Ultimovacs Announces Further Positive Topline Results from Phase I UV1 Cancer Vaccine Combination Study in Metastatic Melanoma

Ultimovacs Announces Further Positive Topline Results from Phase I UV1 Cancer Vaccine Combination Study in Metastatic Melanoma




Ultimovacs Announces Further Positive Topline Results from Phase I UV1 Cancer Vaccine Combination Study in Metastatic Melanoma

  • Cohort 2 showed 60% objective response rate, 30% complete response rate
  • 90% overall survival rate at 12 months follow-up
  • Cohort 2 results reinforce results seen in cohort 1
  • Good safety and tolerability profile supports use of UV1 in combination treatments

Oslo, 12 August 2021: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced positive topline results from the second cohort of 10 patients after one year of 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 primary endpoint of safety and tolerability was achieved with strong initial signs of clinical response.

Tumor shrinkage was evident in six of the 10 patients, a 60% objective response rate. In three of the patients, the tumors were reduced to undetectable levels, a 30% complete response rate. These levels of tumor destruction in response to treatments with the combination of UV1 and pembrolizumab were similar to those seen in the first cohort of 20 patients from the same study.

The overall survival (OS) rate after one year was high and consistent across both patient cohorts, with a 90% OS rate in cohort 2 and 85% in cohort 1. Median progression-free survival (mPFS) was not reached in either cohort at 12 months, a positive outcome indicating that the disease status had either improved or was stable in at least half of the participating patients in both parts of the study.

“The emerging picture is that the UV1-pembrolizumab combination has a strong safety profile and provides consistently high levels of clinical response in advanced melanoma,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “This latest data adds to the accumulating body of evidence demonstrating that UV1 is safe and can mobilize the immune system to play a transformative role in the treatment of solid tumors.”

The study* is ongoing in the U.S. and, as previously announced, the topline 2-year follow-up data on the first patient cohort is still expected in Q4 2021.

“These latest results are compelling, and in line with the data presented at ASCO from the first group of patients in this study,” said Carlos de Sousa, CEO of Ultimovacs. “We will discuss these results further when we present the company’s Q2 2021 financial results to shareholders on 20 August, 2021. We also plan to share more detailed results of the study at a major clinical oncology meeting in 2022.”

* ClinicalTrials.gov Identifier: NCT03538314. Treatments in cohort 1 and cohort 2 of the study differed only in the levels of GM-CSF administered as an adjuvant with UV1.

==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 Hans Vassgård Eid, CFO at Ultimovacs ASA, on 12 August, 2021 at 07:45 CET.