Personalized Cancer Vaccine Platform VaxiGen Completes Phase III Trial: mRNA Vaccine Reduces Melanoma Recurrence by 67%

Personalized Cancer Vaccine Platform VaxiGen Completes Phase III Trial

On October 2, 2028, VaxiGen, a personalized cancer vaccine platform jointly developed by Germany's BioNTech and America's Moderna, published Phase III clinical trial results. In the randomized controlled trial for advanced melanoma, patients receiving VaxiGen personalized vaccines combined with PD-1 inhibitors achieved a two-year recurrence-free survival rate of 78%, compared to 31% for the PD-1 inhibitor-only control group — a 67% reduction in recurrence.

VaxiGen's workflow begins with tumor biopsy. Excised tumor tissue is sent to VaxiGen laboratories for whole exome sequencing and transcriptome analysis. The AI system NeoAntigen Predictor identifies tumor-specific mutant proteins within 48 hours and predicts antigen epitopes most likely to activate immune responses. The system then selects up to 20 optimal targets from hundreds of candidates to design and synthesize personalized mRNA vaccines. Biopsy-to-vaccine completion takes just 14 days.

BioNTech CEO Ugur Sahin stated at the Berlin press conference that VaxiGen represents a paradigm shift in cancer treatment — from one-size-fits-all standardized therapy to precision immunotherapy tailored for each patient. Every person's tumor is unique, and treatment should be too.

The Phase III trial enrolled 1,032 stage III-IV melanoma patients, randomly divided into two groups. The experimental group received VaxiGen vaccines (every 3 weeks, 8 doses) combined with pembrolizumab, while the control group received only pembrolizumab. After median 26-month follow-up, the experimental group's median progression-free survival was not reached (over half remained recurrence-free), compared to 12.3 months for the control group.

Safety-wise, VaxiGen vaccine side effects were predominantly mild. The most common adverse reactions were injection site pain (82%), fatigue (45%), and low-grade fever (38%), all grade 1-2. Grade 3+ adverse reactions occurred in just 4.2%, with no significant difference from the control group.

VaxiGen faces two key challenges. First is cost — current per-patient vaccine production costs approximately $100,000, with total treatment costs around $150,000 including sequencing and AI analysis. BioNTech says costs could drop to $50,000 by 2029 with increased production scale.

Second is scope. The Phase III trial covered only melanoma. VaxiGen's Phase II trials in lung, colorectal, and breast cancers are ongoing. Different cancer types vary significantly in tumor mutation burden, and low-burden tumors may not produce sufficient neoantigens for immune activation.

FDA is expected to complete VaxiGen review in Q1 2029. If approved, this would be the world's first approved personalized mRNA cancer vaccine. The EMA has initiated accelerated review.

Harvard Medical School oncology professor Catherine Wu comments that personalized cancer vaccines went from concept to Phase III in under a decade — rare speed in drug development history. The maturation of mRNA technology accelerated by the COVID-19 pandemic was a critical catalyst.