Ultimovacs Provides 3-Year Update from Phase I Study in Malignant Melanoma: Results Confirm Strong Overall Survival in Patients Treated with UV1 Cancer Vaccine

• All patients in cohort 2 who were alive after 2 years remain alive after 3 years

Oslo, 19 June 2023: Ultimovacs ASA ("Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced encouraging overall survival (OS) data from the cohort 2 in the UV1-103 Phase I clinical trial in malignant melanoma. All patients in cohort 2 who were alive at the 2-year follow-up, remain alive at the 3-year follow-up.

The UV1-103 study evaluates Ultimovacs’ universal cancer vaccine, UV1, in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab, as first-line treatment in patients with advanced non-resectable or metastatic malignant melanoma. The study enrolled 30 patients in the U.S. in two cohorts that differed only in the concentration of GM-CSF used as vaccine adjuvant. 27 of these patients agreed to long-term monitoring after 2 years.

At 3-year follow-up across the two cohorts, 67% (18/27) of patients were still alive. 3-year overall survival in cohort 1 was 71% (12/17), including one patient death between years 2 and 3 as reported in October 2022. 3-year overall survival in cohort 2 was 60% (6/10).

Ultimovacs has previously reported data showing a complete response rate in the UV1-103 study of 33% (complete disappearance of tumors) and an objective response rate of 57% (complete or partial disappearance of tumors). Biomarker analyses reported in October 2022 showed robust clinical responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients’ PD-L1 status. The safety profile of UV1 in combination with pembrolizumab is comparable to that of pembrolizumab alone.

"We are very encouraged to observe a 67% overall survival rate at 3-year follow-up in this Phase I study, which treats the same patient population as our UV1 Phase II study, INITIUM. These data further strengthen the previously reported results from the study, including good safety for UV1 and remarkable 33% complete response rate in patients with metastatic malignant melanoma where surgery is not an option. The data continue to show that UV1 in combination with pembrolizumab has promising signs of efficacy,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. "We are looking forward to receiving more data from the UV1 clinical trials, to advance UV1 further to the benefit of cancer patients.”

Ultimovacs further investigates UV1 in malignant melanoma in its randomized Phase II INITIUM trial of UV1 in combination with ipilimumab and nivolumab. The trial completed enrollment of 156 patients with advanced non-resectable or metastatic malignant melanoma in July 2022. The top-line results will be disclosed after cancer progression has been verified in 70 patients, which was anticipated in the first half of 2023. As announced in April 2023, the readout is now expected in the second half of 2023. This is due to patients taking longer than estimated to experience cancer progression, which is very encouraging and positive for patients.

==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 unresectable metastatic malignant melanoma. The trial evaluates safety, tolerability, and initial signs of clinical response. Thirty patients in the U.S. were treated in the study in two cohorts that differed only in the concentration of GM-CSF used as vaccine adjuvant.  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 malignant 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 (OS) after 12 months: 87% (26/30). OS after 24 months: 73% (22/30). OS after 36 months: 67% (18/27). Out of the 9 deaths, 4 happened during the first year, 4 during the second year, and one during the third year across both cohorts.

Patients will continue to be followed up for long-term survival. Three patients in cohort 1 chose not to be followed up further after 24 months. 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.

As a historical reference (not head-to-head comparison since dosing and the patient population is different), the registration study Keynote-006 for pembrolizumab showed an overall survival rate of 51% at 36 months.

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 a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine candidate UV1 is directed against human telomerase (hTERT) an antigen that is present in 85-90% of cancers in all stages of tumor growth. A broad clinical program, with Phase II trials in five cancer indications enrolling more than 670 patients, aims to demonstrate UV1’s impact in combination with other immunotherapies in multiple cancer types expressing telomerase and where patients have unmet medical needs. UV1 is universal, off-the-shelf and easy to use, and is a patented technology owned by Ultimovacs.

In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-Epitope-Targeting (TET) technology, combines tumor-specific antigens and adjuvant in the same molecule and is in Phase I clinical development.

About UV1

UV1 is a universal cancer vaccine designed to induce a specific T cell response against telomerase. UV1 consists of long, synthetic peptides, representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T cells. These CD4+ T cells have the potential to provide inflammatory signals and T cell support believed to be critical for triggering a strong anti-tumor immune response. Following intradermal injection, antigen presenting cells (APCs) in the skin are exposed to the vaccine peptides. These APCs will process the peptides, and present vaccine epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T cells in the lymph nodes. Activated vaccine specific T cells will then enter the circulation and search for cells displaying their cognate antigen in the context of HLA molecules.

The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation. It is therefore not required to perform HLA pre-screening of patients, which potentially enables broad population utilization of the vaccine. UV1 is administered over three months as eight intradermal injections together with the immune-modulator GM-CSF.

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: anne.worsoe@ultimovacs.com
Phone: +47 90686815

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 Anne Worsøe, Head of IR at Ultimovacs ASA, on 19 June, 2023 at 07:00 am CET.