Cancer vaccination: where do we stand?

Over the past two years, significant progress has been made in cancer treatment with RNA-based vaccines. Some researchers see this as the beginning of a new era in oncology.

RNA-based cancer vaccines: When will the first approvals be granted?

• To date, RNA-based cancer vaccines have demonstrated their potential in more than 120 clinical trials for various malignant tumours.
• The most promising applications include lung, breast and prostate cancer, melanoma and difficult-to-treat cancers such as pancreatic and brain tumours. 
• More than 60 drug candidates are currently in clinical development. 
• Marketing authorisation applications are expected to be submitted in 2026, and the first commercial mRNA cancer vaccines could be approved by 2029.

Progress in RNA vaccination against cancer can be seen on several levels. It concerns:

• The formulation of active ingredients and the manufacturing process
• The integration of artificial intelligence (AI)
• Manufacturing, storage and availability
• The regulatory framework

Nanovaccines and AI enable personalised therapy

The combination of traditional vaccine technology with state-of-the-art nanoscience is considered a groundbreaking development: technically manufactured nanovaccines with multi-layered lipid nanoparticles make it possible to package a large number of mRNA molecules in order to stimulate the immune system quickly and sustainably. In addition, they can be controlled in a tissue-specific manner and achieve better tumour penetration, which can reduce systemic toxicity.

The integration of artificial intelligence further improves the precision of neoantigen selection and immune response optimisation. AI-driven platforms can identify suitable tumour-specific targets while predicting immunogenicity, potential immune escape mechanisms and individual vaccine responses. This allows treatment to be increasingly tailored to individual patients.

To improve availability and enable global access to cancer vaccines, research is also currently being conducted into thermostable formulations. One possibility is alternative RNA formats such as circular RNA, which show improved stability at standard refrigerator temperatures. This would allow vaccines to reach resource-poor regions without the need for complex cooling systems.

Rapid integration of cancer vaccines into clinical practice

Another goal of the researchers and all stakeholders involved is to move quickly. To accelerate the production of personalised vaccines, automated platforms are being used that reduce production times from nine weeks to less than four weeks. However, technology and science alone are not enough to bring progress into clinical practice in a timely manner. A regulatory framework is also needed to speed up the approval process.

The FDA (Food and Drug Administration) has launched a programme called ‘Breakthrough Therapy’ to bring drugs for serious or life-threatening diseases to market more quickly when preliminary clinical data indicate a significant improvement over existing therapies. At European level, this corresponds to the PRIME (PRIority MEdicines) programme of the EMA (European Medicines Agency).

The still young field of RNA-based cancer vaccination could fundamentally change the therapeutic landscape of oncology in the coming years. The goal remains to provide the most precise, effective and, at the same time, low-side-effect treatment for each individual patient – perhaps even for previously incurable cancers.