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Ultimovacs är ett norskt läkemedelsbolag. Bolagets affärsinriktning är att utveckla immunoterapier mot diverse cancertillstånd. Forskning och utveckling utgår ifrån egenbaserad teknologisk plattform, där produkterna huvudsakligen vidareutvecklas som vaccin. Störst närvaro återfinns inom Europa och Nordamerika. Bolaget grundades under 2011 och har sitt huvudkontor i Oslo.

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2021-10-13 08:00:00
  • 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.”

The 12-month follow-up data from Ultimovacs’ Phase I trial can be accessed here. For further information please also see the Q2 2021 financial report.

* 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

==ENDS==

About Ultimovacs
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
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
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.