Ultimovacs ASA - Long term results from UV1 clinical study in patients with malignant melanoma

 

Oslo, 7 February 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a
pharmaceutical company developing novel immunotherapies against cancer, presents
long-term results from a clinical study with UV1 in combination with ipilimumab
in patients with malignant melanoma at the 2020 ASCO-SITC Clinical
Immuno-Oncology Symposium in Orlando, Florida.

In this clinical study where UV1 was combined with ipilimumab, overall survival
was 50% after 4 years (6 out of 12 patients alive). This compares favorably to a
similar phase IV study (IPI4) with ipilimumab alone which shows 4-year overall
survival of 27.5%.

Combining checkpoint blockade with a therapeutic cancer vaccine may induce
broader immune responses, leading to better clinical outcomes. UV1 targets the
enzyme telomerase (hTERT) which is expressed in almost all cancer types and is
essential for the immortality of cancer cells and a hallmark of cancer. UV1
consists of three synthetic long peptides and vaccination induces tumor relevant
immune responses in most patients without any prescreening of patients required.
This study explores the synergistic effect of CTLA-4 blockade (ipilimumab) and
UV1 vaccination, allowing stronger expansion of hTERT-specific T cell clones.

In a phase I/IIa, single-center trial (NCT02275416) conducted at the Oslo
University Hospital, Norway, patients with metastatic malignant melanoma
received treatment with UV1 (300 g) + GM-CSF (75 g) as an adjuvant, combined
with ipilimumab (3 mg/kg).

12 patients were treated from February to November 2015. Treatment was generally
well-tolerated. Adverse events mainly included injection site reactions and
diarrhea. Immune responses towards the UV1 peptides occurred very early and
10/11 (91%) of evaluable patients showed an immune response. With 4 years of
follow-up, one patient obtained a complete tumor response and three patients
obtained a partial response, resulting in an objective response rate of 44%
based on 9 evaluable patients. The median progression free survival (PFS) was
6.7 months. Overall survival at 3 and 4 years was 67% and 50%, respectively.
Although this study did not have a direct comparator arm, the results compare
favorably to the ipilimumab monotherapy phase IV study at the Oslo University
Hospital (the 'IPI4 study'). The hospital enrolled 69 patients in the IPI4
study, with the same investigators, during the same time period and with similar
inclusion criteria as Ultimovacs' phase I study. The IPI4 study had a 4-year
overall survival of 27.5%, which is consistent with survival data in the major
historical ipilimumab studies. 

In conclusion, combining UV1 and ipilimumab is safe and induces favorable
clinical responses in melanoma. The high proportion of immunological responders
and early induction of detectable immune responses suggest synergism between UV1
and ipilimumab. Response rates and overall survival compare favorably to the
IPI4 study and relevant historical controls. The results warrant further
investigation of UV1 in combination with immune checkpoint blockade in malignant
melanoma. 

Detailed results from the study will be presented on 7 February 2020 during a
poster presentation at ASCO-SITC 2020 by Espen Basmo Ellingsen MD. The poster
(ID: 62, board C9) is titled "A phase I/IIa clinical trial investigating the
therapeutic cancer vaccine UV1 in combination with ipilimumab in patients with
malignant melanoma: Four-year survival update". 

The poster is available at www.ultimovacs.com.  


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