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Ultimovacs completes patient recruitment in Phase II trial

Carlos de Sousa

Ultimovacs has announced the completed recruitment of 154 patients in the INITIUM trial.

INITIUM is Ultimovacs’ Phase II clinical trial of its universal cancer vaccine UV1 in combination with the checkpoint inhibitors ipilimumab and nivolumab in metastatic malignant melanoma. Consistent with INITIUM’s event-driven design, topline progression-free survival results will be disclosed after progression of cancer or death has been observed in a total of 70 patients, states the company.

“It is a remarkable achievement that Ultimovacs and its clinical partners have completed recruitment to INITIUM largely on schedule despite challenges caused by the pandemic,” says Carlos de Sousa, Chief Executive Officer of Ultimovacs. “INITIUM has been designed as a robust comparative study to demonstrate that UV1 substantially enhances outcomes for patients over and above those that can be achieved with checkpoint inhibitors alone. The results will provide a rational basis for the design and implementation of future pivotal clinical studies, together with the positive data that we have seen from our Phase I studies in malignant melanoma.”


INITIUM is an Ultimovacs-sponsored randomized Phase II trial for first-line treatment of patients with advanced or metastatic malignant melanoma. Half of the 154 patients recruited to the trial have been dosed with UV1 plus the PD-1 checkpoint inhibitor nivolumab and the CTLA-4 checkpoint inhibitor ipilimumab, while the other half received nivolumab and ipilimumab. All five of Ultimovacs’ current Phase II trials have a similar comparative design, in each case to demonstrate in a statistically robust manner the effectiveness of UV1 as an add-on to standard-of-care treatment in a particular cancer type.

“We are grateful for the continuing work of our international group of collaborators supporting the execution of the INITIUM trial, and for their dedication in improving the treatment of cancer patients,” says Jens Bjørheim, Chief Medical Officer of Ultimovacs. “The topline progression-free survival data in INITIUM will be an important primary readout. Following this readout, we will continue to monitor other efficacy endpoints such as tumor response, duration of response and overall survival.”

In June 2022, Ultimovacs reported positive data from a Phase I trial in malignant melanoma with a treatment that combines UV1 with the PD-1 checkpoint inhibitor, pembrolizumab. Across 30 patients, the 24-month overall survival rate was 73% with an objective response rate of 57% (partial or complete disappearance of tumors) including a complete response rate of 33%.

Photo of Carlos de Sousa: Ultimovacs