety of
UV1 vaccination in combination with nivolumab and ipilimumab.
Ultimovacs has received a dual Fast Track designation from the FDA, granted in
October 2021 (https://ultimovacs.com/investors/news/ultimovacs-receives-dual-
fda-fast-track-designation-for-uv1-in-advanced-malignant-melanoma), for UV1 in
combination with checkpoint inhibitors in the treatment of unresectable or
metastatic melanoma - either as add-on therapy to pembrolizumab or as add-on
therapy to ipilimumab. In December 2021
(https://ultimovacs.com/investors/news/ultimovacs-granted-orphan-drug-
designation-by-fda-for-uv1-cancer-vaccine-in-metastatic-melanoma), UV1 was
granted Orphan Drug designation from the FDA for treatment of stage IIB-IV
melanoma.
==ENDS==
About INITIUM
INITIUM is an Ultimovacs-sponsored randomized, comparative, multicenter Phase II
clinical trial in which the universal cancer vaccine UV1 will be evaluated in
combination with the checkpoint inhibitors ipilimumab and nivolumab for first-
line treatment of patients with unresectable or metastatic malignant melanoma.
The first patient received treatment in the INITIUM trial in June 2020, and the
last patient was enrolled in July 2022. The trial is being conducted at 39
hospitals across the U.S., U.K., Belgium, and Norway. The initial study design
called for enrollment of 154 patients. Two additional patients were enrolled,
bringing the total number of patients to 156.
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. UV1 is a patented technology owned by Ultimovacs.
In addition, Ultimovacs holds all rights to the proprietary TET technology
platform for any possible future formulations use in various solid tumor
indications. The Company is listed on the Euronext Oslo Stock Exchange (OSE:
ULTI).
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 in July 2022. Expected readout in March 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 in January 2023. Data presented at the ESMO
Congress in October 2023 showed that UV1, as an add-on to ipilimumab and
nivolumab, demonstrated a statistically significant and clinically
meaningful improvement in overall survival versus ipilimumab and nivolumab
alone. 31% of the patients receiving the UV1 vaccine experienced an
objective response, compared to 16% in the control arm. The investigator-
initiated trial 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. The enrollment of 75
patients was completed in August 2023, and the expected readout is H2 2024.
The investigator-initiated trial 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. 25% of 184 patients enrolled as of Q3 2023 reporting, and the
expected readout is H2 2024. The investigator-initiated trial 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 enrolled as of Q3
2023 reporting, expected readout H2 2025. The investigator-initiated trial
is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.
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 with eight
intradermal injections and the immune-modulator GM-CSF.
For further information, please contact:
Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com (mailto:carlos.desousa@ultimovacs.com)
Phone: +47 908 92507
Anne Worsøe, Head of Investor Relations
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 January 16, 2023 at 07:00 CET.
Kilde
