Core Insights - Evaxion A/S has announced promising new data for its AML vaccine candidate, EVX-04, which shows strong T-cell responses and effective tumor growth prevention in preclinical models [1][5][10] - The data was presented at the American Society of Hematology Annual Meeting, highlighting the company's engagement with the scientific community and potential business partners [2] - The AI-Immunology™ platform has been instrumental in identifying novel ERV tumor antigens, which are targeted by EVX-04, showcasing the platform's unique capabilities in cancer vaccine development [3][4][11] Company Overview - Evaxion A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines, with a commitment to transforming patient care through innovative immunotherapies [12] - The company’s proprietary AI platform enables the identification of therapeutically relevant tumor antigens, which are crucial for the development of effective cancer vaccines [11][12] Product Details - EVX-04 is designed as an off-the-shelf therapeutic cancer vaccine specifically for acute myeloid leukemia (AML), addressing a significant unmet medical need due to the high mortality rates associated with the disease [10] - The vaccine targets non-conventional ERV tumor antigens, which are selectively expressed in tumors but absent in normal tissues, making them ideal candidates for cancer immunotherapy [4][10] AML Context - Acute myeloid leukemia (AML) is characterized by high mortality rates and limited treatment options, with a median age of diagnosis at 68 years [8][9] - Approximately 50% of AML patients are not fit for intensive treatment, leading to a low overall survival rate of 25% over three years for those receiving standard low-intensity chemotherapy [9]

Core Insights - Evaxion A/S has announced promising new data for its AML vaccine candidate, EVX-04, which shows strong T-cell responses and effective tumor growth prevention in preclinical models [1][5][10] - The data was presented at the American Society of Hematology Annual Meeting, highlighting the company's commitment to engaging with the scientific community and potential partners [2] - The AI-Immunology™ platform has enabled the identification of unique ERV tumor antigens, which are selectively expressed in tumors but absent in normal tissues, making them ideal targets for cancer vaccines [4][11] Company Overview - Evaxion is a clinical-stage TechBio company focused on developing AI-powered vaccines, particularly in the field of immunology [1][12] - The company utilizes its proprietary AI-Immunology™ platform to decode the human immune system and create novel immunotherapies for various diseases, including cancer [12] Product Details - EVX-04 is designed as an off-the-shelf therapeutic cancer vaccine for acute myeloid leukemia (AML), addressing a significant unmet medical need due to high mortality rates associated with the disease [10] - The vaccine targets multiple non-conventional ERV tumor antigens, which have been shown to elicit specific immune responses and prevent tumor growth in preclinical models [5][10] - The data-driven approach ensures broad tumor coverage, making EVX-04 applicable across various cancers where current immunotherapies are inadequate [6][10] Market Context - AML is characterized by high mortality rates and limited treatment options, with a median age of diagnosis at 68 years and a long-term survival rate of only 40% for younger patients undergoing intensive treatment [8][9] - Approximately 50% of AML patients are not fit for intensive treatment, relying on low-intensity chemotherapy, which has a poor three-year overall survival rate of only 25% [9]

Core Insights - Evaxion A/S has expanded its R&D pipeline with the introduction of EVX-04, an AI-designed precision cancer vaccine candidate targeting acute myeloid leukemia (AML) [1][10] - The vaccine is designed to target non-conventional ERV tumor antigens from the dark genome, which are present in tumors but absent in normal tissue, making them attractive for cancer vaccines [2][9] - EVX-04 aims to be an "off-the-shelf" vaccine, preproduced and ready for immediate administration after diagnosis, effective across a wide range of patients regardless of immune and tumor ERV antigen differences [4][5] Research and Development - The AI-Immunology™ platform has identified ERV antigens in patient tumor sequencing data and selects optimal fragments for effective vaccine targets [3][9] - New preclinical data shows that EVX-04 induces strong T-cell responses and kills cancer cells, with results to be presented at the American Society of Hematology (ASH) Annual Meeting on December 6, 2025 [6][10] - The presentation will include an abstract titled "Dark genome interrogation identifies novel antigens in acute myeloid leukemia – developing an off-the-shelf vaccine from machine learning to clinic" [8] Company Overview - Evaxion is a pioneering TechBio company utilizing its AI platform, AI-Immunology™, to develop novel immunotherapies for cancer and infectious diseases [12] - The company is committed to transforming patient outcomes by providing innovative and targeted treatment options [12]

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 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 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 A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines and will present updates at various conferences in the latter half of 2025 [1][3][7] Company Updates - The company will engage with stakeholders and potential partners at multiple conferences across the US, Europe, and Asia to explore business partnerships and scientific collaborations [2][5] - Evaxion is particularly excited about presenting two-year clinical data for its personalized cancer vaccine EVX-01 at the ESMO congress in October 2025 [3][5] Conference Participation - Evaxion's conference schedule includes: - Vaccine Congress, September 7-10, Kyoto - HC Wainwright Global Investment Conference, September 8-10, New York - ESCMID Conference on vaccines, September 10-13, Lisbon - Lake Street Best Ideas Growth Conference, September 12, New York - HC Andersen seminar, September 18, Copenhagen - Vax On Vaccines: Present and future in oncology, October 1, Milan - BiotechX Europe, October 6-8, Basel - World Vaccine Congress Europe, October 14-16, Amsterdam - ESMO Congress 2025, October 17-21, Berlin - Society for Immunotherapy of Cancer (SITC) 2025, November 5-9, National Harbor - Vaccines Summit, November 13-15, Boston - NextGen Omics, November 13-14, London [5][6] Company Background - Evaxion utilizes its proprietary AI platform, AI-Immunology™, to develop novel immunotherapies targeting cancer, bacterial diseases, and viral infections, aiming to transform patient care with innovative treatment options [6][7]

Core Insights - Evaxion A/S is progressing well with its AI-Immunology™ powered vaccine development, maintaining operational momentum and aiming to achieve 2025 milestones [2][5][11] Business Highlights - The company is on track to present two-year clinical data for its personalized cancer vaccine EVX-01 at the ESMO Congress on October 17, 2025, which is expected to attract potential partners [6][7] - Evaxion has received a grant from the Gates Foundation to explore a new sub-unit vaccine against polio, highlighting external interest in its AI-Immunology™ platform [9][10] - The R&D pipeline has been expanded with the addition of EVX-B4, targeting Group A Streptococcus, showcasing the platform's scalability [10] Financial Update - As of June 30, 2025, cash and cash equivalents increased to $14.7 million from $6.0 million at the end of 2024, providing a cash runway until mid-2026 [16] - Revenue for the second quarter of 2025 was $37 thousand, a decrease from $154 thousand in the same period last year, primarily due to changes in collaborative agreements [17] - The net loss for the second quarter of 2025 was $4.8 million, an improvement from a net loss of $6.2 million in the same period of 2024 [21] R&D and Clinical Trials - The phase 2 trial for EVX-01 has completed patient treatment, with three-year data expected in 2026 following a one-year trial extension [8][7] - The company is actively engaged in preclinical activities and has received recognition for its AI-Immunology™ platform, which is applicable to over 100 diseases [9][10] Business Development - Ongoing discussions with MSD regarding the EVX-B2 and EVX-B3 programs may lead to option exercises in the latter half of 2025, with potential milestone payments for Evaxion [11][12] - The company aims to secure at least two new partnership deals in 2025, despite challenges posed by current financial market conditions [13] Capital Structure - An agreement with the European Investment Bank (EIB) converted €3.5 million of debt into equity, improving equity by $4.1 million and enhancing financial flexibility [14][15]

Core Insights - Evaxion A/S will present two-year clinical efficacy data from its phase 2 trial of the personalized cancer vaccine EVX-01 at the ESMO Congress 2025 in Berlin [1][3] - EVX-01, developed using Evaxion's AI-Immunology™ platform, is currently being evaluated for advanced melanoma treatment, showing a 69% Overall Response Rate in interim data [2][4] - The phase 2 trial combines EVX-01 with MSD's KEYTRUDA® therapy, tailored to each patient's unique tumor profile [4][6] Company Overview - Evaxion is a clinical-stage TechBio company focused on AI-driven immunotherapies for cancer and infectious diseases [9] - The company utilizes its AI-Immunology™ platform to create personalized vaccines, aiming to enhance immune responses against tumors [6][9] - Evaxion's pipeline includes novel personalized vaccines for oncology and preclinical candidates for bacterial and viral diseases [9] Clinical Trial Details - The phase 2 trial of EVX-01 has shown promising results, with 67% of metastatic melanoma patients achieving objective clinical responses in earlier trials [7] - The upcoming presentation at ESMO will include data on T-cell responses and disease control over two years [5][6] - The trial emphasizes the correlation between AI predictions and immune responses, highlighting the platform's predictive capabilities [2][7]

Core Viewpoint - Evaxion A/S has initiated a one-year extension of its ongoing phase 2 trial for its personalized cancer vaccine EVX-01, aimed at treating advanced melanoma, leveraging its AI-Immunology™ platform to explore the vaccine's long-term clinical and immune benefits [1][2][4]. Group 1: Trial Details - The first patient has been dosed in the one-year extension of the trial, which will involve two additional doses of EVX-01 as monotherapy [3]. - The initial two years of the trial involved EVX-01 in combination with standard anti-PD-1 therapy, and the extension phase allows for evaluation of EVX-01 as a standalone treatment [4][5]. - The trial extension incurs minimal costs since trial sites are already operational and the vaccine has been produced [2][10]. Group 2: Clinical Data and Results - Interim one-year data presented at the ESMO Congress in September 2024 showed a 69% Overall Response Rate, with tumor target lesions reduced in 15 out of 16 patients [8]. - At the AACR Annual Meeting in April 2025, it was reported that 80% of EVX-01's vaccine targets triggered a targeted immune response, indicating favorable outcomes compared to other treatment approaches [9]. - The completed phase 1/2a clinical trial demonstrated that 67% of metastatic melanoma patients had objective clinical responses, highlighting the predictive power of the AI-Immunology™ platform [12]. Group 3: Product and Technology Overview - EVX-01 is a personalized peptide-based cancer vaccine designed to engage the patient's immune system against tumors, tailored to each individual's unique tumor profile [6][11]. - The AI-Immunology™ platform is central to Evaxion's approach, enabling the development of novel immunotherapies for various diseases, including cancer [13].