Summary of Evaxion Biotech A/S Update / Briefing (October 22, 2025) Company Overview - **Company**: Evaxion Biotech A/S - **Founded**: 2008 in Copenhagen, Denmark - **Focus**: AI-first company leveraging proprietary AI-Immunology platform for vaccine discovery, design, and development [3][4] Industry Context - **Disease Focus**: Advanced melanoma, a highly aggressive skin cancer with high mortality rates, particularly in metastatic cases [14][15] - **Historical Context**: Prior to 2011, melanoma clinical trials had a high failure rate. Introduction of immunotherapy marked a significant shift in treatment efficacy [14][15] Core Points from the Call AI-Immunology Platform - **Functionality**: Decodes human systems for therapeutic target discovery by integrating genomic, transcriptomic, and proteomic data [3][4] - **Success Rate**: High success in selecting targets that induce potent T-cell responses against cancer cells [4] Clinical Trials - **Phase 1 Trial**: - Conducted on patients with Stage 3B and Stage 4 melanoma. - **Results**: 67% objective response rate (ORR) with 8 out of 12 patients showing response; however, 7 relapsed [8][9] - **Safety**: Well tolerated with mainly grade one and two adverse events [7][8] - **Key Learnings**: Recommended Phase 2 dose set at 200 micrograms; booster administrations included in Phase 2 to sustain T-cell levels [8][9] - **Phase 2 Trial**: - Included treatment-naive patients with Stage 3 unresectable or Stage 4 melanoma [18][19] - **Primary Endpoint**: Conversion from stable disease to partial or complete response [19][20] - **Secondary Endpoints**: Objective response rate, progression-free survival, overall survival, and neoantigen-specific T-cell response [20] - **Study Population**: 17 enrolled patients, predominantly Stage 4 melanoma [23] - **Safety Profile**: Consistent with Phase 1, primarily grade one adverse events [24][25] - **Results**: 75% best objective response rate; 54% conversion rate from stable disease to partial response [30][31] Efficacy and Safety - **T-cell Responses**: 81% of neoantigens induced T-cell responses, an increase from 65% in Phase 1 [31] - **Sustained Responses**: 92% of responders maintained responses at the 24-month mark [37] - **Manufacturing Success**: 100% success rate in vaccine manufacturing for all patients [38] Additional Insights - **Personalized Treatment**: Emphasis on the need for personalized therapies to improve efficacy and reduce toxicity compared to standard treatments [17][18] - **Future Directions**: Potential for further studies to explore the efficacy of personalized vaccines in previously treated melanoma patients and the role of booster doses [68][70] Conclusion - **Encouraging Data**: The results from the Phase 2 trial support the ongoing development of Evaxion's personalized cancer vaccine, EVX-01, in high-risk melanoma [38] - **Next Steps**: Continued evaluation of patient responses and potential adjustments to dosing schedules and treatment regimens based on emerging data [62][63]