Evaxion reports 69% Overall Response Rate in its phase 2 trial on lead cancer vaccine candidate EVX-01
Evaxion Biotech A/S (NASDAQ: EVAX) has reported promising results from its phase 2 trial of EVX-01, its lead cancer vaccine candidate. The interim analysis shows a 69% Overall Response Rate, with 11 out of 16 patients experiencing objective clinical responses. Notably, 15 out of 16 patients showed tumor reduction. The trial combines EVX-01 with MSD's anti-PD-1 therapy, KEYTRUDA®, in advanced melanoma patients.
The complete one-year dataset will be presented at the ESMO Congress 2024 in Barcelona. Evaxion's CEO, Christian Kanstrup, expressed excitement about the data, emphasizing its support for EVX-01's clinical profile and the AI-Immunology™ platform's predictive capabilities. The company will host a webinar on September 18, 2024, featuring Professor Georgina V. Long to discuss the trial results and challenges in advanced melanoma treatment.
Evaxion Biotech A/S (NASDAQ: EVAX) ha riportato risultati promettenti dal suo trial di fase 2 per EVX-01, il suo candidato vaccinale contro il cancro di punta. L'analisi intermedia mostra un 69% Rateo di Risposta Complessivo, con 11 pazienti su 16 che hanno mostrato risposte cliniche oggettive. È interessante notare che 15 pazienti su 16 hanno evidenziato una riduzione del tumore. Lo studio combina EVX-01 con la terapia anti-PD-1 di MSD, KEYTRUDA®, in pazienti con melanoma avanzato.
Il dataset completo di un anno sarà presentato al Congresso ESMO 2024 a Barcellona. Il CEO di Evaxion, Christian Kanstrup, ha espresso entusiasmo per i dati, sottolineando il supporto al profilo clinico di EVX-01 e le capacità predittive della piattaforma AI-Immunology™. L'azienda ospiterà un webinar il 18 settembre 2024, con il Professor Georgina V. Long, per discutere i risultati dello studio e le sfide nel trattamento del melanoma avanzato.
Evaxion Biotech A/S (NASDAQ: EVAX) ha informado sobre resultados prometedores de su ensayo de fase 2 de EVX-01, su candidato a vacuna contra el cáncer principal. El análisis intermedio muestra una Tasa de Respuesta Global del 69%, con 11 de 16 pacientes experimentando respuestas clínicas objetivas. Cabe destacar que 15 de 16 pacientes mostraron reducción del tumor. El ensayo combina EVX-01 con la terapia anti-PD-1 de MSD, KEYTRUDA®, en pacientes con melanoma avanzado.
El conjunto de datos completo de un año se presentará en el Congreso ESMO 2024 en Barcelona. El CEO de Evaxion, Christian Kanstrup, expresó su entusiasmo por los datos, enfatizando su apoyo al perfil clínico de EVX-01 y las capacidades predictivas de la plataforma AI-Immunology™. La empresa organizará un seminario web el 18 de septiembre de 2024, con la Profesora Georgina V. Long, para discutir los resultados del ensayo y los desafíos en el tratamiento del melanoma avanzado.
Evaxion Biotech A/S (NASDAQ: EVAX)는 EVX-01, 자사의 주요 암 백신 후보의 2상 시험에서 유망한 결과를 보고했습니다. 중간 분석에 따르면 69%의 전체 응답률을 기록했으며, 16명의 환자 중 11명이 객관적인 임상 반응을 보였습니다. 특히 16명의 환자 중 15명이 종양 감소를 나타냈습니다. 이 시험은 EVX-01과 MSD의 항-PD-1 치료제 KEYTRUDA®를 고급 흑색종 환자에게 결합하여 진행되었습니다.
1년 완전 데이터 세트는 바르셀로나에서 열리는 ESMO Congress 2024에서 발표될 예정입니다. Evaxion의 CEO인 Christian Kanstrup는 데이터에 대한 기대를 표현하며, EVX-01의 임상 프로필 및 AI-Immunology™ 플랫폼의 예측 능력을 강조했습니다. 회사는 2024년 9월 18일에 Professor Georgina V. Long을 초청하여 시험 결과 및 고급 흑색종 치료의 과제에 대해 논의할 웹 세미나를 개최할 예정입니다.
Evaxion Biotech A/S (NASDAQ: EVAX) a rapporté des résultats prometteurs de son essai de phase 2 d'EVX-01, son principal candidat vaccin contre le cancer. L'analyse intermédiaire montre un Taux de Réponse Global de 69%, avec 11 patients sur 16 montrant des réponses cliniques objectives. Il est à noter que 15 patients sur 16 ont montré une réduction de la tumeur. L'essai combine EVX-01 avec la thérapie anti-PD-1 de MSD, KEYTRUDA®, chez des patients atteints de mélanome avancé.
Les données complètes d'un an seront présentées au Congrès ESMO 2024 à Barcelone. Le PDG d'Evaxion, Christian Kanstrup, a exprimé son enthousiasme pour ces données, soulignant leur soutien au profil clinique d'EVX-01 et aux capacités prédictives de la plateforme AI-Immunology™. La société organisera un webinaire le 18 septembre 2024, avec le Professeur Georgina V. Long pour discuter des résultats de l'essai et des défis dans le traitement du mélanome avancé.
Evaxion Biotech A/S (NASDAQ: EVAX) hat vielversprechende Ergebnisse aus der Phase-2-Studie von EVX-01, seinem führenden Impfstoffkandidaten gegen Krebs, berichtet. Die Zwischenanalyse zeigt eine 69% Gesamtansprechrate, wobei 11 von 16 Patienten objektive klinische Reaktionen zeigten. Bemerkenswert ist, dass 15 von 16 Patienten eine Tumorreduktion aufwiesen. Die Studie kombiniert EVX-01 mit MSDs Anti-PD-1-Therapie KEYTRUDA® bei Patienten mit fortgeschrittenem Melanom.
Die vollständigen Daten des einjährigen Datensatzes werden auf dem ESMO-Kongress 2024 in Barcelona präsentiert. Der CEO von Evaxion, Christian Kanstrup, äußerte sich begeistert über die Daten und betonte deren Unterstützung für das klinische Profil von EVX-01 sowie die prädiktiven Fähigkeiten der AI-Immunology™-Plattform. Das Unternehmen wird am 18. September 2024 ein Webinar veranstalten, in dem Professor Georgina V. Long die Studienergebnisse und Herausforderungen bei der Behandlung von fortgeschrittenem Melanom diskutiert.
- 69% Overall Response Rate (ORR) in phase 2 trial of EVX-01
- 15 out of 16 patients showed tumor reduction
- Successful combination with KEYTRUDA® (pembrolizumab) in advanced melanoma treatment
- Positive interim results support EVX-01's clinical profile and AI-Immunology™ platform capabilities
- None.
The 69% Overall Response Rate (ORR) in this phase 2 trial for EVX-01 is remarkably high for melanoma treatment. Typically, anti-PD-1 monotherapy yields ORRs around 30-40%. This suggests that EVX-01, when combined with pembrolizumab, could potentially double the efficacy of current standard treatments.
The fact that 15 out of 16 patients showed tumor reduction is also significant, indicating a broad response across the patient population. This could imply that the AI-designed personalized approach is effectively targeting a wide range of tumor neoantigens.
However, it's important to note that this is an interim analysis with a small sample size. We'll need to see the complete dataset, including progression-free survival and overall survival data, to fully assess the treatment's long-term efficacy and potential.
Evaxion's EVX-01 phase 2 results are highly promising for the company's future. The 69% ORR significantly outperforms current melanoma treatments, potentially positioning EVX-01 as a game-changer in the
Investors should note that these results could lead to increased interest from big pharma for partnerships or acquisitions. The AI-Immunology™ platform's success here may also validate its application in other cancer types, expanding Evaxion's potential market.
However, caution is warranted. The small sample size and interim nature of the data mean that final results could differ. Additionally, the path to market still involves regulatory hurdles and potential competition from other emerging therapies. Investors should closely monitor the complete data presentation at ESMO and any subsequent partnership discussions.
The success of EVX-01 marks a significant milestone in the application of AI to drug discovery and personalized medicine. Evaxion's AI-Immunology™ platform has demonstrated its ability to design effective personalized cancer vaccines, potentially revolutionizing cancer treatment approaches.
This success could accelerate the adoption of AI in other areas of drug discovery and development, potentially reducing time and costs associated with bringing new treatments to market. It also validates the concept of using AI to create truly personalized treatments based on individual genetic profiles.
However, it's important to consider the scalability and cost-effectiveness of this approach. While highly effective, personalized treatments can be complex and expensive to produce. The industry will be watching closely to see how Evaxion addresses these challenges as they move towards potential commercialization.
- Topline data from a one-year interim analysis of the ongoing phase 2 trial show that 11 out of 16 patients had objective clinical responses, equaling a
69% Overall Response Rate - 15 out of the 16 patients had reduction of their tumors (target lesions)
- The complete one-year dataset will be presented at the ESMO congress this week and discussed at a webinar with key opinion leader Professor Georgina V. Long on September 18, 2024
COPENHAGEN, Denmark, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new exciting clinical phase 2 data for its lead compound EVX-01. The data show that 11 out of 16 patients had objective clinical responses, equaling a
This topline data is part of a one-year interim analysis of the ongoing phase 2 trial assessing 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). The complete one-year clinical data will be presented at a poster session at the European Society for Medical Oncology (ESMO) Congress 2024, taking place in Barcelona, Spain, from September 13-17, 2024.
“We are very excited about these data, which strongly support both the clinical profile of EVX-01 as a promising personalized cancer treatment and the unique predictive capabilities of our AI-Immunology™ platform. To present phase 2 efficacy data for an AI-designed vaccine is a major milestone for Evaxion. Huge unmet medical needs remain in the field of melanoma, and we believe that EVX-01 could potentially be an improved treatment option for patients.
We look forward to presenting the complete one-year dataset at ESMO, discussing the data with potential partners and advancing the phase 2 trial towards its completion next year,” says Christian Kanstrup, CEO of Evaxion.
Evaxion’s innovative approach to develop personalized cancer vaccines builds on its AI-Immunology™ platform. The vaccines are designed to target the unique genetic makeup of an individual’s tumor and are tailored to the patients’ immune system, potentially enhancing the efficacy of treatment and improving patient outcomes.
Webinar on September 18
Evaxion will be hosting an online webinar featuring key opinion leader and the trial’s principal investigator, Professor Georgina V. Long, on September 18, 2024, at 19:00 CEST/13.00 EST. The webinar can be attended through registration via this link.
In the webinar, Professor Long will present the data from the one-year interim analysis and discuss challenges in the medical treatment of advanced melanoma. In the end, a Q&A session will be held, and participants are encouraged to present questions.
ESMO presentation details:
| Abstract Title: | Phase 2 study of AI-designed personalized neoantigen cancer vaccine, EVX-01, in combination with pembrolizumab in advanced melanoma |
| Abstract#: | 1084P |
| Poster#: | 2904 |
| Track: | Melanoma and other skin tumours |
| Location: | Hall 6 |
| Date/Time: | September 14 at 12:00 – 13:00 CEST |
| Presenter: | Dr. Paola Queirolo, Director, Medical Oncology of Melanoma, Sarcoma and Rare Tumors, European Institue of Oncology, Milan, Italy |
Link to abstract on the ESMO website: ESMO website.
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.
About EVX-01 phase 2 clinical trial
The Phase 2 clinical study (NCT05309421) is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with leading principal investigators and research centers from Italy and Australia. The trial aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with MSD’s anti-PD1 therapy KEYTRUDA® (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Merck Sharp & Dohme LLC supplies KEYTRUDA® (pembrolizumab) for the trial.
About melanoma
Melanoma accounts for approximately 1 in 5 of the 1.5 million new skin cancer cases estimated globally in 2020 with approximately 325,000 cases and 57,000 deaths. The global burden from melanoma is estimated to increase to 510,000 new cases and 96,000 deaths by 2040 (Arnold et al., JAMA Dermatology 2022). The global market for melanoma treatments is estimated to grow to
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 the worldwide ongoing COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia and the Middle East; 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.
Contact information
Evaxion Biotech A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion-biotech.com
Source: Evaxion Biotech
FAQ
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