Ultimovacs’ UV1 is a universal cancer vaccine designed to induce a specific T cell response against telomerase

Ultimovacs’ UV1 universal cancer vaccine boosted overall survival in malignant melanoma, according to a three-year update from a Phase I clinical trial.

UV1 is a universal cancer vaccine designed to induce a specific T cell response against telomerase. The U.S. Food and Drug Administration (FDA) granted a dual Fast Track designation for UV1 in combination with checkpoint inhibitors in the treatment of unresectable or metastatic melanoma either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. 

The UV1-103 study evaluated UV, in combination with pembrolizumab, as first-line treatment in patients with advanced non-resectable or metastatic malignant melanoma. 

The study enrolled 30 patients in the U.S. in two cohorts that differed only in the concentration of Granulocyte-macrophage colony-stimulating factor (GM-CSF) used as vaccine adjuvant.  Twenty-seven of these patients agreed to long-term monitoring after two years.

At 3-year follow-up across the two cohorts, 67% (18/27) of patients were still alive. 3-year overall survival in cohort 1 was 71% (12/17), including one patient death between years 2 and 3 as reported in October 2022. Three-year overall survival in cohort 2 was 60% (6/10). All patients in cohort 2 who were alive at the 2-year follow-up, remain alive at the 3-year follow-up.

Ultimovacs has previously reported data showing a complete response rate in the UV1-103 study of 33% (complete disappearance of tumors) and an objective response rate of 57% (complete or partial disappearance of tumors).

 Biomarker analyses reported in October 2022 showed robust clinical responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients’ PD-L1 status. The safety profile of UV1 in combination with pembrolizumab is comparable to that of pembrolizumab alone.

“We are very encouraged to observe a 67% overall survival rate at 3-year follow-up in this Phase I study, which treats the same patient population as our UV1 Phase II study, INITIUM. These data further strengthen the previously reported results from the study, including good safety for UV1 and remarkable 33% complete response rate in patients with metastatic malignant melanoma where surgery is not an option. The data continue to show that UV1 in combination with pembrolizumab has promising signs of efficacy,” says Jens Bjørheim, Chief Medical Officer at Ultimovacs, in a news release. “We are looking forward to receiving more data from the UV1 clinical trials, to advance UV1 further to the benefit of cancer patients.”

Ultimovacs is now investigating UV1 in malignant melanoma in its randomized Phase II INITIUM trial of UV1 in combination with ipilimumab and nivolumab. The trial completed enrollment of 156 patients with advanced non-resectable or metastatic malignant melanoma in July 2022. The top-line results will be disclosed after cancer progression has been verified in 70 patients, which was anticipated in the first half of 2023. 

As announced in April 2023, the readout is now expected in the second half of 2023. This is due to patients taking longer than estimated to experience cancer progression, which is very encouraging and positive for patients