Ultimovacs announces first patient enrolled in Phase II FOCUS trial of UV1 in head-and-neck cancer

• Study will assess the benefit of combining UV1 with standard of care pembrolizumab
• Topline data expected in 2023

Oslo, 5 August 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced that the first patient has been enrolled in FOCUS, an investigator-led Phase II randomized clinical trial in head-and-neck cancer of the Company’s telomerase cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab.

FOCUS is one of Ultimovacs' four Phase II trials of UV1 in combination with various immunotherapy agents across four different cancer indications. The primary endpoint of FOCUS is progression-free survival rate at 6 months, with readout of topline results expected in 2023.

"Initiation of recruitment in FOCUS adds further momentum to the expanding clinical program of our lead cancer vaccine UV1,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. "There is a growing body of evidence to support the synergistic potential of UV1 in combination with immunotherapies. We believe the combination of UV1 with pembrolizumab can help address the clear unmet need in treating head and neck cancer.”

The FOCUS Phase II trial will be conducted at 10 sites across Germany and led by principal investigator Professor Mascha Binder, a renowned oncology clinician and researcher specializing in the analysis of immuno-oncology treatments and their interaction with tumor tissues. Professor Binder is Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany.

"Patients with cancer are starting to benefit from advanced immunotherapies with checkpoint inhibitors providing part of the solution,” commented Professor Binder. "The FOCUS study gives us and our collaborators the opportunity to understand how the distinct and additional immunostimulatory mechanism of UV1 affects clinical outcomes.”

FOCUS will enroll a total of 75 patients indicated for treatment with pembrolizumab, randomizing them 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The study is partially supported through an innovation grant of up to NOK 16 million (approx. USD 1.9 million) from the Norwegian Research Council.

About UV1
UV1 is a peptide-based vaccine being investigated in four Phase II trials in solid tumors. UV1 induces a specific T cell response against the universal cancer antigen telomerase. It is being developed as an "off-the-shelf” therapeutic cancer vaccine for use in combination with other immunotherapies that require an ongoing T cell response for their mode of action. In four Phase I trials involving 82 patients, UV1 has maintained a positive safety and tolerability profile and has demonstrated encouraging signals of efficacy.

About the FOCUS study
The FOCUS Phase II trial is an investigator-sponsored, randomized Phase II clinical trial that will recruit patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma across 10 clinical sites in Germany. The trial will evaluate treatment with UV1 in combination with the PD-1 checkpoint inhibitor pembrolizumab compared to the standard of care, pembrolizumab monotherapy. A total of 75 patients will be enrolled in the FOCUS study and randomized 2-to-1 so that 50 patients will receive UV1 with pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint of the study is the progression-free survival rate at 6 months, and readout of topline results is expected in 2023.

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 over 80% 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 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 5 August, 2021 at 08:00 CET.