{"entity":{"id":"autogene-cevumeran","kind":"drug","name":"Autogene cevumeran","aka":[],"tldr":"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.","status":"phase-2","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov: trials of Autogene cevumeran","url":"https://clinicaltrials.gov/search?intr=BNT122"},{"label":"Sethna et al., Nature 2025","url":"https://doi.org/10.1038/s41586-024-08508-4"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac","colorectal","melanoma"],"sections":[],"technologies":["neoantigen-mrna-vaccine"],"targets":[],"drugs":[],"companies":["biontech","roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05968326","autogene-cevumeran-phase-1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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."],"code":"BNT122, RO7198457","modality":"Personalised mRNA neoantigen vaccine","mechanism":"Up to 20 neoantigens in uridine mRNA-lipoplex, intravenous, with atezolizumab.","approvals":[],"mechanismSteps":["Up to 20 neoantigens are selected from the resected tumour's mutations","Uridine mRNA-lipoplex is infused intravenously and taken up by splenic dendritic cells","Neoantigen-specific CD8 T cells are induced (in ~half of patients)","Atezolizumab prevents PD-L1-mediated suppression","Responders show delayed recurrence; non-responders do not"],"dosing":{"route":"Intravenous infusion (lipoplex)","schedule":"Priming: 8 weekly doses; boosters at 6-week intervals; with atezolizumab and mFOLFIRINOX in adjuvant PDAC","monitoring":"Infusion reactions, cytokine-related fever","source":"https://clinicaltrials.gov/study/NCT05968326"},"toxicity":[{"event":"Pyrexia"},{"event":"Chills"},{"event":"Fatigue"},{"event":"Infusion-related reactions"}],"access":[{"country":"US","reimbursement":"Investigational (phase 2 IMCODE003)","asOf":"2026-09-06"}],"regulatoryEvents":[]},"route":"/drugs/autogene-cevumeran/","neighbours":{"cancer":[{"id":"borderline-resectable-pdac","kind":"cancer","name":"Borderline resectable pancreatic ductal adenocarcinoma","route":"/cancers/borderline-resectable-pdac/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"resectable-pdac","kind":"cancer","name":"Resectable pancreatic ductal adenocarcinoma","route":"/cancers/resectable-pdac/"}],"technology":[{"id":"mrna-lnp-manufacturing","kind":"technology","name":"mRNA and lipid nanoparticle manufacturing","route":"/technologies/mrna-lnp-manufacturing/"},{"id":"neoantigen-mrna-vaccine","kind":"technology","name":"Personalised neoantigen (mRNA) vaccines","route":"/technologies/neoantigen-mrna-vaccine/"}],"company":[{"id":"biontech","kind":"company","name":"BioNTech","route":"/companies/biontech/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"trial":[{"id":"nct05968326","kind":"trial","name":"A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC","route":"/trials/nct05968326/"},{"id":"autogene-cevumeran-phase-1","kind":"trial","name":"Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering)","route":"/trials/autogene-cevumeran-phase-1/"}],"paper":[{"id":"paper-sethna-rna-neoantigen-vaccine-long-lived-t-cells-nature-2025","kind":"paper","name":"RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer","route":"/key-papers/paper-sethna-rna-neoantigen-vaccine-long-lived-t-cells-nature-2025/"},{"id":"paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023","kind":"paper","name":"Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer","route":"/key-papers/paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023/"}],"roadmap":[{"id":"pancreatic-roadmap","kind":"roadmap","name":"Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question","route":"/roadmaps/pancreatic-roadmap/"}],"pairing":[{"id":"vaccine-plus-pd1","kind":"pairing","name":"Personalised neoantigen vaccine + PD-1 blockade","route":"/pairings/vaccine-plus-pd1/"}],"idea":[{"id":"idea-shared-kras-vaccine-adjuvant","kind":"idea","name":"Off-the-shelf KRAS vaccines after pancreatic cancer surgery","route":"/ideas/idea-shared-kras-vaccine-adjuvant/"},{"id":"idea-moon-neoantigen-vaccines-at-scale","kind":"idea","name":"Personalised cancer vaccines at commodity cost through fully automated manufacturing","route":"/ideas/idea-moon-neoantigen-vaccines-at-scale/"},{"id":"idea-bio2-mrd-triggered-neoantigen-vaccine","kind":"idea","name":"Personalised vaccines given only when the blood test turns positive","route":"/ideas/idea-bio2-mrd-triggered-neoantigen-vaccine/"},{"id":"idea-neoantigen-immunogenicity-rules","kind":"idea","name":"What makes a neoantigen actually immunogenic?","route":"/ideas/idea-neoantigen-immunogenicity-rules/"}],"person":[{"id":"ugur-sahin","kind":"person","name":"Uğur Şahin","route":"/people/ugur-sahin/"},{"id":"vinod-balachandran","kind":"person","name":"Vinod P. Balachandran","route":"/people/vinod-balachandran/"}],"bottleneck":[{"id":"b-tme-immunosuppression","kind":"bottleneck","name":"Cold tumours and the immunosuppressive microenvironment","route":"/bottlenecks/b-tme-immunosuppression/"}],"institution":[{"id":"uct-mainz","kind":"institution","name":"University Cancer Center Mainz (UCT Mainz) / Universitätsmedizin Mainz","route":"/institutions/uct-mainz/"}]}}