Ultimovacs Completes Patient Recruitment in INITIUM Phase II Trial of UV1 in Malignant Melanoma

  • Full recruitment of 154 patients with malignant melanoma in U.S. and Europe in 24 months
  • Study provides randomized data on impact of UV1 on standard-of-care immunotherapy
  • Topline progression-free survival data expected H1 2023

Oslo, 30 June 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announces the completed recruitment of 154 patients in the INITIUM trial. INITIUM is Ultimovacs’ Phase II clinical trial of its universal cancer vaccine UV1 in combination with the checkpoint inhibitors ipilimumab and nivolumab in metastatic malignant melanoma. Consistent with INITIUM’s event-driven design, topline progression-free survival results will be disclosed after progression of cancer or death has been observed in a total of 70 patients.

“It is a remarkable achievement that Ultimovacs and its clinical partners have completed recruitment to INITIUM largely on schedule despite challenges caused by the pandemic,” said Carlos de Sousa, Chief Executive Officer of Ultimovacs. “INITIUM has been designed as a robust comparative study to demonstrate that UV1 substantially enhances outcomes for patients over and above those that can be achieved with checkpoint inhibitors alone. The results will provide a rational basis for the design and implementation of future pivotal clinical studies, together with the positive data that we have seen from our Phase I studies in malignant melanoma.”

INITIUM is an Ultimovacs-sponsored randomized Phase II trial for first-line treatment of patients with advanced or metastatic malignant melanoma. Half of the 154 patients recruited to the trial 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. All five of Ultimovacs’ current Phase II trials have a similar comparative design, in each case to demonstrate in a statistically robust manner the effectiveness of UV1 as an add-on to standard-of-care treatment in a particular cancer type.

“We are grateful for the continuing work of our international group of collaborators supporting the execution of the INITIUM trial, and for their dedication in improving the treatment of cancer patients,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “The topline progression-free survival data in INITIUM will be an important primary readout. Following this readout, we will continue to monitor other efficacy endpoints such as tumor response, duration of response and overall survival.”

In June 2022, Ultimovacs reported positive data from a Phase I trial in malignant melanoma with a treatment that combines UV1 with the PD-1 checkpoint inhibitor, pembrolizumab. Across 30 patients, the 24-month overall survival rate was 73% with an objective response rate of 57% (partial or complete disappearance of tumors) including a complete response rate of 33%.

About UV1 in malignant melanoma
Ultimovacs has a long-standing commitment to the development of UV1-based treatments for melanoma. Malignant melanoma is a form of skin cancer where there is a large and unmet medical need for improved treatments. More than 130,000 new cases of melanoma are diagnosed worldwide every year and an estimated 50,000 people die from metastatic melanoma every year.

INITIUM is Ultimovacs’ most advanced clinical study in malignant melanoma, an Ultimovacs-sponsored randomized, comparative Phase II study involving 154 patients treated with UV1 plus ipilimumab and nivolumab. In addition, Ultimovacs has completed two Phase I studies: UV1 in combination with ipilimumab involving 12 patients in Norway, and UV1 in combination with pembrolizumab involving 30 patients in the U.S. Based partially on data from those early trials, UV1 has Fast Track designation from the U.S. FDA for UV1 as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab in the treatment of unresectable or metastatic melanoma. UV1 has Orphan Drug designation from the U.S. FDA in the treatment of malignant melanoma.

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 92 507

Anne Worsøe, Head of IR & Communication
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86 815

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 30 June 2022 at 08:00 CET.

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