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- 80% overall survival rate at 24 months follow-up
Oslo, 13 October 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced continuing positive topline results in its ongoing U.S.-based Phase I clinical trial evaluating the Company's universal cancer vaccine, UV1, in combination with the checkpoint inhibitor pembrolizumab as a first-line treatment in metastatic malignant melanoma. The trial had previously reached its primary endpoint of safety and tolerability and at 24 months of follow-up continues to demonstrate strong signs of clinical response.
In the Phase I trial, patients were treated initially for 14 weeks with UV1 in combination with pembrolizumab. At the cut-off date of October 12, 2021, every patient in the first cohort had been followed for at least 24-months from the start of their treatment. The overall survival rate after two years of follow-up was 80% in this first cohort of 20 patients. As previously announced, median progression free survival for these patients was 18.9 months.
The 24-month follow-up data compares favorably with an earlier large-scale study of pembrolizumab alone, which showed an overall survival rate of 58% after 24 months and median progression-free survival of 5.5-11.6 months*.
“The combination of UV1 and pembrolizumab has a strong safety profile and provides a prolonged and effective clinical response in advanced melanoma,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “These two-year follow-up data suggest that the way in which UV1 mobilizes the immune system provides patients with lasting benefits.”
“We believe that UV1 will play a transformative role in the treatment of solid tumors, elevating patients’ response rates in combination with checkpoint inhibitors and providing long-term clinical benefits.” said Carlos de Sousa, CEO of Ultimovacs. “We look forward to sharing more detailed results of this ongoing study at a major clinical oncology meeting in 2022.”
* Keytruda package inserts and Robert C, Ribas A, Schachter J, et al. Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study. Lancet Oncol. 2019;20(9):1239-1251. doi:10.1016/S1470-2045(19)30388-2
Ultimovacs is developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in over 80% of cancers in all stages of tumor growth. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and increase anti-tumor responses. With a broad Phase II program, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types in combination with other immunotherapies. Ultimovacs’ second technology approach, based on the proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant in the same molecule and entered Phase I studies in 2021.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Phone: +47 482 48632
Mary-Ann Chang, LifeSci Advisors
Phone: +44 7483 284 853
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on 13 October, 2021 at 08:00 CET.