Ultimovacs Publishes Positive Long-term UV1 Data from Phase I Malignant Melanoma Combination Study in Frontiers in Immunology

 

Oslo, 11 May 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage
leader in immune stimulatory vaccines for cancer, today announced the
publication in Frontiers in Immunology of its positive long-term Overall
Survival (OS) data from the Phase I trial evaluating the Company's universal
cancer vaccine, UV1, in combination with checkpoint inhibitor ipilimumab in
patients with metastatic malignant melanoma. As published in the journal, in
addition to the achievement of the primary endpoints of safety and tolerability,
50% of the patients were still alive at the data cut-off, supporting the
combination of the Company's proprietary UV1 vaccine with ipilimumab, a CTLA-4
checkpoint inhibitor and standard-of-care treatment, in this late-stage patient
population. 

"Publishing our clinical trial data in such a prestigious peer-reviewed
publication adds validation for UV1 as a promising therapeutic option for cancer
patients. As we continue to evaluate UV1 in various combinations and
indications, it is valuable to gain increased international recognition from the
clinical community for this study," stated Jens Bjørheim, Chief Medical Officer
at Ultimovacs. "Historical data on the use of ipilimumab as monotherapy in
malignant melanoma have shown a 5-year survival rate below 20%, therefore the
results published today reinforce UV1's potential in this indication."

The data published in Frontiers in Immunology covers 4.8 years of follow-up on
the total of 12 metastatic malignant melanoma patients that were enrolled in the
Phase I trial. As reported in the journal, the OS was 50% at 4.8 years, which
was confirmed by the results of 5 years of follow-up announced by the Company in
December 2020. 

Building on these promising Phase I results, Ultimovacs is currently enrolling
INITIUM, its Phase II clinical trial evaluating UV1 in combination with
ipilimumab and nivolumab in patients with metastatic malignant melanoma. The
company expects to announce data on the trial's primary endpoint in 2H2022. In
addition, Ultimovacs has an ongoing and fully-enrolled Phase I trial evaluating
UV1 in combination with pembrolizumab, a PD-1 checkpoint inhibitor, as a first
line treatment in metastatic malignant melanoma patients. 

The publication in Frontiers in Immunology can be found under doi:
10.3389/fimmu.2021.663865.

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 an
"off-the-shelf" 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: INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 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. The DOVACC study is sponsored by the Nordic Society of
Gynaecological Oncology. In total, 184 patients with high-grade ovarian cancer
will be enrolled to evaluate UV1 in combination with durvalumab and olaparib,
both provided by AstraZeneca. FOCUS is an investigator-sponsored, randomized
clinical trial enrolling 75 patients with metastatic head and neck cancer
receiving pembrolizumab as standard of care, and will evaluate the impact of
adding UV1 to this regimen. Ultimovacs anticipates announcing data on the
primary endpoints for the NIPU and INITIUM studies in 2H2022 and for the DOVACC
and FOCUS studies in 2023. 

About Ultimovacs
Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to
treat a broad range of cancers. Ultimovacs' lead universal cancer vaccine
candidate UV1 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
many cancer types and in combination with other immunotherapies. The Company
will expand its pipeline using its novel TET-platform, which is an innovative
vaccine technology that can generate multiple vaccine candidates designed to
achieve increased T cell responses to a broad range of target antigens. 


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