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Zelluna ASA Earnings Release 2021

Oct 13, 2021

3779_rns_2021-10-13_12e1784e-7286-4924-94f3-8e631ce3b37a.html

Earnings Release

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Ultimovacs Announces Positive 24-month Follow-up Data from Phase I UV1 Cancer Vaccine-Pembrolizumab Combination Study in Metastatic Melanoma

Ultimovacs Announces Positive 24-month Follow-up Data from Phase I UV1 Cancer Vaccine-Pembrolizumab Combination Study in Metastatic Melanoma

* 80% overall survival rate at 24 months follow-up

Oslo, 13 October 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical

stage leader in immune stimulatory vaccines for cancer, announced continuing

positive topline results in its ongoing U.S.-based Phase I clinical trial

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

checkpoint inhibitor pembrolizumab as a first-line treatment in metastatic

malignant melanoma. The trial had previously reached its primary endpoint of

safety and tolerability and at 24 months of follow-up continues to demonstrate

strong signs of clinical response.

In the Phase I trial, patients were treated initially for 14 weeks with UV1 in

combination with pembrolizumab. At the cut-off date of October 12, 2021, every

patient in the first cohort had been followed for at least 24-months from the

start of their treatment. The overall survival rate after two years of follow-up

was 80% in this first cohort of 20 patients. As previously announced, median

progression free survival for these patients was 18.9 months.

The 24-month follow-up data compares favorably with an earlier large-scale study

of pembrolizumab alone, which showed an overall survival rate of 58% after 24

months and median progression-free survival of 5.5-11.6 months*.

"The combination of UV1 and pembrolizumab has a strong safety profile and

provides a prolonged and effective clinical response in advanced melanoma," said

Jens Bjørheim, Chief Medical Officer of Ultimovacs. "These two-year follow-up

data suggest that the way in which UV1 mobilizes the immune system provides

patients with lasting benefits."

"We believe that UV1 will play a transformative role in the treatment of solid

tumors, elevating patients' response rates in combination with checkpoint

inhibitors and providing long-term clinical benefits." said Carlos de Sousa, CEO

of Ultimovacs. "We look forward to sharing more detailed results of this ongoing

study at a major clinical oncology meeting in 2022."

The 12-month follow-up data from Ultimovacs' Phase I trial can be accessed here

(https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=3823802&la

ng=en-GB&companycode=no-ulti&v=). For further information please also see the Q2

2021 financial report (http://asia.blob.euroland.com/press-releases-

attachments/1330542/ultimovacs-asa-q221-report.pdf).

* Keytruda package inserts and 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, randomised, controlled, phase 3

study. Lancet Oncol. 2019;20(9):1239-1251. doi:10.1016/S1470-2045(19)30388-2

\==ENDS==

About Ultimovacs

Ultimovacs is developing immune-stimulatory vaccines to treat a broad range of

cancers. Ultimovacs' lead universal cancer vaccine candidate UV1 targets human

telomerase (hTERT), present in over 80% 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, Ultimovacs aims to

clinically demonstrate UV1's impact in multiple cancer types in combination with

other immunotherapies. 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] (mailto:[email protected])

Phone: +47 908 92507

Hans Vassgård Eid, CFO

Email: [email protected] (mailto:[email protected])

Phone: +47 482 48632

Mary-Ann Chang, LifeSci Advisors

Email: [email protected] (mailto:[email protected])

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 13 October, 2021 at 08:00 CET.