Ultimovacs Announces Completion of Patient Enrollment in Supplementary Study to INITIUM, UV1 Phase II Trial in Malignant Melanoma

• The supplementary study to INITIUM is designed to provide in-depth data on the biological activity and mode of action of the vaccine-induced T cells, to support the next stages of development
  
  
• Enrollment of 21 patients with unresectable or metastatic malignant melanoma completed
  
  
• All patients received UV1 vaccination as an add-on to the checkpoint inhibitors ipilimumab and nivolumab
  
  

Oslo, November 2, 2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced the completed recruitment of 21 patients in the exploratory single-arm study complementing the INITIUM trial. INITIUM (NCT04382664) is Ultimovacs’ randomized Phase II trial investigating its universal cancer vaccine UV1 in combination with the checkpoint inhibitors ipilimumab and nivolumab in the treatment of patients with unresectable or metastatic malignant melanoma.

The supplementary study was designed to elucidate and describe the mechanisms leading to improved clinical effects in patients treated with UV1 vaccination. The study will provide in-depth data on the biological activity and mode of action of the T cells induced by the UV1 vaccination on top of ipilimumab and nivolumab.

The results from the research will help identify patients with vaccine-specific immune responses and evaluate the vaccine’s impact on broadening the overall immune response. The data will also help assess the vaccine’s effectiveness in enhancing responsiveness to checkpoint inhibitors in otherwise resistant patients. Analyses from the supplementary study will be performed in parallel with the analyses from the randomized INITIUM study. The results from the supplementary study will not be included in the topline results from the INITIUM study.

"The insights from this supplementary study will enhance our comprehension of vaccine-specific induced immune responses in patients with malignant melanoma. As we prepare for the next stage of UV1 clinical development, these supplementary data will support us in designing late-stage clinical trial programs,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs.

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About INITIUM

INITIUM is an Ultimovacs-sponsored randomized, comparative, multicenter Phase II trial in which the universal cancer vaccine UV1 will be evaluated in combination with the checkpoint inhibitors ipilimumab and nivolumab for first-line treatment of patients with unresectable or metastatic malignant melanoma. The first patient received treatment in the INITIUM trial in June 2020, and the last patient was enrolled in July 2022. The study is being conducted at 39 hospitals across the U.S., U.K., Belgium, and Norway. The initial study design called for enrollment of 154 patients. Two additional patients were enrolled bringing the total number of patients in the study to 156.

The patients in the INITIUM study are taking longer than anticipated to experience cancer progression. The current slow pace of event development has justified an amendment of the study protocol approved by the regulatory authorities. Analysis of the INITIUM data will be initiated in mid-January 2024 to enable readout based on a minimum of 18-month follow-up of all evaluable patients and a mean follow-up time of 24 months. The protocol amendment will have minor consequences for the study's statistical integrity.

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 the Euronext Oslo Stock Exchange (ULTI.OL).

About the UV1 Phase II program

The immunotherapeutic cancer vaccine UV1 is investigated in combination with checkpoint inhibitors in patients with various cancer indications with diverse tumor biology. The diversity of the UV1 Phase II program places Ultimovacs in a favorable position to capture the cancer vaccine’s potential broad applicability when combined with checkpoint inhibitors:

• INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as first-line treatment for patients with unresectable or metastatic malignant melanoma. Enrollment of 156 patients completed in July 2022. Expected readout H1 2024. Sponsored by Ultimovacs.
• NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-line treatment for patients with malignant pleural mesothelioma. Enrollment of 118 patients completed in January 2023. Data presented at the ESMO Congress in October 2023, showed that UV1 as an add-on to ipilimumab and nivolumab, demonstrated a statistically significant and clinically meaningful improvement in overall survival versus ipilimumab and nivolumab alone. 31% of the patients receiving the UV1 vaccine experienced an objective response, compared to 16% in the control arm. The investigator-initiated study is led by Oslo University Hospital and supported by Bristol-Myers Squibb and Ultimovacs.
• FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line treatment for patients with head and neck cancer. Enrollment of 75 patients completed in August 2023, expected readout H2 2024. The investigator-initiated study is led by Halle University in Germany, supported by Ultimovacs.
• DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as maintenance therapy in non-BRCA mutated patients with advanced ovarian cancer. >20% of 184 patients enrolled as of Q2 2023 reporting, expected readout H2 2024. The investigator-initiated study is led by NSGO-CTU and supported by ENGOT, AstraZeneca, and Ultimovacs.
• LUNGVAC: Evaluating UV1 combined with cemiplimab as first-line treatment of non-small cell lung cancer patients. <10% of 138 patients enrolled as of Q2 2023 reporting, expected readout H2 2025. The investigator-initiated study is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.

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 is 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
Phone: +47 908 92 507

Anne Worsøe, Head of IR
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86 815

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 November 2, 2023, at 07:00 CET.