Ultimovacs ASA - Announces Positive 5-Year Overall Survival Update from Phase I Combination Trial Evaluating Universal Cancer Vaccine UV1 in Metastatic Melanoma

 

Oslo, 10 December 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTI), today
announced positive five-year Overall Survival (OS) data from the Phase I trial
evaluating the company's universal cancer vaccine, UV1, in combination with the
checkpoint inhibitor, ipilimumab, in patients with metastatic malignant
melanoma. After 5-years of follow-up, 50% of the patients in the open-label
trial were still alive, providing encouraging signals of long-term survival
benefit for UV1 in this late-stage patient population and as compared to
historical data of ipilimumab monotherapy. As previously reported at ASCO-SITC
in 2020, the trial achieved its primary endpoints of safety and tolerability.
These results represent the third clinical trial with UV1 to provide positive
data for 5-years of patient follow-up, further strengthening UV1's profile as a
safe and potentially effective addition to immuno-oncology treatment regimens. 

"When we look at the trial results of ipilimumab monotherapy conducted in nearly
identical clinical settings and patient population, we see in the literature a
5-year survival rate around 20%, median overall survival of around 16 months and
median progression free survival of about 3.5 to 4 months," stated Jens
Bjørheim, Chief Medical Officer at Ultimovacs. "Combining ipilimumab, which was
the standard-of-care treatment at the time of the study initiation, with UV1,
resulted in promising signs of improved survival with a safe and well-tolerated
profile. At 5 years of follow-up, the median overall survival had not been
reached and 50% of the patients were still alive, which are encouraging results
in patients with metastatic melanoma." 

A total of 12 malignant melanoma patients with metastatic disease were treated
in the Phase I trial. Eight patients of the 12 received UV1 combined with
ipilimumab as first line treatment, and the remaining four patients received the
combination after progression on previous systemic treatment. Immune responses
toward the UV1 peptides occurred very early post administration, with 91% of the
evaluable patients showing an immune response. In the efficacy-evaluable patient
population, one patient achieved a complete tumor response and three patients
achieved a partial response, resulting in an objective response rate of 44%.
Primary endpoints for the study included the safety and tolerability of UV1 as
well as initial signs of clinical response. As per the data cut-off at the end
of November 2020, every patient in the trial reached at least 60 months of
follow-up post treatment with UV1 and ipilimumab. At the five-year mark, the OS
rate was 50%, median OS had not yet been reached and median Progression Free
Survival (mPFS) was 6.7 months. Over the course of the follow-up period, none of
the patients experienced any unexpected safety issues related to UV1. 

"In all four Phase I trials where UV1 has been tested, we have observed a
consistent set of positive signals of clinical effect and a good safety profile
for UV1. This strengthens our commitment to developing UV1 as a potential
universal cancer vaccine that can be applied across multiple indications, in
different combinations with other cancer treatments and in different stages of
cancer," stated Carlos de Sousa, Chief Executive Officer at Ultimovacs."Our
ongoing INITIUM Phase II clinical trial combines UV1 with ipilimumab and
nivolumab in this patient population and today's results reinforce the
confidence we have in our approach of directing the immune system towards
telomerase expressing cancer cells to improve clinical outcomes for patients in
need of new treatment options." 

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