Ultimovacs Announces Publication in Clinical Cancer Research of the UV1-103 Phase I Malignant Melanoma Trial Results

• Results from the UV1-103 trial published in Clinical Cancer Research highlight the promising efficacy and safety of UV1 and pembrolizumab in malignant melanoma
• Biomarker analyses demonstrate strong clinical efficacy also in patients considered less likely to respond to monotherapy checkpoint inhibition, supporting UV1's potential as a valuable combination therapy

Oslo, 28 June 2023 -- Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announced today the publication of clinical and biomarker analyses of the UV1-103 Phase I trial in Clinical Cancer Research, a renowned peer-reviewed journal of the American Association for Cancer Research. The Clinical Cancer Research article further expands upon the clinical data presented by Dr. Yousef Zakharia at the 19^th International Congress of the Society for Melanoma Research (SMR) in October 2022.

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 or 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 checkpoint inhibitors, underscoring the need for more effective treatment options.

The article in Clinical Cancer Research outlines results showing that UV1 in combination with pembrolizumab has a good safety profile and encouraging signs of efficacy, in particular, extended overall survival and complete responses in 33% of the patients. Biomarker data demonstrated equally strong responses to the combination in PD-L1 negative tumors, which are typically less amenable to monotherapy checkpoint inhibition. A drastic decrease in telomerase reverse transcriptase (TERT) was observed in responding tumors, indicating eradication of tumor cells expressing the antigen that UV1 is targeting.

"We are proud that the article on the clinical activity of UV1 in the UV1-103 study has been published in the distinguished journal Clinical Cancer Research. The article reinforces previously reported positive results, showing that UV1 in combination with pembrolizumab was safe and well-tolerated and displays signals of encouraging efficacy in malignant melanoma. Biomarker analyses further demonstrate UV1’s potential to extend immunotherapy efficacy to patients considered less responsive to standard checkpoint inhibitors. This suggests a potential for UV1 to improve clinical outcomes also in tumor types that are more difficult to treat with current treatment options,” said Jens Bjørheim, Chief Medical Officer at Ultimovacs. "Ultimovacs is building a substantial body of evidence on UV1 across cancer types in an extensive program of five randomized Phase II trials, including malignant melanoma, and we look forward to further learning its potential to improve treatment outcomes for this patient population with the read-out of the randomized Phase II trial, INITIUM, where data is expected later this year.”

For the full article in Clinical Cancer Research, click here.

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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 a vaccine adjuvant.  The 20 patients in the first cohort received a 37.5 mcg GM-CSF adjuvant dose per UV1 vaccination. The ten 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 nine deaths, four happened during the first year, four 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.

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 an 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: +47 906 86815

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 28 June 2023 at 16:30 CET.