80% of the EVX-01 vaccine targets trigger a tumor-reactive immune response - Evaxion presents striking EVX-01 data at the AACR Annual meeting
Evaxion Biotech (NASDAQ: EVAX) has presented compelling new data for its personalized cancer vaccine EVX-01 at the AACR Annual Meeting. The vaccine, designed using AI-Immunology™ platform, demonstrated an impressive 80% tumor-specific immune response rate among vaccine targets, surpassing previously reported rates of 71% and 79% at ASCO and ESMO 2024 meetings.
The ongoing phase 2 trial evaluates EVX-01 in combination with KEYTRUDA® for advanced melanoma treatment. The immune response data shows strong and sustained results, with enhanced effects from booster immunizations. The trial, which previously showed strong one-year interim clinical data, is progressing toward its two-year data readout in H2 2025 and has been extended for a third year for comprehensive assessment.
Evaxion Biotech (NASDAQ: EVAX) ha presentato nuovi dati convincenti per il suo vaccino personalizzato contro il cancro EVX-01 durante l'AACR Annual Meeting. Il vaccino, progettato utilizzando la piattaforma AI-Immunology™, ha mostrato un impressionante tasso di risposta immunitaria specifica del tumore dell'80% tra gli obiettivi del vaccino, superando i tassi precedentemente riportati del 71% e 79% agli incontri ASCO e ESMO 2024.
Lo studio di fase 2 in corso valuta EVX-01 in combinazione con KEYTRUDA® per il trattamento del melanoma avanzato. I dati sulla risposta immunitaria mostrano risultati forti e duraturi, con effetti potenziati dalle immunizzazioni di richiamo. Lo studio, che aveva già evidenziato dati clinici intermedi solidi a un anno, sta procedendo verso la lettura dei dati a due anni nella seconda metà del 2025 ed è stato esteso per un terzo anno per una valutazione più completa.
Evaxion Biotech (NASDAQ: EVAX) ha presentado datos nuevos y convincentes sobre su vacuna personalizada contra el cáncer EVX-01 en la Reunión Anual de AACR. La vacuna, diseñada con la plataforma AI-Immunology™, demostró una impresionante tasa de respuesta inmune específica al tumor del 80% entre los objetivos vacunales, superando las tasas reportadas previamente del 71% y 79% en las reuniones ASCO y ESMO 2024.
El ensayo de fase 2 en curso evalúa EVX-01 en combinación con KEYTRUDA® para el tratamiento del melanoma avanzado. Los datos de respuesta inmune muestran resultados sólidos y sostenidos, con efectos mejorados tras las inmunizaciones de refuerzo. El ensayo, que anteriormente mostró datos clínicos intermedios sólidos a un año, avanza hacia la lectura de datos a dos años en la segunda mitad de 2025 y se ha extendido por un tercer año para una evaluación más completa.
Evaxion Biotech (NASDAQ: EVAX)는 AACR 연례회의에서 개인 맞춤형 암 백신 EVX-01에 대한 새로운 강력한 데이터를 발표했습니다. AI-Immunology™ 플랫폼을 활용해 설계된 이 백신은 백신 대상에서 80%의 종양 특이 면역 반응률을 보여 ASCO 및 ESMO 2024 회의에서 보고된 71%와 79%의 수치를 뛰어넘었습니다.
현재 진행 중인 2상 임상시험은 진행성 흑색종 치료를 위해 KEYTRUDA®와 EVX-01의 병용을 평가하고 있습니다. 면역 반응 데이터는 강력하고 지속적인 결과를 보여주며, 부스터 접종으로 효과가 더욱 향상되었습니다. 1년 중간 임상 데이터에서 강력한 결과를 보였던 이 시험은 2025년 하반기 2년차 데이터 발표를 앞두고 있으며, 보다 포괄적인 평가를 위해 3년차까지 연장되었습니다.
Evaxion Biotech (NASDAQ : EVAX) a présenté de nouvelles données convaincantes sur son vaccin personnalisé contre le cancer EVX-01 lors de la réunion annuelle de l'AACR. Le vaccin, conçu grâce à la plateforme AI-Immunology™, a démontré un impressionnant taux de réponse immunitaire spécifique à la tumeur de 80% parmi les cibles du vaccin, dépassant les taux précédemment rapportés de 71% et 79% lors des réunions ASCO et ESMO 2024.
L'essai de phase 2 en cours évalue EVX-01 en association avec KEYTRUDA® pour le traitement du mélanome avancé. Les données de réponse immunitaire montrent des résultats solides et durables, avec des effets renforcés par les rappels vaccinaux. L'essai, qui avait déjà présenté de solides données cliniques intermédiaires à un an, progresse vers la publication des données à deux ans au second semestre 2025 et a été prolongé d'une troisième année pour une évaluation complète.
Evaxion Biotech (NASDAQ: EVAX) hat auf dem AACR-Jahrestreffen überzeugende neue Daten zu seinem personalisierten Krebsimpfstoff EVX-01 vorgestellt. Der mit der AI-Immunology™-Plattform entwickelte Impfstoff zeigte eine beeindruckende 80% tumorspezifische Immunantwort bei den Impfstoffzielen und übertraf damit die zuvor auf den ASCO- und ESMO-2024-Tagungen berichteten Raten von 71% bzw. 79%.
Die laufende Phase-2-Studie bewertet EVX-01 in Kombination mit KEYTRUDA® zur Behandlung des fortgeschrittenen Melanoms. Die Immunantwortdaten zeigen starke und anhaltende Ergebnisse, mit verstärkten Effekten durch Booster-Impfungen. Die Studie, die bereits starke einjährige Zwischenklinische Daten zeigte, schreitet auf die Auswertung der zweijährigen Daten in der zweiten Hälfte 2025 zu und wurde für ein drittes Jahr verlängert, um eine umfassendere Bewertung zu ermöglichen.
- Achieved 80% tumor-specific immune response rate, higher than competitor vaccines
- Strong and durable immune response with enhancement from boosters
- Trial extended to third year, indicating promising potential
- Previously showed strong one-year interim clinical data
- Final clinical efficacy data not yet available until H2 2025
Insights
Evaxion's cancer vaccine EVX-01 shows exceptional 80% immune response rate, validating their AI platform and enhancing prospects for melanoma treatment.
The 80% target-specific immune response reported for EVX-01 represents a significant technical achievement in the personalized cancer vaccine space. This hit rate—improved from previously reported
What makes this particularly notable is the robustness and durability of the immune responses observed. Cancer vaccines often struggle with maintaining sustained immune activity against tumor targets, but EVX-01 appears to generate persistent responses that actually strengthen with booster immunizations, suggesting potential for long-term therapeutic effect.
The combination strategy with pembrolizumab (Keytruda) follows the current paradigm in immuno-oncology where checkpoint inhibitors can be significantly enhanced by tumor-specific immune activation. For advanced melanoma, where immune escape mechanisms often limit monotherapy efficacy, this dual approach addresses multiple aspects of tumor immunology.
While these immunological data are encouraging, they represent surrogate endpoints. The extension of the trial to three years suggests promising activity, as trials are rarely extended without some evidence of benefit. The upcoming two-year clinical readout in H2 2025 will provide the critical efficacy metrics needed to fully evaluate therapeutic potential.
The personalized manufacturing approach—creating unique vaccines for each patient—presents both advantages (precise targeting) and challenges (production complexity), but success here would validate Evaxion's entire technological platform beyond just melanoma applications.
Evaxion's 80% immune response rate validates AI platform and strengthens EVX-01's competitive position, boosting long-term company value despite early-stage status.
This 80% target hit rate significantly strengthens Evaxion's scientific credibility and validates their AI-Immunology™ platform as a potentially best-in-class technology for personalized cancer vaccine development. For a
The progressive improvement in response rates across sequential data presentations (
Strategically, the collaboration with MSD/Merck using Keytruda creates multiple upside scenarios: strong combination data could position EVX-01 as a compelling companion therapy to the blockbuster checkpoint inhibitor, potentially attracting partnership interest from major oncology players.
The extension to a three-year trial timeline, while delaying ultimate readout, suggests confidence in durability of effect—an essential factor for adoption in the competitive oncology landscape. This longer-term view aligns with the growing recognition that immunotherapy benefits often extend beyond conventional measurement periods.
For risk assessment, it's important to note these remain interim immunological data, not definitive efficacy results. The two-year clinical data expected in H2 2025 will provide the critical proof-of-concept that could dramatically accelerate Evaxion's trajectory if positive.
80% of EVX-01 vaccine targets triggered a tumor-specific immune response, a substantially higher frequency than what has been reported for other similar vaccine candidates- The data underscores the precision of Evaxion’s AI-Immunology™ platform in selecting therapeutically relevant vaccine targets
- New findings show EVX-01 inducing a robust and durable immune response, further enhanced by booster immunizations
- The ongoing phase 2 trial with EVX-01 remains on track for two-year data readout in the second half of 2025
COPENHAGEN, Denmark, April 28, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new data underscoring the ability of cancer vaccine EVX-01 to drive a targeted and robust immune response. 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).
New immune data from the ongoing phase 2 trial with EVX-01 will be presented at a poster session tomorrow at the American Association for Cancer Research (AACR) Annual Meeting taking place in Chicago. The data demonstrates that
In earlier interim analyses presented at the ASCO and ESMO 2024 meetings, a vaccine target hit rate of
“We are excited to report yet another positive set of data for our lead vaccine candidate EVX-01. Its ability to trigger an immune response is unprecedented compared to what has been reported by others. We are further encouraged by the data showing this response to be strong and long-lasting and increasing with additional booster immunizations. The data package for EVX-01 gets stronger and stronger and we are eagerly anticipating the two-year clinical readout,” says Birgitte Rønø, CSO of Evaxion.
The trial previously yielded strong interim one-year clinical data and remains on track for readout of two-year clinical data in the second half of 2025. Additionally, the trial has been extended with a third year, allowing for a more comprehensive assessment of the full potential of EVX-01.
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.
AACR presentation details:
| Abstract title: | T-cell immunogenicity and biomarker profiling in advanced melanoma patients receiving the personalized vaccine EVX-01 in combination with pembrolizumab |
| Abstract#: | 4538 |
| Poster#: | 9 |
| Session (category): | Immune responses to therapies including chemotherapy and radiotherapy (Clinical research) |
| Location: | Poster section 28 |
| Date/Time: | April 29, 2025, at 9am-12pm CST/16-19 CET |
| Presenter: | Mads Lausen Nielsen, PhD, Project Manager at Evaxion |
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 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 clinical trials, EVX-01 has demonstrated
Contact information
Evaxion Biotech A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai
About EVAXION
Evaxion Biotech A/S 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
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FAQ
What are the latest efficacy results for EVAX's EVX-01 cancer vaccine?
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