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Evaxion A/S (EVAX) Discusses 2-Year Phase II Data and AI Immunology Platform in High-Risk Melanoma Transcript
Seeking Alpha· 2025-10-22 21:13
PresentationBenjamin Wolthers Welcome to this webinar sharing the 2-year readout from our Evaxion Phase II study in advanced melanoma. We are very, very happy with the virtual turnout for this call here. And together with the Professor Adnan Khattak, I look forward to sharing results and discussing data and implications of these data with all of you right from this important Phase II study in high-risk melanoma. So if we look into the next hour or so, we will be covering an exciting agenda. Initially, I wi ...
Evaxion Biotech A/S (NasdaqCM:EVAX) Update / Briefing Transcript
2025-10-22 15:30
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]
Evaxion reports 75% Objective Response Rate in phase 2 trial with AI-designed personalized cancer vaccine EVX-01
Globenewswire· 2025-10-17 12:15
75% Objective Response Rate as 12 out of 16 advanced melanoma patients had objective clinical responses, with 11 of the 12 responders continuing to respond at 24 months follow-upImmune activation observed in all patients with 81% of EVX-01’s vaccine targets triggering a specific responseTreatment was well toleratedData is presented today at the ESMO Congress and will be discussed at a webinar with key opinion leader Professor Muhammad Adnan Khattak on October 22, 2025 COPENHAGEN, Denmark, October 17, 2025 - ...
Comparing Investment Potential in Biotech: Evaxion Biotech vs. TransCode Therapeutics
Financial Modeling Prep· 2025-10-15 15:00
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]
Evaxion Biotech A/S (NasdaqCM:EVAX) Earnings Call Presentation
2025-10-15 11:00
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]
Evaxion to present a breadth of data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025
Globenewswire· 2025-10-13 12:00
Presentation will cover two-year clinical efficacy, immunogenicity and safety dataData will be presented at an oral session on October 17, 2025, followed by a webinar on October 22, 2025, providing further insights into the clinical findings COPENHAGEN, Denmark, October 13, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will present a wide range of data from its phase 2 trial with lead compound EVX-01 at the Europe ...
Evaxion expands AI-Immunology™ platform with automated vaccine design module
Globenewswire· 2025-10-08 12:12
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]
Evaxion to present new biomarker data for AI-designed personalized cancer vaccine EVX-01 at the SITC 2025 Annual Meeting
Globenewswire· 2025-10-03 13:00
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]
Evaxion A/S - Special Call
Seeking Alpha· 2025-09-25 15:07
PresentationI would now like to hand the conference over to your first speaker today, Interim CEO and CSO, Birgitte Rono. Please go ahead.Good day, and thank you for standing by. Welcome to the Evaxion out-licenses vaccine candidate, EVX-B3 to MSD Webcast and Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.Birgitte RonoInterim CEO & Chief Scientific Officer Thank you. So good morning and good afternoon, and thank you all for joining us, and a warm welcome ...
Evaxion out-licenses vaccine candidate EVX-B3 to MSD
Globenewswire· 2025-09-25 11:00
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]