Ultimovacs Announces Publication of Phase II FOCUS Trial Results on medRxiv
Oslo, October 25, 2024: (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced that the results from Phase II FOCUS trial () have been on the preprint platform medRxiv.
As previously , 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 the late-stage head and neck squamous cell carcinoma (HNSCC) patients recruited in the study. The study therefore did not meet its primary and secondary endpoints. UV1 continued to demonstrate a positive safety profile in line with other UV1 studies with similar events observed in the control arm and good tolerability.
==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.
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 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.
About Ultimovacs
Ultimovacs is a clinical-stage biotechnology company developing novel immunotherapies against cancer. The product candidate UV1 is an off-the-shelf therapeutic cancer vaccine designed to enhance the benefits of immunotherapy and improve cancer treatment efficacy for patients. UV1 triggers an immune response against the shared cancer antigen telomerase, a target present in 85-90% of all cancer indications across disease stages.
Ultimovacs is investigating the safety and efficacy of UV1 in a wide-ranging clinical development program including various cancer indications and different immunotherapy combinations. The ongoing Phase II program comprises five randomized clinical trials in melanoma, mesothelioma, head and neck cancer, ovarian cancer, and non-small cell lung cancer. More than 640 patients in the U.S., Europe, and Australia are being enrolled in all Phase I and Phase II trials in the current program.
Furthermore, Ultimovacs is developing a novel conjugation technology, initially formed to support the expansion of our vaccine pipeline. With the objective of driving value and future pipeline growth, this flexible conjugation technology has the potential to be broadly applicable to a variety of therapeutic modalities, such as innovative drug conjugates with favorable pharmacological properties, and in multiple disease areas.
Ultimovacs is listed on the Euronext Oslo Stock Exchange (OSE:ULTI).
For further information, please see or contact:
Carlos de Sousa, CEO
Email:
Phone:
Hans Vassgård Eid, CFO
Email:
Phone:
