Ultimovacs Announces Publication of Phase I Melanoma Trial Data in Journal of Translational Medicine

Ultimovacs Announces Publication of Phase I Melanoma Trial Data in Journal of Translational Medicine

12 Sep 2022 15:05 CEST

* Comprehensive characterization of phase I UV1-checkpoint inhibitor
combination trial
* Clinical responses seen in patients with favored and less favored baseline
characteristics
* T cell activation observed post-treatment in tumors of responding patients

Oslo, September 12, 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical
stage leader in immune stimulatory vaccines for the treatment of cancer,
announced today the publication of data from its phase I melanoma trial in
Journal of Translational Medicine.

The clinical data give details of potential additional benefit in the treatment
of patients with malignant melanoma from using the company's universal cancer
vaccine, UV1, in combination with the checkpoint inhibitor ipilimumab.

The new data demonstrated highly positive clinical outcome signals. Vaccine-
induced immune responses were apparent in 91% of evaluable patients, with strong
T cell proliferation demonstrated in peripheral blood, and vaccine-related T
cell receptor clones detected in blood and in tumor biopsy. Patients who
responded clinically to treatment with UV1 and ipilimumab, also demonstrated an
increase in the tumor interferon-gamma signature, a generally accepted predictor
for the efficacy of checkpoint inhibitors.

The research team observed clinical responses to the UV1-ipilimumab combination
not only in patients with baseline characteristics of high tumor immunogenicity
('hot' tumors) but also in patients without ('cold' tumors). This breadth of
response is noteworthy since 'cold' tumors are more difficult to treat with
checkpoint inhibitors, suggesting that the addition of UV1 vaccination may
extend clinical efficacy against these tumor types.

These clinical data further expand upon the previously published safety and
feasibility findings from an open-label phase 1/2a clinical trial (NCT02275416)
of the combination of UV1 with the CTLA-4 checkpoint inhibitor, ipilimumab. The
combination of UV1 and ipilimumab produced an overall response rate (ORR) of
33%. The median progression-free survival (mPFS) among patients treated with UV1
and ipilimumab was 6.7 months, and the median overall survival (mOS) was 66.3
months.

Ultimovacs' phase II trial, INITIUM, evaluates the combination of the UV1
vaccine combined with both ipilimumab and the PD-1 inhibitor, nivolumab, in the
first-line treatment of patients with advanced malignant melanoma. Ultimovacs
completed enrollment in INITIUM in June 2022. Topline progression-free survival
data from INITIUM are expected in H1 2023.

The new data were published in the Journal of Translational Medicine (JTRM), an
open access, peer-reviewed journal. The link to the article can be found on the
Company's website.

Ellingsen, E.B., Bounova, G., Kerzeli, I. et al. Characterization of the T cell
receptor repertoire and melanoma tumor microenvironment upon combined treatment
with ipilimumab and hTERT vaccination. J Transl Med 20, 419 (2022).
https://doi.org/10.1186/s12967-022-03624-z

About the phase I trial with UV1 and ipilimumab in malignant melanoma
This clinical trial evaluated a novel telomerase-targeting therapeutic cancer
vaccine, UV1, in combination with ipilimumab, in twelve patients with metastatic
melanoma. The trial was an open-label, single-center phase I/IIa study. Eligible
patients had unresectable metastatic melanoma. Patients were followed up for
progression-free survival (PFS) and overall survival (OS).

The U.S. Food and Drug Administration (FDA) granted orphan drug designation
(ODD) for UV1 for the treatment of stage IIB - IV melanoma, and Fast Track
designation in the treatment of unresectable or metastatic melanoma - either as
add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. Ultimovacs
is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as
first-line treatment for unresectable or metastatic melanoma in a Phase II study
named INITIUM.

About Ultimovacs
Ultimovacs is an immunotherapy company 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
indications 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: [email protected]
Phone: +47 908 92507

Anne Worsøe, Head of Investor Relations
Email: [email protected]
Phone: +47 906 86 815

Mary-Ann Chang, LifeSci Advisors
Email: [email protected]
Phone: +44 7483 284?853

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Source

Ultimovacs ASA

Provider

Oslo Børs Newspoint