AI-Driven EVX-01 Cancer Vaccine Demonstrates “Unprecedented” 75% Objective Response Rate in Advanced Melanoma Trial
COPENHAGEN, Denmark — Evaxion A/S (NASDAQ: EVAX), a clinical-stage TechBio company leveraging its proprietary AI-Immunology™ platform, has announced highly encouraging two-year clinical efficacy data for its personalized cancer vaccine, EVX-01, in patients with advanced melanoma. The Phase 2 results, released on October 17, 2025, highlight a significant milestone in the development of individualized cancer treatments.
Groundbreaking Efficacy Metrics
The two-year follow-up data from the study reported an Objective Response Rate (ORR) of 75% for the EVX-01 personalized cancer vaccine. This rate is considered unprecedented in this challenging patient population.
- Objective Responses: 12 out of 16 patients enrolled in the trial exhibited objective clinical responses.
- Complete Responses: Four patients achieved a complete response, meaning all signs of cancer disappeared.
- Response Improvement: The ORR has improved from the 69% observed after one year of treatment, indicating a continued therapeutic effect over time.
- Tumor Reduction: 15 out of 16 patients showed a reduction in their target tumor lesions.
Durability and Deepening of Response
Beyond the high initial response rate, the study demonstrated remarkable long-term durability:
- Durable Clinical Benefit: A compelling 92% of the patients who responded were still maintaining their clinical benefit at the 24-month follow-up data cut-off.
- No Relapses: Notably, no relapses were observed among the responders at the two-year mark.
- Response Deepening: 54% of patients experienced a deepened response during the treatment period, improving their classification from stable disease or partial response to a partial or complete response.
Validation of AI-Immunology™ Platform
EVX-01 is a first-in-class personalized vaccine designed to target multiple neoantigens—the cancer-specific proteins resulting from tumor mutations—identified by Evaxion’s advanced AI-Immunology™ platform. The clinical data strongly validates the predictive power of this technology:
- Universal Immune Activation: The EVX-01 vaccine successfully induced an immune response in all patients.
- Target Precision: An exceptional 81% of the targeted neoantigens generated potent, specific T-cell responses in the patients. This high immunogenicity rate underscores the platform’s ability to accurately identify clinically relevant neoantigens.
Birgitte Rønø, CSO and interim CEO of Evaxion, stated: “This study sets a new benchmark in personalized immunotherapy. The long-term efficacy and safety of EVX-01 demonstrate that Evaxion’s AI-Immunology™ approach is not just innovative; it’s clinically meaningful and ready to shape the future of oncology.”
Evaxion is now focused on discussing the data with stakeholders and potential partners, as further clinical development will be pursued in collaboration. The treatment was also noted to be well tolerated, confirming the favorable safety profile observed in earlier studies.
Source :
Evaxion A/S, via an official press release dated October 17, 2025, titled “Evaxion reports 75% Objective Response Rate in phase 2 trial with AI-designed personalized cancer vaccine EVX-01.” (The link you provided, which directs to the news on Yahoo Finance, is a re-publication of this announcement.)
