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Oslo, 18 August 2020: Ultimovacs ASA (“Ultimovacs”, ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, announced today 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. 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.

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: