BNT116: World’s 1st mRNA lung cancer vaccine begins human trials

The world’s first lung cancer vaccination trials have begun in the United Kingdom. 

Janusz Racz, a 67-year-old lung cancer patient, is the first to receive this groundbreaking vaccine. He is part of a clinical trial that is taking place across multiple countries.

BioNTech, a German biotechnology firm, has developed this mRNA-based vaccine dubbed BNT116. The vaccine works by activating the immune system, which then recognizes and combats cancer cells.

“We are now entering this very exciting new era of mRNA-based immunotherapy clinical trials to investigate the treatment of lung cancer,” said Siow Ming Lee, consultant medical oncologist from University College London Hospitals (UCLH), who leads the national study. 

Lee added: “Lung cancer remains the leading cause of cancer deaths worldwide, with an estimated 1.8 million deaths in 2020.”

mRNA based-vaccine

This experimental cancer immunotherapy is designed for the treatment of non-small cell lung cancer (NSCLC). NSCLC is the most prevalent type of lung cancer.

It uses messenger RNA to expose the patient’s immune system to NSCLC-associated tumor markers. This allows the immune system to identify and attack cancer cells that carry these markers.

Over several weeks, the patients will receive numerous jabs, each with a unique RNA sequence. 

The experimental vaccine is specifically designed to boost immune responses against targets primarily found on cancer cells, thereby minimizing the risk of harm to healthy, non-cancerous cells. This differs from chemotherapy, which often damages both malignant and healthy cells.

“The strength of the approach we are taking is that the treatment is aimed at being highly targeted towards cancer cells. In this way we hope that in time we are able to show that the treatment is effective against lung cancer whilst leaving other tissues untouched,” said UCLH consultant medical oncologist Dr Sarah Benafif.

This initial trial will establish the safety and tolerability of BNT116. The trial will enroll patients with NSCLC at various stages, from early-stage before surgery or radiotherapy, to late-stage disease or recurrent cancer.

130 patients to take part

The study will enroll approximately 130 participants across 34 research sites in seven countries, six of which are in the United Kingdom. The other countries include the US, Germany, Hungary, Poland, Spain, and Turkey.

Racz, the trial’s first patient, received his diagnosis in May and began chemotherapy and radiation therapy immediately after.

On Tuesday, Racz received the initial dose of six consecutive injections at the National Institute for Health Research UCLH Clinical Research Facility. 

Reportedly, each injection was administered five minutes after the previous one, and the entire process took 30 minutes. Racz will receive the vaccine weekly for six consecutive weeks, followed by shots every three weeks for 54 weeks.

“As a scientist myself, I know that science can only advance if people agree to participate in programmes like this. I work in artificial intelligence, and I am open to trying new things. My family did research about the trial too, and they supported me taking part,” Racz said in the press statement.