Core Insights - The webinar focuses on the 2-year readout from Evaxion's Phase II study in advanced melanoma, highlighting the significance of the results and their implications for high-risk melanoma treatment [1][2]. Group 1: Company Overview - Evaxion is introducing its AI-Immunology platform, which is central to its research and development efforts in advanced melanoma [2]. Group 2: Study Details - The agenda includes an introduction to Evaxion, a review of data from the Phase I study that led to the Phase II study, and a detailed presentation of the Phase II study design and results by Professor Khattak [2]. - The Phase II study results are expected to provide insights into the effectiveness of the treatment for high-risk melanoma patients [1][2]. Group 3: Engagement and Interaction - The webinar encourages audience participation through a question-and-answer session, allowing attendees to engage directly with the presenters [2].

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]

Core Insights - Evaxion A/S announced unprecedented two-year clinical efficacy data for its personalized cancer vaccine EVX-01 in patients with advanced melanoma, showcasing a significant potential as a new treatment option [1][6] Clinical Efficacy Data - The two-year phase 2 data revealed an Objective Response Rate (ORR) of 75%, with 12 out of 16 patients showing objective clinical responses, including four achieving complete response [2][11] - A durable clinical benefit was noted, with 92% of patients still responding at the 24-month follow-up and no relapses observed [2][11] - 54% of patients experienced a deepened response during treatment, transitioning from stable disease or partial response to partial or complete response [3][9] Immune Response and Safety - EVX-01 induced an immune response in all patients, with 81% of targeted neoantigens generating potent specific T-cell responses, indicating high immunogenicity [4][11] - The treatment was confirmed to be well-tolerated, aligning with the favorable safety profile observed in the phase 1 study [5][11] Future Developments - The trial has been extended for an additional year, during which participants will receive EVX-01 as monotherapy, with data from this extension expected to be presented in 2026 [14] - Evaxion plans to discuss the data with stakeholders and potential partners, emphasizing the need for partnerships in further clinical development [6][12] Presentation and Engagement - Data was presented at the European Society for Medical Oncology (ESMO) Congress 2025, with opportunities for discussions at the conference [8][11] - An online webinar featuring key opinion leader Professor Muhammad Adnan Khattak is scheduled for October 22, 2025, to discuss the two-year phase 2 data and challenges in treating advanced melanoma [12]

Core Insights - Evaxion Biotech A/S (NASDAQ:EVAX) has a target price of -0.34, which is 104.29% below its current market price of 7.84, indicating a pessimistic outlook from analysts [1][3][5] - TransCode Therapeutics, Inc. (RNAZ) has a current stock price of 14.28 and a target price of 16.21, suggesting a growth potential of 13.52%, positioning it as a more favorable investment opportunity compared to EVAX [2][4][5] Company Analysis - The significant gap between EVAX's target and market prices raises concerns about its future performance and may impact investor confidence [3][5] - RNAZ's positive target price change reflects confidence in its growth prospects, making it an attractive option for investors in the biotech sector [4][5]

Company Overview - Evaxion is pioneering AI-powered drug development, focusing on vaccines for cancer and infectious diseases[5] - The company leverages a clinically validated AI-Immunology platform for target discovery, design, and development[5, 26] - Evaxion aims to generate positive cash flow and become the AI partner of choice in the TechBio industry[13, 14] Financial Highlights - An exercise fee of $7.5 million from MSD extends Evaxion's cash runway to H1 2027[8, 17] - Evaxion has potential cash generation of up to $592 million over the coming two decades through the MSD partnership[8] - As of June 30, 2025, Evaxion has $14.7 million in cash and $9.2 million in debt[60] - The market capitalization of Evaxion is $29.3 million as of September 30, 2025[60] Pipeline and Partnerships - MSD acquired EVX-B3, validating Evaxion's AI-Immunology platform and pipeline[8] - The global cancer immunotherapy market is estimated to grow to $277 billion by 2030[11] - The infectious disease vaccines market is expected to reach $67.5 billion by 2031[11] - The melanoma market is estimated to grow to $7.4 billion by 2029[11]

Core Insights - Evaxion A/S will present data from its phase 2 trial of the personalized cancer vaccine EVX-01 at the ESMO Congress 2025, highlighting its clinical efficacy, immunogenicity, and safety [1][2][10] Group 1: Presentation Details - The presentation will include two-year clinical efficacy, immunogenicity, and safety data, focusing on overall response rates, deepened response rates, and durability of response [2][10] - The oral session is scheduled for October 17, 2025, at 14:10 CEST, with Dr. Muhammad Adnan Khattak as the presenter [8][10] Group 2: Clinical Trial Insights - EVX-01, designed using Evaxion's AI-Immunology™ platform, is being evaluated for advanced melanoma treatment, showing a 69% overall response rate in previous trials [5][6] - The phase 2 trial combines EVX-01 with MSD's KEYTRUDA® (pembrolizumab), with each vaccine tailored to the individual patient's biology [7] Group 3: Company Background - Evaxion is a clinical-stage TechBio company focused on AI-powered vaccines, with a commitment to developing personalized immunotherapies for cancer and infectious diseases [14]

Core Insights - Evaxion A/S is launching a new automated vaccine design module as an enhancement to its AI-Immunology™ platform, aimed at improving vaccine development efficiency and quality [1][4][7] - The new module automates the entire process of target discovery and vaccine design, significantly reducing design time from months to days and offering cost savings [2][3][7] - The module can be applied to both new and existing vaccines, potentially leading to the development of improved vaccine generations [5][7] Group 1 - The new automated design module ensures optimal sequence and conformation of vaccine targets, enhancing protective immune responses [2][3] - The launch of this module is a milestone for Evaxion in 2025, enhancing its value proposition to potential partners and expanding in-house capabilities [4][5] - Evaxion plans to present validation data on the improvements at the World Vaccine Congress Europe on October 15, 2025 [5][7] Group 2 - Evaxion is a clinical-stage TechBio company focused on AI-powered vaccine development, with a pipeline addressing high unmet medical needs in oncology and infectious diseases [6] - The AI-Immunology™ platform utilizes AI to decode the human immune system, facilitating the development of novel immunotherapies [6] - The company is committed to transforming patient care through innovative and targeted treatment options [6]

Core Insights - Evaxion A/S is set to present new data for its lead asset EVX-01, a personalized cancer vaccine, at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting [1] - The ongoing phase 2 trial of EVX-01 is investigating its efficacy in combination with Merck's KEYTRUDA® for advanced melanoma patients [3][5] - EVX-01 has shown promising results with overall response rates of 69% and 67% in advanced melanoma patients [6] Presentation Details - New biomarker and immune data from the phase 2 trial will be presented at SITC 2025, with two-year clinical efficacy data to be shared at the ESMO 2025 congress on October 17, 2025 [2][8] - The SITC presentation will include an abstract titled "Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients" [9] About EVX-01 - EVX-01 is designed using Evaxion's AI-Immunology™ platform, targeting the unique tumor profile and immune characteristics of each patient [5][10] - The vaccine aims to engage the patient's immune system to mount a targeted response against tumors, representing a first-line treatment option for multiple advanced solid cancers [5] Clinical Trial Insights - The phase 2 trial combines EVX-01 with KEYTRUDA®, allowing for a personalized approach to treatment based on individual patient biology [3] - The trial has already provided strong one-year interim data, contributing to a robust data package for EVX-01 [2][8]

Core Insights - Evaxion has achieved a significant milestone by having MSD (Merck) exercise its option to license the EVX-B3 vaccine candidate, marking the first instance of a pharmaceutical company in-licensing a vaccine candidate discovered using AI [3] Company Updates - The licensing of EVX-B3 is a notable achievement for Evaxion and highlights the potential of AI-driven drug development in the pharmaceutical industry [3] - MSD also holds an option on another vaccine candidate, EVX-B2, with an extended evaluation period and a decision on potential in-licensing expected in the first half of 2026 [4]

Core Insights - Evaxion A/S has out-licensed its vaccine candidate EVX-B3 to MSD, receiving an initial cash payment of $7.5 million and potential future payments totaling up to $592 million [1][2][10] - The EVX-B3 vaccine, currently in preclinical development, targets a pathogen linked to serious medical complications and aims to address a significant global health issue [3][4] - The collaboration with MSD validates Evaxion's AI-Immunology™ platform, which has identified novel vaccine targets for challenging pathogens [4][5] Financial Implications - The cash payment extends Evaxion's cash runway into the first half of 2027, allowing continued investment in its AI-Immunology™ platform and R&D projects [6] - Future milestone payments from MSD for EVX-B3 could reach up to $592 million, along with royalties on net sales [2][10] - Should MSD exercise its option on EVX-B2, Evaxion would receive an additional cash payment of $2.5 million and similar milestone and royalty structures as with EVX-B3 [9][10] Development and Collaboration - The collaboration between Evaxion and MSD began in September 2023 and has now expanded to include EVX-B2, a preclinical vaccine candidate against Gonorrhea [7][8] - The evaluation period for EVX-B2 has been extended, with a decision on potential licensing expected in the first half of 2026 [8][9] - MSD will assume full responsibility for the further development of EVX-B3, allowing Evaxion to focus on its strategic partnerships [2][10]