A comprehensive review published in the June 2025 issue of Nature Biotechnology summarizes the current status of personalized mRNA cancer vaccine development. Neoantigen-based mRNA vaccines, tailored to individual patients’ tumor mutations, are emerging as a promising new approach in cancer immunotherapy.
Clinical Progress from Leading Developers
Moderna and Merck’s jointly developed mRNA-4157 demonstrated a 49% reduction in recurrence and death risk in melanoma patients in clinical trials (reported at ASCO 2023). This success has significantly accelerated commercial efforts in the personalized mRNA vaccine space.
Challenges in Neoantigen Selection and Role of AI
The key challenge lies in selecting appropriate neoantigens. While prediction for MHC class I-presented antigens has improved, predicting MHC class II epitopes remains difficult. Multiple companies are adopting AI-driven algorithms to improve neoantigen selection accuracy.
Major Players and Active Programs
- Moderna/Merck
- BioNTech
- Genentech
- Transgene + NEC (with Japan’s NEC contributing AI analysis)
- CureVac
- Nouscom
- NeoCura (China)
Expanding into Solid Tumors
Beyond melanoma, clinical development is expanding into colorectal, pancreatic, renal, head and neck, and other solid tumors.
Manufacturing and Regulatory Considerations
The complexity of individualized production raises challenges for regulatory pathways, prompting discussions around hybrid frameworks combining drug and device oversight.
Source: Nature Biotechnology (June 2025), Article Link
【My Thoughts】
Personalized mRNA cancer vaccines hold great promise in transforming cancer immunotherapy. However, key challenges remain across manufacturing scalability, neoantigen selection precision, and cost-effectiveness. Ongoing advancements in AI, regulatory frameworks, and commercial models will be critical for realizing their full potential. I will continue following these developments in this series.
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