Global study on BioNTech’s mRNA-based lung cancer vaccine starts

A lung cancer patient at University College London Hospitals (UCLH) was the first to receive a novel mRNA-based vaccine that is designed to prepare the immune system to fight cancer cells in a very targeted manner. The BioNTech immunotherapy (BNT116) is being tested in a worldwide Lung cancer studyThe NIHR UCLH Clinical Research Facility is the leading research site.

Consultant medical oncologist Siow Ming Lee, PhD, who is leading the national study, said: “Lung cancer remains the leading cause of cancer death worldwide, with an estimated 1.8 million people expected to die from it in 2020.” He added: “We are now entering a very exciting new era of clinical trials of mRNA-based immunotherapy.”

The Phase I clinical trial of BNT116 has been initiated at 34 research sites in seven countries: the UK, the USA, Germany, Hungary, Poland, Spain and Turkey.

BNT116 uses messenger RNA (mRNA) to present common tumor markers of non-small cell lung cancer (NSCLC) to the patient's immune system. The goal is to help the immune system recognize and fight cancer cells that express these markers. The vaccine boosts the immune response against specific targets that are primarily expressed by cancer cells, reducing the risk of toxicity to healthy cells.

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

The aim of the study is to determine the safety profile and safe dosing of BNT116 as monotherapy and in combination with established treatments for NSCLC to find out whether BNT116 has a synergistic anti-tumor effect when administered together with these established chemotherapy or immunotherapy treatments.

“A cancer diagnosis is very worrying, but access to groundbreaking trials – alongside other innovations to diagnose and treat cancer earlier – offers hope. We expect thousands more patients to take part in trials over the next few years,” said NHS England's national cancer director, Dame Cally Palmer.

The study will involve approximately 130 participants at 34 research sites in seven countries, with six sites selected in the UK. CConsultant medical oncologist Sarah Benafif, PhD, is leading the study at UCLH.

Janusz Racz, 67, from London, is the first participant in the trial. He said: “… Sarah [Benafif] explained how the vaccine was supposed to work and how it was different from the treatment I had recently completed. I hoped it would prevent the cancer from coming back.”

“The NHS is playing a leading role in testing cancer vaccines worldwide. If we are successful, this could revolutionise the way people are vaccinated against their own cancer, preventing the cancer from returning after initial treatment,” said Palmer.

“Hospitals across the country, along with their universities and industry partners, are pioneering ways to harness the body's own immune system to treat a range of cancers,” she added.