Ultimovacs Announces Completed Enrollment in FOCUS Phase II Clinical Trial of UV1 in Head and Neck Cancer Patients

• The randomized, investigator-initiated FOCUS trial has completed enrollment of 75 patients with recurrent or metastatic head and neck squamous cell carcinoma
• The study will provide randomized data on the benefit of UV1 vaccination as add-on to standard pembrolizumab treatment
• Topline results, including overall survival, will be provided to the Company by the Principal Investigator 12 months after the last patient received first dose, expected in second half of 2024
  
  

Oslo, 3 August 2023 – Ultimovacs ASA ("Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced the completion of enrollment of 75 patients and that the last patient has received the first dose in the FOCUS study (NCT05075122).

FOCUS is an investigator-initiated Phase II randomized clinical trial sponsored by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs. The study investigates Ultimovacs’ therapeutic cancer vaccine, UV1, in combination with pembrolizumab versus pembrolizumab alone, as first-line treatment for patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). For these patients, pembrolizumab is a standard of care treatment.  

The FOCUS trial is being conducted at ten sites across Germany and is led by Principal Investigator Mascha Binder, M.D., Professor of Medical Oncology at the Faculty of Medicine, University Hospital of Basel. Professor Binder is a renowned oncology clinician and researcher specializing in the analysis of immune-oncology treatments and their interaction with tumor tissues.

The topline results will include overall survival (OS) with minimum 12 months of follow-up in addition to progression-free survival (PFS), enabling a full assessment of the study outcomes. These data will be analyzed 12 months after the last patient was enrolled and is expected to be disclosed in the second half of 2024. The results will be announced through a press release followed by an in-depth presentation of the data at a medical conference and in a peer-reviewed journal.

"Metastatic or recurrent head and neck cancer is a highly aggressive disease, and there is a significant need for improved treatment options. The successful enrollment of patients in the FOCUS study marks a key milestone as we evaluate novel immunotherapy approaches such as UV1 in combination with checkpoint inhibitors. By advancing our understanding of these novel therapies, we hope to bring about a positive impact on the lives of patients battling this devastating disease,” said Professor Mascha Binder, M.D., Principal Investigator of the FOCUS trial.

"We are pleased to announce the completion of patient enrollment in the FOCUS trial, the third of five randomized Phase II clinical trials evaluating UV1 in different cancer indications and in combination with various checkpoint inhibitors,” added Carlos de Sousa, Chief Executive Officer at Ultimovacs. "We look forward to learning the impact of UV1, particularly in terms of overall survival, the most important efficacy measurement in cancer treatment. We expect to provide topline data in the second half of 2023 for the Phase II trial in malignant melanoma, INITIUM. For the Phase II trial in pleural mesothelioma, NIPU, we expect the full data, including overall survival, to be presented at a medical conference in the fall of this year. The results from these studies will increase our understanding of how UV1 can potentially improve outcomes for cancer patients and provide a foundation for our future pivotal clinical studies.”

Head and neck cancer is the seventh most common type of cancer worldwide, and squamous cell carcinoma (HNSCC) represents about 90 percent of these patients. HNSCC occurs in the head and neck region, including the throat, mouth, sinuses and nose. Despite advances in treatment strategies, the prognosis for these patients is poor.

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. UV1 is a patented, proprietary technology owned by Ultimovacs.

Ultimovacs is evaluating the universal cancer vaccine UV1 in a broad clinical development program across various cancer indications with different biologies and disease stages, in combination with different checkpoint inhibitors. In addition to head and neck cancer, Phase II studies are ongoing in patients with malignant melanoma, pleural mesothelioma, ovarian cancer, and non-small cell lung cancer.

The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council.

==ENDS==

About FOCUS
The FOCUS trial (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study) is an investigator-sponsored, randomized, open-label Phase II clinical trial. The primary objective of this study is to determine the clinical performance of UV1 vaccination as add-on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma. Professor Mascha Binder is the principal investigator for the trial, which is sponsored by the Medical Faculty, University of Halle-Wittenberg in Germany. The first patient in the FOCUS trial was enrolled in August 2021, and patients have been treated at ten sites across Germany. The trial is investigating the tolerability and efficacy addition of UV1 to the standard of care treatment with programmed death receptor-1 (PD 1)-blocking antibody pembrolizumab versus pembrolizumab monotherapy. The 75 patients indicated for treatment with pembrolizumab have been randomized 2-to-1, so 50 patients will receive UV1 and pembrolizumab, and 25 patients will receive pembrolizumab alone.  The primary endpoint is PFS rate at 6 months after the first administration of study medication. Secondary endpoints include PFS and OS (overall survival, by Kaplan-Meier estimate), objective response rate (ORR), duration of response (DOR), and safety, with a minimum 12 months follow-up. As OS is recognized as the determining efficacy measure in guiding further development in this cancer indication, the topline results will be disclosed 12 months after enrollment of the last patient, allowing simultaneous disclosure of both PFS and OS. Ultimovacs expects to report the topline readout in the second half of 2024 when the Principal Investigator discloses the data. The full analysis will be presented thereafter at a medical meeting and published in a peer-reviewed journal.

About Head and Neck Squamous Cell Carcinoma (HNSCC)
Head and neck cancer is the term used to describe different malignant tumors that develop in or around the throat, larynx, nose, sinuses, and mouth. Squamous cell carcinoma represents about 90 percent of head and neck cancer patients. Overall survival of patients with metastatic or recurrent HNSCC has improved over the past decade, but remains poor overall. Median overall survival is limited to less than 15 months, with the current standard of care (immune checkpoint blockade with or without chemotherapy). Many patients with HNSCC are frail and therefore cannot tolerate chemotherapy, reducing their treatment options to checkpoint inhibitors. Therefore, developing effective and tolerable combination regimens is urgently needed, especially in first-line therapy. 

About 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 puts Ultimovacs in an advantageous position to capture the cancer vaccine’s potential broad applicability when combined with checkpoint inhibitors, for further clinical development:

• INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as first-line treatment for patients with advanced or metastatic malignant melanoma. Enrollment of 156 patients completed. Expected readout H2 2023. Sponsored by Ultimovacs.
• NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-line treatment for patients with advanced malignant pleural mesothelioma. Enrollment of 118 patients completed. Topline results announced June 2023, and detailed data including overall survival expected H2 2023. Investigator-initiated study led by Oslo University Hospital, supported by Bristol-Myers Squibb and Ultimovacs.
• FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line treatment for patients with metastatic or recurrent head and neck cancer. Recruitment of 75 patients completed, expected topline readout on PFS and OS in H2 2024. Investigator-initiated study 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 recruited as of Q1 2023 reporting, expected readout H2 2024. Investigator-initiated study led by NSGO-CTU, supported by ENGOT, AstraZeneca, and Ultimovacs.
• LUNGVAC: Evaluating UV1 in combination with cemiplimab as first-line treatment of patients with advanced or metastatic non-small cell lung cancer. <10% of 138 patients recruited as of Q1 2023 reporting, expected readout H2 2025. Investigator-initiated study led by Vestre Viken (Drammen Hospital), supported by Ultimovacs.

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 that is 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.

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 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 92507

Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86815

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 3 August, 2023 at 08:00 CEST.