# Autogene cevumeran

Source: https://onco.cc/drugs/autogene-cevumeran/  
OnCo record `autogene-cevumeran` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Autogene cevumeran is BioNTech and Genentech's personalised mRNA vaccine encoding each patient's own tumour neoantigens. In a small phase 1 in resected pancreatic cancer, half of patients mounted T-cell responses and stayed free of recurrence far longer; phase 2 IMCODE003 tests whether that holds.

## Summary

Phase 1 (Rojas/Balachandran, Nature 2023; 3-year follow-up 2025): half of resected PDAC patients mounted T-cell responses and had markedly longer recurrence-free survival than non-responders. Phase 2 IMCODE003 in adjuvant PDAC and trials in colorectal (ctDNA+ after surgery) and melanoma. BioNTech/Genentech.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-09-04
- Code: BNT122, RO7198457
- Modality: Personalised mRNA neoantigen vaccine
- Mechanism: Up to 20 neoantigens in uridine mRNA-lipoplex, intravenous, with atezolizumab.
- Dosing: Intravenous infusion (lipoplex); Priming: 8 weekly doses; boosters at 6-week intervals; with atezolizumab and mFOLFIRINOX in adjuvant PDAC

## Notes

- Pancreatic cancer: the phase 1 (16 vaccinated patients) induced T cells in 8, with recurrence-free survival not reached in responders against 13.4 months in non-responders at 3.2 years and vaccine-induced clones estimated to live 7.7 years (Nature 2023 and 2025); IMCODE003 (NCT05968326, 260 patients, disease-free survival, eight UK sites) is active but closed to recruitment.

## Sources

- ClinicalTrials.gov: trials of Autogene cevumeran: https://clinicaltrials.gov/search?intr=BNT122
- Sethna et al., Nature 2025: https://doi.org/10.1038/s41586-024-08508-4

## Connected records

- cancers: [Borderline resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/borderline-resectable-pdac/), [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Melanoma](https://onco.cc/cancers/melanoma/), [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/)
- technologies: [mRNA and lipid nanoparticle manufacturing](https://onco.cc/technologies/mrna-lnp-manufacturing/), [Personalised neoantigen (mRNA) vaccines](https://onco.cc/technologies/neoantigen-mrna-vaccine/)
- companies: [BioNTech](https://onco.cc/companies/biontech/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- trials: [A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC](https://onco.cc/trials/nct05968326/), [Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering)](https://onco.cc/trials/autogene-cevumeran-phase-1/)
- key papers: [RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer](https://onco.cc/key-papers/paper-sethna-rna-neoantigen-vaccine-long-lived-t-cells-nature-2025/), [Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer](https://onco.cc/key-papers/paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023/)
- roadmaps: [Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question](https://onco.cc/roadmaps/pancreatic-roadmap/)
- pairings: [Personalised neoantigen vaccine + PD-1 blockade](https://onco.cc/pairings/vaccine-plus-pd1/)
- ideas: [Off-the-shelf KRAS vaccines after pancreatic cancer surgery](https://onco.cc/ideas/idea-shared-kras-vaccine-adjuvant/), [Personalised cancer vaccines at commodity cost through fully automated manufacturing](https://onco.cc/ideas/idea-moon-neoantigen-vaccines-at-scale/), [Personalised vaccines given only when the blood test turns positive](https://onco.cc/ideas/idea-bio2-mrd-triggered-neoantigen-vaccine/), [What makes a neoantigen actually immunogenic?](https://onco.cc/ideas/idea-neoantigen-immunogenicity-rules/)
- people: [Uğur Şahin](https://onco.cc/people/ugur-sahin/), [Vinod P. Balachandran](https://onco.cc/people/vinod-balachandran/)
- bottlenecks: [Cold tumours and the immunosuppressive microenvironment](https://onco.cc/bottlenecks/b-tme-immunosuppression/)
- institutions: [University Cancer Center Mainz (UCT Mainz) / Universitätsmedizin Mainz](https://onco.cc/institutions/uct-mainz/)

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