Ultimovacs has reported positive top-line data from the second cohort of its Phase I clinical trial of universal cancer vaccine candidate, UV1, plus pembrolizumab as a first-line therapy for metastatic malignant melanoma.

UV1 works against human telomerase (hTERT), which is seen in more than 80% of cancers at all tumour growth stages.

The vaccine candidate directs the immune system to hTERT antigens to guide CD4 helper T cells to the tumour. This approach triggers an immune system cascade and boosts anti-tumour responses.

The second cohort of the ongoing Phase I trial in the US had ten subjects.

Data showed that the vaccine combination met the primary goal of safety and tolerability, demonstrating robust preliminary signs of clinical response.

In six of the ten subjects, the combination treatment offered tumour shrinkage, an objective response rate of 60%.

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By GlobalData

Furthermore, the tumours shrank to undetectable levels in three of the subjects, indicating a 30% complete response rate.

The levels of tumour destruction in response to therapy with UV1 plus the checkpoint inhibitor, pembrolizumab, were in line with those observed in the first cohort of 20 subjects from the trial.

After 12 months of treatment, a 90% and 85% overall survival (OS) rate was noted in cohort 2 and cohort 1, respectively, signifying elevated and consistent OS rate across both cohorts.

In addition, median progression-free survival (mPFS) was not attained in both cohorts at one year. The company reported this as a positive outcome, showing that the disease status either improved or was stable in a minimum of 50% of the total trial participants.

Ultimovacs chief medical officer Jens Bjørheim said: “The emerging picture is that the UV1-pembrolizumab combination has a strong safety profile and provides consistently high levels of clinical response in advanced melanoma.

“This latest data adds to the accumulating body of evidence demonstrating that UV1 is safe and can mobilise the immune system to play a transformative role in the treatment of solid tumours.”

The top-line two-year follow-up data from the first cohort of the trial is anticipated in the fourth quarter of this year.