Evaxion’s AI-Powered Vaccine Achieves 75% Objective Response Rate in Advanced Melanoma—Phase 2 Data Points to Durable and Safe Outcomes
Clinical Data Shows EVX-01’s Efficacy Remains High at Two-Year Mark
Evaxion has unveiled compelling results from its phase 2 trial of EVX-01, a personalized cancer vaccine powered by the company’s AI-Immunology™ platform. At the two-year follow-up, the objective response rate (ORR) climbed to 75%, with 12 of 16 advanced melanoma patients exhibiting measurable clinical improvement—and 11 of those patients maintaining their responses after two years.
This long-lasting benefit is underscored by a lack of relapses during the follow-up, and four patients even achieved a complete response. Compared to last year’s 69% ORR, this year’s results highlight continued progress for the AI-designed therapy. The clinical durability stands out: at the data cut-off, 92% of initial responders were still seeing positive outcomes.
Most Patients Experienced Tumor Reduction or Improved Disease Status
Deepening responses were seen throughout the treatment, with over half (54%) of participants shifting from stable or partial response to an even better response category. Out of 16 enrolled patients, 15 saw some degree of tumor shrinkage. Notably, 81% of EVX-01’s selected vaccine targets generated strong immune reactions—showcasing the platform’s precision in pinpointing and engaging neoantigens (unique cancer proteins).
| Metric | Value | Interpretation |
|---|---|---|
| Objective Response Rate | 75% | 12 of 16 patients responded |
| Durable Responses at 24 Months | 92% | 11 of 12 responders maintained outcome |
| Tumor Reduction | 94% | 15 of 16 patients saw reduction |
| Immune Response to Neoantigens | 81% | Specific T-cell response triggered |
| Improved Response During Trial | 54% | Shifted to stronger response category |
Safety Profile Remains Encouraging as AI-Designed Approach Sets New Benchmark
Alongside efficacy, safety continues to look favorable—EVX-01 was well tolerated, and no major adverse effects were reported. The precision of the AI-Immunology™ platform is further supported by high immunogenicity rates compared to what is usually seen with traditional immunotherapy vaccines. This level of performance in a challenging patient group positions EVX-01 as a frontrunner in next-generation, AI-driven oncology treatment.
The study, conducted with Merck’s anti-PD-1 therapy (KEYTRUDA®), involved each patient receiving a uniquely designed vaccine matched to their tumor’s mutations. Results are currently being discussed at the 2025 ESMO Congress, with further analysis expected at an October 22 webinar hosted by key opinion leader Professor Muhammad Adnan Khattak.
Unmet Needs and What Comes Next for EVX-01
The phase 2 study’s secondary endpoints—Progression-Free Survival and Overall Survival—could not yet be formally analyzed, since most patients continued to benefit at data cut-off. A trial extension will further evaluate EVX-01 as a standalone therapy, with additional data set for 2026.
With the AI-Immunology™ approach demonstrating both robust efficacy and safety, these findings may set the stage for broader applications in other solid tumors, not just melanoma. The partnership-focused path forward could help expedite access and clinical validation for this potentially game-changing immunotherapy.
Key Takeaway: Durable Responses Highlight Promise of AI in Oncology
Evaxion’s latest phase 2 results mark a noteworthy milestone: an unprecedented combination of high objective response rate, durable outcomes, and immune activation—all with a tolerable safety profile. While longer-term survival data are awaited, investors and researchers will be watching closely to see how these findings may shape the future of personalized, AI-powered cancer vaccines.
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