Ultimovacs ASA Announces First Patient Dosed in the Phase II INITIUM Trial in Metastatic Malignant Melanoma

 

Oslo, 15 June 2020: Ultimovacs ASA ("Ultimovacs" or "Company", ticker ULTIMO), a
pharmaceutical company developing novel immunotherapies against cancer,
announced today that the first patient has been dosed in the global, randomized
Phase II INITIUM clinical trial testing Ultimovacs' lead candidate, UV1, in
combination with ipilimumab and nivolumab in 154 patients with metastatic
malignant melanoma. The first patient was dosed at the Oslo University Hospital
(OUS) which is the first site to open in this trial. Topline results are
anticipated to be announced in the second half of 2022.

Jens Bjørheim, Chief Medical Officer at Ultimovacs ASA commented: 
"As our Company-sponsored Phase II trial, INITIUM represents an important focus
for our UV1 clinical development program. The first patient dosed marks the
achievement of an important milestone for the Company in our lead indication,
metastatic malignant melanoma, in which patients often do not have a
long-lasting response to current treatments. As a Phase II proof of concept
study, the INITIUM trial has the potential for regulatory submission based on
supportive trial results. We look forward to the continued enrollment in the
INITIUM trial as it is an important part of our extensive Phase II clinical
program in which we are planning to include more than 400 patients in three
studies."

Carlos de Sousa, Chief Executive Officer at Ultimovacs ASA added: 
"The dosing of the first patient in the INITIUM trial today coincides with the
dosing of the first patient in the other Phase II clinical trial, NIPU, which
will test UV1 in patients with advanced malignant pleural mesothelioma. These
important milestones follow our recent announcement of entry into a
collaboration with a big pharma company and European oncology clinical trial
group to evaluate UV1 in another oncological indication. Subsequently, the
Company also successfully completed an oversubscribed private placement, which
fully finances the current UV1 clinical development program. It is exciting to
join Ultimovacs at this particularly dynamic time and I look forward to
supporting the Company as it explores the potential of its universal cancer
vaccine in patients with difficult to treat cancers." 

Ultimovacs is in the process of activating more than 35 sites globally for the
INITIUM trial. Additional hospitals in Norway, other European countries as well
as the United States will be opened for patient inclusion throughout the second
and third quarters of 2020. 

About INITIUM
The INITIUM trial is an Ultimovacs-sponsored, global, 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). A total of 154 patients will be enrolled in the INITIUM study. 77 of
the patients will be treated with nivolumab and ipilimumab, whereas the other 77
patients will receive nivolumab, ipilimumab and UV1. The primary endpoint of the
study is progression-free survival. Planned readout of topline results is
expected in the second half of 2022. 

About UV1 and the 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
immuno-oncology drugs which require an ongoing T cell response for their mode of
action. To date, UV1 has been tested in four clinical trials in a total of 78
patients and maintained a positive safety and tolerability profile as well as
encouraging signals of efficacy. 

In addition to the INITIUM trial described above, UV1 will be tested in two
other randomized Phase II trials: 
      o	The NIPU trial is a randomized, multi-center Phase II trial in which 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 (OUS) 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, ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab
(PD-1 checkpoint inhibitor), whereas the other half will receive nivolumab and
ipilimumab only. The study is planned to be conducted at six national hospital
centers specialized in treating mesothelioma in four countries (Norway, Sweden,
Denmark and Australia). Planned readout of the primary endpoint progression-free
survival is H2-2022.
      o	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 (malignant melanoma, 154
patients) and NIPU (mesothelioma, 118 patients). In the 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. 

The Phase II clinical program builds on three completed studies and one ongoing
Phase I clinical trial. The Phase II trials will evaluate UV1 in three different
indications in more than 400 patients and in collaboration with two big pharma
companies. These trials are all fully financed. The ongoing and planned clinical
trials represent a strong platform for Ultimovacs to advance towards a potential
registration of the universal cancer vaccine, UV1.


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

Carlos de Sousa, CEO 
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507 
	
Hans Vassgård Eid, CFO 
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632