Ultimovacs Ends Patient Recruitment in Lung Cancer Trial

Ultimovacs Announces Changes to LUNGVAC Trial

Oslo: Ultimovacs ASA (OSE: ULTI), a biotechnology company focused on immunotherapeutic cancer vaccines, has made a significant decision regarding its LUNGVAC trial. After careful consideration and discussions with the involved investigators, the company has opted to discontinue patient recruitment for this clinical study.

The LUNGVAC Trial Overview

The LUNGVAC trial, an investigator-initiated and randomized Phase II study, was aimed at evaluating the effectiveness of the UV1 vaccine. This trial focused on patients with advanced non-small cell lung cancer (NSCLC) and was designed to assess UV1 in combination with either cemiplimab or pembrolizumab – both of which are checkpoint inhibitors used as first-line treatments. However, the trial has faced challenges in recruitment due to a variety of new treatment options that are now available to NSCLC patients.

Current Patient Enrollment Status

Despite the discontinuation of recruitment, the 31 patients already enrolled in the study since 2022 will continue to receive treatment and will be monitored accordingly. Ultimovacs anticipates releasing topline data from these patients in the first half of 2025, providing valuable insights into the vaccine’s effectiveness when used alongside established therapies.

CEO's Insights and Future Directions

Carlos de Sousa, the CEO of Ultimovacs, expressed appreciation for the efforts of the study investigators and the commitment of the patients involved. He underscored the need to adapt to changing standards of care in NSCLC, which influenced the decision to halt recruitment. Moving forward, the company will focus on analyzing the data collected to enhance its understanding of UV1's performance in combating this form of cancer.

Ongoing Research and Developments

While the LUNGVAC trial stands paused in terms of new patient recruitment, Ultimovacs remains dedicated to advancing its other research initiatives. The company is currently evaluating UV1 in the Phase II DOVACC trial, which is examining the combination of olaparib and durvalumab, with or without UV1, as a second-line treatment for high-grade BRCA negative ovarian cancer. This ongoing work aims to generate topline results in the near future.

Innovation in Cancer Treatments

Beyond LUNGVAC, Ultimovacs is also investigating a pioneering drug conjugation platform designed to broaden its therapeutic capabilities. This unique technology is intended to support the development of new drug conjugates that can address various types of cancers and enhance the pharmacological properties of treatments. An update on this promising technology is anticipated before the year concludes.

The Role of UV1 in Cancer Therapy

UV1 is a universal cancer vaccine tailored to trigger T cell responses against the enzyme telomerase, which is prevalent in most cancer cells. By employing synthetic peptides, UV1 seeks to initiate an immune response that could potentially lead to improved patient outcomes across various cancer types. Unlike some therapeutic approaches, UV1 treats a wide patient demographic without necessitating prior HLA screening, making it more accessible.

About Ultimovacs

Ultimovacs is a forward-thinking biotechnology company immersed in the development of innovative immunotherapies targeting cancer. Its investigational product, UV1, is designed to extend the benefits of immunotherapy with the goal of enhancing treatment responses for cancer patients. Presently, Ultimovacs is conducting extensive clinical trials with over 750 participants across multiple cancer indications, primarily within the U.S., Europe, and Australia.

For inquiries, Ultimovacs can be contacted through:

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

Frequently Asked Questions

What triggered the discontinuation of recruitment for the LUNGVAC trial?

The discontinuation is primarily due to slow patient recruitment resulting from new treatment options available for NSCLC patients.

What are the next steps after patient recruitment has stopped?

Patients already enrolled will continue treatment, and data analysis on their results will proceed, with topline data expected in 2025.

What is Ultimovacs currently investigating besides the LUNGVAC trial?

Ultimovacs is actively conducting the DOVACC trial focusing on ovarian cancer and developing a novel drug conjugation platform for future therapies.

How does UV1 work as a cancer vaccine?

UV1 targets telomerase, prompting the immune system to elicit a T cell response against cancer cells, enhancing treatment efficacy.

What is the scope of Ultimovacs' clinical trials?

Ultimovacs has a comprehensive clinical development program with trials spanning melanoma, mesothelioma, head and neck cancer, ovarian cancer, and NSCLC.

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