Ultimovacs Announces Updated Positive Results from Phase I Trial Evaluating Universal Cancer Vaccine, UV1, in Non-Small Cell Lung Cancer

 

Oslo, 19 October 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), today
announced five-year overall survival data from the Phase I trial evaluating UV1
as maintenance therapy in patients with non-small cell lung cancer. The results
confirm achievement of the primary endpoints of safety and tolerability and
indicate encouraging initial signals of long-term survival benefit. 

"Ultimovacs has established a growing body of clinical data demonstrating a
strong safety and tolerability profile for UV1 and a range of preliminary
efficacy signals in several cancer indications, all of which supports the
further development of our proprietary cancer vaccine candidate," stated Carlos
de Sousa, Chief Executive Officer at Ultimovacs. "The long-term follow-up
results announced today demonstrate that treatment with UV1 is safe both at the
time of administration and throughout the follow-up period of at least 5 years.
Non-small cell lung cancer highly expresses telomerase and remains an indication
in great need of new treatment options for patients."

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. Outcomes of
the study included the safety and tolerability of UV1 as well as initial signs
of clinical response. As per the cut-off date of June 2020, every patient in the
trial reached at least 60-months of follow-up post treatment with UV1. At the
five-years landmark, the Overall Survival (OS) rate was 33% and median
Progression Free Survival (mPFS) was 10.7 months. Throughout the follow-up
period, none of the patients experienced unexpected safety issues related to
UV1. Further, none of the patients alive after 5 years have received other
immunotherapy after the vaccination with UV1. 

"At the time of the study initiation, there were no checkpoint inhibitors
available for treatment of this patient population. For patients that received a
second-line of chemotherapy the expected 5-year survival rate was less than 5
percent," stated Jens Bjørheim, Chief Medical Officer at Ultimovacs. "While our
Phase I study is non-randomized and conducted in a small population, it is
promising to see that UV1 was safe and well-tolerated and that using UV1 as a
maintenance therapy could potentially provide benefit to patients in need of
novel approaches." 

Ultimovacs presented 48-months of follow-up data at the Society for
Immunotherapy of Cancer's (SITC) 34th Annual Meeting in November of last year. 

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