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during Q3 2024, in which the treatment combination is the same as in the
UV1-103 trial
Oslo, June 11, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage
biotechnology company developing immunotherapeutic cancer vaccines, today
announced encouraging overall survival (OS) data from both cohorts in the UV1-
103 Phase I clinical trial in malignant melanoma.
The UV1-103 study evaluates Ultimovacs’ universal cancer vaccine, UV1, in
combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line
treatment in patients with advanced non-resectable or metastatic malignant
melanoma. The study enrolled 30 patients in the U.S. in two cohorts that
differed only in the concentration of GM-CSF used as vaccine adjuvant. With a
minimum follow-up of 4 years (median 53.0 months), the updated OS results show
that all patients who were alive at the 3-year mark remain alive at 4 years,
with an OS rate of 69.5%
Ultimovacs has previously reported data showing a complete response rate in the
UV1-103 study of 33% (complete disappearance of tumors) and an objective
response rate of 57% (complete or partial disappearance of tumors). Biomarker
analyses reported in October 2022 showed robust clinical responses in patients
treated with the combination of UV1 and pembrolizumab, regardless of patients’
PD-L1 status. The safety profile of UV1 in combination with pembrolizumab is
comparable to that of pembrolizumab alone.
“We are encouraged by the strong overall survival rate observed in this Phase I
study,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. “The data show
a high survival rate among patients enrolled in the UV1-103 trial, even after a
minimum of 4 years of follow-up. We look forward to the read-out of the FOCUS
trial in head and neck cancer, where the same treatment combination has been
used”.
==ENDS==
About the UV1-103 phase I trial in Malignant Melanoma
This US-based Phase I clinical trial evaluates the Company’s lead candidate,
UV1, combined with the anti-PD-1 checkpoint inhibitor, pembrolizumab, as a
first-line treatment in patients with unresectable metastatic malignant
melanoma. The trial evaluates safety, tolerability, and initial signs of
clinical response. Thirty patients in the U.S. were treated in the study in two
cohorts that differed only in the concentration of GM-CSF used as vaccine
adjuvant. The 20 patients in the first cohort received a 37.5 mcg GM-CSF
adjuvant dose per UV1 vaccination. The 10 patients in the second cohort received
the standard 75 mcg GM-CSF adjuvant dose per UV1 vaccination. The study has
completed the enrollment of 30 patients, as announced on August 18, 2020. All
included patients received the drugs as first-line treatment for advanced and
metastatic malignant melanoma.
Compiled clinical results for the 30 patients enrolled are:
Three patients in cohort 1 chose not to be followed beyond 24 months. The trial
had previously reached its primary endpoint of safety and tolerability, and no
unexpected safety issues related to UV1 have been observed in this trial.
As a historical reference (not head-to-head comparison since dosing and the
patient population are different), the registrational study for pembrolizumab,
Keynote-006, showed an overall survival rate of 42% at 48 months (Long GV et al,
ASCO 2018).
The U.S. Food and Drug Administration (FDA) granted a dual Fast Track
designation 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.
About Ultimovacs
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic
cancer vaccines. The lead cancer vaccine candidate UV1 is an off-the-shelf
vaccine 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
investigate UV1’s impact in combination with other immunotherapies in multiple
cancer types. UV1 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. The Company is listed on
the Euronext Oslo Stock Exchange (ULTI).
About UV1
UV1 is a therapeutic 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 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 Investor Relations
Email: anne.worsoe@ultimovacs.com (mailto:anne.worsoe@ultimovacs.com)
Phone: +47 90686815
This information is considered inside information pursuant to the EU Market
Abuse Regulation and is subject to 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 June 11, 2024, at 07:00 am CET.
This information is subject to the disclosure requirements pursuant to Section
5-12 the Norwegian Securities Trading Act
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