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Zelluna ASA — Earnings Release 2021
Aug 12, 2021
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Earnings Release
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Ultimovacs Announces Further Positive Topline Results from Phase I UV1 Cancer Vaccine Combination Study in Metastatic Melanoma
Ultimovacs Announces Further Positive Topline Results from Phase I UV1 Cancer Vaccine Combination Study in Metastatic Melanoma
* Cohort 2 showed 60% objective response rate, 30% complete response rate
* 90% overall survival rate at 12 months follow-up
* Cohort 2 results reinforce results seen in cohort 1
* Good safety and tolerability profile supports use of UV1 in combination
treatments
Oslo, 12 August 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage
leader in immune stimulatory vaccines for cancer, announced positive topline
results from the second cohort of 10 patients after one year of its ongoing
U.S.-based Phase I clinical trial evaluating the Company's universal cancer
vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab as a
first-line treatment in metastatic malignant melanoma. The primary endpoint of
safety and tolerability was achieved with strong initial signs of clinical
response.
Tumor shrinkage was evident in six of the 10 patients, a 60% objective response
rate. In three of the patients, the tumors were reduced to undetectable levels,
a 30% complete response rate. These levels of tumor destruction in response to
treatments with the combination of UV1 and pembrolizumab were similar to those
seen in the first cohort of 20 patients from the same study.
The overall survival (OS) rate after one year was high and consistent across
both patient cohorts, with a 90% OS rate in cohort 2 and 85% in cohort 1. Median
progression-free survival (mPFS) was not reached in either cohort at 12 months,
a positive outcome indicating that the disease status had either improved or was
stable in at least half of the participating patients in both parts of the
study.
"The emerging picture is that the UV1-pembrolizumab combination has a strong
safety profile and provides consistently high levels of clinical response in
advanced melanoma," said Jens Bjørheim, Chief Medical Officer of Ultimovacs.
"This latest data adds to the accumulating body of evidence demonstrating that
UV1 is safe and can mobilize the immune system to play a transformative role in
the treatment of solid tumors."
The study* is ongoing in the U.S. and, as previously announced, the topline 2-
year follow-up data on the first patient cohort is still expected in Q4 2021.
"These latest results are compelling, and in line with the data presented at
ASCO from the first group of patients in this study," said Carlos de Sousa, CEO
of Ultimovacs. "We will discuss these results further when we present the
company's Q2 2021 financial results to shareholders on 20 August, 2021. We also
plan to share more detailed results of the study at a major clinical oncology
meeting in 2022."
* ClinicalTrials.gov Identifier: NCT03538314. Treatments in cohort 1 and cohort
2 of the study differed only in the levels of GM-CSF administered as an adjuvant
with UV1.
\==ENDS==
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 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: [email protected] (mailto:[email protected])
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: [email protected] (mailto:[email protected])
Phone: +47 482 48632
Mary-Ann Chang, LifeSci Advisors
Email: [email protected] (mailto:[email protected])
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 Hans Vassgård Eid, CFO at
Ultimovacs ASA, on 12 August, 2021 at 07:45 CET.