Evaxion completes dosing in phase 2 trial with personalized cancer vaccine EVX-01
Evaxion Biotech (NASDAQ: EVAX) has completed dosing all 16 patients in its phase 2 trial of EVX-01, a personalized cancer vaccine for advanced melanoma treatment. The trial, which combines EVX-01 with MSD's KEYTRUDA®, remains on track for completion and data readout in H2 2025.
The company's AI-Immunology™ platform-designed vaccine has shown promising interim results presented at ESMO Congress in September 2024, including a 69% Overall Response Rate and tumor reduction in 15 out of 16 patients. The data demonstrated a positive correlation between AI-platform predictions and immune responses, with 79% of vaccine targets triggering targeted immune responses.
EVX-01 is tailored to each patient's unique tumor profile and immune characteristics, targeting a market of over 300,000 new melanoma cases annually.
Evaxion Biotech (NASDAQ: EVAX) ha completato la somministrazione a tutti e 16 i pazienti nel suo studio di fase 2 su EVX-01, un vaccino personalizzato contro il cancro per il trattamento del melanoma avanzato. Lo studio, che combina EVX-01 con KEYTRUDA® di MSD, è ancora in linea per completamento e lettura dei dati nella seconda metà del 2025.
Il vaccino progettato sulla piattaforma AI-Immunology™ dell'azienda ha mostrato risultati preliminari promettenti presentati al Congresso ESMO nel settembre 2024, inclusa una 69% di Tasso di Risposta Globale e riduzione tumorale in 15 su 16 pazienti. I dati hanno dimostrato una correlazione positiva tra le previsioni della piattaforma AI e le risposte immunitarie, con il 79% degli obiettivi del vaccino che hanno attivato risposte immunitarie specifiche.
EVX-01 è personalizzato in base al profilo tumorale unico e alle caratteristiche immunitarie di ciascun paziente, mirando a un mercato di oltre 300.000 nuovi casi di melanoma all'anno.
Evaxion Biotech (NASDAQ: EVAX) ha completado la dosificación de los 16 pacientes en su ensayo de fase 2 de EVX-01, una vacuna personalizada contra el cáncer para el tratamiento del melanoma avanzado. El ensayo, que combina EVX-01 con KEYTRUDA® de MSD, sigue en camino para completarse y presentar los datos en la segunda mitad de 2025.
La vacuna diseñada en la plataforma AI-Immunology™ de la compañía ha mostrado resultados intermedios prometedores presentados en el Congreso ESMO en septiembre de 2024, incluyendo una Tasa de Respuesta Global del 69% y reducción tumoral en 15 de 16 pacientes. Los datos demostraron una correlación positiva entre las predicciones de la plataforma de IA y las respuestas inmunitarias, con el 79% de los objetivos de la vacuna provocando respuestas inmunitarias específicas.
EVX-01 está adaptada al perfil tumoral único y a las características inmunitarias de cada paciente, apuntando a un mercado de más de 300,000 nuevos casos de melanoma anualmente.
Evaxion Biotech (NASDAQ: EVAX)는 고급 멜라노마 치료를 위한 개인화된 암 백신인 EVX-01의 2상 시험에서 16명의 모든 환자에 대한 투약을 완료했습니다. MSD의 KEYTRUDA®와 EVX-01을 결합한 이 시험은 2025년 하반기 완료 및 데이터 발표를 목표로 진행되고 있습니다.
회사의 AI-Immunology™ 플랫폼에서 설계된 백신은 2024년 9월 ESMO 총회에서 발표된 바와 같이 69%의 전체 반응률과 16명의 환자 중 15명의 종양 축소라는 긍정적인 중간 결과를 보여주었습니다. 데이터는 AI 플랫폼 예측과 면역 반응 간의 긍정적인 상관관계를 입증했으며, 백신 목표의 79%가 특정 면역 반응을 유도했습니다.
EVX-01은 각 환자의 고유한 종양 프로필과 면역 특성에 맞춰 조정되며, 연간 300,000건 이상의 신규 멜라노마 사례 시장을 목표로 하고 있습니다.
Evaxion Biotech (NASDAQ: EVAX) a terminé l'administration des doses à tous les 16 patients dans son essai de phase 2 sur l'EVX-01, un vaccin anticancéreux personnalisé pour le traitement du mélanome avancé. L'essai, qui combine l'EVX-01 avec le KEYTRUDA® de MSD, reste sur la bonne voie pour être terminé et pour les résultats de données au second semestre 2025.
Le vaccin conçu sur la plateforme AI-Immunology™ de l'entreprise a montré des résultats intermédiaires prometteurs présentés au Congrès ESMO en septembre 2024, y compris un Taux de Réponse Global de 69% et une réduction tumorale chez 15 des 16 patients. Les données ont montré une corrélation positive entre les prédictions de la plateforme d'IA et les réponses immunitaires, avec 79% des cibles vaccinales déclenchant des réponses immunitaires spécifiques.
EVX-01 est adapté au profil tumoral unique et aux caractéristiques immunitaires de chaque patient, visant un marché de plus de 300 000 nouveaux cas de mélanome par an.
Evaxion Biotech (NASDAQ: EVAX) hat die Dosierung bei allen 16 Patienten in seiner Phase-2-Studie zu EVX-01, einem personalisierten Krebsimpfstoff zur Behandlung von fortgeschrittenem Melanom, abgeschlossen. Die Studie, die EVX-01 mit KEYTRUDA® von MSD kombiniert, bleibt auf Kurs, um in der zweiten Hälfte von 2025 abgeschlossen zu werden und Daten zu veröffentlichen.
Der Impfstoff, der auf der AI-Immunology™-Plattform des Unternehmens basiert, hat beim ESMO-Kongress im September 2024 vielversprechende Zwischenergebnisse gezeigt, darunter eine 69% Gesamtansprechrate und Tumorverkleinerung bei 15 von 16 Patienten. Die Daten zeigten eine positive Korrelation zwischen den Vorhersagen der KI-Plattform und den Immunantworten, wobei 79% der Impfstoffziele gezielte Immunantworten auslösten.
EVX-01 ist auf das einzigartige Tumorprofil und die Immunmerkmale jedes Patienten zugeschnitten und zielt auf einen Markt von über 300.000 neuen Melanomfällen jährlich ab.
- 69% Overall Response Rate in phase 2 trial
- Tumor reduction observed in 15 out of 16 patients
- 79% of vaccine targets triggered immune response
- Trial timeline on track for H2 2025 completion
- Large market potential with 300,000+ annual melanoma cases
- Full trial results not yet available
- Small patient sample size of only 16 participants
Insights
The completion of dosing in EVX-01's Phase 2 trial represents a important milestone for Evaxion. The trial's 69% Overall Response Rate and tumor reduction in 15 out of 16 patients are particularly impressive metrics in the advanced melanoma space. The 79% target engagement rate for vaccine-triggered immune responses significantly outperforms typical neoantigen approaches, which often achieve 30-40% engagement.
The statistical significance (p=0.00013) of correlation between AI-Immunology™ platform predictions and actual immune responses validates the platform's precision in neoantigen selection. This could revolutionize personalized cancer vaccine development, potentially reducing manufacturing costs and improving efficacy compared to traditional approaches.
The combination with Keytruda, which generates over
The completion of dosing ahead of schedule demonstrates robust trial execution capabilities and efficient patient recruitment - critical factors for biotech companies. The trial design combining a personalized vaccine with an established checkpoint inhibitor (Keytruda) follows current best practices in immuno-oncology.
The interim data showing tumor reduction in 94% of patients (15/16) exceeds typical response rates seen in advanced melanoma trials. For context, Keytruda monotherapy typically achieves 30-40% response rates in similar patient populations. The successful manufacturing and administration of 16 unique patient-specific vaccines also validates Evaxion's production capabilities, a important consideration for commercial scalability.
For a micro-cap biotech (
The partnership with Merck (Keytruda) adds significant credibility and could make Evaxion an attractive acquisition target for larger pharmaceutical companies looking to expand their oncology portfolios. The AI-driven platform's demonstrated accuracy could also lead to licensing deals for other indications, providing additional value drivers beyond EVX-01.
- Trial remains on track for completion and data readout in the second half of 2025
COPENHAGEN, Denmark, January 15, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has now completed the dosing of all 16 patients in its phase 2 trial with the company’s lead asset EVX-01. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine being developed as a treatment of advanced melanoma (skin cancer).
Dosing has been completed according to trial protocol and timelines, meaning the trial remains on track for completion and data readout in the second half of 2025. Coincidently, the first patient has now completed the trial and has had last visit according to the protocol. Patients will continue to be monitored and data collected.
“We are happy to report completion of the dosing in this important trial, demonstrating our strong capabilities in trial execution. Now we focus on carrying the trial through to completion and we are eagerly anticipating the full clinical data readout later this year. Based on the impressive data generated so far, we see that EVX-01 could potentially become a new and effective treatment option for advanced melanoma. With more than 300,000 new melanoma cases each year and significant medical needs, this offers great commercial potential for Evaxion”, says Christian Kanstrup, CEO of Evaxion.
EVX-01 is designed with Evaxion’s AI-Immunology™ platform and tailored to target the unique tumor profile and immune characteristics of each individual patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors.
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.
Convincing one-year phase 2 data
Convincing interim one-year data from the trial was presented at the European Society for Medical Oncology (ESMO) Congress in September 2024. Data demonstrated a
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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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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