OnCo
drugsProductPhase 2

Autogene cevumeran

BioNTech's personalised vaccine, notable for a small pancreatic cancer study where vaccine responders stayed cancer-free for years.

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.

Schematic of the modality · Personalised mRNA neoantigen vaccine · not a molecule; see the Personalised neoantigen (mRNA) vaccines page
How it works, step by step · animated schematic, not to scale
Personalised neoantigen (mRNA) vaccines
Mechanism, step by step
auto-advancing · hover to pause

1.Up to 20 neoantigens are selected from the resected tumour's mutations

Modality
Personalised mRNA neoantigen vaccine
Mechanism
Up to 20 neoantigens in uridine mRNA-lipoplex, intravenous, with atezolizumab.
Brand / code
BNT122, RO7198457
Dosing & schedule
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: clinicaltrials.gov/study/NCT05968326. Doses are for orientation; the current label governs.

Safety

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Toxicity profile
Adverse event
Pyrexia
Chills
Fatigue
Infusion-related reactions

Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesInvestigational (phase 2 IMCODE003)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
3 studies0 recruiting3 Phase 2
Search “Autogene cevumeran” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Autogene cevumeran
intervention: Autogene cevumeran
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Literature trend6 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Autogene cevumeran" OR ABSTRACT:"Autogene cevumeran" OR TITLE:"BNT122" OR ABSTRACT:"BNT122" OR TITLE:"RO7198457" OR ABSTRACT:"RO7198457") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Autogene cevumeran, not a curated reading list.

Connected

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