Zelluna ASA — Earnings Release 2023

Jun 19, 2023

Ultimovacs Provides 3-Year Update from Phase I Study in Malignant Melanoma: Results Confirm Strong Overall Survival in Patients Treated with UV1 Cancer Vaccine

Ultimovacs Provides 3-Year Update from Phase I Study in Malignant Melanoma: Results Confirm Strong Overall Survival in Patients Treated with UV1 Cancer Vaccine

* All patients in cohort 2 who were alive after 2 years remain alive after 3

years

Oslo, 19 June 2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage

biotechnology leader in novel immunotherapeutic cancer vaccines, today announced

encouraging overall survival (OS) data from the cohort 2 in the UV1-103 Phase I

clinical trial in malignant melanoma. All patients in cohort 2 who were alive at

the 2-year follow-up, remain alive at the 3-year follow-up.

The UV1-103 study evaluates Ultimovacs' universal cancer vaccine, UV1, in

combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line

treatment in patients with advanced non-resectable or metastatic malignant

melanoma. The study enrolled 30 patients in the U.S. in two cohorts that

differed only in the concentration of GM-CSF used as vaccine adjuvant. 27 of

these patients agreed to long-term monitoring after 2 years.

At 3-year follow-up across the two cohorts, 67% (18/27) of patients were still

alive. 3-year overall survival in cohort 1 was 71% (12/17), including one

patient death between years 2 and 3 as reported in October 2022. 3-year overall

survival in cohort 2 was 60% (6/10).

Ultimovacs has previously reported data showing a complete response rate in the

UV1-103 study of 33% (complete disappearance of tumors) and an objective

response rate of 57% (complete or partial disappearance of tumors). Biomarker

analyses reported in October 2022 showed robust clinical responses in patients

treated with the combination of UV1 and pembrolizumab, regardless of patients'

PD-L1 status. The safety profile of UV1 in combination with pembrolizumab is

comparable to that of pembrolizumab alone.

"We are very encouraged to observe a 67% overall survival rate at 3-year follow-

up in this Phase I study, which treats the same patient population as our UV1

Phase II study, INITIUM. These data further strengthen the previously reported

results from the study, including good safety for UV1 and remarkable 33%

complete response rate in patients with metastatic malignant melanoma where

surgery is not an option. The data continue to show that UV1 in combination with

pembrolizumab has promising signs of efficacy," said Jens Bjørheim, Chief

Medical Officer at Ultimovacs. "We are looking forward to receiving more data

from the UV1 clinical trials, to advance UV1 further to the benefit of cancer

patients."

Ultimovacs further investigates UV1 in malignant melanoma in its randomized

Phase II INITIUM trial of UV1 in combination with ipilimumab and nivolumab. The

trial completed enrollment of 156 patients with advanced non-resectable or

metastatic malignant melanoma in July 2022. The top-line results will be

disclosed after cancer progression has been verified in 70 patients, which was

anticipated in the first half of 2023. As announced in April 2023, the readout

is now expected in the second half of 2023. This is due to patients taking

longer than estimated to experience cancer progression, which is very

encouraging and positive for patients.

\==ENDS==

About the UV1-103 phase I trial in Malignant Melanoma

This US-based Phase I clinical trial is evaluating the Company's lead candidate,

UV1, in combination with the anti-PD-1 checkpoint inhibitor, pembrolizumab, as a

first-line treatment in patients with unresectable metastatic malignant

melanoma. The trial evaluates safety, tolerability, and initial signs of

clinical response. Thirty patients in the U.S. were treated in the study in two

cohorts that differed only in the concentration of GM-CSF used as vaccine

adjuvant.  The 20 patients in the first cohort received a 37.5 mcg GM-CSF

adjuvant dose per UV1 vaccination. The 10 patients in the second cohort received

the standard 75 mcg GM-CSF adjuvant dose per UV1 vaccination. The study has

completed the enrollment of 30 patients, as announced on August 18, 2020. All

included patients received the drugs as first line treatment for advanced and

metastatic malignant melanoma.

Compiled clinical results for the 30 patients enrolled are:

* Objective response rate (ORR): 57%. Complete response rate (CR): 33%

* Median Progression Free Survival (mPFS): 18.9 months (as measured by

iRECIST)

* Overall survival (OS) after 12 months: 87% (26/30). OS after 24 months: 73%

(22/30). OS after 36 months: 67% (18/27). Out of the 9 deaths, 4 happened

during the first year, 4 during the second year, and one during the third

year across both cohorts.

Patients will continue to be followed up for long-term survival. Three patients

in cohort 1 chose not to be followed up further after 24 months. The trial had

previously reached its primary endpoint of safety and tolerability, and no

unexpected safety issues related to UV1 have been observed in this trial.

As a historical reference (not head-to-head comparison since dosing and the

patient population is different), the registration study Keynote-006 for

pembrolizumab showed an overall survival rate of 51% at 36 months.

The U.S. Food and Drug Administration (FDA) granted a dual Fast Track

designation for UV1 in combination with checkpoint inhibitors 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 of patients with unresectable or metastatic melanoma in the phase II

study INITIUM.

About Ultimovacs

Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic

cancer vaccines with broad applicability. Ultimovacs' lead cancer vaccine

candidate UV1 is directed against human telomerase (hTERT) an antigen that is

present in 85-90% of cancers in all stages of tumor growth. A broad clinical

program, with Phase II trials in five cancer indications enrolling more than

670 patients, aims to demonstrate UV1's impact in combination with other

immunotherapies in multiple cancer types expressing telomerase and where

patients have unmet medical needs. UV1 is universal, off-the-shelf and easy to

use, and is a patented technology owned by Ultimovacs.

In addition, Ultimovacs' adjuvant platform, based on the proprietary Tetanus-

Epitope-Targeting (TET) technology, combines tumor-specific antigens and

adjuvant in the same molecule and is in Phase I clinical development.

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 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.

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

Anne Worsøe, Head of Investor Relations

Email: anne.worsoe@ultimovacs.com (mailto:anne.worsoe@ultimovacs.com)

Phone: +47 90686815

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 Anne Worsøe, Head of IR at

Ultimovacs ASA, on 19 June, 2023 at 07:00 am CET.