mRNA Groups Press Ahead in Cancer Push

Personalised oncology programmes advance as regulators engage and payers scrutinise costs

19 Feb 2026

Messenger RNA technology, once associated mainly with Covid-19 vaccines, is moving into a new phase as drugmakers invest heavily in personalised cancer treatments.

Moderna and Merck are among the most advanced. Their tailored mRNA vaccine, developed for patients with melanoma, is designed to train the immune system to target mutations specific to an individual’s tumour. In a mid-stage trial, the combination of Moderna’s vaccine and Merck’s immunotherapy Keytruda reduced the risk of recurrence or death compared with Keytruda alone. The results have strengthened confidence that personalised cancer vaccines could become commercially viable.

BioNTech is pursuing a similar strategy. Its candidate, autogene cevumeran, has shown early signs of immune activation and delayed recurrence in pancreatic cancer when used alongside checkpoint inhibitors and chemotherapy. The programme reflects the German group’s broader shift from pandemic-related revenues towards long-term oncology development based on customised immunotherapies.

Regulators are adapting to the scientific shift. The US Food and Drug Administration has granted breakthrough therapy and fast-track status to several personalised cancer vaccine programmes. Such designations are intended to speed up development and review in areas of high unmet need, while allowing closer dialogue between companies and regulators. They can shorten approval timelines but still require robust evidence of benefit.

Significant hurdles remain. Personalised therapies depend on rapid genetic sequencing, bespoke manufacturing and complex logistics tailored to each patient. Expanding that model beyond small trials will test production capacity and supply chains, particularly if demand increases.

Cost is also likely to shape the market. Insurers and public payers are showing greater interest in reimbursement models tied to patient outcomes. For mRNA developers, demonstrating durable survival benefits will be central to securing broad coverage and defending premium prices.

Investors increasingly view the move into oncology as a structural shift rather than a temporary response to falling vaccine sales. Whether mRNA platforms can deliver consistent clinical gains at scale will determine how far and how quickly personalised cancer vaccines enter routine care.