A major milestone in this market was the approval of Sipuleucel-T (Provenge), which was approved by the US Food and Drug Administration in 2010 for the treatment of metastatic castration-resistant prostate cancer. It became the first personalized therapeutic cancer vaccine ever to be developed and approved. Global Regulatory Milestones for Personalized Cancer Vaccines Country Approved Vaccine Developer Year of Approval Indication US Sipuleucel-T (Provenge) Dendreon 2010 Metastatic castration-resistant prostate cancer (mCRPC) Russia NeoOncovac Gamaleya National Research Centre for Epidemiology and Microbiology 2025 Skin Melanoma Oncorna FMBA's Center for Strategic Planning, the Lopukhin Federal Research, and Clinical Center for Physico-Chemical Medicine 2026 Colorectal Cancer The market for personalized cancer vaccines is at the clinical development stage, with only a limited number of regulatory milestones. Most clinical trials are in Phase I and II, reflecting the complexity of the design, production, and validation process. Personalized Cancer Vaccine Clinical Pipeline Company Development Candidate Mechanism of Action Development Phase Indication Moderna & Merck mRNA-4157 (V940) Personalized mRNA neoantigen vaccine encoding patient-specific tumor neoantigens; administered with PD-1 blockade Phase III High-risk melanoma BioNTech Autogene Cevumeran (BNT122/RO7198457) Individualized mRNA neoantigen vaccine designed from each patient's tumor mutanome Phase II Pancreatic ductal adenocarcinoma (PDAC), colorectal cancer, melanoma Transgene & NEC TG4050 Individualized viral vector vaccine expressing patient-specific neoantigens identified by AI (myvac platform) Phase I/II Head and neck squamous cell carcinoma; ovarian cancer Nouscom NOUS-PEV Personalized viral-vector prime/boost neoantigen vaccine inducing CD4+/CD8+ T-cell responses Phase I Melanoma, solid tumors Evaxion Biotech EVX-01 AI-designed personalized peptide neoantigen vaccine Phase II Metastatic melanoma (with checkpoint inhibitor) AIVITA Biomedical AV-GBM-1 Personalized dendritic cell vaccine loaded with autologous tumor-initiating cell antigens Phase II Newly diagnosed glioblastoma CureVac CVGBM (personalized mRNA program) Individualized mRNA neoantigen vaccine Phase I Glioblastoma and selected solid tumors The US dominates the personalized cancer vaccines landscape due to active clinical research in late-phase pipeline cancer vaccines leveraging the progress made in mRNA technology and precision immunotherapy. Europe is emerging as a key innovation hub, with biotech companies creating AI-based neoantigen and viral vector vaccines for solid tumors. Russia is also authorizing clinical application of a personalized cancer vaccine, reflecting growing global interest in individualized oncology solutions. Share this article