Ultimovacs provides updated guidance on timeline for readout of INITIUM Phase II clinical trial of UV1 in malignant melanoma

• It is taking longer than estimated for the patients in the INITIUM study to experience disease progression, which is positive for patients
• Results will be disclosed after cancer progression has been verified in 70 patients, which has not yet occurred
• Guidance for readout is consequently adjusted from the first half to the second half of 2023
• INITIUM completed enrollment of 156 patients in June 2022, and will provide comparative, randomized data on efficacy of UV1 treatment added to standard of care immunotherapy

Oslo, 25 April, 2023 -- Ultimovacs ASA (OSE: ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announced today that it has adjusted guidance from the first half of 2023 to the second half of 2023 for communication of topline progression free survival (PFS) data from the INITIUM Phase II trial in malignant melanoma patients.

"We are encouraged that disease progression in the INITIUM trial is slower than anticipated when compared with historical data. This is positive for patients, though we do not know if UV1-related efficacy is responsible for this extended time to expected readout since both Ultimovacs and the investigators remain blinded.  We look forward to learning to what degree UV1 may have contributed to the clinical outcome for patients,” said Carlos de Sousa, Chief Executive Officer of Ultimovacs.

INITIUM is an Ultimovacs-sponsored comparative, randomized Phase II trial for first-line treatment of patients with advanced or metastatic malignant melanoma. The first patient was enrolled in the trial in June 2020, and the study completed enrollment of 156 patients in June 2022. Half of the patients enrolled have been dosed with UV1 plus the PD-1 checkpoint inhibitor nivolumab and the CTLA-4 checkpoint inhibitor ipilimumab, while the other half received nivolumab and ipilimumab only.

According to INITIUM’s event-driven design, topline progression free survival results will be disclosed after progression of cancer or death has been verified in 70 patients. Based on published historical data for the combination of ipilimumab and nivolumab, progression was estimated to occur in 70 patients by the first half of 2023. The last update from the INITIUM trial shows that it is taking longer than anticipated to observe the required number of patients showing progression. With this shift in timeline, the topline results will not be announced before the second half of 2023.

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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 which 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 peptides and adjuvant in the same molecule and is in Phase I clinical development.

About UV1 Phase II clinical program

• INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as first line treatment for patients with malignant melanoma. Enrollment of 156 patients completed. Expected readout H2 2023. Sponsored by Ultimovacs.
• NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second line treatment for patients with malignant pleural mesothelioma. Enrollment of 118 patients completed. Expected readout H1 2023. Investigator-initiated study led by Oslo University Hospital, supported by Bristol-Myers Squibb and Ultimovacs.
• FOCUS: Evaluating UV1 in combination with pembrolizumab as first line treatment for patients with head and neck cancer. 67% of 75 patients recruited as of Q4 2022 reporting, expected readout H1 2024. Investigator-initiated study led by Halle University in Germany, supported by Ultimovacs.
• DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as maintenance therapy in BRCA- mutated patients with advanced ovarian cancer. <10% % of 184 patients recruited as of Q4 2022 reporting, expected readout H2 2024. Investigator-initiated study led by NSGO-CTU, supported by ENGOT, AstraZeneca and Ultimovacs.
• LUNGVAC: Evaluating UV1 in combination with cemiplimab as first line treatment of patients with non-small cell lung cancer. <10% % of 138 patients recruited as of Q4 2022 reporting, expected readout H2 2025. Investigator-initiated study led by Vestre Viken (Drammen Hospital), supported by Ultimovacs.

About UV1

UV1 is a universal cancer vaccine designed to induce a specific T cell response against human telomerase (hTERT). UV1 consists of long, synthetic peptides, representing a sequence in the reverse transcriptase subunit 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

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 Anne Worsøe, Head of IR at Ultimovacs ASA, on 25 April, 2023 at 07:00 CET.