Ultimovacs ASA Announces Completion of Patient Enrollment in Phase I Trial in Malignant Melanoma

 

Oslo, 18 August 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a
pharmaceutical company developing novel immunotherapies against cancer,
announced today that patient enrollment has been completed in the ongoing
US-based Phase I clinical trial testing Ultimovacs' lead candidate, UV1, in
combination with pembrolizumab as first line treatment in patients with
metastatic malignant melanoma. The study was designed to assess the safety and
tolerability of UV1 combined with checkpoint inhibitor pembrolizumab and to
explore initial signs of clinical response.

The Phase I trial investigates Ultimovacs' cancer vaccine, UV1, in combination
with PD-1 checkpoint inhibitor, pembrolizumab. Pembrolizumab is standard-of-care
therapy for malignant melanoma, improving the ability of immune cells to kill
tumor cells. The preliminary safety information obtained from the first 20
patients in the Phase I trial allowed for the exploration of a higher dose of
the adjuvant GM-CSF in 10 additional patients. The first 20 patients received
37.5 g GM-CSF per UV1 vaccination versus 75 g GM-CSF per UV1 vaccination in
the second cohort of 10 patients. GM-CSF is used as an adjuvant together with
UV1 to strengthen the ability of UV1 to stimulate the immune system. With 30
patients enrolled and treated as of today, the trial reached its targeted
enrollment criteria. No unexpected safety issues related to UV1 have been
observed to date and UV1 has generally been well tolerated by the patients.

Carlos de Sousa, Chief Executive Officer at Ultimovacs, commented: 
"Early data on the patients enrolled in the Phase I trial of UV1 in combination
with pembrolizumab demonstrate a strong safety profile to date and provide
further support for Ultimovacs' approach of combining UV1 treatment with
checkpoint inhibitors. The preliminary safety data builds further on a previous
Phase I trial in malignant melanoma, where UV1 was combined with the CTLA-4
checkpoint inhibitor ipilimumab. In both combination trials, treatment with UV1
has been well tolerated by patients, providing a solid basis for the triple
combination of UV1 with CTLA-4 and PD-1, which is currently investigated in the
Company's Phase II trials INITIUM and NIPU. We are proud of the Company's
progress and would like to thank the patients, their families and healthcare
providers for their participation, particularly in the current challenging
environment. "

Jens Bjørheim, Chief Medical Officer of Ultimovacs, added: 
"We are pleased that we have completed the enrollment of the second cohort in
this Phase I trial despite challenging times related to the ongoing pandemic. In
September of this year, all patients in the first cohort will have reached their
1-year follow-up period and we look forward to announcing top-line safety and
preliminary efficacy data from patients in the first cohort in the fourth
quarter of this year, followed by more detailed results at an international
medical conference early next year." 

About UV1 and the UV1 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 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. 

UV1 will be tested in three different randomized Phase II trials: 

o	The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II
trial for patients with metastatic malignant melanoma. Patients will be treated
with UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and
nivolumab (PD-1 checkpoint inhibitor). The trial will be conducted in the U.S.
and Europe, including Norway. The first patient was dosed on 15 June 2020. A
total of 154 patients will be enrolled in the study, 77 patients will receive
nivolumab and ipilimumab and the second half of the patients will receive
nivolumab, ipilimumab and UV1. The primary endpoint for the study is
progression-free survival and the planned readout of the primary endpoint is in
the second half of 2022. 
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 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. The first patient was dosed
on 15 June 2020. 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 the second half of
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 Phase I trials and one
ongoing Phase I 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. 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 see 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