• Fifth phase II UV1 trial in cancer, and largest category of disease to date
  • UV1 will be studied in combination with the reference pembrolizumab
  • Data reading expected by the end of 2024

OSLO, Norway, October 26, 2021 (GLOBE NEWSWIRE) – Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical leader in immunostimulatory cancer vaccines, has announced that the company’s universal cancer vaccine, UV1, will be studied in a new phase II clinical trial in combination with pembrolizumab in non-small cell lung cancer (NSCLC). The first patient is expected to be treated in the first half of 2022, with data from the LUNGVAC trial expected to be read by the end of 2024.

Lung cancer is currently one of the most common cancers in the world and by far the leading cause of cancer death in both men and women. NSCLC accounts for about 85% of all lung cancers. An estimated 850,000 new cases * of NSCLC are diagnosed each year. Most of these cases are metastatic patients, for whom the 5-year survival rate is approximately 7%.

“We see this new trial as an important opportunity for Ultimovacs to make a difference in the lives of thousands of patients with advanced lung cancer,” said Carlos de Sousa, CEO of Ultimovacs. “Our large Phase II program aims to build a substantial evidence base that UV1 in combination with checkpoint inhibitors can stimulate the immune response, which improves treatment outcomes.”

The LUNGVAC trial will be a multicenter, randomized, open-label trial evaluating the safety and efficacy of UV1 in combination with pembrolizumab compared to pembrolizumab alone in patients with NSCLC with advanced or metastatic disease. The trial will treat patients with tumors classified in the adenomcarcinoma or squamous subgroups of NSCLC, where at least half of the tumor cells express the PD-L1 antigen and who have never received treatment. by pembrolizumab. These subgroups represent approximately 1/3 of all patients with advanced and metastatic NSCLC. The primary endpoint of the trial will be progression-free survival. Secondary endpoints will include response rate and overall survival.

Professor Odd Terje Brustugun will be the principal investigator of the trial, which will be sponsored by Drammen Hospital, a leading oncology research center in Norway. The trial will enroll around 138 patients and will be conducted in 8-10 clinical centers in Norway.

“NSCLC remains a major cause of premature death,” said Odd Terje Brustugun. “Checkpoint inhibitors like pembrolizumab have changed the landscape of lung cancer treatment in advanced health systems. The LUNGVAC trial will show whether combining UV1 with pembrolizumab can further improve the outlook for patients.

UV1 is currently being investigated in four additional Phase II trials in advanced malignant melanoma, ovarian cancer, squamous cell carcinoma of the head and neck, and malignant pleural mesothelioma. In total, the five phase II trials will recruit more than 650 patients in nearly 100 hospitals in around 15 countries. The combination of UV1 and pembrolizumab recently obtained a Fast Track designation by the US FDA for the treatment of advanced malignant melanoma.

* in the United States, in the EU5, in Japan, in China

About Ultimovacs
Ultimovacs is developing immunostimulatory vaccines to treat a wide range of cancers. Ultimovacs UV1’s leading universal cancer vaccine candidate targets human telomerase (hTERT), which is present in 85-90% of cancers at all stages of tumor growth. By directing the immune system to hTERT antigens, UV1 directs CD4 helper T cells to the tumor to activate a cascade of the immune system and increase anti-tumor responses. With an extensive phase II program, Ultimovacs aims to clinically demonstrate the impact of UV1 in several types of cancer in combination with other immunotherapies. Ultimovacs’ second technology approach, based on proprietary Epitope Targeting (TET) platform, combines tumor-specific peptides and adjuvant in the same molecule and entered Phase I studies in 2021 .

For more information, visit www.ultimovacs.com or contact:

Carlos de Sousa, CEO
Email: [email protected]
Telephone: +47 908 92507

Hans Vassgård Eid, Chief Financial Officer
Email: [email protected]
Telephone: +47 482 48632

Mary-Ann Chang, LifeSci Advisors
Email: [email protected]
Telephone: +44 7483 284 853

This information is considered inside information in accordance with the EU Market Abuse Regulation and is subject to disclosure requirements in accordance with Section 5-12 of the Norwegian Securities Act.

This stock market announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on October 26, 2021 at 4.30 p.m. CET.


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