Ultimovacs Halts Patient Recruitment in LUNGVAC Trial for UV1 with Checkpoint Inhibitors in NSCLC

Ultimovacs ASA, a biotechnology company based in Oslo, announced on September 11, 2024, that it will discontinue patient recruitment for the LUNGVAC trial. This decision was reached in agreement with the investigators of the study, which is an investigator-initiated, randomized Phase II trial. LUNGVAC aims to evaluate the efficacy of UV1 in combination with checkpoint inhibitors cemiplimab or pembrolizumab as a first-line treatment for patients with inoperable advanced or metastatic non-small cell lung cancer (NSCLC).

The primary reason for halting recruitment is the slow pace of patient enrollment, attributed largely to the availability of new treatment options for NSCLC patients. Despite this, the 31 patients who have already been enrolled since the trial began in 2022 will continue to receive treatment and be monitored according to the study protocol. Topline data from these patients is anticipated in the first half of 2025.

Carlos de Sousa, the Chief Executive Officer of Ultimovacs, commented on the situation, noting the challenges faced in trial recruitment due to the evolving standard of care for NSCLC patients. He expressed gratitude to the investigators, clinical teams, and patients involved in the trial, and expressed eagerness to analyze the data next year.

In addition to the LUNGVAC trial, Ultimovacs is also engaged in other research efforts. One notable ongoing study is the Phase II DOVACC trial, which is investigating UV1 combined with olaparib and durvalumab as a second-line maintenance treatment for high-grade BRCA negative ovarian cancer. Patient screening and enrollment for this trial are ongoing, with topline results expected in the first half of 2025.

Ultimovacs is also conducting pre-clinical research on a novel drug conjugation platform aimed at exploring its potential in various therapeutic modalities across multiple disease areas. The company plans to update the market on this technology before the end of 2024.

The LUNGVAC trial specifically focuses on NSCLC patients with advanced or metastatic disease, where tumor biopsies exhibit a PD-L1 expression score of 50% or higher. These subgroups account for about 30% of all advanced and metastatic NSCLC cases. The trial has been overseen by Professor Odd Terje Brustugun and sponsored by Drammen Hospital under the Vestre Viken Hospital Trust in Norway.

UV1, the cancer vaccine under investigation, is designed to elicit a specific T cell response against telomerase. It comprises synthetic peptides that trigger CD4+ T cells, which in turn can provide critical inflammatory signals and support for a robust anti-tumor immune response. The vaccine is administered via intradermal injections over three months, alongside an immune-modulator, GM-CSF.

Ultimovacs, a clinical-stage biotechnology company, is dedicated to developing innovative cancer immunotherapies. Its lead product, UV1, is an off-the-shelf therapeutic cancer vaccine intended to enhance immunotherapy benefits and improve treatment efficacy. Ultimovacs is currently conducting a comprehensive Phase II clinical development program across various cancer indications, including melanoma, mesothelioma, head and neck cancer, ovarian cancer, and NSCLC. With more than 750 patients enrolled in trials across the U.S., Europe, and Australia, Ultimovacs continues to investigate the safety and effectiveness of UV1.

Furthermore, the company is advancing a novel conjugation technology designed to expand its vaccine pipeline and explore new therapeutic applications. Ultimovacs is listed on the Euronext Oslo Stock Exchange under the ticker ULTI.

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