Ultimovacs’ SITC2021 Data Shows Enduring T cell Response for UV1 Combination in Melanoma

• UV1 vaccine combined with ipilimumab induced immune responses in 91% of melanoma patients
• Immune responses persist and are detectable up to 5 years

Oslo, November 9, 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage leader in immune stimulatory vaccines for cancer, announces data showing that the Company’s universal cancer vaccine UV1 in combination with ipilimumab induces dynamic, multi-functional T cell responses in patients with melanoma, with the potential for protection of 5 years or more. The data will be presented as a poster at the Society For Immunotherapy of Cancer’s 36^th Annual Meeting (SITC2021) being held in Washington, DC, USA November 10-14, 2021.

The SITC2021 data are from an early Ultimovacs’ Phase I/IIa study of UV1 with the checkpoint inhibitor ipilimumab in twelve patients with melanoma (NCT02275416). They show that the drug combination induces a T cell immune response in 91% of patients, and that the response can persist as long as 5 years (the end of the study period). The UV1-ipilimumab combination induces T cells that are polyfunctional and produce multiple effector cytokines such as interferon-gamma and TNF-alpha essential for a robust anti-tumor response. Tumor biopsies revealed an influx of tumor-infiltrating lymphocytes (TIL) in patients who responded well to treatment. The finding is a positive early signal in a broader R&D program aimed at documenting the mechanistic effects of UV1.

"These are pleasing and clear data. The UV1-induced T cells continue to respond dynamically to the presence of antigen over a prolonged period. The longevity of the induced immune response and the persisting proliferative capacity of the T cells provide optimism for UV1’s potential to provide long-term clinical impact for the patients.” said Gustav Gaudernack, Chief Scientific Officer of Ultimovacs. "Ultimovacs is delighted to be able to share these data with the scientific and clinical community at SITC. As a company, we remain committed to progressing UV1 in our ongoing Phase II clinical studies.”

Ultimovacs’ poster is entitled: "The Synthetic Long Peptide Cancer Vaccine UV1 in Combination with Ipilimumab Induces a CD4+ Th1 Anti-hTERT Immune Response and an Inflammatory Tumor Microenvironment in Patients with Melanoma”. The poster presentation will be made available via the Ultimovacs website at November 12, 2021.

UV1 is being investigated in combination with checkpoint inhibitors in Phase II trials covering advanced malignant melanoma, ovarian cancer, head and neck squamous cell carcinoma, malignant pleural mesothelioma, and non-small cell lung cancer (NSCLC).

In total, the five Phase II trials will enroll more than 650 patients at nearly 100 clinical centers across 15 countries. The U.S. FDA recently granted Fast Track designations to the combinations of UV1 with ipilimumab and UV1 with pembrolizumab in the treatment of advanced malignant melanoma.

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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 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, 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: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

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

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284 853

This announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on November 9, 2021 at 14:00 CET.