Ultimovacs, a clinical-stage biotechnology company, has said that its cancer vaccine UV1 has failed to meet primary or secondary endpoints in Phase II FOCUS trial.
UV1 is a therapeutic cancer vaccine designed to induce a specific T cell response against human telomerase (hTERT) antigen which is present in around 85-90% of cancers across all stages of tumour growth.
The FOCUS investigator-initiated randomised Phase II clinical trial was initiated to assess the efficacy of UV1 vaccination, in combination with pembrolizumab, 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).
The primary endpoint was determined to be progression free survival at six months.
According to the topline data, the addition of UV1 to the standard pembrolizumab treatment did not improve progression free survival or overall survival in late-stage HNSCC patients.
Ultimovacs CEO Carlos de Sousa said: “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.”
The trial, sponsored by Martin-Luther-University Halle-Wittenberg, is being conducted at ten sites across Germany.
Besides FOCUS, the performance of UV1 is also being assessed in ovarian cancer under the ongoing Phase II DOVACC trial.
The topline results for this study are expected to be announced in the first half of next year.
Ultimovacs chief medical officer Jens Bjørheim said: “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 programme 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.”
