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Oslo, 20 June 2022: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage
leader in immune stimulatory vaccines for cancer, announced today positive 2-
year overall survival data in its ongoing phase I clinical study of the cancer
vaccine UV1 in combination with pembrolizumab for the treatment of malignant
melanoma. Across all 30 patients in the study, the 24-month survival rate was
73%. Patients will continue to be followed for long-term survival.
“This result is the latest in a stream of highly encouraging data that indicate
the effectiveness of UV1 in enhancing treatment of malignant melanoma. It
underlines the potential of UV1 in promoting a concerted immune response in many
solid tumor types including those in Ultimovacs’ broader phase II programs.”
said Carlos de Sousa, Chief Executive Officer of Ultimovacs. “We have seen
consistently more positive outcomes from UV1 in combination with pembrolizumab
than with the checkpoint inhibitor alone - higher complete response rates,
higher overall response rates, higher median progression-free survival and now
better 24-month overall survival rates.”
In the same malignant melanoma study, as reported in March 2022, the complete
response rate is 33% (i.e. with complete disappearance of tumors) and the
objective response rate is 57% (i.e. with a partial or complete disappearance of
tumors). Earlier trials with checkpoint inhibitors have shown that patients with
clinical responses have improved survival rates.
The data represent the latest result from Ultimovacs’ phase I study of its
universal cancer vaccine UV1 used in combination with the PD-1 checkpoint
inhibitor pembrolizumab. Thirty patients were treated in the study in two
cohorts that differed only in the concentration of GM-CSF used as a vaccine
adjuvant. Two years have passed since the beginning of treatment of the last
patient in the second cohort. Ultimovacs expects to provide 3-year overall
survival data from the first cohort of 20 patients in Q4 2022.
About UV1
UV1 is a peptide-based vaccine inducing a specific T cell response against the
universal cancer antigen telomerase. It is being developed as an “off-the-shelf”
therapeutic cancer vaccine for use in combination with other immunotherapies
that require an ongoing T cell response for their mode of action. In four Phase
I trials involving 82 patients, UV1 has maintained a positive safety and
tolerability profile and has demonstrated encouraging signals of
efficacy. In 2021, the U.S. FDA granted Fast Track designation to UV1 as add-on
therapy to ipilimumab or to pembrolizumab for the treatment of unresectable or
metastatic melanoma, as well as Orphan Drug designation to UV1 for the treatment
of stage IIB - IV melanoma.
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 85-90% 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 in five cancer indication enrolling
more than 650 patients, Ultimovacs aims to clinically demonstrate UV1’s impact
in multiple cancer types in combination with other immunotherapies, for patients
with unmet needs. Ultimovacs’ second technology approach, 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 or contact:
Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507
Anne Worsøe, Head of IR & Communication
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86815
Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284?853
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Joachim Midttun, Finance
Manager at Ultimovacs ASA, on 20 June, 2022 at 08:00 CET.
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