Europe’s RNA Immunotherapy Enters a New Phase: Trials Scale Up, Deals Consolidate, and Regulators Move

Europe Builds Momentum in RNA-Based Immunotherapy Amid Major Deals and Breakthrough Trials

• Europe’s RNA immunotherapy sector is gaining speed with new in vivo CAR-T and mRNA vaccine trials.
• Germany approved the region’s first in vivo CAR-T study, marking regulatory progress.
• The UK’s Cancer Vaccine Launch Pad advances personalised mRNA cancer vaccine trials with BioNTech.
• BioNTech’s $1.25 billion CureVac deal strengthens Europe’s mRNA oncology capabilities.
• EMA guidance and EU-FAB capacity boost Europe’s RNA therapy infrastructure.
• AstraZeneca’s Imfinzi trials show immunotherapy’s move into earlier treatment stages.
• CREATE Medicines’ shift to multi-lineage RNA programming reflects this broader momentum.

(NEWS) BRUSSELS / LONDON / BERLIN, 8-Oct-2025 — /EuropaWire/ —Across Europe, RNA-driven immunotherapy is transitioning from promise to practice. In the past 12–18 months, we’ve seen first-in-region in vivo cell-reprogramming trials open, national infrastructures stand up fast-track pipelines for personalised mRNA cancer vaccines, and a marquee all-stock deal that concentrates know-how and manufacturing depth inside Europe. Together, these moves point to a continent building the clinical, industrial, and regulatory scaffolding needed to take RNA immunotherapy mainstream.

Clinical momentum: from first in vivo CAR to national vaccine “launch pads”

First in vivo CAR trial on EU soil (Germany). Interius BioTherapeutics’ Phase 1 program (INT2104) secured German regulatory clearance, marking the first in vivo CAR gene therapy trial in Europe—a signal that EU regulators are ready to evaluate next-gen, body-as-bioreactor approaches that generate CAR-T/NK cells inside patients.

UK builds the pipeline for personalised mRNA cancer vaccines. NHS England’s Cancer Vaccine Launch Pad (CVLP) is actively matching patients to personalised mRNA vaccine trials (e.g., head & neck, bowel, skin) and has already enabled sites dosing for BioNTech’s BNT116 lung-cancer program across multiple UK centres; additional European sites (Germany, Spain, Poland, Hungary) are participating via related studies. The UK and BioNTech also expanded their R&D partnership with up to £1bn investment over the next decade, tying trials to domestic capacity and jobs. 

Consolidation & scale: BioNTech–CureVac redraws Europe’s RNA oncology map

In June, BioNTech agreed to acquire CureVac in a ~$1.25bn all-stock deal, anchoring more mRNA oncology design, delivery, and GMP capacity in Germany and consolidating two of Europe’s most experienced RNA shops. This is the year’s defining European RNA-oncology transaction—and it directly supports larger, faster oncology programs on the continent.

Regulation & manufacturing: Europe builds the “boring but vital” backbone

EMA guidance for cutting-edge therapies. The EMA’s guideline covering quality, non-clinical and clinical requirements for investigational ATMPs came into effect in 2025, clarifying expectations for novel modalities—including RNA-delivered immunotherapies and in vivo gene-editing approaches. That clarity shortens iteration loops for sponsors and CROs operating across multiple Member States.

HERA & EU-FAB keep capacity warm. The EU’s Health Emergency Preparedness and Response Authority (HERA) is maintaining ever-warm manufacturing capacity for mRNA and other countermeasures through EU-FAB and related mechanisms—dry powder that can be repurposed from vaccines to oncology use cases as pipelines mature. 

Why peri-operative immunotherapy matters for RNA’s runway

While not RNA-based, the peri-operative immunotherapy trend is crucial context: it signals regulator and clinician comfort with moving immunotherapy earlier in the care pathway—precisely where many RNA cancer vaccines aim to prevent relapse. Three announcements made on EuropaWire capture that shift around AstraZeneca’s durvalumab:

MATTERHORN Phase III shows event-free survival gains in resectable gastric/GEJ cancers, supporting filings globally. The FDA Priority Review for Imfinzi in gastric/GEJ peri-operative use underscores the momentum into curative-intent settings. NIAGARA Phase III in muscle-invasive bladder cancer delivered risk reductions that led to Priority Review (and subsequent US approval), with EU reviews also underway—a bellwether for European uptake. 

CREATE Medicines and where it fits (as one part of the trend)

CREATE Medicines (ex-Myeloid Therapeutics) illustrates the convergence of RNA delivery and in vivo cell programming now edging toward multi-lineage control (T cells, myeloid, NK). Its platform aims for redosable, off-the-shelf RNA-based in vivo CARs, and the company reports >40 patients treated across Phase 1 studies with manageable safety, informing HER2/TROP2/GPC3 programs and a retrotransposon-based in vivo CAR-T for B-cell depletion. 

What to watch next in Europe (near-term signals)

1. Personalised mRNA vaccine readouts from UK-anchored programs (BNT116 cohorts; additional CVLP-backed trials) and broader EU sites—early durability and minimal-residual-disease endpoints will be closely scrutinised.
2. Further in vivo programming entrants (beyond Interius) seeking EU trial clearances—especially those pairing RNA payloads with new LNPs or gene-integration systems.
3. Integration effects of the BioNTech–CureVac deal on European GMP capacity, CMC timelines, and the speed of multi-centre oncology trials.
4. EMA implementation of the investigational ATMP guideline across Member States—and how national authorities interpret CMC comparability for personalised vaccines.