The UK’s drug regulatory authority has launched a public consultation process to design a new regulatory guidance for personalised mRNA cancer immunotherapies.
The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback from industry stakeholders, healthcare professionals, and patients, to refine the regulatory pathway for these therapies until 31 March 2025.
Personalised cancer immunotherapies are designed to train a patient’s immune system to recognise and destroy cancer cells based on their own unique genetic profile. Unlike conventional treatments, each therapy is tailored using technologies like artificial intelligence (AI) to match the specific molecular characteristics of a patient’s tumour. The MHRA’s executive director of healthcare quality and access Julian Beach highlighted that because these treatments are tailored to an individual’s tumour, they pose unique scientific questions on how they should be regulated.
The guidance will outline key regulatory considerations, including product design, manufacturing requirements, clinical trial evidence, and post-approval safety monitoring for personalised mRNA cancer vaccines. The UK regulatory agency said that future updates may extend the guidance to other personalised therapies, including treatments for rare diseases.
June Raine, MHRA’s CEO said: “As an enabling regulator, we do not wish to keep patients waiting unnecessarily for important new medicines such as personalised immunotherapies. We are asking all stakeholders to comment on draft guidance that addresses the questions this new regulatory pathway raises.”
The UK government has been making broader efforts to advance mRNA-based cancer treatments. In January 2023, the UK government signed a memorandum of understanding (MoU) with the mRNA therapeutics leader BioNTech to accelerate clinical trials of cancer vaccines in England. Oxford University Hospitals NHS Foundation Trust (OUH) began a clinical trial in 2023 of an mRNA vaccine manufactured by BioNTech to treat patients with head and neck cancer. Through the Cancer Vaccine Launch Pad, a collaboration between NHS England and Genomics England, the UK aims to deliver 10,000 personalised cancer vaccine treatments by 2030.
Across the pond, the US Food and Drug Administration (FDA) regulates mRNA vaccines as biologic products. Sponsors must submit an investigational drug application (IND) through the FDA’s Center for Biologics Evaluation and Research (CBER) before initiating any human clinical trials. If the trials demonstrate safety and efficacy, sponsors can seek approval to market the mRNA-based product through the CBER biological licence application (BLA) process.
In the European Union (EU), there are currently no regulatory guidelines specifically addressing mRNA-based vaccines. However, the existing regulatory framework clearly defines that mRNA-based vaccines, in most cases, must be centrally approved by the European Medicines Agency (EMA).
On a global scale, new initiatives are ongoing at the World Health Organization (WHO) to establish a broad consensus on international guidance for the manufacture, quality control, and nonclinical and clinical evaluation of mRNA vaccines worldwide.
