BioNTech mRNA Vaccine: The World's First Lung Cancer Vaccine Study Begins in 7 Countries

Lung cancer is the leading cause of cancer-related death worldwide, claiming approximately 1.8 million lives annually, with low survival in advanced stages. Scientists led by Uğur Şahin and Özlem Türeci are now working on a new vaccine that directs the body to find and destroy cancer cells and prevent recurrence. Called BNT116 and manufactured by BioNTech, it targets non-small cell lung cancer, the most common type.

How Does the mRNA Cancer Vaccine Work?

The vaccine uses an approach similar to the mRNA technology in COVID-19 vaccines.

By introducing the patient's immune system to tumor markers specific to non-small cell lung cancer cells, the mRNA cancer vaccine trains it to recognize and destroy cancer cells carrying those markers.

By strengthening the immune response against these cancer cells, the vaccine also aims to prevent recurrence.

Where Has the Phase 1 Study Begun, and Where Is It Running in Turkey?

BNT116's first human study , a phase 1 trial, has begun at 34 research centers in England, the United States, Germany, Hungary, Poland, Spain, and Turkey.

NOTE: A phase-1 human trial is the stage at which a treatment is first tested in humans. Its main aims are to determine safety and tolerable doses. A small patient group is generally used, with close monitoring of adverse effects and the body's response. 

The first vaccine was administered to a patient in England.

Approximately 130 patients, ranging from early-stage disease before surgery or radiotherapy to advanced or recurrent cancer, will receive this vaccine together with immunotherapy as part of the study.

Approximately 20 participants are planned to be enrolled in England and about 45 in Turkey.

LuCa-MERIT-1 is led in Turkey by SBÜ Ankara Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. It also runs at 11 different centers in Turkey, including major medical faculties and research hospitals such as Dokuz Eylül University, Koç University, Hacettepe University, İstanbul Faculty of Medicine, and Yıldırım Beyazıt University.

Promising Early Results and Future Plans

According to the BNT116 study design, whether the vaccine will become a main treatment in the future remains uncertain and depends on phase 1 results and subsequent studies.

The study aims to investigate BNT116 both as monotherapy and with treatments such as cemiplimab and docetaxel. It therefore focuses on evaluating effectiveness, particularly alongside existing immunotherapies and chemotherapy. Another aim is to determine the safety and adverse effects of these combinations.

What Happens After Phase 1? 

Phase 1, the initial stage of such research, generally focuses on safety and tolerability. If successful, phase 2 and phase 3 studies test effectiveness in larger patient groups, ultimately determining whether the vaccine can become standard treatment.

This research will continue with the expectation that adding the mRNA vaccine to immunotherapy could improve survival. Experts hope to move to phase 2 and phase 3 trials and eventually see the vaccine become a global standard, saving many patients with lung cancer.