Ultimovacs Announces Webcast to Elaborate on the Results from Randomized UV1 Phase II NIPU Trial in Malignant Mesothelioma

NON-REGULATORY PRESS RELEASE

Oslo, October 25, 2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announces that the Company will host a webcast presentation and discussion of the results from the NIPU study presented at the ESMO Congress 2023.

The results from the randomized Phase II trial showed that Ultimovacs’ cancer vaccine UV1, in combination with ipilimumab and nivolumab, demonstrated a statistically significant and clinically meaningful improvement of overall survival versus ipilimumab and nivolumab alone, a key secondary endpoint. Twice as many patients in the UV1 arm responded to treatment. No additional safety concerns were reported from the UV1 treatment.

The positive outcome from the NIPU study is the first demonstration of a universal cancer vaccine efficacy in a randomized Phase II clinical trial, showing Proof of Concept and supporting further clinical development as per investigators' recommendation.

NIPU (NCT04300244) is an investigator-initiated, randomized, multi-center, open-label Phase II clinical trial for second-line treatment in patients with malignant mesothelioma (MPM). The data from the study was published initially in a late-breaking abstract at the ESMO Congress in Madrid. Further details were provided in an oral presentation by the Principal Investigator at the ESMO Congress and was detailed in a press release announced by the Company on Monday, October 23, 2023.

This webcast follows the presentation of the NIPU results at ESMO by the Principal Investigator, Professor Åslaug Helland, MD, PhD. The webcast held in Madrid on Monday, October 23, 2023, had technical difficulties due to unexpected bandwidth issues at the premises.

The webcasts will take place on Tuesday, October 31, 2023, at:

9:00 am CET (in Norwegian): Link

2:00 pm CET/ 8:00 am ET (in English): Link  

The webcasts can be accessed live or as a replay. Questions can be sent during the webcast, or in advance to IR@ultimovacs.com

UV1 is a therapeutic cancer vaccine used to generate an immune response against the enzyme human telomerase (hTERT).  The enzyme is essential for the ability of cancer cells to proliferate. Telomerase is present in 85-90% of all cancers, across the stages of the disease. The vaccine is manufactured as an off-the-shelf product with a long shelf life. UV1 is easy to use and does not require sophisticated hospital infrastructure, enabling patient access to therapy also in community centers, and in rural and underserved communities.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical development program across various cancer indications with different biology and disease stages, in combination with different checkpoint inhibitors. The topline data from NIPU are the first results among the five randomized trials in the UV1 Phase II clinical program. In addition to malignant mesothelioma, Phase II studies are ongoing in patients with malignant melanoma, head and neck cancer, ovarian cancer, and non-small cell lung cancer. The topline data from the malignant melanoma and head and neck cancer trials are expected during the first and second half of 2024. UV1 is a patented, proprietary technology owned by Ultimovacs.

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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 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. The Company is listed on Euronext Oslo Stock Exchange (ULTI.OL).

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 IR & Communication
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86815

This stock exchange announcement was published by Anne Worsøe, Head of IR at Ultimovacs ASA, on October 25, 2023 at 17:45 CET.