Ultimovacs has announced positive results from the second cohort of 10 patients after one year of its ongoing US-based Phase I clinical trial.

The clinical trial evaluates the company’s universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab as a first-line treatment in metastatic malignant melanoma.

“These latest results are compelling, and in line with the data presented at ASCO from the first group of patients in this study,” says Carlos de Sousa, CEO of Ultimovacs. “We will discuss these results further when we present the company’s Q2 2021 financial results to shareholders on 20 August, 2021. We also plan to share more detailed results of the study at a major clinical oncology meeting in 2022.”

Similar results to those seen in the first cohort

The primary endpoint of safety and tolerability was achieved with strong initial signs of clinical response.

“Tumor shrinkage was evident in six of the 10 patients, a 60% objective response rate. In three of the patients, the tumors were reduced to undetectable levels, a 30% complete response rate.”

Tumor shrinkage was evident in six of the 10 patients, a 60% objective response rate. In three of the patients, the tumors were reduced to undetectable levels, a 30% complete response rate. These levels of tumor destruction in response to treatments with the combination of UV1 and pembrolizumab were similar to those seen in the first cohort of 20 patients from the same study.

The overall survival (OS) rate after one year was high and consistent across both patient cohorts, with a 90% OS rate in cohort 2 and 85% in cohort 1. Median progression-free survival (mPFS) was not reached in either cohort at 12 months, a positive outcome indicating that the disease status had either improved or was stable in at least half of the participating patients in both parts of the study.

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

“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,” says Jens Bjørheim, Chief Medical Officer of Ultimovacs. “This latest data adds to the accumulating body of evidence demonstrating that UV1 is safe and can mobilize the immune system to play a transformative role in the treatment of solid tumors.”

The study is ongoing in the US and, as previously announced, the topline 2-year follow-up data on the first patient cohort is still expected in Q4 2021.

Photo: Ultimovacs lab