Zelluna ASA — Earnings Release 2022

Oct 5, 2022

Ultimovacs Announces Positive Three-Year Results of 71% Overall Survival Rate in Cohort 1 of UV1-103 Study in Metastatic Malignant Melanoma

Ultimovacs Announces Positive Three-Year Results of 71% Overall Survival Rate in Cohort 1 of UV1-103 Study in Metastatic Malignant Melanoma

* Malignant melanoma patients treated with immunotherapy combination UV1 and

pembrolizumab in phase I clinical trial

* Consistently high overall survival (OS) rate: 71% at three-year follow-up of

patients in first cohort

* UV1 and pembrolizumab combination continues to demonstrate strong signals of

clinical efficacy, including prolonged patient survival

Oslo, 5 October 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage

leader in immune stimulatory vaccines for cancer, announced continuing positive

efficacy data in its ongoing U.S.-based phase I clinical trial, UV1-103. The

study evaluates the Company's universal cancer vaccine, UV1, in combination with

the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in

advanced non-resectable and metastatic malignant melanoma patients.

"Given the historic trajectory for patients with metastatic malignant melanoma,

this three-year 71% OS rate is very positive," said Carlos de Sousa, CEO of

Ultimovacs. "Overall, these promising data support our continuing belief that

UV1 can play a transformative role in treating solid tumors in combination with

checkpoint inhibitors, providing long-term clinical benefits for patients with

unmet medical needs."

After the study ended at two years follow up, the protocol was amended to follow

patients for overall survival for up to five years. Three of the patients, all

in cohort 1, did not consent to further follow up, changing the number of

participating patients in cohort 1 from 20 to 17 after two years. In addition,

one patient died within the past year.

At the three years cut-off date for patients in the first cohort the three-year

overall survival (OS) rate was 71% (12/17). The trial has shown a consistently

high OS rate; in this patient cohort it was 85% (17/20) after one year and 80%

(16/20) after two years follow-up. Having already reached its primary endpoint

of safety and tolerability, the UV1-pembrolizumab combination continues to

demonstrate strong signals of clinical efficacy in both response rates and

extended survival.

Pembrolizumab is a standard of care for patients with unresectable or metastatic

melanoma, based on data from the KEYNOTE-006 trial*. Follow up of first-line

patients with metastatic melanoma in that trial showed an overall survival rate

of 51% at 36 months.**

"The high survival rate after three years for metastatic malignant melanoma

patients is very encouraging and reinforces the positive data we have

consistently observed throughout the UV1-103 trial," said Jens Bjørheim, Chief

Medical Officer of Ultimovacs. "As previously reported, the combination of UV1

and pembrolizumab has a strong safety and tolerability profile. These three-year

data also signal that UV1 continues to mobilize the immune system providing

patients with a long-term, effective clinical response. We are very pleased to

see the positive results for these patients."

UV1-103 (Cohort 1) Overall Survival Rate % (Patients alive/total):

12 months: 85% (17/20)

24 months: 80% (16/20)

36 months: 71% (12/17) 3 patients declined follow-up post 24 months, 1 patient

died

Further data from the UV1-103 study will be presented at the International

Congress of the Society for Melanoma Research, October 18, 2022.

*For reference only; not a head-to-head comparison

**Robert C, Ribas A, Schachter J, et al. Pembrolizumab versus ipilimumab in

advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label,

multicentre, randomized, controlled, phase 3 study. Lancet Oncol.

2019;20(9):1239-1251. Doi:10.1016/S1470-2045(19)30388-2. Supplementary table S6:

Overall survival in patients receiving first-line treatment - combined

pembrolizumab arms: 36-month rate (%).

\==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 metastatic malignant melanoma. The trial

is evaluating the safety, tolerability, and initial signs of clinical response.

The 20 patients in the first cohort received a 37.5 µg GM-CSF adjuvant dose per

UV1 vaccination. The 10 patients in the second cohort received the standard 75

µg 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

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 after 12 months: 87%. Overall survival after 24 months:

73%.

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

year of follow-up data on cohort 1+2 will be available in the second half of

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 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: carlos.desousa@ultimovacs.com

Phone: +47 908 92507

Anne Worsøe, Head of Investor Relations

Email: ir@ultimovacs.com

Phone: +47 906 86 815

Mary-Ann Chang, LifeSci Advisors

Email: mchang@lifesciadvisors.com

Phone: +44 7483 284 853

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 Joachim Midttun, Finance

Manager at Ultimovacs ASA, on 5 October, 2022 at 19:25 CET.