Ultimovacs ASA – Initiates FOCUS Phase II Trial for Universal Cancer Vaccine, UV1, in Head and Neck Cancer Patients Receiving Pembrolizumab

 

Oslo, 22 December 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTI), today
announced the initiation of FOCUS, a Phase II randomized clinical trial that
will evaluate the Company's proprietary universal cancer vaccine, UV1, in 75
patients with recurrent or metastatic head and neck cancer who will be treated
with standard of care therapy pembrolizumab. The trial will be conducted at 10
sites across Germany and led by principal investigator Prof. Mascha Binder,
M.D., Medical Director and Head of the Immunological Tumor Group at University
Medicine Halle, Germany, who is a renowned oncology clinician and researcher
specializing in the analysis of immuno-oncology treatments and their interaction
with tumor tissues. The FOCUS trial is Ultimovacs' fourth Phase II clinical
trial with UV1 and comes in addition to the collaboration Phase II trial
announced in May 2020. 

"We continue to strategically expand our clinical development program for our
proprietary cancer vaccine, not only by testing UV1 in additional cancer
indications with critical need, such as head and neck cancer, but also by
collaborating with clinicians like Professor Binder who can provide us with
unique insights," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs.
"Professor Binder and her team are well-recognized experts who will increase our
understanding of UV1's mechanism of action and contribute data on anti-tumor
activity induced by UV1 vaccination." 

The FOCUS (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1
Study) Phase II trial is an investigator-sponsored, randomized Phase II clinical
trial that will recruit patients with recurrent or metastatic PD-L1 positive
head and neck squamous cell carcinoma across 10 clinical sites in Germany. The
trial will evaluate the addition of UV1 to a standard of care treatment with
PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab
monotherapy. A total of 75 patients indicated for treatment with pembrolizumab
will be enrolled in the FOCUS study, randomized 2-to-1 so that 50 patients will
receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone.
The primary endpoint of the study is the progression-free survival rate at 6
months, and planned readout of topline results is expected in 2023. The FOCUS
Phase II trial is partially supported through an innovation grant of up to NOK
16 million from the Norwegian Research Council and will not require Ultimovacs
to secure additional financing at this stage.

"This clinical trial is the extension of an earlier collaboration with
Ultimovacs that introduced me to the therapeutic potential of the UV1 approach,"
commented Professor Mascha Binder, M.D., Medical Director and Head of the
Immunological Tumor Group at University Medicine Halle. "I am excited to apply
my own insights as well as my team's expertise to this trial with the goal of
potentially providing head and neck cancer patients with better treatment
options." 

"We have continued to build momentum in our broad clinical development program
with the start of the FOCUS study, representing the important opportunity to
test UV1 in combination with pembrolizumab in a randomized setting for the first
time," said Carlos de Sousa, Chief Executive Officer at Ultimovacs. "We welcome
the funding provided by the Norwegian Research Council, which supports our
ability as a small biotechnology company to conduct four Phase II trials in
parallel and evaluate UV1 in different indications with more than 450 patients
and as part of various treatment combinations." 

Dr. de Sousa added: "Although we have signed our agreement with the lead
investigator for our previously announced third Phase II clinical trial, we will
need to wait for the investigator and the pharmaceutical partner to finalize the
signature process for their agreement before we can provide full details, which
we expect to do before year end." 



About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the
universal cancer antigen telomerase. UV1 is being developed as a therapeutic
cancer vaccine which may serve as a platform for use in combination with other
immunotherapy which requires an ongoing T cell response for their mode of
action. To date, UV1 has been tested in four phase I clinical trials in a total
of 82 patients and maintained a positive safety and tolerability profile as well
as encouraging signals of efficacy. 

About UV1 Clinical Programs 
As a universal cancer vaccine, UV1's unique mechanism of action has the
potential to be applicable across most cancer types. The clinical development of
the UV1 vaccine includes four randomized, multinational, Phase II combination
trials recruiting more than 450 patients in total. The INITIUM trial is an
Ultimovacs-sponsored clinical trial recruiting 154 patients with metastatic
malignant melanoma to evaluate UV1 in combination with ipilimumab and nivolumab
as first-line treatment. The NIPU study is testing UV1 in combination with
checkpoint inhibitors ipilimumab and nivolumab as second-line treatment in 118
patients with advanced malignant pleural mesothelioma, a rare lung cancer. The
study is sponsored by Oslo University Hospital and Bristol-Myers Squibb is
providing the checkpoint inhibitors for this study. Ultimovacs anticipates
announcing data on the primary endpoints for the NIPU and INITIUM studies in
2022. A third Phase II clinical trial will evaluate UV1 in a new cancer
indication in combination with indication-specific standard of care cancer
therapies different from those to be tested in INITIUM and NIPU. In this new
collaboration, Ultimovacs will supply UV1 and a big pharma company will supply
its proprietary cancer treatment to the clinical trial group, which will sponsor
the trial. The fourth trial, FOCUS, is an investigator-sponsored, randomized
clinical trial, enrolling 75 patients with metastatic head and neck cancer
receiving pembrolizumab as standard of care, to evaluate the impact of adding
UV1 to this regimen.

About Ultimovacs
Ultimovacs' UV1 universal cancer vaccine candidate leverages the high prevalence
of the human telomerase (hTERT) to be effective across the dynamic stages of the
tumor's growth and its microenvironment. By directing the immune system to hTERT
antigens that are present in over 80% of all cancers, UV1 drives CD4 helper T
cells to the tumor with the goal of activating an immune system cascade to
increase anti-tumor responses. Ultimovacs' strategy is to clinically demonstrate
UV1's impact in a range of cancers and in several immunotherapy combinations
while expanding our pipeline of cancer vaccine therapies, convinced that a
universal approach may be the key to achieving better outcomes for patients.

For further information, please see www.ultimovacs.com or contact:

Carlos de Sousa, Chief Executive Officer
Email: carlos.desousa@ultimovacs.com 
Phone: +47 908 92507 

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