First Lung Cancer Vaccine Trial for BioNTech's BNT116 Launched Across 7 Countries

The first human trial of BNT116, an mRNA-based lung cancer vaccine, has started, and the first patient received the treatment at UCLH. Developed by BioNTech, the vaccine targets non-small cell lung cancer (NSCLC) by enhancing the immune response to cancer cells. Spanning seven countries, the global trial aims to evaluate the safety and efficacy of the vaccine alongside traditional cancer treatments.

The UK has initiated the first human trial of an innovative mRNA-based lung cancer vaccine, BioNTech's BNT116, designed to enhance the body's ability to recognize and attack NSCLC cells. Spearheaded by the University College London Hospitals NHS Foundation Trust (UCLH), this trial marks a significant shift towards targeted cancer therapies that aim to spare healthy tissues while combating cancer cells.

The vaccine, developed by German biotechnology firm BioNTech, uses the same mRNA technology that proved successful in COVID-19 vaccines. It introduces specific tumor markers to the immune system, priming it to target and destroy cells that exhibit these markers, offering a new hope in the fight against the most common form of lung cancer.

Janusz Racz, a 67-year-old Londoner, became the first participant to receive this treatment at UCLH. Following a recent round of chemotherapy and radiotherapy, Racz began his vaccine regimen, which consists of six weekly sessions followed by additional doses every three weeks over a year.

The Phase 1 clinical trial, operational across 34 sites in seven countries—including the UK, US, Germany, Hungary, Poland, Spain, and Turkey—aims to enroll around 130 patients. These participants range from those in early-stage NSCLC, who have not yet undergone surgery or radiotherapy, to those with late-stage or recurrent forms of the disease.

This trial not only seeks to establish the safety and optimal dosage of BNT116 but also its potential synergistic effects when used alongside existing cancer treatments like cemiplimab and chemotherapy. By combining BNT116 with these treatments, researchers hope to enhance the immune response against tumor cells, potentially preventing the cancer from returning—a common challenge in NSCLC management.

Professor Siow Ming Lee, a leading consultant medical oncologist at UCLH and the national study leader, expressed optimism about this groundbreaking trial. He stated, “We are now entering this very exciting new era of mRNA-based immunotherapy clinical trials to investigate the treatment of lung cancer. We hope this will provide an opportunity to further improve outcomes for our NSCLC patients, whether in the early or advanced stages.”

Furthermore, the trial extends beyond treatment to also focus on prevention, aiming to establish BNT116 as part of a neo-adjuvant therapy in resectable NSCLC. This approach involves administering BNT116 and cemiplimab prior to surgery, followed by adjuvant therapy to minimize the risk of recurrence post-surgery.

“The UK's role in this global initiative is pivotal, as noted by NHS England's national cancer director, Dame Cally Palmer, who highlighted the NHS's leadership in cancer vaccine trials and expressed,  “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.”

BioNTech has signed a special agreement with the UK Government for BNT116 to provide up to 10,000 patients with precision cancer immunotherapies by 2030. This trial not only represents a leap forward in cancer treatment but also brings a wave of hope to thousands of patients, potentially setting a new standard in the treatment of lung cancer globally.