Evaxion(US:EVAX)2025-10-22 15:32Summary 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]