Immuno-oncology Company Ultimovacs developing a vaccine, UV1, which aims to enhance the immune system of cancer patients to help them fight cancer. UV1 is a storable peptide-based vaccine that induces a specific T-cell response against telomerase, an antigen expressed in 85–90 percent of all cancer types. This property makes the vaccine universal.
The company has a broad Phase II program in five cancer indications with the aim of clinically demonstrating UV1's efficacy in multiple cancer types, in combination with other immunotherapies.
Ultimovacs has a long-standing commitment to the development of UV1-based treatments for melanoma – a form of skin cancer with more than 130 new cases worldwide each year.
Study with UV1 in malignant melanoma is fully recruited
INITIAL is an Ultimovacs-sponsored randomized phase II study for the first-line treatment of patients with advanced or metastatic malignant melanoma. The study tests the triple combination of UV1 with checkpoint inhibitors (KPIs) ipilimumab (Yervoy) and nivolumab (Opdivo).
The company now announces that the recruitment of 154 patients with malignant melanoma in the US and Europe is complete. Half of the recruited patients 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.
Topline data regarding progression-free survival is expected to be published in the first half of 2023. After the readout, Ultimovacs will continue to monitor other efficacy measures such as tumor response, duration of response and overall survival.. Ultimovac CEO Carlos de Sousa commented on the news in a statement:
"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,"
"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."
Two of three phase I studies completed
In addition to the INITIUM study, Ultimovacs has conducted two phase I studies in melanoma: UV1 in combination with ipilimumab with 12 patients in Norway and UV1 in combination with pembrolizumab with 30 patients in the USA.
Based on data from these studies, UV1 has received Fast Track designation from the FDA for UV1 as an adjuvant treatment to pembrolizumab or as an adjuvant treatment to ipilimumab in the treatment of unresectable or metastatic melanoma. UV1 also has orphan drug status from FDA in the treatment of malignant melanoma.
Finally, Ultimovacs also has an ongoing Phase I study with its cancer vaccine adjuvant technology – TET (Tetanus-Epitope Targeting). This study is also progressing according to plan.
For a closer look at Ultimovac's UV1 cancer vaccine, watch the video below.
Learn more about Ultimovacs.