Ultimovacs Announces Patient Recruitment Discontinuation in LUNGVAC Trial Investigating UV1 Combined with Checkpoint Inhibitor Therapy in Non-Small Cell Lung Cancer

11 Sep 2024 17:00 CEST

Oslo, September 11, 2024: Ultimovacs ASA (https://ultimovacs.com/)
("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology company developing
immunotherapeutic cancer vaccines, today announced that the company has agreed
with the investigators conducting the LUNGVAC trial (NCT05344209
(https://clinicaltrials.gov/study/NCT05344209?id=%22NCT05344209%22&rank=1)) to
discontinue patient recruitment. LUNGVAC is an investigator-initiated,
randomized Phase II trial designed to assess the impact of UV1 in combination
with the checkpoint inhibitor cemiplimab or pembrolizumab as first-line
treatment in patients with inoperable advanced or metastatic non-small cell lung
cancer (NSCLC). The decision is driven by very slow recruitment in the study,
which is primarily due to new treatment options available to NSCLC patients.
 All 31 patients that have been enrolled in the LUNGVAC study since 2022 will be
treated and followed up as per the trial protocol. Topline data from these
patients is expected in the first half of 2025.

"We have consulted closely with the LUNGVAC investigators regarding the
challenges in trial recruitment which relate to the evolution of standard of
care for NSCLC patients and the resulting impact on the number of NSCLC patients
eligible for the trial. Based on the investigators' recommendations, recruitment
will stop and the investigators will analyze the data on UV1 in this indication
from the patients that have been enrolled so far," said Carlos de Sousa, Chief
Executive Officer at Ultimovacs. "We are grateful to the study investigators,
their clinical teams and all patients who enrolled in the trial and we look
forward to analyzing the topline data next year."

Currently, Ultimovacs is investigating UV1 in ovarian cancer in the ongoing
Phase II DOVACC trial which evaluates a combination of olaparib and durvalumab
+/- UV1 vs. olaparib alone as second-line maintenance treatment of high-grade
BRCA negative ovarian cancer. Patients continue to be screened and enrolled in
this trial, and topline results are expected to be available in the first half
of 2025. Additionally, Ultimovacs is conducting pre-clinical research on a novel
drug conjugation platform to investigate its potential applicability, including
additional therapeutic modalities for multiple disease areas, such as innovative
drug conjugates with favorable pharmacological properties. Ultimovacs will
provide an update on this technology platform to the market before the end of
2024.

==ENDS==

About LUNGVAC
The LUNGVAC trial is an investigator-initiated, randomized, comparative Phase II
clinical trial in which the cancer vaccine UV1 is evaluated in combination with
the checkpoint inhibitor cemiplimab or pembrolizumab as first-line treatment of
NSCLC patients with advanced or metastatic disease. The trial has enrolled
previously untreated patients with adenocarcinoma or squamous NSCLC, where tumor
biopsies show a PD-L1-expression score equal to or above 50%. These subgroups
represent approximately 30% of all advanced and metastatic NSCLC patients.
Professor Odd Terje Brustugun is the principal investigator for the trial, which
is sponsored by Drammen Hospital in Vestre Viken Hospital Trust, Norway.

About UV1
UV1 is a universal cancer vaccine designed to induce a specific T cell response
against telomerase. UV1 consists of long, synthetic peptides, representing a
sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to
induce CD4+ T cells. These CD4+ T cells have the potential to provide
inflammatory signals and T cell support that are believed to be critical for
triggering a strong anti-tumor immune response. Following intradermal injection,
antigen presenting cells (APCs) in the skin are exposed to the vaccine peptides.
These APCs will process the peptides, and present vaccine epitopes on Human
Leukocyte Antigen (HLA) molecules to naïve T cells in the lymph nodes. Activated
vaccine-specific T cells will then enter the circulation and search for cells
displaying their cognate antigen in the context of HLA molecules.

The UV1 peptides contain several epitopes, shown to be non-restrictive in terms
of (HLA) alleles for presentation. It is therefore not required to perform HLA
pre-screening of patients, which potentially enables broad population
utilization of the vaccine. UV1 is administered over three months as eight
intradermal injections together with the immune-modulator, GM-CSF.

About Ultimovacs
Ultimovacs is a clinical-stage biotechnology company developing novel
immunotherapies against cancer. The product candidate UV1 is an off-the-shelf
therapeutic cancer vaccine designed to enhance the benefits of immunotherapy and
improve cancer treatment efficacy for patients. UV1 triggers an immune response
against the shared cancer antigen telomerase, a target present in 85-90% of all
cancer indications across disease stages.

Ultimovacs is investigating the safety and efficacy of UV1 in a wide-ranging
clinical development program including various cancer indications and different
immunotherapy combinations. The ongoing Phase II program comprises five
randomized clinical trials in melanoma, mesothelioma, head and neck cancer,
ovarian cancer, and non-small cell lung cancer. More than 750 patients in the
U.S., Europe, and Australia are being enrolled in all Phase I and Phase II
trials in the current program.

Furthermore, Ultimovacs is developing a novel conjugation technology, initially
formed to support the expansion of our vaccine pipeline. With the objective of
driving value and future pipeline growth, this flexible conjugation technology
has the potential to be broadly applicable to a variety of therapeutic
modalities, such as innovative drug conjugates with favorable pharmacological
properties, and in multiple disease areas.

Ultimovacs is listed on the Euronext Oslo Stock Exchange (OSE:ULTI).

For further information, please see www.ultimovacs.com or contact:

Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com (mailto:carlos.desousa@ultimovacs.com)
Phone: +47 908 92507

Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

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
September 11, 2024, at 17:00 CEST.

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