Evaxion doses first patient in extension of phase 2 trial exploring the full potential of AI-designed personalized cancer vaccine EVX-01
La sperimentazione originale di Fase 2 ha mostrato risultati promettenti, con un tasso di risposta complessiva del 69% e una riduzione del tumore in 15 pazienti su 16 dopo un anno. In particolare, l'80% degli obiettivi del vaccino EVX-01 ha attivato con successo risposte immunitarie. L'estensione dello studio fornirà dati sulla durata del trattamento fino a tre anni, con i risultati a due anni attesi nella seconda metà del 2025.
El ensayo original de Fase 2 mostró resultados prometedores, con una tasa de respuesta global del 69% y reducción tumoral en 15 de 16 pacientes al año. Notablemente, el 80% de los objetivos de la vacuna EVX-01 activaron respuestas inmunitarias exitosamente. La extensión del ensayo proporcionará información sobre la durabilidad del tratamiento hasta por tres años, con datos a dos años esperados para la segunda mitad de 2025.
원래 2상 시험에서는 1년 시점에서 전체 반응률 69%와 16명 중 15명의 종양 감소라는 유망한 결과가 나타났습니다. 특히 EVX-01 백신 표적의 80%가 면역 반응을 성공적으로 유도했습니다. 이번 연장 시험은 최대 3년간 치료 지속성을 파악할 수 있게 하며, 2년 데이터는 2025년 하반기에 공개될 예정입니다.
L'essai de phase 2 initial a montré des résultats prometteurs, avec un taux de réponse globale de 69% et une réduction tumorale chez 15 patients sur 16 après un an. Notamment, 80% des cibles du vaccin EVX-01 ont déclenché avec succès des réponses immunitaires. L'extension de l'essai fournira des informations sur la durabilité du traitement jusqu'à trois ans, avec des données à deux ans attendues au second semestre 2025.
Die ursprüngliche Phase-2-Studie zeigte vielversprechende Ergebnisse mit einer Gesamtansprechrate von 69% und Tumorverkleinerungen bei 15 von 16 Patienten nach einem Jahr. Bemerkenswert ist, dass 80% der Impfstoffziele von EVX-01 erfolgreich Immunantworten auslösten. Die Verlängerung der Studie wird Einblicke in die Haltbarkeit der Behandlung für bis zu drei Jahre geben, wobei Daten für zwei Jahre in der zweiten Hälfte 2025 erwartet werden.
- Strong interim results with 69% Overall Response Rate and tumor reduction in 15/16 patients
- 80% of vaccine targets triggered immune responses, outperforming other approaches
- Extension phase involves minimal additional costs as trial sites are running and vaccines are produced
- Potential for EVX-01 to become a standalone treatment option after checkpoint inhibitor therapy
- Limited patient data with only 16 patients reported in interim results
- Still in Phase 2 trials, requiring further studies before potential approval
Insights
Evaxion's EVX-01 trial extension provides valuable opportunity to assess the vaccine as monotherapy following promising initial combination therapy results.
The extension of Evaxion's Phase 2 trial for EVX-01 represents a strategic enhancement to their clinical development program. This extension focuses on assessing the vaccine as monotherapy after initial combination with checkpoint inhibitors, addressing an important clinical question in the field of cancer immunotherapy.
The reported 69% Overall Response Rate from the one-year data is notably strong for advanced melanoma. For context, standard checkpoint inhibitor monotherapy typically achieves 30-40% response rates in this setting. The observation that 15 out of 16 patients showed tumor reduction further strengthens the efficacy signal.
Particularly impressive is the 80% neoantigen-specific immune response rate, which exceeds typical rates seen with other personalized cancer vaccine approaches that often achieve 30-60% target-specific responses. The statistically significant correlation (p=0.00013) between AI predictions and actual immune responses validates their AI-Immunology platform's capability to select optimal neoantigens.
The extension also creates a cost-efficient opportunity to generate valuable durability data up to three years. In the advanced melanoma treatment landscape, where checkpoint inhibitor therapy is typically limited to two years, the potential for EVX-01 as maintenance monotherapy could address an important unmet need in the treatment paradigm if data confirms continued benefit.
Evaxion's approach of using AI to design truly personalized vaccines represents the cutting edge of precision oncology. The ability to efficiently match specific tumor mutations with immune targets could potentially improve efficacy while minimizing off-target effects compared to less tailored approaches.
- Generation of additional clinical data allows for a more comprehensive assessment of the full potential of EVX-01, while strengthening the already strong clinical data package
- Will provide insights into the durability of immune and clinical responses up to three years
- Extension phase enables exploration of EVX-01 as monotherapy, following initial combination with standard of care
- Minimal costs are associated with the extension as clinical sites are already running and the vaccines are produced
- The trial remains on track for two-year data readout in the second half of 2025
COPENHAGEN, Denmark, May 22, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has dosed the first patient in its one-year extension of the ongoing phase 2 trial with its lead asset EVX-01. 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 extension will further explore the full potential of EVX-01 as a possible new and innovative treatment of advanced melanoma, particularly its long-term clinical and immune benefits. The trial extension involves minimal cost as trial sites are running and the vaccine product has already been produced.
Having completed the initial two-year treatment, the first patient in the extension of the trial has now received the first additional dose of EVX-01. Patients entering the one-year extension of the trial will in total receive two additional EVX-01 doses as monotherapy.
In the first two years of the trial, EVX-01 was administered in combination with standard anti-PD-1 therapy (checkpoint inhibitors). With checkpoint inhibitor treatment restricted to a two-year duration, the extension phase provides an opportunity to evaluate the benefits of EVX-01 monotherapy. This could position EVX-01 as a potential standalone treatment for advanced melanoma.
“Extending the trial allows us to explore EVX-01’s potential beyond its combination use with checkpoint inhibitors. By studying EVX-01 as a monotherapy, we aim to assess the independent effects of EVX-01, including its induced immune response and clinical outcome. Given that checkpoint inhibitor therapy is not approved beyond two years of treatment, this additional EVX-01 treatment option could offer a meaningful option for patients”, says Birgitte Rønø, Chief Scientific Officer 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. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Convincing one-year phase 2 data
Initially planned to run for two years, the trial remains on track to yield two-year data for presentation in the second half of 2025. 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
Further,
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 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.
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FAQ
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