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2021-04-10 14:30:00
Oslo, 10 April 2021: Ultimovacs ASA ("Ultimovacs", ticker ULTI), announced that
it is presenting a poster today on the trial design of its ongoing Phase II
INITIUM clinical study evaluating nivolumab and ipilimumab in combination with
the Company's proprietary universal cancer vaccine, UV1, as first line treatment
in patients with metastatic malignant melanoma, at the 2021 AACR Annual Meeting,
held virtually from April 9 to April 14, 2021.
The poster, titled, "Nivolumab and ipilimumab +/- UV1 vaccine as 1st line
treatment in patients with malignant melanoma (INITIUM-trial)", details the
INITUM study, a randomized, open label study investigating the efficacy and
safety of UV1 vaccination in combination with nivolumab and ipilimumab as first
line treatment in histologically confirmed unresectable metastatic melanoma
patients. The INITIUM study is enrolling 154 patients, randomly assigned to the
experimental arm or the control arm. Patients in the experimental arm will
receive 8 UV1 vaccinations over 4 cycles of nivolumab and ipilimumab, whereas
patients in the control arm will receive 4 cycles of nivolumab and ipilimumab
without UV1 vaccination. In both arms, patients will start maintenance therapy
with nivolumab after the last dose of induction therapy and will be followed
until the end of the study. The primary outcome of the study is the Progression
Free Survival (PFS) of patients in the experimental arm compared to patients in
the control arm. Secondary outcomes include the comparison of Overall Survival
(OS) and Objective Response Rate (ORR) between the groups.
Details of the presentation are as follows:
Title: Nivolumab and ipilimumab +/- UV1 vaccine as 1st line treatment in
patients with malignant melanoma (INITIUM-trial)
Session Type: E-poster Session
Session Title: Phase II Clinical Trials in Progress
Abstract Number: CT23
The poster is available on Ultimovacs' corporate website at www.ultimovacs.com.
About Ultimovacs
Ultimovacs seeks to become a leader in developing immune-stimulatory vaccines to
treat a broad range of cancers. Ultimovacs' lead universal cancer vaccine
candidate UV1 leverages the high prevalence of the human telomerase (hTERT) to
be effective across the dynamic stages of the tumor's growth and its
microenvironment. By directing the immune system to hTERT antigens that are
present in over 80% of all cancers, UV1 drives CD4 helper T cells to the tumor
with the goal of activating an immune system cascade to increase anti-tumor
responses. Ultimovacs' strategy is to clinically demonstrate UV1's impact in
many cancer types and in combination with other immunotherapies. The Company
will expand its pipeline using its novel TET-platform, which is an innovative
vaccine technology that can generate multiple vaccine candidates designed to
achieve increased T cell responses to a broad range of target antigens.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632