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including the Company’s universal cancer vaccine, UV1. The article in Frontiers
in Immunology
(https://www.frontiersin.org/articles/10.3389/fimmu.2021.682492)examines the
broad relevance of telomerase as an attractive cancer target and examines
opportunities for optimizing anti-telomerase vaccine performance both by
selecting appropriate cancer types and by analyzing the underlying limitations
of current standard treatments.
The article focusses on the synergy between telomerase-based cancer vaccines and
checkpoint inhibitors. In particular, it highlights areas within cancer
treatment where clinical trials have shown that specific combinations of the two
components are more effective than either component used alone. Checkpoint
inhibitors, of which there are several varieties, have become the standard
treatment for many solid tumor types. There is a strong rationale for combining
them with telomerase vaccines to boost the activity of cells involved in the
anti-cancer immune response.
“This  latest article  articulates the  rationale for using telomerase-targeting
cancer vaccines as a key to unlock the full potential of checkpoint inhibitors.”
stated  Carlos  de  Sousa,  Chief  Executive  Officer  at  Ultimovacs.  “For our
universal  cancer vaccine, UV1,  the early read-outs  from our combination trial
with  pembrolizumab  indicate  that  this  rationale  is playing out well in the
clinic.”
Ultimovacs recently released data from the first cohort of a Phase I trial where
UV1  in  combination  with  pembrolizumab  showed  a 60% objective response rate
(including  30% complete responses)  in advanced  malignant melanoma, an evident
improvement  over pembrolizumab alone*. UV1 is currently in clinical development
with  four  randomized,  multinational,  Phase  II combination trials which will
recruit  over 500 patients in advanced malignant melanoma, ovarian cancer, head-
and-neck cancer and malignant pleural mesothelioma.
As the review in Frontiers in Immunology points out, telomerase is an attractive
target  because it is broadly expressed on 85-90% of all tumor types, especially
in  metastatic cancer cells.  Furthermore, it plays  an essential role in cancer
cell  reproduction, making it difficult for tumor  cells to mutate and evade the
treatment.  Combining  telomerase  cancer  vaccines  with  checkpoint inhibitors
appears  to  improve  overall  treatment  responses  and  outcomes by helping to
prevent tumors hiding from or disabling patients’ immune defenses.
The  Frontiers in  Immunology review  also suggests  that, although  most of the
current  clinical trials  evaluate treatments  of late-stage  disease in heavily
pre-treated  patients, there  is potential  for telomerase-targeting therapeutic
cancer  vaccines in earlier disease settings, when the need to combine them with
other treatments might be reduced.
The   publication   in   Frontiers   in  Immunology  can  be  found  under  doi:
10.3389/fimmu.2021.682492.
“Telomerase  as a target for therapeutic  cancer vaccines and considerations for
optimizing their clinical potential”
*Sources: FDA pembrolizumab packet insert
(https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s066lbl.pdf);
EMA pembrolizumab product information; Robert, C. et al (2019) Lancet Oncology
20, 1239-1251 (https://www.thelancet.com/pdfs/journals/lanonc/PIIS1470-
2045(19)30388-2.pdf)
About UV1
UV1  is a peptide-based vaccine inducing a  specific T cell response against the
universal  cancer antigen  telomerase. UV1  is being  developed as  an “off-the-
shelf”  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. 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.
About UV1 Clinical Programs
As  a  universal  cancer  vaccine,  UV1’s  unique  mechanism  of  action has the
potential to be applicable across most cancer types. The clinical development of
the  UV1 vaccine includes  four randomized, multinational,  Phase II combination
trials:  INITIUM, NIPU, DOVACC and FOCUS, recruiting over 500 patients in total.
Ultimovacs anticipates announcing data on the primary endpoints for the NIPU and
INITIUM studies in 2H2022 and for the DOVACC and FOCUS studies in 2023.
- The INITIUM trial is an Ultimovacs-sponsored clinical trial recruiting 154
patients with metastatic malignant melanoma to evaluate UV1 in combination
with ipilimumab and nivolumab as first-line treatment. 
- The NIPU study is testing UV1 in combination with checkpoint inhibitors
ipilimumab and nivolumab as second-line treatment in 118 patients with
advanced malignant pleural mesothelioma, a rare lung cancer. The study is
sponsored by Oslo University Hospital and Bristol-Myers Squibb is providing
the checkpoint inhibitors for this study. 
- The DOVACC study is sponsored by the Nordic Society of Gynecological
Oncology. In total, 184 patients with high-grade ovarian cancer will be
enrolled to evaluate UV1 in combination with durvalumab and olaparib, both
provided by AstraZeneca. 
- FOCUS is an investigator-sponsored, randomized clinical trial enrolling 75
patients with metastatic head and neck cancer receiving pembrolizumab as
standard of care, and will evaluate the impact of adding UV1 to this
regimen. 
About Ultimovacs
Ultimovacs  is developing immune-stimulatory vaccines to  treat a broad range of
cancers.  Ultimovacs’ lead universal cancer  vaccine candidate UV1 targets human
telomerase  (hTERT),  present  in  over  80% of  cancers  in all stages of tumor
growth.  By directing the immune system to hTERT antigens, UV1 drives CD4 helper
T  cells to the  tumor to activate  an immune system  cascade and increase anti-
tumor  responses. With a  broad Phase II  program, Ultimovacs aims to clinically
demonstrate  UV1’s impact  in multiple  cancer types  in combination  with other
immunotherapies.  Ultimovacs’ second  vaccine design,  based on  the proprietary
Tetanus-Epitope-Targeting  (TET) platform, combines  tumor-specific peptides and
adjuvant in the same molecule and entered Phase I studies in 2021.
For       further      information,      please      see      www.ultimovacs.com
(http://www.ultimovacs.com) or contact:
Carlos de Sousa, Chief Executive Officer
Email: carlos.desousa@ultimovacs.com (mailto:carlos.desousa@ultimovacs.com)
Phone: +47 908 92507
Hans Vassgård Eid, Chief Financial Officer
Email: hans.eid@ultimovacs.com (mailto:hans.eid@ultimovacs.com)
Phone: +47 482 48632
Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284 853
This information is subject to the disclosure requirements pursuant to Section
5-12 the Norwegian Securities Trading Act
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