Ultimovacs Announces Positive Three-Year Results of 71% Overall Survival Rate in Cohort 1 of UV1-103 Study in Metastatic Malignant Melanoma

• Malignant melanoma patients treated with immunotherapy combination UV1 and pembrolizumab in phase I clinical trial
• Consistently high overall survival (OS) rate: 71% at three-year follow-up of patients in first cohort
• UV1 and pembrolizumab combination continues to demonstrate strong signals of clinical efficacy, including prolonged patient survival

Oslo, 5 October 2022: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced continuing positive efficacy data in its ongoing U.S.-based phase I clinical trial, UV1-103. The study evaluates the Company’s universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in advanced non-resectable and metastatic malignant melanoma patients.

“Given the historic trajectory for patients with metastatic malignant melanoma, this three-year 71% OS rate is very positive,” said Carlos de Sousa, CEO of Ultimovacs. “Overall, these promising data support our continuing belief that UV1 can play a transformative role in treating solid tumors in combination with checkpoint inhibitors, providing long-term clinical benefits for patients with unmet medical needs.”

After the study ended at two years follow up, the protocol was amended to follow patients for overall survival for up to five years. Three of the patients, all in cohort 1, did not consent to further follow up, changing the number of participating patients in cohort 1 from 20 to 17 after two years. In addition, one patient died within the past year.

At the three years cut-off date for patients in the first cohort the three-year overall survival (OS) rate was 71% (12/17). The trial has shown a consistently high OS rate; in this patient cohort it was 85% (17/20) after one year and 80% (16/20) after two years follow-up. Having already reached its primary endpoint of safety and tolerability, the UV1-pembrolizumab combination continues to demonstrate strong signals of clinical efficacy in both response rates and extended survival.

Pembrolizumab is a standard of care for patients with unresectable or metastatic melanoma, based on data from the KEYNOTE-006 trial*. Follow up of first-line patients with metastatic melanoma in that trial showed an overall survival rate of 51% at 36 months.**

“The high survival rate after three years for metastatic malignant melanoma patients is very encouraging and reinforces the positive data we have consistently observed throughout the UV1-103 trial,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “As previously reported, the combination of UV1 and pembrolizumab has a strong safety and tolerability profile. These three-year data also signal that UV1 continues to mobilize the immune system providing patients with a long-term, effective clinical response. We are very pleased to see the positive results for these patients.”

UV1-103 (Cohort 1) Overall Survival Rate % (Patients alive/total):
12 months: 85% (17/20)
24 months: 80% (16/20)
36 months: 71% (12/17) 3 patients declined follow-up post 24 months, 1 patient died

Further data from the UV1-103 study will be presented at the International Congress of the Society for Melanoma Research, October 18, 2022.

*For reference only; not a head-to-head comparison
**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, randomized, controlled, phase 3 study. Lancet Oncol. 2019;20(9):1239-1251. Doi:10.1016/S1470-2045(19)30388-2. Supplementary table S6: Overall survival in patients receiving first-line treatment – combined pembrolizumab arms: 36-month rate (%).

==ENDS==

About the UV1-103 phase I trial in Malignant Melanoma

This US-based Phase I clinical trial is evaluating the Company’s lead candidate, UV1, in combination with the anti-PD-1 checkpoint inhibitor, pembrolizumab, as a first-line treatment in patients with metastatic malignant melanoma. The trial is evaluating the safety, tolerability, and initial signs of clinical response. The 20 patients in the first cohort received a 37.5 µg GM-CSF adjuvant dose per UV1 vaccination. The 10 patients in the second cohort received the standard 75 µg GM-CSF adjuvant dose per UV1 vaccination. The study has completed the enrollment of 30 patients, as announced on August 18, 2020. All included patients received the drugs as first line treatment for advanced and metastatic melanoma.

Compiled clinical results for the 30 patients enrolled are:

• Objective response rate (ORR): 57%. Complete response rate (CR): 33%
• Median Progression Free Survival (mPFS): 18.9 months (as measured by iRECIST)
• Overall survival after 12 months: 87%. Overall survival after 24 months: 73%.

Patients will continue to be followed up long-term for survival. The trial had previously reached its primary endpoint of safety and tolerability, and no unexpected safety issues related to UV1 have been observed in this trial. Three-year of follow-up data on cohort 1+2 will be available in the second half of 2023.

The U.S. Food and Drug Administration (FDA) granted a dual Fast Track designation for UV1 in combination with checkpoint inhibitors in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as first-line treatment of patients with unresectable or metastatic melanoma in the phase II study INITIUM.

About Ultimovacs
Ultimovacs is an immunotherapy company developing immune-stimulatory vaccines to treat a broad range of cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human telomerase (hTERT), present in 85-90% 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 in five cancer indications enrolling more than 650 patients, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types, in combination with other immunotherapies, for patients with unmet needs. 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

Anne Worsøe, Head of Investor Relations
Email: ir@ultimovacs.com
Phone: +47 906 86 815

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 5 October, 2022 at 19:25 CET.