On August 18, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, reported that patient enrollment has been completed in the ongoing US-based Phase I clinical trial testing Ultimovacs’ lead candidate, UV1, in combination with pembrolizumab as first line treatment in patients with metastatic malignant melanoma (Press release, Ultimovacs, AUG 18, 2020, View Source [SID1234563783]). The study was designed to assess the safety and tolerability of UV1 combined with checkpoint inhibitor pembrolizumab and to explore initial signs of clinical response.

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The Phase I trial investigates Ultimovacs’ cancer vaccine, UV1, in combination with PD-1 checkpoint inhibitor, pembrolizumab. Pembrolizumab is standard-of-care therapy for malignant melanoma, improving the ability of immune cells to kill tumor cells. The preliminary safety information obtained from the first 20 patients in the Phase I trial allowed for the exploration of a higher dose of the adjuvant GM-CSF in 10 additional patients. The first 20 patients received 37.5 μg GM-CSF per UV1 vaccination versus 75 μg GM-CSF per UV1 vaccination in the second cohort of 10 patients. GM-CSF is used as an adjuvant together with UV1 to strengthen the ability of UV1 to stimulate the immune system. With 30 patients enrolled and treated as of today, the trial reached its targeted enrollment criteria. No unexpected safety issues related to UV1 have been observed to date and UV1 has generally been well tolerated by the patients.

Carlos de Sousa, Chief Executive Officer at Ultimovacs, commented:
"Early data on the patients enrolled in the Phase I trial of UV1 in combination with pembrolizumab demonstrate a strong safety profile to date and provide further support for Ultimovacs’ approach of combining UV1 treatment with checkpoint inhibitors. The preliminary safety data builds further on a previous Phase I trial in malignant melanoma, where UV1 was combined with the CTLA-4 checkpoint inhibitor ipilimumab. In both combination trials, treatment with UV1 has been well tolerated by patients, providing a solid basis for the triple combination of UV1 with CTLA-4 and PD-1, which is currently investigated in the Company’s Phase II trials INITIUM and NIPU. We are proud of the Company’s progress and would like to thank the patients, their families and healthcare providers for their participation, particularly in the current challenging environment. "

Jens Bjørheim, Chief Medical Officer of Ultimovacs, added:
"We are pleased that we have completed the enrollment of the second cohort in this Phase I trial despite challenging times related to the ongoing pandemic. In September of this year, all patients in the first cohort will have reached their 1-year follow-up period and we look forward to announcing top-line safety and preliminary efficacy data from patients in the first cohort in the fourth quarter of this year, followed by more detailed results at an international medical conference early next year."

About UV1 and the UV1 Phase II Clinical Trials
UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen, telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immuno-oncology drugs which require an ongoing T cell response for their mode of action. To date, UV1 has been tested in four Phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.

UV1 will be tested in three different randomized Phase II trials:

The INITIUM trial is an Ultimovacs-sponsored, global, randomized Phase II trial for patients with metastatic malignant melanoma. Patients will be treated with UV1 in combination with ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor). The trial will be conducted in the U.S. and Europe, including Norway. The first patient was dosed on 15 June 2020. A total of 154 patients will be enrolled in the study, 77 patients will receive nivolumab and ipilimumab and the second half of the patients will receive nivolumab, ipilimumab and UV1. The primary endpoint for the study is progression-free survival and the planned readout of the primary endpoint is in the second half of 2022.
The NIPU trial is a randomized, multi-center Phase II trial in which the universal cancer vaccine, UV1, is investigated in combination with the checkpoint inhibitors, ipilimumab and nivolumab, as second-line treatment in mesothelioma. Oslo University Hospital is the sponsor of the NIPU study. Bristol-Myers Squibb and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. The first patient was dosed on 15 June 2020. A total of 118 patients will be included in the NIPU study. Half of the patients will be treated with the combination of UV1, ipilimumab (CTLA-4 checkpoint inhibitor) and nivolumab (PD-1 checkpoint inhibitor), whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at six national hospital centers specialized in treating mesothelioma in four countries (Norway, Sweden, Denmark and Australia). Planned readout of the primary endpoint progression-free survival is the second half of 2022.
A third Phase II clinical trial will evaluate UV1 in a new cancer indication in combination with indication-specific standard of care cancer therapies different from those to be tested in INITIUM (malignant melanoma, 154 patients) and NIPU (mesothelioma, 118 patients). In the collaboration, Ultimovacs will supply UV1 and a big pharma company will supply its proprietary cancer treatment to the clinical trial group which will sponsor the trial.
The Phase II clinical program builds on three completed Phase I trials and one ongoing Phase I trial. The Phase II trials will evaluate UV1 in three different indications in more than 400 patients and in collaboration with two big pharma companies. The ongoing and planned clinical trials represent a strong platform for Ultimovacs to advance towards a potential registration of the universal cancer vaccine, UV1.