BioNTech doses first patient in Phase 1 pancreatic cancer mRNA vaccine trial
100% citation coverage2 peer-reviewed sources
BioNTech and Genentech have dosed the first patient in the Phase 1 pancreatic cancer mRNA vaccine trial of autogene cevumeran. Earlier Nature data showed immune responses in 8 of 16 patients and established the study as the first mRNA vaccine trial in pancreatic cancer.
Intelligence Snapshot
Executive Summary
BioNTech and Genentech are the joint developers of autogene cevumeran for pancreatic cancer.
Key Insights
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The Phase 1 trial opened in November 2019 as the first mRNA vaccine study in pancreatic…
The Phase 1 trial opened in November 2019 as the first mRNA vaccine study in pancreatic cancer, enrolling 16 patients.
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Eight of 16 patients showed an immune response measured by activated T cells up to three…
Eight of 16 patients showed an immune response measured by activated T cells up to three years after treatment, establishing durable immunogenicity in early-stage testing.
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A Phase 2 trial is currently recruiting patients with resected pancreatic ductal…
A Phase 2 trial is currently recruiting patients with resected pancreatic ductal adenocarcinoma , combining autogene cevumeran with atezolizumab and mFOLFIRINOX.
Market Impact
| Regulatory | medium |
|---|---|
| Commercial | medium |
| Competitive | high |
| Investment | medium |
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Quick Answer
BioNTech and Genentech are the joint developers of autogene cevumeran for pancreatic cancer.
Key Questions
- Is the mRNA vaccine for pancreatic cancer BioNTech?
- What is autogene cevumeran?
- What did the Phase 1 pancreatic cancer mRNA vaccine clinical trial show?
- What is the next step for autogene cevumeran in pancreatic cancer?
- When will the mRNA cancer vaccine be available?
Executive Scorecard
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Contents10 sections
BioNTech doses first patient in Phase 1 pancreatic cancer mRNA vaccine trial
BioNTech and Genentech are the joint developers of autogene cevumeran, an mRNA pancreatic cancer vaccine. A Phase 1 trial opened in November 2019 and enrolled 16 patients, with 8 showing immune responses measured by activated T cells up to three years post-administration, establishing the program as the first mRNA vaccine clinical trial in pancreatic cancer.
IntelligenceRegulatory Impact
FDA and EMA decisions frame this story. Regulatory relevance is medium for pancreatic cancer, with autogene cevumeran most exposed. Track designations, submission types, and label or guidance shifts that could move timelines.
Key Takeaways
- BioNTech and Genentech are the joint developers of autogene cevumeran for pancreatic cancer.
- The Phase 1 trial opened in November 2019 as the first mRNA vaccine study in pancreatic cancer, enrolling 16 patients.
- Eight of 16 patients showed an immune response measured by activated T cells up to three years after treatment, establishing durable immunogenicity in early-stage testing.
- A Phase 2 trial is currently recruiting patients with resected pancreatic ductal adenocarcinoma, combining autogene cevumeran with atezolizumab and mFOLFIRINOX.
IntelligenceCompetitive Intelligence
Competitive pressure is high. BioNTech and Genentech reshape positioning, formulary leverage, and partnership options. Benchmark pipeline differentiation and regional market access assumptions against this development.
The development
Autogene cevumeran is an individualized neoantigen vaccine based on uridine mRNA–lipoplex nanoparticles. The joint BioNTech and Genentech program opened enrollment in November 2019 to evaluate the candidate in pancreatic cancer, marking the first clinical application of mRNA neoantigen technology in this indication.
The Phase 1 cohort enrolled 16 patients with resected pancreatic cancer. Published data from the trial demonstrate that 8 of 16 patients mounted an immune response measured by activated T cells persisting up to three years post-administration. The durability of T-cell response observed in this early-stage cohort supports continued development of the mRNA neoantigen approach in pancreatic cancer, though larger Phase 2 testing is required to establish clinical benefit.
IntelligenceMarket Signals
Commercial pull is medium and investment relevance medium for pancreatic cancer. Expect implications for pricing, access, and launch sequencing.
What the evidence confirms
mRNA-based neoantigen vaccines elicit cytotoxic T-cell responses against tumor-restricted antigens in pancreatic ductal adenocarcinoma, a mechanism aligned with the Phase 1 immunogenicity signals. The trial data have now been published in a peer-reviewed format, providing a foundation for the ongoing Phase 2 expansion and supporting the rationale for combination strategies with checkpoint inhibitors.
ClinicalTrials.gov lists an active Phase 2 trial (NCT05968326) evaluating autogene cevumeran plus atezolizumab and mFOLFIRINOX versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma. The program also includes a Phase 2 trial (NCT06534983) in muscle-invasive urothelial carcinoma combining autogene cevumeran with nivolumab, indicating expansion of the BioNTech pancreatic cancer vaccine candidate and related neoantigen programs beyond pancreatic indications.
IntelligenceStrategic Takeaways
BioNTech and Genentech are the joint developers of autogene cevumeran for pancreatic cancer. The Phase 1 trial opened in November 2019 as the first mRNA vaccine study in pancreatic cancer, enrolling 16 patients. Eight of 16 patients showed an immune response measured by activated T cells up to three years after treatment, establishing durable immunogenicity in early-stage testing.
What to watch
The Phase 2 pancreatic cancer trial represents the critical next step for autogene cevumeran, as it will evaluate whether the immune responses observed in the Phase 1 cohort translate to clinical benefit in a larger, more diverse patient population. Enrollment progress and interim efficacy or safety signals from this study will be key catalysts for the program. Additionally, the expansion of autogene cevumeran into other solid tumors and combinations with established checkpoint inhibitors may inform the broader mRNA cancer vaccine clinical trial landscape and competitive positioning of personalized neoantigen approaches in oncology.
IntelligenceEvidence Quality
Grounded in 2 peer-reviewed sources.
Trial Snapshot
| Trial | Title | Status | Phase | Sponsor |
|---|---|---|---|---|
| NCT03289962 | A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors | COMPLETED | PHASE1 | Genentech, Inc. |
| NCT05968326 | A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC | RECRUITING | PHASE2 | Genentech, Inc. |
| NCT06534983 | A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC) | RECRUITING | PHASE2 | Hoffmann-La Roche |
| NCT03815058 | A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. | COMPLETED | PHASE2 | Genentech, Inc. |
Competitor Matrix
| Company / Program | Indication | Active trials |
|---|---|---|
| National Cancer Institute (NCI) | pancreatic cancer | 2 |
| Perspective Therapeutics | pancreatic cancer | 1 |
| University of Florida | pancreatic cancer | 1 |
| Bayer | pancreatic cancer | 1 |
| University of Arizona | pancreatic cancer | 1 |
| Blueprint Medicines Corporation | pancreatic cancer | 1 |
Timeline
- Recruiting trial NCT05968326 (PHASE2)
- Recruiting trial NCT06534983 (PHASE2)
Frequently Asked Questions
Is the mRNA vaccine for pancreatic cancer BioNTech?
Yes. BioNTech and Genentech are the joint developers of autogene cevumeran, an individualized neoantigen vaccine for pancreatic cancer.
What is autogene cevumeran?
Autogene cevumeran is an individualized neoantigen vaccine based on uridine mRNA–lipoplex nanoparticles. The candidate is designed as a personalized therapeutic vaccine for cancer patients.
What did the Phase 1 pancreatic cancer mRNA vaccine clinical trial show?
In the Phase 1 trial of 16 patients, 8 showed an immune response measured by activated T cells up to three years post-administration. This demonstrates durable immunogenicity in early-stage pancreatic cancer testing.
What is the next step for autogene cevumeran in pancreatic cancer?
A Phase 2 trial is currently recruiting participants with resected pancreatic ductal adenocarcinoma, combining autogene cevumeran with atezolizumab and mFOLFIRINOX. This trial will evaluate safety and efficacy in a larger patient population.
When will the mRNA cancer vaccine be available?
Autogene cevumeran is investigational and not yet approved by the FDA. The ongoing Phase 2 trial will determine whether the candidate advances toward potential regulatory submission in pancreatic cancer.
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- Sources analyzed
- 2
- Evidence strength
- 92/100
- Last verified
- Jun 7, 2026
- AI-assisted review
- Yes
- Editorial review
- Dr. Sarah Chen
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