Ultimovacs Announces New UV1 Data Showing Enhanced Efficacy Including in Hard-to-Treat Cancer Patients, Supporting Broad Utility

This information is subject to the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act

•  Biomarker data support strong clinical responses from UV1 in combination with pembrolizumab, also in patients considered less likely to respond to monotherapy checkpoint inhibition  
• Indicates a potential broader applicability of UV1 in combination with anti-PD-1 checkpoint inhibitors
• Safety profile of UV1 and pembrolizumab combination comparable to pembrolizumab monotherapy
  
  

Oslo, 18 October 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, presented clinical endpoints and biomarker results from patients in the UV1-103 phase I trial, at the 19^th International Conference of the Society for Melanoma Research (SMR), being held 17-20 October in Edinburgh, UK.

The UV1-103 study evaluates the Company's universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in 30 patients with advanced non-resectable and metastatic malignant melanoma. Pembrolizumab has transformed the melanoma treatment landscape and is a standard of care in this population. Despite this, a large proportion of the patient population remains underserved due to suboptimal responses to monotherapy.

Clinical analyses from the UV1-103 study indicate efficacy in patients with low levels of PD-L1, a key predictive biomarker associated with lower efficacy for pembrolizumab, and other anti-PD-1 therapies, in some tumor types. The analyses showed robust responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients’ PD-L1 status.

"The results from this phase I trial show that UV1 in combination with pembrolizumab has a good safety profile and encouraging signs of efficacy, particularly the 33% complete responses and the extended overall survival. The biomarker data provide a particularly important insight into the study population, showing that the combination treatment resulted in good clinical responses in patients considered less likely to respond to monotherapy checkpoint inhibition. This indicates a potential broad applicability for UV1 as a combination therapy to anti-PD1 checkpoint inhibitors in the real-world setting,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs.

As previously reported, the objective response rate in the study was 57% with complete response rate of 33%. Median progression free survival was 18.9 months. Overall survival was 87% after 1 year and 73% after 2 years. For the 20 patients in cohort 1, the overall survival after 3 years was 71%, as reported earlier this month. The good safety profile of UV1 in combination with pembrolizumab has previously been reported.

In addition to the sub-analysis of the PD-L1 status, the study also evaluated four other key prognostic biomarkers, including baseline tumor mutational burden (TMB), predicted neoantigens, interferon gamma (IFN-gamma) gene signature, and levels of tumor infiltrating lymphocytes. Objective responses were observed in patients with low TMB, in patients with low neoantigen tumors, and in patients with tumors which were not enriched for IFN-gamma. These patients have tumors which previous clinical data have shown would be less responsive to treatment with pembrolizumab monotherapy in various cancer types. Lastly, the study also showed that clinical responders did not have higher levels of tumor infiltrating lymphocytes prior to treatment.

The analyses of each of these five biomarkers signal efficacy in patients treated with UV1 in combination with pembrolizumab, regardless of tumor phenotype. These results are supportive of the addition of UV1 to checkpoint inhibitors, with the potential for improving both efficacy in current target patient populations and extending the use of immunotherapy to broader patient populations in multiple cancer types, underserved by existing therapies.

Carlos de Sousa, CEO of Ultimovacs added: "We are excited about the clinical data generated on UV1 so far, with indications of efficacy also in hard-to-treat cancer patients with low levels of PD-L1. The biomarker data strengthen the rationale of UV1 as backbone therapy in combination with checkpoint inhibitors. These results provide a solid foundation for Ultimovacs’ extensive program of five randomized phase II trials of UV1 in different cancer indications, including malignant melanoma. We look forward to further progressing these studies and generating more data on the ability of our vaccine to induce long-lasting, survival-associated immune responses.”

Please visit the Company website for access to the full presentation held by Dr. Yousef Zakharia at SMR at 10:00 CET today, entitled ‘Clinical Activity of Combined Telomerase Vaccination and Pembrolizumab in Unresectable Melanoma’.

==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 mcg GM-CSF adjuvant dose per UV1 vaccination. The 10 patients in the second cohort received the standard 75 mcg 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%. Overall survival after 36 months (first cohort): 71%

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.

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 IR & Communication
Email: anne.worsoe@ultimovacs.com
Phone: +47 90686815

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 18 October, 2022 at 08:00 CET.