Ultimovacs Announces Publication of Phase II FOCUS Trial Results on medRxiv

25 Oct 2024 17:00 CEST

Oslo, October 25, 2024: Ultimovacs ASA (https://ultimovacs.com/) ("Ultimovacs")
(OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic
cancer vaccines, today announced that the results from Phase II FOCUS trial
(NCT05075122
(https://www.globenewswire.com/Tracker?data=bKKMFSBPumiwxqSFnuYBmKZxD6NH5EKEd7Xr
HrBNmhltttJAW4AG12WAsPbF3uNIHSxvyDjS2EgkwfsPeZu0PuupLWN_AF-
9zOnH_uECSHG_6G6dK6RvVnNfhQEg5W4U)) have been published online
(https://www.medrxiv.org/content/10.1101/2024.10.24.24315748v1.full.pdf+html) on
the preprint platform medRxiv.

As previously reported
(https://www.medrxiv.org/content/10.1101/2024.10.24.24315748v1), topline data
readout demonstrated that adding UV1 to the standard of care pembrolizumab did
not lead to clinical benefits in progression free survival or overall survival
in the late-stage head and neck squamous cell carcinoma (HNSCC) patients
recruited in the study. The study therefore did not meet its primary and
secondary endpoints. UV1 continued to demonstrate a positive safety profile in
line with other UV1 studies with similar events observed in the control arm and
good tolerability.

==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 as a first-line treatment in metastatic patients or a second-line
treatment in patients with recurrent 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 10 sites across Germany. The trial is
investigating the tolerability and efficacy addition of UV1 to 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 that 50 patients
will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab
alone. The primary endpoint is PFS rate at 6 months after 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 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.

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 that are 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.

About Ultimovacs
Ultimovacs is a clinical-stage biotechnology company developing novel
immunotherapies against cancer. The product candidate UV1 is an off-the-shelf
therapeutic cancer vaccine designed to enhance the benefits of immunotherapy and
improve cancer treatment efficacy for patients. UV1 triggers an immune response
against the shared cancer antigen telomerase, a target present in 85-90% of all
cancer indications across disease stages.

Ultimovacs is investigating the safety and efficacy of UV1 in a wide-ranging
clinical development program including various cancer indications and different
immunotherapy combinations. The ongoing Phase II program comprises five
randomized clinical trials in melanoma, mesothelioma, head and neck cancer,
ovarian cancer, and non-small cell lung cancer. More than 640 patients in the
U.S., Europe, and Australia are being enrolled in all Phase I and Phase II
trials in the current program.

Furthermore, Ultimovacs is developing a novel conjugation technology, initially
formed to support the expansion of our vaccine pipeline. With the objective of
driving value and future pipeline growth, this flexible conjugation technology
has the potential to be broadly applicable to a variety of therapeutic
modalities, such as innovative drug conjugates with favorable pharmacological
properties, and in multiple disease areas.

Ultimovacs is listed on the Euronext Oslo Stock Exchange (OSE:ULTI).

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

Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

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