Ultimovacs to Launch Phase II Combination Trial of UV1 in Lung Cancer (NSCLC)

• Fifth Phase II trial of UV1 in cancer, and largest disease category to date
  
• UV1 will be investigated in combination with the standard-of-care pembrolizumab
• Expected data read-out by end of 2024
  
  

Oslo, 26 October 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announced that the company’s universal cancer vaccine, UV1, will be investigated 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 H1 2022, with data read-out from the trial, LUNGVAC, anticipated by the end of 2024.

Lung cancer is currently one of the most common cancers globally, and by far the biggest cause of cancer deaths in both men and women. NSCLC accounts for approximately 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 around 7%.

"We see this new trial as a significant opportunity for Ultimovacs to make a difference to the lives of thousands of patients with advanced lung cancer.” said Carlos de Sousa, CEO of Ultimovacs. "Our extensive Phase II program is aimed at building a substantial evidence base that UV1 in combination with checkpoint inhibitors can stimulate the immune response resulting in enhanced treatment outcomes.”

The LUNGVAC trial will be 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 trial will treat patients with tumors classified within the adenomcarcinoma or squamous subgroups of NSCLC, 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 primary endpoint of the trial will be progression-free survival. Secondary end-points will include response rate and overall survival.

Professor Odd Terje Brustugun will be the principal investigator for the trial, which will be sponsored by Drammen Hospital, a leading oncology research center in Norway. The trial will enroll approximately 138 patients and will be conducted at 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 treatment landscape for lung cancer in advanced healthcare systems. The LUNGVAC trial will indicate whether the combination of UV1 with pembrolizumab can further improve the prospects for patients.”

UV1 is currently being investigated in four other Phase II trials in advanced malignant melanoma, ovarian cancer, head and neck squamous cell carcinoma and malignant pleural mesothelioma. In total, the five Phase II trials will enroll more than 650 patients at close to 100 hospitals in around 15 countries. The combination of UV1 and pembrolizumab was recently granted a Fast Track designation by the U.S. FDA in the treatment of advanced malignant melanoma.

*in the US, EU5, Japan, China

==ENDS==

About Ultimovacs
Ultimovacs is 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, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types in combination with other immunotherapies. 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 92507

Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

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 26 October, 2021 at 16:30 CET.