• The clinical trial of the personalized cancer vaccine EVX-01 met its primary endpoints of safety and tolerability
• Positive clinical responses were reported in 8 out of 12 EVX-01 treated patients
• High-quality neoantigens, predicted by AI technology, were associated with longer progression-free survival
• Strong vaccine-specific immune responses were induced in all 12 EVX-01 treated patients 
• Higher EVX-01 dose induced a stronger immune response and was associated with improved clinical outcome

The Phase 1 trial successfully met primary endpoints for safety and tolerability of EVX-01 in metastatic melanoma patients and demonstrated positive clinical responses in 8 out of 12 (67%) treated patients. In addition, Evaxion’s proprietary AI technology PIONEER™ was able to identify high-quality cancer vaccine targets, so-called neoantigens, associated with longer progression-free survival.

“We are excited that our AI technology could effectively identify vaccine neoantigens associated with better clinical responses and longer progression-free survival. And the data suggest a treatment effect, with response rates nearly double of those observed in historical data for checkpoint inhibitors. Our findings in this study position us well to prospectively identify patients who will benefit from personalized cancer immunotherapy for our upcoming trials, potentially making the benefit for patients even greater,” said Per Norlén, Chief Executive Officer of Evaxion. 

The study demonstrated the ability of the PIONEER™ platform to identify vaccine targets that are associated with improved patient outcomes. Stratification based on PIONEER™ scores outperformed tumor mutational burden as a predictive biomarker, with patients having high-quality neoantigens showing better treatment responses and longer progression-free survival. 

The evaluation of treatment-related immune responses revealed strong neoantigen T-cell responses in all 12 patients, mediated by activated CD4+ T cells in all cases and CD8+ T cells in 7 out of 12 patients. Further, immune response magnitude correlated with the vaccination dose.  

“The positive association between clinical outcome and prevalence of immunogenic cancer neoantigens validates the PIONEER™ platform for its use for personalized cancer vaccines and emphasizes the importance of a robust AI system for designing neoantigen vaccines. Moreover, the dose-dependent increase in responses has been instrumental for Phase 2 dose selection in the ongoing clinical trial. We have great expectations on the upcoming interim Phase 2 results that are planned to be presented later this year,” Per Norlén continues.