Evaxion extends phase 2 trial with personalized cancer vaccine EVX-01 to further enhance clinical data package
Evaxion Biotech (NASDAQ: EVAX) has announced an extension of its Phase 2 trial for EVX-01, a personalized cancer vaccine for advanced melanoma, from two to three years. This extension will allow the company to collect additional clinical outcome data and potentially demonstrate enhanced treatment effects and immune response durability.
The trial, which has already yielded convincing one-year data, will offer active participants the opportunity to receive additional EVX-01 doses as monotherapy after completing the initial two-year protocol. The two-year data readout remains on track for the second half of 2025.
Interim one-year data presented at the ESMO Congress in September 2024 showed promising results:
- 69% Overall Response Rate
- Reduction in tumor target lesions in 15 out of 16 patients
- Positive correlation between AI-Immunology™ platform predictions and immune responses
- 79% of vaccine targets triggered a targeted immune response
EVX-01 is designed using Evaxion's AI-Immunology™ platform and is being tested in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).
Evaxion Biotech (NASDAQ: EVAX) ha annunciato un'estensione della sua sperimentazione di Fase 2 per EVX-01, un vaccino personalizzato contro il cancro per il melanoma avanzato, da due a tre anni. Questa estensione permetterà all'azienda di raccogliere ulteriori dati sugli esiti clinici e potenzialmente dimostrare effetti terapeutici migliorati e una maggiore durata della risposta immunitaria.
La sperimentazione, che ha già fornito dati convincenti dopo un anno, offrirà ai partecipanti attivi la possibilità di ricevere ulteriori dosi di EVX-01 come monoterapia dopo aver completato il protocollo iniziale di due anni. La lettura dei dati a due anni rimane prevista per la seconda metà del 2025.
I dati provvisori a un anno presentati al Congresso ESMO nel settembre 2024 hanno mostrato risultati promettenti:
- 69% Tasso di Risposta Complessivo
- Riduzione delle lesioni tumorali target in 15 pazienti su 16
- Correlazione positiva tra le previsioni della piattaforma AI-Immunology™ e le risposte immunitarie
- 79% degli obiettivi del vaccino ha attivato una risposta immunitaria mirata
EVX-01 è progettato utilizzando la piattaforma AI-Immunology™ di Evaxion ed è attualmente in fase di test in combinazione con la terapia anti-PD-1 di MSD, KEYTRUDA® (pembrolizumab).
Evaxion Biotech (NASDAQ: EVAX) ha anunciado una extensión de su ensayo de Fase 2 para EVX-01, una vacuna personalizada contra el cáncer para melanoma avanzado, de dos a tres años. Esta extensión permitirá a la empresa recopilar datos adicionales sobre los resultados clínicos y potencialmente demostrar efectos de tratamiento mejorados y durabilidad en la respuesta inmunitaria.
El ensayo, que ya ha producido datos convincentes de un año, ofrecerá a los participantes activos la oportunidad de recibir dosis adicionales de EVX-01 como monoterapia tras completar el protocolo inicial de dos años. La lectura de los datos a dos años sigue programada para la segunda mitad de 2025.
Los datos provisionales de un año presentados en el Congreso ESMO en septiembre de 2024 mostraron resultados prometedores:
- 69% Tasa de Respuesta Global
- Reducción de lesiones tumorales objetivo en 15 de 16 pacientes
- Correlación positiva entre las predicciones de la plataforma AI-Immunology™ y las respuestas inmunitarias
- 79% de los objetivos de la vacuna desencadenaron una respuesta inmunitaria dirigida
EVX-01 está diseñado utilizando la plataforma AI-Immunology™ de Evaxion y se está probando en combinación con la terapia anti-PD-1 de MSD, KEYTRUDA® (pembrolizumab).
Evaxion Biotech (NASDAQ: EVAX)는 진행성 흑색종에 대한 개인 맞춤형 암 백신 EVX-01의 2상 시험 기간을 2년에서 3년으로 연장한다고 발표했습니다. 이번 연장은 회사가 추가적인 임상 결과 데이터를 수집하고 치료 효과와 면역 반응의 지속성을 향상시킬 가능성을 보여줄 수 있게 할 것입니다.
이미 1년 동안 설득력 있는 데이터를 얻은 이 시험은 초기 2년 프로토콜을 완료한 후 활성 참가자들에게 추가 EVX-01 용량을 단독 요법으로 제공할 기회를 제공합니다. 2년 데이터 리딩은 2025년 하반기에 예정되어 있습니다.
2024년 9월 ESMO Congress에서 발표된 1년 중간 데이터는 유망한 결과를 보여주었습니다:
- 69% 전체 반응률
- 16명의 환자 중 15명에서 종양 목표 병변의 감소
- AI-Immunology™ 플랫폼 예측과 면역 반응 간의 긍정적인 상관관계
- 백신 목표의 79%가 목표 면역 반응을 유도
EVX-01은 Evaxion의 AI-Immunology™ 플랫폼을 사용하여 설계되었으며, MSD의 항-PD-1 치료제 KEYTRUDA® (펨브롤리주맙)와 병용하여 시험되고 있습니다.
Evaxion Biotech (NASDAQ: EVAX) a annoncé une extension de son essai de Phase 2 pour EVX-01, un vaccin personnalisé contre le cancer pour le mélanome avancé, de deux à trois ans. Cette extension permettra à l'entreprise de collecter des données cliniques supplémentaires et de démontrer potentiellement des effets de traitement améliorés ainsi qu'une durabilité de la réponse immunitaire.
L'essai, qui a déjà produit des données convaincantes après un an, offrira aux participants actifs l'opportunité de recevoir des doses supplémentaires d'EVX-01 en monothérapie après avoir complété le protocole initial de deux ans. La lecture des données à deux ans reste prévue pour la seconde moitié de 2025.
Les données intermédiaires d'un an présentées au Congrès ESMO en septembre 2024 ont montré des résultats prometteurs :
- 69% Taux de Réponse Global
- Réduction des lésions tumorales cibles chez 15 patients sur 16
- Corrélation positive entre les prévisions de la plateforme AI-Immunology™ et les réponses immunitaires
- 79% des cibles du vaccin ont déclenché une réponse immunitaire ciblée
EVX-01 est conçu en utilisant la plateforme AI-Immunology™ d'Evaxion et est testé en combinaison avec la thérapie anti-PD-1 de MSD, KEYTRUDA® (pembrolizumab).
Evaxion Biotech (NASDAQ: EVAX) hat eine Verlängerung seiner Phase-2-Studie für EVX-01, einen personalisierten Impfstoff gegen Krebs bei fortgeschrittenem Melanom, von zwei auf drei Jahre angekündigt. Diese Verlängerung ermöglicht es dem Unternehmen, zusätzliche klinische Ergebnisdaten zu sammeln und potenziell verbesserte Behandlungseffekte sowie eine längere Immunantwort zu demonstrieren.
Die Studie, die bereits überzeugende Einjahresdaten geliefert hat, wird aktiven Teilnehmern die Möglichkeit bieten, nach Abschluss des ursprünglichen zweijährigen Protokolls zusätzliche Dosen von EVX-01 als Monotherapie zu erhalten. Die Auswertung der Zweijahresdaten bleibt für die zweite Hälfte von 2025 geplant.
Die vorläufigen Einjahresdaten, die auf dem ESMO Kongress im September 2024 präsentiert wurden, zeigten vielversprechende Ergebnisse:
- 69% Gesamtansprechrate
- Reduktion der tumoralen Zielherde bei 15 von 16 Patienten
- Positive Korrelation zwischen den Vorhersagen der AI-Immunology™-Plattform und den Immunantworten
- 79% der Impfstoffziele lösten eine gezielte Immunantwort aus
EVX-01 wurde unter Verwendung der AI-Immunology™ Plattform von Evaxion entwickelt und wird in Kombination mit der Anti-PD-1-Therapie von MSD, KEYTRUDA® (Pembrolizumab), getestet.
- 69% Overall Response Rate in one-year data
- Reduction in tumor target lesions in 15 out of 16 patients
- 79% of vaccine targets triggered immune responses
- Positive correlation between AI platform predictions and immune responses (p=0.00013)
- Trial extension may demonstrate enhanced treatment effects and durability
- All active patients achieved reduction in tumor target lesions
- Extended timeline pushes complete data availability to 2026
Insights
Evaxion Biotech's decision to extend its Phase 2 EVX-01 trial by an additional year represents a strategic enhancement of its clinical data package that could significantly strengthen the company's position in the competitive personalized cancer vaccine landscape.
The extension comes after impressive one-year data showing a 69% Overall Response Rate and tumor reduction in 15 of 16 patients - metrics that compare favorably to standard-of-care outcomes in advanced melanoma. The statistical correlation (p=0.00013) between AI predictions and actual immune responses validates Evaxion's technological approach and differentiates it from competitors like BioNTech and Moderna, whose personalized cancer vaccines typically show lower neoantigen response rates in the 20-60% range.
What's particularly noteworthy is the transition to EVX-01 monotherapy in year three, following combination therapy with pembrolizumab in years one and two. This design could answer a critical question that impacts commercial potential: can EVX-01 maintain durable responses without concurrent checkpoint inhibition? Positive results here would substantially increase the vaccine's value proposition and potentially position it as a maintenance therapy after initial combination treatment.
For a micro-cap biotech with a market capitalization of just $15.3 million, this trial extension represents a calculated risk. While it will require additional capital allocation, the enhanced data package could significantly improve partnership and licensing opportunities. The melanoma immunotherapy market is projected to reach $7.5 billion by 2027, and robust three-year data could position Evaxion to capture meaningful market share.
Investors should note that this extension doesn't delay the planned two-year data readout in H2 2025, maintaining near-term catalysts while adding potential long-term value. The extension also suggests management confidence in both the existing data and patient tolerability, as dropout rates would typically make such extensions challenging if the treatment weren't well-tolerated.
The 79% target-specific immune response rate is particularly significant, as it suggests Evaxion's AI platform may be more precise at identifying immunogenic neoantigens than competing approaches. This technical advantage could translate to superior efficacy and potentially broader applications across multiple tumor types, expanding the addressable market beyond melanoma.
While this extension adds complexity to Evaxion's clinical timeline, it demonstrates a commitment to generating comprehensive data that could ultimately accelerate regulatory discussions and commercial partnerships, potentially transforming this undervalued biotech into a significant player in the personalized cancer vaccine space.
- Originally planned as a two-year study, the trial has been extended by an additional year to collect three-year clinical outcome data
- The additional third year of EVX-01 dosing may provide further insights into potential enhanced treatment effects and durability of induced immune response
- The trial already yielded convincing one-year data and remains on track for two-year data readout in the second half of 2025
COPENHAGEN, Denmark, February 25, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will further enhance the data package from its ongoing phase 2 trial with the company’s lead asset EVX-01 by extending the trial from two to three years. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine being developed as a treatment for advanced melanoma (skin cancer).
Active participants in the trial will be given the opportunity to enter the one-year extension after completing the two-year protocol. They will receive additional EVX-01 doses as monotherapy, with close monitoring to assess clinical response duration and immune activation. In the first two years of the trial, patients received EVX-01 in combination with standard anti-PD-1 therapy.
The trial is progressing according to plan, with two-year data readout expected in the second half of 2025. All trial active patients have achieved reduction in tumor target lesions and are faring well, which should allow for a seamless transition into the extension of the trial.
“We are very pleased with how this trial has been progressing and the encouraging data obtained so far. Patients are responding positively to the therapy, which is generally well tolerated. We are happy to support patients further by offering additional EVX-01 treatment. Extending the trial also allows us to collect even more data and further enhance the data package for this promising new potential treatment option for advanced melanoma. Adding another year might allow us to document even better effects of the treatment than what will be observed after one and two years”, 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
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.
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
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 geo-political 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 U.S. 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
What are the key results from Evaxion's EVX-01 Phase 2 trial for melanoma?
How is Evaxion's EVX-01 cancer vaccine personalized for each patient?
When will Evaxion Biotech (EVAX) release the two-year data for its EVX-01 melanoma vaccine?
Why is Evaxion (EVAX) extending its Phase 2 trial for EVX-01 from two to three years?
What treatment will patients receive during the third year of Evaxion's EVX-01 trial?
