Lung Cancer Vaccine Clinical Trial Launches in London

For the first time, messenger RNA (mRNA) immunotherapy will be studied in a phase 1 clinical trial for lung cancer in the UK, where the University College London Hospitals (UCLH) Clinical Research Facility is the lead research site.

As of August 23, 2024, a lung cancer patient at UCLH became the first person to receive a novel cancer vaccine candidate designed to prime the immune system to recognize and fight cancer cells.

Made by BioNTech SE, the investigational mRNA cancer immunotherapy/vaccine for non-small cell lung cancer (NSCLC) known as BNT116 is designed to enhance immune responses against targets primarily expressed by cancer cells.

This process reduces 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 in a press release, “Lung cancer remains the leading cause of cancer deaths worldwide, with an estimated 1.8 million deaths in 2020."

“We are now entering this exciting new era of mRNA-based immunotherapy clinical trials to investigate lung cancer treatment, 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.

The trial will enroll patients at different stages of NSCLC, from early-stage NSCLC before surgery or radiotherapy (Stages 2 and 3) to late-stage disease (Stage 4) or recurrent cancer.

The trial aims to establish the safety profile and safe dose of BNT116 monotherapy combined with established NSCLC treatments to see if it has a synergistic anti-tumor 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. Patients interested in participating in the trial should be directed to their GP or oncologist in the first instance, and their doctor can refer them to the study's trial centers to assess suitability.

BNT116 is also being evaluated in a Phase 2 trial as a first-line treatment for patients with metastatic NSCLC in combination with cemiplimab, a PD-1 inhibitor, and cemiplimab alone.