Ultimovacs announces Acceptance of Publication in ‘Frontiers in Immunology’ featuring positive results from Phase I trial evaluating UV1 in Non-Small Cell Lung Cancer

 

Oslo, 2 November 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), today
announced the acceptance of publication in Frontiers in Immunology, outlining
the positive long-term follow-up data from the company's Phase I trial
evaluating its proprietary universal cancer vaccine, UV1, in non-small cell lung
cancer. The publication will cover detailed outcomes of the study for the 18
patients receiving UV1 monotherapy as maintenance treatment. 

"Today's acceptance of publication in Frontiers in Immunology supports our goal
to raise UV1 awareness among the scientific and medical communities through
publications and presentations at medical conferences," stated Carlos de Sousa,
Chief Executive Officer at Ultimovacs. "Continued positive signs of safety and
tolerability are of great importance for us as we are currently evaluating UV1
in triple combinations in two Phase II studies and safety remains our primary
focus as we develop treatments for patients in need." 

In the study, a total of 18 non-small cell lung cancer patients whose disease
had not progressed after receiving at least 2nd line treatment with chemotherapy
were enrolled to receive UV1 monotherapy as maintenance treatment. Patients were
assigned to three different dose-groups, of 100, 300 and 700 µg, with each
cohort enrolling 6 patients. Data in the publication with a cut-off date of
March 2020, demonstrated that administration of UV1 resulted in specific T-cell
responses in the majority of the patients. The highest dose of 700 µg, resulted
in the highest proportion of immune responses. In addition, immune responses in
the high-dose cohort were stronger, occurred at an earlier timeframe and were
associated with long survival. The 4-year overall survival (OS) for the patients
in the highest cohort was 83%, as compared to 39% for the total patient group. 

"The acceptance of our publication is a recognition of the confidence we have in
UV1 as a universal cancer vaccine that could potentially treat a range of cancer
indications," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "The
data in the publication together with the 5-year topline results that we
announced last month, confirm that UV1 can potentially benefit patients with
non-small cell lung cancer. In all four Phase I trials that Ultimovacs has
conducted with UV1, we see promising overall survival outcomes that support our
ongoing, extensive clinical development program for UV1." 

The abstract of the publication is available here:
https://www.frontiersin.org/articles/10.3389/fimmu.2020.572172/abstract, the
full article can be accessed after publication at the Frontiers in Immunology
website: www.frontiersin.org. 

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 three randomized, multinational, Phase II combination
trials recruiting more than 400 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.

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