Ultimovacs ASA Announces Collaboration with Big Pharma Company and Leading European Oncology Clinical Trial Group to Evaluate UV1 in a Third Phase II Clinical Trial

 

Oslo, 27 May 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO, or the
"Company"), a pharmaceutical company developing novel immunotherapies against
cancer, announced today that the Company has entered into a collaboration with a
leading Big Pharma company and a European oncology clinical trial group to
evaluate the Company's universal cancer vaccine, UV1, in an additional
randomized, multi-center Phase II clinical trial. 

This 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 the other Phase II clinical trials, INITIUM
(malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients). In the
collaboration, Ultimovacs will supply UV1 and the Big Pharma company will supply
its proprietary cancer treatment to the clinical trial group which will sponsor
the trial. Subject to final agreement between Ultimovacs, the sponsor and the
Big Pharma partner, which is planned to be signed in Q3 2020, the first patient
is expected to be enrolled in the study during Q4 2020 with the read-out of
primary endpoints anticipated during the first half of 2023.

The new Phase II clinical trial will strengthen the already extensive clinical
program within Ultimovacs, containing three completed and one ongoing Phase I
clinical trials and three Phase II clinical trials. The Phase II clinical trials
will be in three different indications with more than 400 patients when fully
enrolled, and with a close collaboration with two Big Pharma companies. The
ongoing clinical trials represent a good platform for Ultimovacs towards a
possible registration of the universal cancer vaccine UV1.


Øyvind Kongstun Arnesen, CEO of Ultimovacs, commented: 

"This collaboration with a Big Pharma company as well as a leading international
oncology clinical trial group, highlights UV1's potential as a cancer vaccine
that could be applicable across many indications and in combination with a
variety of cancer therapies. The upcoming Phase II clinical trial is testing UV1
in yet another cancer indication. This is a further expansion of our clinical
development pipeline and enable us to continue to build value for patients, the
Company and our shareholders." 

The upcoming Phase II clinical trial will test UV1 in Ultimovacs' fifth cancer
indication to-date. Previously, UV1 was tested in patients with prostate cancer,
non-small cell lung cancer and malignant melanoma. In Q2 2020, Ultimovacs
expects to enroll the first patients in both the Phase II INITIUM trial in
malignant melanoma and in the Phase II NIPU trial in mesothelioma. In total, the
INITIUM and the NIPU trials will include 272 patients. 
 


Jens Bjørheim, Chief Medical Officer of Ultimovacs, added: 

"As we plan to enter our third Phase II clinical trial, we are paving the way
for multiple clinical results and value inflection points in 2022 and 2023.
These results will have a high clinical and statistical relevance for the next
strategic steps in the drug development process for UV1 with our goal set on
eventual market approval. Our expanded development program will also form a
strong foundation for future industrial partnerships that can bring us closer to
delivering UV1 to patients in need."

The new clinical trial will be financed through a fully underwritten private
placement. This private placement will further strengthen the solid cash
position of Ultimovacs and ensure that the defined development program for UV1
will be fully financed through the read-out of primary end-points in the three
phase II trials in 2022 and 2023.

An updated Corporate Presentation is available at our website under the Reports
and presentations section:

https://ultimovacs.com/investors/reports-and-presentations 


About UV1 and the ongoing Phase II Clinical Trials

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. 

The INITIUM trial is a Ultimovacs-sponsored randomized phase II trial for
patients with metastatic malignant melanoma. Patients will be given UV1 in
combination with ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1
checkpoint inhibitor). The trial will be run in the US and Europe (including
Norway). In total, 154 patients will be enrolled, where 77 patients will receive
nivolumab and ipilimumab and the other 77 patients will receive nivolumab,
ipilimumab and UV1. 

The NIPU trial is a randomized, multi-center phase II trial where the universal
cancer vaccine UV1 is investigated in combination with the checkpoint inhibitors
ipilimumab and nivolumab as second-line treatment in mesothelioma. Oslo
University Hospital is the sponsor of the NIPU study. Bristol-Myers Squibb 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 NIPU
study. Half of the patients will be treated with the combination of UV1, with
ipilimumab and nivolumab, whereas the other half will receive nivolumab and
ipilimumab only. The study is planned to be conducted in Scandinavia and
Australia. 



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

Jónas Einarsson, Chair of the Board of Directors of Ultimovacs ASA
je@radforsk.no, +47 480 96 355

Øyvind Kongstun Arnesen, CEO 
oeyvind.arnesen@ultimovacs.com, +47 469 33810 

Hans Vassgård Eid, CFO 
hans.eid@ultimovacs.com, +47 482 48632