Ultimovacs Announces Topline Data from FOCUS Phase II Trial of UV1 Combined with Pembrolizumab in Patients with Metastatic or Recurrent Head and Neck Cancer

• Adding Ultimovacs’ cancer vaccine UV1 to checkpoint inhibitor pembrolizumab did not meet primary or secondary endpoints in patients with metastatic or recurrent head and neck squamous cell carcinoma
• UV1 continues to show a positive safety profile in line with other UV1 studies with similar events observed in the control arm and good tolerability
• As previously communicated, financial runway secured until Q4 2025 beyond expected topline results from DOVACC Phase II study in 1H2025
• Within the available resources, the company is also actively developing a novel technology platform identified during the TET development and will provide an update before the end of 2024

Oslo, August 5, 2024: Ultimovacs ASA ("Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced the topline results from the Phase II FOCUS trial (NCT05075122). The topline data readout demonstrated that adding UV1 to the standard of care pembrolizumab did not lead to clinical benefits in progression free survival or overall survival in those late-stage HNSCC patients, therefore, the study did not meet its primary and secondary endpoints.

FOCUS is an investigator-initiated randomized Phase II clinical trial sponsored by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs. It investigates Ultimovacs’ therapeutic cancer vaccine, UV1, in combination with pembrolizumab versus pembrolizumab alone, as a first-line treatment in metastatic patients or a second-line treatment in patients with recurrent PD-L1 positive head and neck squamous cell carcinoma (HNSCC). In this indication, pembrolizumab is currently considered the standard of care treatment for patients. The primary endpoint of the study is progression free survival at 6 months. All patients have been followed up for close to 12 months or longer for PFS, overall survival (OS) and safety.

"We have implemented a broad Phase II clinical development program testing our cancer vaccine in a range of different indications. Unfortunately, the FOCUS study did not provide us with the results we had hoped for, and we are disappointed that UV1 was not able to provide added clinical benefit for these HNSCC patients,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs. "Earlier this year we implemented a cash preservation program, enabling us to extend our runway to the fourth quarter of 2025 beyond the anticipated DOVACC Phase II topline readout in the first half of next year. Further, the Ultimovacs team is actively developing a novel technology platform identified during the TET development and we look forward to providing more details before year-end.”

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 specialized in the analysis of immune-oncology treatments and their interaction with tumor tissues.

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.

Jens Bjørheim, Chief Medical Officer at Ultimovacs added, "We are disappointed that the FOCUS trial did not achieve the desired outcome for patients, which underscores the complexities of treating metastatic and recurrent head and neck cancer. This cancer type is particularly aggressive with limited treatment options and high rates of recurrence. Our broad clinical development program was designed to identify the best patient populations for UV1 and we are now focusing our efforts on the upcoming DOVACC data readout in the first half of next year.”

Ultimovacs is also investigating UV1 in ovarian cancer in the ongoing Phase II DOVACC trial which evaluates a combination of olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment for patients with high-grade BRCA negative ovarian cancer. Topline results are expected in the first half of 2025 well within the current financial runway which reaches to the fourth quarter of 2025.

Ultimovacs will host its Q2 2024 webcast on Wednesday, August 21^st, 2024, at 14.00 CEST.

==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 as a first-line treatment in metastatic patients or a second-line treatment in patients with recurrent 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 10 sites across Germany. The trial is investigating the tolerability and efficacy addition of UV1 to 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 that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint is PFS rate at 6 months after 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 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. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council. 

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 inhibitor. Therefore, the development of effective and tolerable combination regimens is urgently needed, especially in first-line therapy. 

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 therapeutic 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 that are 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

Hans Vassgård Eid, CFO
Email: ir@ultimovacs.com

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 Hans Vassgård Eid, CFO at Ultimovacs ASA, on August 5, 2024 at 19.10 CEST.