Ultimovacs ASA - Start of inclusion of additional group of 10 patients

Oslo, 1 October 2019: Ultimovacs ASA (“Ultimovacs” or the “Company”, ticker
ULTIMO), a pharmaceutical company developing novel immunotherapies against
cancer, announces that all formal criteria are fulfilled to start the inclusion
of 10 additional patients in the ongoing US based phase I trial in malignant
melanoma. Thus, the total number of patients in the ongoing trial will be
increased from 20 to 30. 

In this malignant melanoma trial, UV1 is given to patients in combination with
the PD-1 checkpoint inhibitor pembrolizumab. Pembrolizumab is a therapy
improving immune cells’ ability to attack tumor cells. All of the originally
planned 20 patients have now been enrolled in this trial. 

The safety information obtained in the trial so far creates an opportunity to
explore a higher dose of the adjuvant GM-CSF in some patients. In the additional
group of 10 patients, the dosing of GM-CSF will be increased from 37.5 μg to 75
μg per UV1 vaccination, which is the same dose given in the three phase I trials
conducted in Norway. This will give Ultimovacs valuable additional information
on the combination regimen with pembrolizumab and increased confidence regarding
future dosing of GM-CSF. GM-CSF is used as an adjuvant together with UV1 to
strengthen the ability of UV1 to stimulate the immune system. An adjuvant is a
medical substance used to enhance the effect of another medical substance. The
UV1 dose remains unchanged in the additional group of patients.
 
Ultimovacs expects that all patients in the ongoing trial will be recruited by
early 2020. The initiation of other trials is not expected to be influenced by
the expansion of the ongoing trial. 

On 30 September 2019, the ongoing malignant melanoma trial was presented during
a poster session at the ESMO 2019 Congress in Barcelona, Spain. The poster
presentation was entitled “Phase I Clinical Trial Investigating the Therapeutic
Cancer Vaccine UV1 in Combination with Pembrolizumab as First-Line Treatment of
Patients with Malignant Melanoma”.

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.

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