A lung cancer patient at University College London Hospitals (UCLH) was the first to receive a novel mRNA-based vaccine designed to prime the immune system to fight cancer cells very specifically. The BioNTech immunotherapy (BNT116) is being studied in a worldwide lung cancer trial. The NIHR UCLH Clinical Research Facility is the lead research site.
UCLH consultant medical oncologist Siow Ming Lee, PhD, 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.” He added, “We are now entering this very exciting new era of mRNA-based immunotherapy clinical trials.”
The Phase I clinical trial of BNT116 has launched in 34 research sites in seven countries: the U.K., U.S., Germany, Hungary, Poland, Spain, and Turkey.
BNT116 uses messenger RNA (mRNA) to present common tumor markers from non-small cell lung cancer (NSCLC) to the patient’s immune system, with the aim of helping the immune system recognize and fight cancer cells expressing these markers. The vaccine enhances the immune responses against specific targets primarily expressed by cancer cells, reducing the risk of toxicity to healthy cells.
The primary objective of this study is to determine if BNT116 is safe and well-tolerated. The trial 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 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-tumor effect when given 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 cancers earlier—provides hope. We expect to see thousands more patients taking part in trials over the next few years,” said NHS England national cancer director Dame Cally Palmer.
Approximately 130 participants will be enrolled in the study across 34 research sites in seven countries, with six U.K. sites selected. Consultant medical oncologist Sarah Benafif, PhD, is leading the delivery of the study at UCLH.
Janusz Racz, 67, from London, is the first participant in the trial. He said: “… 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.”
“The NHS has a leading role globally in trialing 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,” said Palmer.
“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,” she added.
