Ultimovacs ASA - With support from Bristol-Myers Squibb and Ultimovacs, UV1 will be tested in a large, randomized combination trial in mesothelioma initiated by Oslo University Hospital

 

Oslo, 13 December 2019: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a
pharmaceutical company developing novel immunotherapies against cancer,
announces that the universal cancer vaccine UV1 will be investigated in a
randomized, multi-center phase II trial in mesothelioma. The trial, named NIPU,
investigates UV1 in combination with the checkpoint inhibitors nivolumab and
ipilimumab as second-line treatment in mesothelioma. 

Oslo University Hospital ('OUS') is the sponsor of the study. Bristol-Myers
Squibb ('BMS') and Ultimovacs have entered into agreements with OUS to support
the preparations and execution of the trial.  

A total of 118 patients will be included in the study. Half of the patients will
be treated with the combination of UV1, nivolumab and ipilimumab, whereas the
other half will receive nivolumab and ipilimumab only. 

The study is planned to be conducted at 6 hospitals in 5 countries (Norway,
Sweden, Denmark, Finland, and Australia). The study is about to be initiated and
patient inclusion is expected to start in Q1 2020. The primary endpoint of the
trial is progression-free survival (PFS) and the PFS read-out is expected
mid-2022. The necessary approvals from the Norwegian Medicinal Agency and the
ethics committee in Norway are in place to initiate the trial. 

Ultimovacs will cover the costs associated with its participation in the study
from existing funds. 

Dr. Åslaug Helland, Oslo University Hospital, principal investigator of the
study, says: 
"We are enthusiastic about the initiation of this clinical trial which will be
run with the support from BMS and Ultimovacs. Malignant pleural mesothelioma is
the most common type of mesothelioma and is a disease with a high unmet medical
need. The immunotherapy combination of nivolumab, ipilimumab and UV1 could
represent a highly interesting treatment regime where the different mechanisms
of action of the three drugs could provide synergistic effects that could be of
clinical benefit to patients. "

Øyvind Kongstun Arnesen, CEO of Ultimovacs, says: 
"We are pleased to take part in this exciting clinical trial with our universal
therapeutic cancer vaccine, UV1. As we have previously seen, the combination of
UV1 and ipilimumab provided rapid and durable immune responses in our phase I
melanoma trial suggesting a synergistic immunological activity. The simultaneous
administration of another checkpoint inhibitor, nivolumab, may further support
the immune system's ability to recognize and effectively kill the cancer cells.
"

The initiation of the NIPU trial brings UV1 in clinical investigation in its
fourth cancer type to date. Previously, UV1 has been tested within prostate
cancer, non-small cell lung cancer, and malignant melanoma. In Q1 2020,
Ultimovacs expects to include the first of 154 patients in a randomized trial in
malignant melanoma where UV1 is combined with nivolumab and ipilimumab. 

Øyvind Kongstun Arnesen, CEO of Ultimovacs, adds: 
"The fact that UV1 will be investigated in two large randomized clinical trials
in different cancer types and with a total of 272 patients is a major step
forward for Ultimovacs and the development of UV1. This will enhance the
opportunities for successful clinical results in an additional cancer indication
and support that UV1 may be broadly applicable across cancer types."

About NIPU
NIPU is an investigator-initiated, Oslo University Hospital sponsored,
randomized, multi-center, open-label, proof of concept study comparing the
efficacy and safety of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) with
and without UV1 in patients with inoperable malignant pleural mesothelioma (MPM)
who have progressed after first-line platinum-based chemotherapy. Biological
material will be sampled, and there will be several explorative analyses aiming
at identifying biomarkers and revealing mechanisms of action. 

In total, 118 patients will be randomized into two patient groups treated with
ipilimumab and nivolumab with or without UV1 together with sargramostim (GM-CSF)
as vaccine adjuvant. The objective of the study is to induce a meaningful
progression-free survival (PFS) benefit in patients with MPM after progression
on first-line standard platinum doublet chemotherapy. 

The study sites are planned to be Oslo University Hospital in Norway, Karolinska
University Hospital and Skåne University Hospital Lund in Sweden, Rigshospitalet
in Denmark, Helsinki University Hospital in Finland, and Sir Charles Gairdner
Hospital in Perth, Australia.    

About Malignant Pleural Mesothelioma
Malignant pleural mesothelioma (MPM) is a rare malignant tumor originating from
the cells lining the mesothelial surface in the lungs. MPM is the most common
type of mesothelioma and is a disease with a high unmet medical need with a
median overall survival of approximately 1 year. Most patients are treated with
palliative chemotherapy. Patients with disease progression after first-line
therapy have few therapeutic options. Asbestos exposure is heavily linked to the
development of the disease. It may take 10 - 50 years for symptoms of
mesothelioma to manifest after initial asbestos exposure. Even though the use of
asbestos to a large extent is banned today, new incidences of mesothelioma will
continue to be a medical challenge for decades.

About Ipilimumab
Ipilimumab is a recombinant, human monoclonal antibody that binds to the
cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative
regulator of T-cell activity. Ipilimumab binds to CTLA-4 and blocks the
interaction of CTLA-4 with its ligands, CD80/CD86.

About Nivolumab
Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is
designed to uniquely harness the body's own immune system to help restore
anti-tumor immune response. By harnessing the body's own immune system to fight
cancer, nivolumab has become an important treatment option across multiple
cancers.

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. With its mechanism of action, UV1 is potentially a universal cancer
vaccine that can be applied across most cancer types. 


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

Øyvind Kongstun Arnesen, CEO 
oeyvind.arnesen@ultimovacs.com, +47 469 33 810 

Hans Vassgård Eid, CFO 
hans.eid@ultimovacs.com, +47 469 19 822