Evaxion to present two-year clinical efficacy data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025
Evaxion (NASDAQ: EVAX) announced it will present two-year clinical efficacy data from its phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine for advanced melanoma, at the ESMO Congress 2025 in Berlin. The trial combines EVX-01 with MSD's KEYTRUDA庐 and has shown promising results, with interim one-year data demonstrating a 69% Overall Response Rate and tumor reduction in 15 out of 16 patients.
The presentation will take place on October 17, 2025, featuring data that validates their AI-Immunology鈩� platform's predictions, which showed significant correlation (p=0.00013) with immune responses to the personalized vaccine's neoantigens. Each patient in the trial received a unique vaccine designed based on their individual biology.
Evaxion (NASDAQ: EVAX) ha annunciato che presenter脿 i dati sull'efficacia clinica a due anni del suo studio di fase 2 su EVX-01, un vaccino personalizzato contro il cancro progettato con l'IA per il melanoma avanzato, al Congresso ESMO 2025 a Berlino. Lo studio combina EVX-01 con KEYTRUDA庐 di MSD e ha mostrato risultati promettenti, con dati intermedi a un anno che evidenziano un tasso di risposta globale del 69% e una riduzione del tumore in 15 pazienti su 16.
La presentazione si terr脿 il 17 ottobre 2025 e presenter脿 dati che confermano le previsioni della loro piattaforma AI-Immunology鈩�, che ha mostrato una correlazione significativa (p=0,00013) con le risposte immunitarie ai neoantigeni del vaccino personalizzato. Ogni paziente nello studio ha ricevuto un vaccino unico progettato in base alla propria biologia individuale.
Evaxion (NASDAQ: EVAX) anunci贸 que presentar谩 datos de eficacia cl铆nica a dos a帽os de su ensayo de fase 2 de EVX-01, una vacuna personalizada contra el c谩ncer dise帽ada con IA para melanoma avanzado, en el Congreso ESMO 2025 en Berl铆n. El ensayo combina EVX-01 con KEYTRUDA庐 de MSD y ha mostrado resultados prometedores, con datos intermedios de un a帽o que demuestran una tasa de respuesta global del 69% y reducci贸n tumoral en 15 de 16 pacientes.
La presentaci贸n tendr谩 lugar el 17 de octubre de 2025, mostrando datos que validan las predicciones de su plataforma AI-Immunology鈩�, que mostr贸 una correlaci贸n significativa (p=0.00013) con las respuestas inmunitarias a los neoant铆genos de la vacuna personalizada. Cada paciente en el ensayo recibi贸 una vacuna 煤nica dise帽ada seg煤n su biolog铆a individual.
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Evaxion (NASDAQ : EVAX) a annonc茅 qu'elle pr茅sentera les donn茅es d'efficacit茅 clinique sur deux ans de son essai de phase 2 sur EVX-01, un vaccin personnalis茅 contre le cancer con莽u par IA pour le m茅lanome avanc茅, lors du Congr猫s ESMO 2025 脿 Berlin. L'essai combine EVX-01 avec KEYTRUDA庐 de MSD et a montr茅 des r茅sultats prometteurs, avec des donn茅es interm茅diaires 脿 un an d茅montrant un taux de r茅ponse globale de 69% et une r茅duction tumorale chez 15 des 16 patients.
La pr茅sentation aura lieu le 17 octobre 2025 et mettra en avant des donn茅es validant les pr茅dictions de leur plateforme AI-Immunology鈩�, qui a montr茅 une corr茅lation significative (p=0,00013) avec les r茅ponses immunitaires aux n茅oantig猫nes du vaccin personnalis茅. Chaque patient de l'essai a re莽u un vaccin unique con莽u en fonction de sa biologie individuelle.
Evaxion (NASDAQ: EVAX) gab bekannt, dass es klinische Wirksamkeitsdaten 眉ber zwei Jahre aus seiner Phase-2-Studie zu EVX-01, einem KI-entworfenen personalisierten Krebsimpfstoff f眉r fortgeschrittenes Melanom, auf dem ESMO Kongress 2025 in Berlin vorstellen wird. Die Studie kombiniert EVX-01 mit MSDs KEYTRUDA庐 und zeigte vielversprechende Ergebnisse, wobei Zwischenjahresdaten eine Gesamtansprechrate von 69% und Tumorverkleinerungen bei 15 von 16 Patienten zeigten.
Die Pr盲sentation findet am 17. Oktober 2025 statt und enth盲lt Daten, die die Vorhersagen ihrer AI-Immunology鈩�-Plattform validieren, welche eine signifikante Korrelation (p=0,00013) mit Immunreaktionen auf die Neoantigene des personalisierten Impfstoffs zeigte. Jeder Patient erhielt einen einzigartigen Impfstoff, der auf seiner individuellen Biologie basierte.
- Strong interim results with 69% Overall Response Rate
- Tumor reduction observed in 15 out of 16 patients (94%)
- Statistically significant correlation (p=0.00013) between AI platform predictions and immune responses
- Acceptance to present at prestigious ESMO Congress indicates data significance
- None.
Insights
Evaxion's AI-designed cancer vaccine EVX-01 showing promising efficacy in melanoma with upcoming 2-year data presentation at major oncology conference.
Evaxion's upcoming presentation of two-year efficacy data for their AI-designed personalized cancer vaccine EVX-01 at ESMO 2025 represents a significant milestone in their clinical development program. The phase 2 trial evaluates EVX-01 in combination with Merck's KEYTRUDA庐 for advanced melanoma patients, with each participant receiving a customized vaccine based on their individual biology.
The previously presented one-year data demonstrated impressive clinical outcomes, including a
This upcoming data presentation is particularly noteworthy because two-year efficacy data provides critical insights into the durability of response - a key factor in cancer immunotherapy evaluation. For a personalized cancer vaccine, demonstrating sustained efficacy would represent a major advancement in the field of precision oncology.
The selection for presentation at ESMO, one of the world's premier oncology conferences, suggests the data is considered meaningful by expert reviewers. Additionally, the combination approach with KEYTRUDA庐 (an established immune checkpoint inhibitor) follows a rational therapeutic strategy of potentially enhancing T-cell responses against cancer through complementary mechanisms.
For Evaxion's business trajectory, this presentation offers an important opportunity to showcase their technology platform to potential partners, which could accelerate the clinical development process through strategic collaborations.
COPENHAGEN, Denmark, July 25, 2025 - Evaxion A/S (NASDAQ: EVAX) (鈥淓vaxion鈥�), a clinical-stage TechBio company specializing in developing AI-Immunology鈩� powered vaccines, will be presenting two-year clinical efficacy 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.
Designed with Evaxion鈥檚 AI-Immunology鈩� 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 in September 2024. Data demonstrated a
鈥淲e are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO Congress 2025. As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners,鈥� says Birgitte R酶n酶, CSO and interim CEO of Evaxion.
The phase 2 trial investigates EVX-01 in combination with MSD鈥檚 (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA庐 (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庐 is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Presentation details听
| 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:听 | Mini oral session: Investigational immunotherapy |
| Location: | Nuremberg Auditorium - Hall 5.2 |
| 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 |
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鈥檚 lead clinical asset.
EVX-01 is a personalized therapy designed with our AI-Immunology鈩� 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鈩� predictions was observed, underlining the predictive power of the platform.
Contact information
听
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
About Evaxion
Evaxion is a pioneering TechBio company based upon its AI platform, AI-Immunology鈩�. Evaxion鈥檚 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鈩�, 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鈥� lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology鈩� platform and vaccine pipeline, please .
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FAQ
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