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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.
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.
Up to 20 neoantigens in uridine mRNA-lipoplex, intravenous, with atezolizumab.
1.Up to 20 neoantigens are selected from the resected tumour's mutations
Source: clinicaltrials.gov/study/NCT05968326. Doses are for orientation; the current label governs.
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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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Investigational (phase 2 IMCODE003) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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The strongest human evidence that a cancer vaccine can make durable T cells in a tumour with few mutations; the randomised phase 2 IMCODE003 (260 patients, primary completion listed for January 2031) is the test of whether that translates into fewer relapses.
Pancreatic cancer was thought to be immunologically inert because of its low mutation burden; this study showed that with the right vaccine platform its few neoantigens can still be targeted. It is the strongest human evidence so far that personalised cancer vaccines can generate durable, tumour-specific immunity, and it justifies the randomised trials now running in pancreatic cancer and melanoma. Benefit is not yet proven, because responders may simply have had more immunogenic tumours.
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.
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