Europe Advances RNA Immunotherapy Infrastructure

• Clinical trials, regulatory clarity, and industry consolidation signal a new phase for RNA-based cancer treatments across the continent.

RNA immunotherapy in Europe is entering a more mature phase, marked by expanded clinical activity, strategic industry deals, and evolving regulatory frameworks. Over the past 18 months, the region has seen its first in vivo cell-reprogramming trials, the launch of national pipelines for personalised mRNA cancer vaccines, and a major acquisition that consolidates RNA expertise within Europe. These developments reflect a coordinated effort to build the necessary clinical, industrial, and regulatory foundations for RNA therapies to become mainstream. The shift suggests growing confidence in RNA’s potential to reshape cancer treatment pathways.

Clinical Trials: From In Vivo CAR to Personalised Vaccines

Germany recently approved the continent’s first in vivo CAR gene therapy trial, led by Interius BioTherapeutics under its Phase 1 program INT2104. This milestone indicates that European regulators are prepared to assess next-generation approaches that generate CAR-T and NK cells directly within patients. Meanwhile, the UK has launched the Cancer Vaccine Launch Pad (CVLP), a national initiative matching patients to personalised mRNA vaccine trials for various cancers. BioNTech’s BNT116 lung cancer program is already active across multiple UK sites, with related studies underway in Germany, Spain, Poland, and Hungary.

The UK’s partnership with BioNTech includes a long-term R&D investment of up to £1 billion, linking clinical trials to domestic manufacturing and employment. These efforts aim to accelerate access to tailored immunotherapies while strengthening national infrastructure. As more European countries join these programs, the continent is positioning itself as a hub for RNA-based oncology innovation. Regulatory support and patient recruitment pipelines are key to sustaining this momentum.

Industry Consolidation and Regulatory Support

In June, BioNTech announced a $1.25 billion all-stock acquisition of CureVac, merging two of Europe’s leading RNA-focused companies. The deal enhances Germany’s capacity for mRNA design, delivery, and GMP manufacturing, supporting larger and faster oncology programs. Regulatory clarity has also improved, with the European Medicines Agency (EMA) implementing new guidelines for investigational advanced therapy medicinal products (ATMPs) in 2025. These guidelines outline expectations for RNA-delivered immunotherapies and in vivo gene-editing, helping sponsors navigate multi-country trials more efficiently.

The EU’s Health Emergency Preparedness and Response Authority (HERA) is maintaining flexible manufacturing capacity through EU-FAB, ensuring readiness for both vaccine and oncology applications. This infrastructure can be repurposed as RNA pipelines evolve, providing a stable foundation for future scale-up. Together, these measures form the “boring but vital” backbone that enables clinical and commercial progress. The combination of industrial depth and regulatory alignment is essential for sustaining innovation.

Emerging Trends and What to Watch

Although not RNA-based, recent peri-operative immunotherapy trials highlight a shift toward earlier intervention in cancer care. AstraZeneca’s durvalumab has shown promising results in Phase III studies, including MATTERHORN and NIAGARA, which support regulatory filings and approvals in both the U.S. and EU. This trend aligns with RNA vaccine strategies aimed at preventing relapse shortly after surgery. Growing acceptance of immunotherapy in curative-intent settings may ease the path for RNA-based approaches.

CREATE Medicines, formerly Myeloid Therapeutics, exemplifies the convergence of RNA delivery and in vivo cell programming. Its platform targets multi-lineage control and has treated over 40 patients in Phase 1 trials, informing programs for HER2, TROP2, and GPC3. A retrotransposon-based in vivo CAR-T for B-cell depletion is also in development, adding to the diversity of RNA applications. These innovations suggest that RNA immunotherapy is expanding beyond single-cell targets.

Near-Term Signals in Europe

Key developments to monitor include early readouts from UK-based personalised mRNA vaccine trials and related studies across the EU. Additional entrants in in vivo programming are expected to seek trial clearance, especially those combining RNA payloads with novel lipid nanoparticles or gene-integration technologies. The impact of the BioNTech–CureVac merger on GMP capacity and trial timelines will be closely watched. Finally, EMA’s guideline implementation across Member States will shape how national regulators assess comparability for personalised vaccines.