Ultimovacs Announces Positive Three-Year Results of 71%

• Malignant melanoma sufferers handled with immunotherapy mixture UV1 and pembrolizumab in part I medical trial
• Consistently excessive total survival (OS) price: 71% at three-year follow-up of sufferers in first cohort
• UV1 and pembrolizumab mixture continues to show robust alerts of medical efficacy, together with extended affected person survival

Oslo, 5 October 2022: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a medical stage chief in immune stimulatory vaccines for most cancers, introduced persevering with optimistic efficacy knowledge in its ongoing U.S.-based part I medical trial, UV1-103. The research evaluates the Company’s common most cancers vaccine, UV1, together with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line therapy in superior non-resectable and metastatic malignant melanoma sufferers.

“Given the historic trajectory for patients with metastatic malignant melanoma, this three-year 71% OS rate is very positive,” mentioned 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 research ended at two years comply with up, the protocol was amended to comply with sufferers for total survival for as much as 5 years. Three of the sufferers, all in cohort 1, didn’t consent to additional comply with up, altering the quantity of taking part sufferers in cohort 1 from 20 to 17 after two years. In addition, one affected person died throughout the previous yr.

At the three years deadline for sufferers within the first cohort the three-year total survival (OS) price was 71% (12/17). The trial has proven a constantly excessive OS price; on this affected person cohort it was 85% (17/20) after one yr and 80% (16/20) after two years follow-up. Having already reached its main endpoint of security and tolerability, the UV1-pembrolizumab mixture continues to show robust alerts of medical efficacy in each response charges and prolonged survival.

Pembrolizumab is a normal of take care of sufferers with unresectable or metastatic melanoma, based mostly on knowledge from the KEYNOTE-006 trial*. Follow up of first-line sufferers with metastatic melanoma in that trial confirmed an total survival price 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,” mentioned 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/complete):
12 months: 85% (17/20)
24 months: 80% (16/20)
36 months: 71% (12/17) 3 sufferers declined follow-up submit 24 months, 1 affected person died

Further knowledge from the UV1-103 research will probably be introduced on the International Congress of the Society for Melanoma Research, October 18, 2022.

*For reference solely; not a head-to-head comparability
**Robert C, Ribas A, Schachter J, et al. Pembrolizumab versus ipilimumab in superior melanoma (KEYNOTE-006): post-hoc 5-year outcomes from an open-label, multicentre, randomized, managed, part 3 research. Lancet Oncol. 2019;20(9):1239-1251. Doi:10.1016/S1470-2045(19)30388-2. Supplementary desk S6: Overall survival in sufferers receiving first-line therapy – mixed pembrolizumab arms: 36-month price (%).

==ENDS==

About the UV1-103 part I trial in Malignant Melanoma

This US-based Phase I medical trial is evaluating the Company’s lead candidate, UV1, together with the anti-PD-1 checkpoint inhibitor, pembrolizumab, as a first-line therapy in sufferers with metastatic malignant melanoma. The trial is evaluating the protection, tolerability, and preliminary indicators of medical response. The 20 sufferers within the first cohort acquired a 37.5 µg GM-CSF adjuvant dose per UV1 vaccination. The 10 sufferers within the second cohort acquired the usual 75 µg GM-CSF adjuvant dose per UV1 vaccination. The research has accomplished the enrollment of 30 sufferers, as introduced on August 18, 2020. All included sufferers acquired the medicine as first line therapy for superior and metastatic melanoma.

Compiled medical outcomes for the 30 sufferers enrolled are:

• Objective response price (ORR): 57%. Complete response price (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 proceed to be adopted up long-term for survival. The trial had beforehand reached its main endpoint of security and tolerability, and no surprising issues of safety associated to UV1 have been noticed on this trial. Three-year of follow-up knowledge on cohort 1+2 will probably be accessible within the second half of 2023.

The U.S. Food and Drug Administration (FDA) granted a twin Fast Track designation for UV1 together with checkpoint inhibitors within the therapy of unresectable or metastatic melanoma – both as add-on remedy to pembrolizumab or as add-on remedy to ipilimumab. Ultimovacs is at the moment evaluating UV1 as add-on remedy to ipilimumab and nivolumab as first-line therapy of sufferers with unresectable or metastatic melanoma within the part II research INITIUM.

About Ultimovacs
Ultimovacs is an immunotherapy firm growing immune-stimulatory vaccines to deal with a broad vary of cancers. Ultimovacs’ lead common most cancers vaccine candidate UV1 targets human telomerase (hTERT), current in 85-90% of cancers in all levels of tumor progress. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and improve anti-tumor responses. With a broad Phase II program in 5 most cancers indications enrolling greater than 650 sufferers, Ultimovacs goals to clinically show UV1’s impression in a number of most cancers sorts, together with different immunotherapies, for sufferers with unmet wants. Ultimovacs’ second expertise strategy, based mostly on the proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant in the identical molecule and entered Phase I research in 2021.

For additional info, please see www.ultimovacs.com or contact:

Carlos de Sousa, CEO
Email: [email protected]
Phone: +47 908 92507

Anne Worsøe, Head of Investor Relations
Email: [email protected]
Phone: +47 906 86 815

Mary-Ann Chang, LifeSci Advisors
Email: [email protected]
Phone: +44 7483 284 853

This info is taken into account to be inside info pursuant to the EU Market Abuse Regulation and is topic to the disclosure necessities pursuant to Section 5-12 within the Norwegian Securities Trading Act.
This inventory alternate announcement was revealed by Joachim Midttun, Finance Manager at Ultimovacs ASA, on 5 October, 2022 at 19:25 CET.