Evaxion to present a breadth of data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025
Evaxion (NASDAQ: EVAX) will present two-year phase 2 data for its AI-designed personalized cancer vaccine EVX-01 at ESMO Congress 2025 on October 17, 2025 (oral session) with a follow-up webinar on October 22, 2025. The presentation covers two-year clinical efficacy, immunogenicity and safety, including best overall response, deepened response/conversion rates, durability of response, and T-cell breadth/magnitude/duration after booster dosing.
Earlier interim data reported a 69% overall response rate, tumor target lesion reduction in 15 of 16 patients, a correlation between AI predictions and immune responses (p=0.00013), and that 80% of vaccine targets triggered tumor-specific immune responses. The trial tests EVX-01 plus KEYTRUDA® in advanced melanoma; Evaxion will be available at booth #3035 for discussions.
Evaxion (NASDAQ: EVAX) presenterà dati di fase 2 di due anni per il suo vaccino personalizzato anti-cancro progettato dall'AI EVX-01 all'ESMO Congress 2025 il 17 ottobre 2025 (sessione orale) con un webinar di follow-up il 22 ottobre 2025. La presentazione copre efficacia clinica a due anni, immunogenicità e sicurezza, inclusi la miglior risposta globale, tassi di risposta profonda/conversione, durata della risposta e ampiezza/magnttude/durata delle cellule T dopo dose di richiamo.
In precedenza, i dati interini hanno riportato un 69% tasso di risposta globale, una riduzione delle lesioni bersaglio tumorali in 15 su 16 pazienti, una correlazione tra previsioni AI e risposte immunitarie (p=0.00013) e che l'80% degli obiettivi vaccinali hanno scatenato risposte immunitarie specifiche al tumore. Il trial testa EVX-01 più KEYTRUDA® in melanoma avanzato; Evaxion sarà disponibile allo stand n. 3035 per discussioni.
Evaxion (NASDAQ: EVAX) presentará datos de fase 2 de dos años para su vacuna personalizada contra el cáncer diseñada por IA, EVX-01, en el Congreso ESMO 2025 el 17 de octubre de 2025 (sesión oral) con un seminario web de seguimiento el 22 de octubre de 2025. La presentación cubre eficacia clínica a dos años, inmunogenicidad y seguridad, incluyendo la mejor respuesta global, tasas de respuesta profunda/conversión, durabilidad de la respuesta y amplitud/magnitud/duración de las células T tras la dosis de refuerzo.
Datos interinos previos reportaron una tasa de respuesta global del 69%, reducción de lesiones diana tumorales en 15 de 16 pacientes, una correlación entre predicciones de IA y respuestas inmunitarias (p=0,00013), y que el 80% de los objetivos de la vacuna desencadenaron respuestas inmunes específicas al tumor. El ensayo prueba EVX-01 más KEYTRUDA® en melanoma avanzado; Evaxion estará disponible en el stand #3035 para discusiones.
Evaxion (NASDAQ: EVAX)은 AI가 설계한 개인화 암 백신 EVX-01의 2상 2년 데이터를 2025년 ESMO 학회에서 2025년 10월 17일(구두 세션)에 발표하고 2025년 10월 22일에 후속 웨비나를 진행합니다. 발표에는 2년 간 임상 효능, 면역원성 및 안전성이 포함되며, 최우선 전체 반응, 깊은 반응/전환율, 반응 지속성, 부스터 투여 후 T세포의 폭/강도/지속 시간 등이 다뤄집니다.
이전 중간 데이터에서는 69%의 전체 반응률, 16명 중 15명의 종양 표적 병변 감소, AI 예측과 면역 반응 사이의 상관관계(p=0.00013), 그리고 백신 표적의 80%가 종양 특이적 면역 반응을 촉발했다는 사실이 보고되었습니다. 이 시험은 진행성 흑색종에서 EVX-01과 KEYTRUDA®를 함께 테스트합니다; Evaxion은 토론을 위해 부스 #3035에서 대기합니다.
Evaxion (NASDAQ : EVAX) présentera des données de phase 2 sur deux ans pour son vaccin personnalisé contre le cancer conçu par IA, EVX-01, lors du congrès ESMO 2025 le 17 octobre 2025 (session orale) avec un webinaire de suivi le 22 octobre 2025. La présentation couvre l’efficacité clinique sur deux ans, l’immunogénicité et la sécurité, y compris la meilleure réponse globale, les taux de réponse profonde/de conversion, la durabilité de la réponse et l’étendue/ amplitude/durée des cellules T après une dose de rappel.
Des données intermédiaires antérieures ont rapporté un taux de réponse globale de 69%, une réduction des lésions cibles tumorales chez 15 sur 16 patients, une corrélation entre les prédictions par IA et les réponses immunitaires (p=0,00013) et que 80% des cibles vaccinales ont déclenché des réponses immunitaires spécifiques à la tumeur. L’essai évalue EVX-01 plus KEYTRUDA® chez le mélanome avancé; Evaxion sera disponible au stand #3035 pour discussions.
Evaxion (NASDAQ: EVAX) wird Phase-2-Daten zu EVX-01, seinem KI-designten personalisierten Krebsimpfstoff, zwei Jahre lang beim ESMO-Kongress 2025 am 17. Oktober 2025 (Oral-Sitzung) präsentieren, mit einem Folge-Webinar am 22. Oktober 2025. Die Präsentation deckt zwei Jahre klinische Wirksamkeit, Immunogenität und Sicherheit ab, einschließlich bestes Gesamtergebnis, tiefergehende Reaktions-/Konversionsraten, Dauer der Reaktion sowie Breite/Stärke/Dauer der T-Zell-Reaktion nach Booster-Dosis.
Frühere Zwischenmeldungen berichteten eine 69%-ige Gesamtansprechrate, eine Reduktion der Tumorziel-Läsionen bei 15 von 16 Patienten, eine Korrelation zwischen KI-Vorhersagen und Immunantworten (p=0,00013) und dass 80% der Impfzielmoleküle Tumorspezifische Immunreaktionen auslösten. Die Studie testet EVX-01 plus KEYTRUDA® beim fortgeschrittenen Melanom; Evaxion wird am Stand #3035 für Diskussionen zur Verfügung stehen.
Evaxion (NASDAQ: EVAX) ستعرض بيانات المرحلة الثانية لمدة سنتين للقاحها المضاد للسرطان الذي صممه الذكاء الاصطناعي EVX-01 في مؤتمر ESMO 2025 في 17 أكتوبر 2025 (الجلسة الشفوية) مع ندوة إلكترونية متابعة في 22 أكتوبر 2025. تغطي العرض الفعالية السريرية لمدة عامين، والمناعة/المناعة الفعالة والسلامة، بما في ذلك الاستجابة الإجمالية الأفضل، معدلات الاستجابة العميقة/التحويل، دوام الاستجابة، ونطاق/شدة/مدة استجابات خلايا T بعد جرعة المعزز.
كانت البيانات المرحلية السابقة قد أفادت بمعدل استجابة إجمالي قدره 69%، انخفاض في آفات الورم المستهدفة لدى 15 من 16 مريضا، وجود ارتباط بين توقعات الذكاء الاصطناعي والاستجابات المناعية (p=0.00013)، وأن 80% من أهداف اللقاح أطلقت استجابات مناعية محددة للورم. الاختبار يختبر EVX-01 مع KEYTRUDA® في ميلانوما متقدم؛ ستكون Evaxion متاحة في الجناح #3035 للمناقشات.
Evaxion（NASDAQ：EVAX） 将在 ESMO 2025 会议 就其由 AI 设计的个性化癌症疫苗 EVX-01 的两年 II 期 数据进行展示，时间为 2025 年 10 月 17 日（口头会）并于 2025 年 10 月 22 日 举行后续网络研讨会。报告涵盖两年的临床疗效、免疫原性和安全性，包括最佳总体应答、深度应答/转化率、应答持续性，以及 booster 给药后 T 细胞的广度/强度/持续时间。
早期中期数据报道了 69% 的总体应答率，肿瘤靶病灶在 16 例中 15 例 的缩小，AI 预测与免疫应答之间的相关性（p=0.00013），以及 疫苗靶点的 80% 激发了肿瘤特异性免疫应答。该试验在晚期黑色素瘤中测试 EVX-01 与 KEYTRUDA®；Evaxion 将在展位 #3035 提供讨论。
- 69% Overall Response Rate reported in interim data
- Tumor reduction in 15 of 16 patients
- p=0.00013 correlation between AI predictions and immune responses
- 80% of vaccine targets triggered tumor-specific immune responses
- Two-year follow-up data on efficacy, immunogenicity and safety
- Small evaluable cohort: 16 patients, limiting statistical power
Insights
Two‑year phase 2 data for EVX-01 show strong response and T‑cell activity, supporting clinical promise and partnership interest.
Evaxion's AI‑designed personalized vaccine EVX-01 demonstrates clinical activity when combined with KEYTRUDA®, with a reported
The program's near‑term value depends on confirmatory durability and safety details at the two‑year readout, plus reproducibility in larger cohorts. The announcement lists specific efficacy, immunogenicity and safety endpoints; interpretation requires the full dataset (e.g., confidence intervals, progression‑free survival, adverse event grades, and comparator context) which are not restated here. Watch for detailed subgroup breakdowns, durability metrics and safety grading reported on
- Presentation will cover two-year clinical efficacy, immunogenicity and safety data
- Data 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 European Society for Medical Oncology (ESMO) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025.
The data, which will be presented at an oral session, will include two-year clinical efficacy, immunogenicity and safety data. More specifically, data will be presented on best overall response, deepened response/conversion rates and durability of response. Furthermore, the presentation will include data on the breadth, magnitude and duration of T-cell response upon booster immunization as well as data on the vaccine’s safety profile.
“We are eagerly anticipating the presentation of the data and the subsequent discussions with medical and scientific colleagues as well as potential partner companies. We are excited to have been selected for oral presentation at an event as important as the ESMO Congress, one of the most prestigious medical oncology conferences in the world. This is a testament to the interest in EVX-01 and the field of personalized cancer vaccines in general,” says Birgitte Rønø, CSO and interim CEO of Evaxion.
Evaxion will be present and available for discussions at a booth (#3035) throughout the conference to allow for interactions and discussions of the data with all interested stakeholders.
Convincing data
Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The trial has yielded numerous convincing data already, including interim one-year data presented at the ESMO Congress last year.
Data demonstrated a
The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Presentation details
Abstract Title: EVX-01, a personalized cancer vaccine, induces potent T-cell responses and durable disease control in advanced melanoma: 2-year follow-up
Abstract#: #6308
Presentation#: 1516MO
Track: Mini oral session: Investigational immunotherapy
Location: Nuremberg Auditorium - Hall 5.2
Booth: n#3035
Date/Time: October 17 at 14:10 - 14:15 CEST
Presenter: Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia
Webinar on October 22, 2025
Evaxion will be hosting an online webinar featuring key opinion leader and trial investigator, Dr. Muhammad Adnan Khattak, on October 22, 2025, at 16.30 CEST/10.30am EDT.
The webinar can be attended through registration via this link.
In the webinar, Dr. Khattak will present the two-year phase 2 data and discuss challenges in the medical treatment of advanced melanoma. In the end, a Q&A session will be held, and participants are encouraged to present questions.
About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.
EVX-01 is a personalized therapy designed with our AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors.
In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (
In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology™ predictions was observed, underlining the predictive power of the platform.
Contact information
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai
About Evaxion
Evaxion is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website.
Forward-looking statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.
FAQ
When will Evaxion (EVAX) present EVX-01 phase 2 data at ESMO 2025?
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