First Cancer Patients Receive mRNA Therapy in Clinical Trial

Imperial College Healthcare NHS Trust has enrolled the first United Kingdom (UK) patients who have received an experimental messenger RNA (mRNA) therapy — a type of immunotherapy treatment called mRNA-4359 — in its Phase I/II clinical trial. The trial aims to evaluate its safety and potential for treating melanoma, lung cancer and other solid tumor cancers. The treatment is designed using mRNA and works by presenting common markers of tumors to the patients’ immune systems. The goal is to help train patients’ immune systems to recognize and fight cancer cells expressing these markers, but also to potentially eliminate cells that may suppress the immune response.

Patients in the trial will receive either mRNA-4359 alone, or mRNA-4359 and pembrolizumab (Keytruda), and will be followed up for a period of up to 34 months. Preclinical testing in both cell and animal models of cancer provided initial evidence that mRNA-4359 had an effect on the immune system, providing a rationale for it to be offered in early-phase clinical trials. The study is a non-randomized trial, so all patients receive the same treatment. It is also an open-label trial, so clinicians and patients know what they are receiving — unlike blinded trials in which patients don’t know which treatment they are receiving. 

The trial is sponsored by pharmaceutical company Moderna and is set to recruit patients globally over the next three years. It is being undertaken through the Moderna-UK Strategic Partnership, which is bringing mRNA vaccine manufacturing to the UK and building resilience to future health emergencies. Under the 10-year partnership with the government, Moderna has also committed substantial investment to research and development, which includes running a large number of clinical trials such as this one in the UK.