Ultimovacs Announces First Patient Randomized in Phase II LUNGVAC Trial of UV1 in Non-Small Cell Lung Cancer (NSCLC)

• Fifth phase II trial assessing the impact of UV1 in various immunotherapy combinations
• Enrollment of 138 patients at approximately all lung cancer centers in Norway
• Non-small cell lung cancer is one of the largest cancer indications globally

Oslo, October 25 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced today that the first patient has been randomized in the LUNGVAC study. The study in non-small cell lung cancer (NSCLC) is the fifth Phase II clinical trial in which the universal cancer vaccine, UV1, is being investigated in combination with checkpoint inhibitors.

The LUNGVAC study is designed to assess the impact of UV1 in combination with standard-of-care immunotherapy, the anti-PD1 checkpoint inhibitor pembrolizumab. Topline data read-out from LUNGVAC is anticipated by the end of 2024. The guiding will be reviewed in the Company’s Q4 2022 reporting.

“LUNGVAC addresses one of the world’s largest cancer indications, and we have designed the trial to test if UV1 in combination with pembrolizumab can improve the treatment of patients with unmet needs,” said Jens Bjørheim, Chief Medical Officer of Ultimovacs. “LUNGVAC’s focus within Norway provides efficient access to the country’s well-organized lung cancer networks as well as a single national portal for clinical trial registration.”

Lung cancer is one of the most common cancers globally, and by far the biggest cause of cancer deaths in both men and women. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers. LUNGVAC will focus on a subset of NSCLC patients with adenocarcinoma or squamous tumors, where at least half of the tumor cells express the PD-L1 antigen, and who have not previously received pembrolizumab treatment. These subgroups represent approximately 1/3 of all advanced and metastatic NSCLC patients. The squamous form of NSCLC is particularly difficult to treat.

LUNGVAC is a multi-center, randomized, open-label trial assessing the safety and efficacy of UV1 in combination with pembrolizumab versus pembrolizumab alone in NSCLC patients with advanced or metastatic disease. The primary endpoint of the trial will be progression-free survival. Secondary endpoints will include overall survival, response rate, duration of response and safety. The principal investigator for LUNGVAC is Professor Odd Terje Brustugun, a leading oncologist in the Nordic region with active involvement in multiple international lung cancer clinical trials.

"Our motivation for starting clinical trials is to contribute to the further improvement in treatment options for patients with non-small cell lung cancer," added professor Odd Terje Brustugun the principal investigator of the study. "The evaluation of UV1 and pembrolizumab is an important next step in changing the standard of care for patients with non-small cell lung cancer. We look forward to working with Ultimovacs to reach our mutual goal."

About UV1 

UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. It is being developed as an “off-the-shelf” therapeutic cancer vaccine for use in combination with other immunotherapies that require an ongoing T cell response for their mode of action. In four Phase I trials involving 82 patients, UV1 has maintained a positive safety and tolerability profile and has demonstrated encouraging signals of efficacy. The U.S. FDA granted Fast Track designation to UV1 as add-on therapy to ipilimumab or to pembrolizumab for the treatment of unresectable or metastatic melanoma, as well as Orphan Drug designation to UV1 for the treatment of stage IIB – IV 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 or contact: 

Carlos de Sousa, CEO  

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Anne Worsøe, Head of IR

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Phone: +47 906 86 815

Mary-Ann Chang, LifeSci Advisors 

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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 25 October, 2022 at 08:00 CET.