Ultimovacs Announces Positive Topline Results from Phase I Combination Trial Evaluating Universal Cancer Vaccine, UV1, in Malignant Melanoma Patients
--Results confirm achievement of primary endpoints of safety and tolerability--
--Initial signs of clinical response observed based on Overall Survival and
median Progression-Free Survival outcomes reported to date--
Oslo, 30 September 2020: Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), today
announced positive topline results from the first cohort of 20 patients in its
ongoing US-based Phase I clinical trial evaluating the Company's lead candidate,
UV1, in combination with PD-1 checkpoint inhibitor, pembrolizumab, as a first
line treatment in patients with metastatic malignant melanoma. The results
confirm achievement of the primary endpoints of safety and tolerability and
indicate initial signs of clinical response.
As per the cut-off date of September 30, 2020, every patient in the first cohort
reached at least 12-months of follow-up post treatment with UV1 and
pembrolizumab. At the one-year landmark, the overall survival (OS) rate was 85%.
Median Progression-Free Survival (mPFS) was not reached at 12 months, indicating
that more than half of the participating patients did not demonstrate disease
progression. None of the patients experienced unexpected safety issues related
to UV1 and the vaccine was well-tolerated. The safety events observed are in
line with the established data on UV1 and pembrolizumab.
"The safety profile observed to date in this first cohort of the PD-L1
combination study is consistent with the promising safety profiles seen in our
earlier Phase I trials. For the further development of our vaccine, it is
important to demonstrate that UV1 can be combined with different classes of
immunotherapies without compromising on safety," commented Jens Bjørheim, Chief
Medical Officer at Ultimovacs. "From our perspective, an appropriate historical
comparison for our trial is the cohort in the KEYNOTE006 trial in which patients
with advanced melanoma without prior treatment history were treated with
pembrolizumab only. Results from that study demonstrated a 68% OS and a mPFS of
11.6 months. Comparing this to our data presented today, we are encouraged by
the results and look forward to additional data readouts over the next years
that will demonstrate if the initial signs of efficacy in this cohort persist
and mature into long-term added clinical benefit for the patients."
The Phase I trial in malignant melanoma is evaluating the safety, tolerability
and initial signs of clinical response in patients treated with UV1 in
combination with pembrolizumab. Pembrolizumab improves the ability of immune
cells to kill tumor cells and is a current standard-of-care therapy for
malignant melanoma. The 20 patients in the first cohort had no prior treatment
history and received a 37.5 µg GM-CSF adjuvant dose per UV1 vaccination,
combined to strengthen the ability of UV1 to stimulate the immune system. The
study has completed full enrollment of 30 patients, as announced on August 18,
2020. The 10 patients in the second cohort have received the standard 75 µg
GM-CSF adjuvant dose per UV1 vaccination. One-year of follow-up data on these
patients will be available in the second half of 2021.
"In all four Phase I studies, UV1 has demonstrated a consistent and positive
safety and tolerability profile. The topline results announced today complement
our extensive and growing clinical data package, confirming that this strong
safety profile holds when combining UV1 with a PD-1 checkpoint inhibitor,"
stated Carlos de Sousa, Chief Executive Officer at Ultimovacs. "As an update on
other clinical development progress, we had announced in May this year a
collaboration with a leading Big Pharma company and a European oncology clinical
trial group to evaluate UV1 in an additional Phase II study, which we had
planned to confirm with all details in the third quarter. Ultimovacs, the
sponsor and the Big Pharma partner have been making improvements to the trial
protocol and due to the challenges of operating in the current pandemic
environment, the agreement is still in the process of finalization. We look
forward to announcing the collaboration and trial timelines during the fourth
More complete data on the patients in the first cohort will be presented at an
upcoming oncology conference in the first half of 2021.
About UV1 and the UV1 Phase II Clinical Trials
UV1 is a peptide-based vaccine inducing a specific T cell response against the
universal cancer antigen, telomerase. UV1 is being developed as a therapeutic
cancer vaccine which may serve as a platform for use in combination with other
immuno-oncology drugs which require 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.
UV1 is being tested in different randomized Phase II trials:
o The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II
trial for patients with metastatic malignant melanoma. Patients will be treated
with UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and
nivolumab (PD-1 checkpoint inhibitor). The trial will be conducted in the U.S.
and Europe, including Norway. The first patient was dosed on June 15, 2020. A
total of 154 patients will be enrolled in the study, 77 patients will receive
nivolumab and ipilimumab and the second half of the patients will receive
nivolumab, ipilimumab and UV1. The primary endpoint for the study is
progression-free survival and the planned readout of the primary endpoint is in
the second half of 2022.
o The NIPU trial is a randomized, multi-center Phase II trial in which the
universal cancer vaccine, UV1, is investigated in combination with the
checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in
mesothelioma. Oslo University Hospital is the sponsor of the NIPU study.
Bristol-Myers Squibb and Ultimovacs have entered into agreements with OUS to
support the preparations and execution of the trial. The first patient was dosed
on June 15, 2020. A total of 118 patients will be included in the NIPU study.
Half of the patients will be treated with the combination of UV1, ipilimumab
(CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor), whereas
the other half will receive nivolumab and ipilimumab only. The study is planned
to be conducted at six national hospital centers specialized in treating
mesothelioma in four countries (Norway, Sweden, Denmark and Australia). Planned
readout of the primary endpoint progression-free survival is the second half of
o A third Phase II clinical trial will evaluate UV1 in a new cancer indication
in combination with indication-specific standard of care cancer therapies
different from those to be tested in INITIUM (malignant melanoma, 154 patients)
and NIPU (mesothelioma, 118 patients). In the collaboration, Ultimovacs will
supply UV1 and a big pharma company will supply its proprietary cancer treatment
to the clinical trial group which will sponsor the trial.
Ultimovacs' UV1 universal cancer vaccine candidate 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 a range of cancers and in several immunotherapy combinations
while expanding our pipeline of cancer vaccine therapies, convinced that a
universal approach may be the key to achieving better outcomes for patients.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, Chief Executive Officer
Phone: +47 908 92507
Hans Vassgård Eid, Chief Financial Officer
Phone: +47 482 48632