First UK patient receives innovative lung cancer vaccine

A lung cancer patient at UCLH is the first to receive a novel cancer vaccine designed to prime the immune system to recognise and fight cancer cells.

It is the first time this immunotherapy made by BioNTech, the German biotechnology company, will be studied in a clinical trial for lung cancer in the UK, where the NIHR UCLH Clinical Research Facility is the lead research site.

The investigational mRNA cancer immunotherapy for non-small cell lung cancer (NSCLC) – known as BNT116 – utilises a messenger RNA (mRNA) to present common tumour markers from NSCLC to the patient’s immune system, with the aim of helping the immune system recognise and fight cancer cells expressing these markers.

The investigational vaccine is designed to specifically enhance immune responses against targets primarily expressed by cancer cells, reducing the risk of toxicity to healthy, non-cancerous cells – unlike chemotherapy, which often affects both cancerous and healthy cells.

UCLH consultant medical oncologist Siow Ming Lee, who leads the national study said: “Lung cancer remains the leading cause of cancer deaths worldwide, with an estimated 1.8 million deaths in 2020.

“We are now entering this very exciting new era of mRNA-based immunotherapy clinical trials to investigate the treatment of lung cancer, thanks to the foundation laid by the Office for Life Sciences, within the Department for Science, Innovation and Technology and the Department for Health and Social Care.

“We hope this will provide an opportunity to further improve outcomes for our NSCLC patients, whether in the early or advanced stages,” said Prof Lee, who is also Professor of Medical Oncology at UCL. Prof Lee’s research is supported by the National Institute for Health and Care Research (NIHR) Biomedical Research Centre at UCLH.

The primary objective of this study is to determine if BNT116 is safe and well tolerated. The trial will be enrolling patients at different stages of NSCLC, from early-stage NSCLC before surgery or radiotherapy (Stage 2 and 3) to late-stage disease (Stage 4) or recurrent cancer.

The trial aims to establish the safety profile and a safe dose of BNT116 monotherapy, as well as of BNT116 in combination with established treatments for NSCLC to see if BNT116 has a synergistic anti-tumour effect when given with these established chemotherapy or immunotherapy treatments.

Approximately 130 participants will be enrolled in the study across 34 research sites in seven countries, with six UK sites selected.

UCLH consultant medical oncologist Dr Sarah Benafif is leading the delivery of the study at UCLH.

Dr Benafif said: “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.”

Janusz Racz, 67, from London, is the first participant in the trial. He said: “… Dr Sarah (Benafif) explained how the vaccine should work and how it was different to the treatment I had recently completed. The hope was that it would stop the cancer coming back.

“I thought it over, and … decided to take part because I hope it will provide a defence against cancer cells. But I also thought that my participation in this research could help other people in future and help this therapy become more widely available.

“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.”

Professor Karl Peggs, UCLH Director of Research and Director of the NIHR UCLH Biomedical Research Centre, said: “Developing new approaches to treating cancer is a major priority for research at UCLH and within the BRC, and it’s exciting to see this first-in-human research get started at UCLH.

“We are able to do this kind of research thanks to our first-rate clinicians and research teams, our track record of working alongside industry, and our facilities and infrastructure which receive crucial support from the NIHR.”

Science Minister Lord Vallance said: “It is good to see this vaccine taking its next important step. This approach has the potential to save the lives of thousands diagnosed with lung cancer every year.

"With Government support, these trials demonstrate again that the UK’s world-leading life sciences sector is at the forefront of turning research into new treatments like cancer vaccines, which could be transformative for patients up and down the country. We back our researchers so that they continue to be an integral part of projects that produce groundbreaking therapies, like this one.”

NHS England national cancer director Dame Cally Palmer said: “The NHS has a leading role globally in trialling cancer vaccines and if we are successful, they could be revolutionary in vaccinating people against their own cancers to prevent the cancer recurring after their initial treatment. 

“Pioneering work is being undertaken by hospitals throughout the country with their university and industry partners to look at ways of harnessing the body’s own immune system to treat a range of cancers. 

“A cancer diagnosis is very worrying, but access to groundbreaking trials – alongside other innovations to diagnose and treat cancers earlier – provides hope. We expect to see thousands more patients taking part in trials over the next few years.”