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Evaxion establishes new AI-derived precision cancer vaccine concept

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Evaxion Biotech (NASDAQ: EVAX), a clinical-stage TechBio company, has achieved preclinical Proof-of-Concept (PoC) for its AI-Immunology™ platform, which designs precision cancer vaccines targeting non-conventional ERV tumor antigens. The new data, presented at the ESMO Immuno-Oncology Congress, confirm the approach's effectiveness by inducing strong T-cell responses and inhibiting tumor growth in mice.

The AI-Immunology™ platform identifies ERV fragments, or hotspots, that match diverse immune system profiles, potentially broadening the applicability of cancer vaccines to patients unresponsive to conventional immunotherapies. Evaxion plans to select a lead ERV precision vaccine candidate by the second half of 2025.

CEO Christian Kanstrup highlighted the milestone achievement, emphasizing the potential for improved treatment options leveraging AI-Immunology™ to design broadly applicable precision vaccines. The data from human cell and mouse model studies demonstrate the platform's capability to induce functional, antigen-specific T-cells and inhibit tumor growth.

Evaxion Biotech (NASDAQ: EVAX), un'azienda TechBio in fase clinica, ha raggiunto la prova-concetto preclinica (PoC) per la sua piattaforma AI-Immunology™, che progetta vaccini per il cancro di precisione mirati ad antigeni tumorali ERV non convenzionali. I nuovi dati, presentati al Congresso ESMO Immuno-Oncology, confermano l'efficacia dell'approccio inducendo forti risposte delle cellule T e inibendo la crescita tumorale nei topi.

La piattaforma AI-Immunology™ identifica frammenti ERV, o hotspot, che corrispondono a diversi profili del sistema immunitario, ampliando potenzialmente l'applicabilità dei vaccini per il cancro a pazienti non responsivi alle immunoterapie convenzionali. Evaxion prevede di selezionare un candidato vaccino di precisione ERV entro la seconda metà del 2025.

Il CEO Christian Kanstrup ha sottolineato il traguardo raggiunto, enfatizzando il potenziale per migliorare le opzioni di trattamento sfruttando AI-Immunology™ per progettare vaccini di precisione ampiamente applicabili. I dati ottenuti da studi su cellule umane e modelli murini dimostrano la capacità della piattaforma di indurre cellule T specifiche per antigeni e inibire la crescita tumorale.

Evaxion Biotech (NASDAQ: EVAX), una empresa TechBio en etapa clínica, ha logrado la prueba de concepto preclínica (PoC) para su plataforma AI-Immunology™, que diseña vacunas contra el cáncer de precisión dirigidas a antígenos tumorales ERV no convencionales. Los nuevos datos, presentados en el Congreso ESMO Immuno-Oncology, confirman la efectividad del enfoque al inducir respuestas fuertes de células T e inhibir el crecimiento tumoral en ratones.

La plataforma AI-Immunology™ identifica fragmentos de ERV, o puntos críticos, que coinciden con diversos perfiles del sistema inmunológico, ampliando potencialmente la aplicabilidad de las vacunas contra el cáncer a pacientes que no responden a las inmunoterapias convencionales. Evaxion planea seleccionar un candidato de vacuna de precisión ERV para la segunda mitad de 2025.

El CEO Christian Kanstrup destacó el logro importante, enfatizando el potencial de mejorar las opciones de tratamiento aprovechando AI-Immunology™ para diseñar vacunas de precisión ampliamente aplicables. Los datos de estudios en células humanas y modelos de ratón demuestran la capacidad de la plataforma para inducir células T específicas para antígenos e inhibir el crecimiento tumoral.

Evaxion Biotech (NASDAQ: EVAX)는 임상 단계의 TechBio 회사로, 비전형 ERV 종양 항원을 표적으로 하는 정밀 암 백신을 설계하는 AI-Immunology™ 플랫폼에 대해 임상 전 개념 증명(PoC)을 달성했습니다. ESMO 면역종양학 컨퍼런스에서 발표된 새로운 데이터는 강력한 T세포 반응을 유도하고 쥐에서 종양 성장을 억제함으로써 접근 방식의 효과를 확인했습니다.

AI-Immunology™ 플랫폼은 다양한 면역 체계 프로필에 맞는 ERV 조각 또는 핫스팟을 식별하여 전통적인 면역 요법에 반응하지 않는 환자에게 암 백신의 적용 가능성을 넓힐 수 있습니다. Evaxion은 2025년 하반기까지 주요 ERV 정밀 백신 후보를 선택할 계획입니다.

CEO인 Christian Kanstrup는 이 이정표를 강조하며 AI-Immunology™를 활용하여 광범위하게 적용 가능한 정밀 백신을 설계할 수 있는 가능성을 강조했습니다. 인간 세포 및 쥐 모델 연구의 데이터는 플랫폼이 항원 특이적 T세포를 유도하고 종양 성장을 억제하는 능력을 보여줍니다.

Evaxion Biotech (NASDAQ: EVAX), une entreprise TechBio en phase clinique, a atteint la preuve de concept préclinique (PoC) pour sa plateforme AI-Immunology™, qui conçoit des vaccins contre le cancer de précision visant des antigènes tumoraux ERV non conventionnels. Les nouvelles données, présentées au Congrès ESMO Immuno-Oncology, confirment l'efficacité de l'approche en induisant de fortes réponses des cellules T et en inhibant la croissance tumorale chez des souris.

La plateforme AI-Immunology™ identifie des fragments ERV, ou points chauds, qui correspondent à divers profils du système immunitaire, élargissant ainsi potentiellement l'applicabilité des vaccins contre le cancer aux patients non réactifs aux immunothérapies conventionnelles. Evaxion prévoit de sélectionner un candidat de vaccin de précision ERV d'ici la seconde moitié de 2025.

Le PDG Christian Kanstrup a souligné cette réalisation importante, en mettant en avant le potentiel d'améliorer les options de traitement grâce à l'AI-Immunology™ pour concevoir des vaccins de précision largement applicables. Les données issues d'études sur des cellules humaines et des modèles de souris démontrent la capacité de la plateforme à induire des cellules T fonctionnelles spécifiques aux antigènes et à inhiber la croissance tumorale.

Evaxion Biotech (NASDAQ: EVAX), ein Unternehmen der klinischen TechBio-Phase, hat den präklinischen Proof-of-Concept (PoC) für seine AI-Immunologie™-Plattform erreicht, die zielgerichtete Präzisionsimpfstoffe gegen nicht-konventionelle ERV-Tumorantigene entwirft. Die neuen Daten, die auf dem ESMO Immuno-Oncology Congress präsentiert wurden, bestätigen die Wirksamkeit des Ansatzes, indem sie starke T-Zell-Reaktionen induzieren und das Tumorwachstum bei Mäusen hemmen.

Die AI-Immunologie™-Plattform identifiziert ERV-Fragmente oder Hotspots, die zu verschiedenen Immunprofilen passen und somit potenziell die Anwendbarkeit von Krebsimpfstoffen auf Patienten erweitern, die nicht auf konventionelle Immuntherapien ansprechen. Evaxion plant, bis zur zweiten Hälfte von 2025 einen führenden ERV-Präzisionsimpfstoffkandidaten auszuwählen.

CEO Christian Kanstrup hob den Meilenstein hervor und betonte das Potenzial, verbesserte Behandlungsoptionen durch die Nutzung von AI-Immunologie™ zur Entwicklung breit anwendbarer Präzisionsimpfstoffe zu schaffen. Die Daten von Studien mit menschlichen Zellen und Mäusemodellen zeigen die Fähigkeit der Plattform, funktionelle, antigen-spezifische T-Zellen zu induzieren und das Tumorwachstum zu hemmen.

Positive
  • Achieved preclinical PoC for precision cancer vaccines targeting non-conventional ERV tumor antigens.
  • Strong T-cell responses and tumor growth inhibition demonstrated in mice.
  • Potential broader applicability of cancer vaccines for patients unresponsive to conventional immunotherapies.
  • Plan to select a lead ERV precision vaccine candidate by the second half of 2025.
Negative
  • None.

Insights

The preclinical proof-of-concept data for Evaxion's AI-derived ERV-based cancer vaccine platform represents an innovative approach in cancer immunotherapy. The platform's ability to identify shared ERV antigens across patients could potentially address a major limitation of current personalized cancer vaccines - the need for patient-specific manufacturing. The demonstrated T-cell response and tumor growth inhibition in preclinical models are encouraging early signals.

However, investors should note that the 2025 timeline for lead candidate selection indicates a lengthy development path ahead. With a market cap of just $7.1M, the company will likely need additional funding to advance this program. While the technology is promising, translation of preclinical success to human efficacy remains a significant hurdle in cancer vaccine development.

Evaxion's AI-Immunology™ platform demonstrates sophisticated capabilities in identifying and optimizing ERV hotspots as vaccine targets. The platform's ability to analyze the "dark genome" and select antigens compatible with diverse immune profiles showcases advanced machine learning applications in drug discovery. This approach could potentially democratize cancer vaccine development by creating more broadly applicable treatments.

The technology's ability to successfully predict functional ERV antigenic hotspots validates the AI platform's predictive power. However, the real test will be clinical validation. The 2025 timeline for candidate selection suggests significant computational and experimental work remains to optimize the platform's predictions for clinical application.

  • Evaxion’s AI-Immunology™ platform allows for the design of precision cancer vaccines targeting non-conventional ERV tumor antigens shared across patients
  • Novel preclinical data confirms the effectiveness of the precision vaccine approach by inducing strong T-cell responses and tumor growth inhibition in mice, thereby establishing preclinical Proof-of-Concept
  • The approach could allow for a broader use of cancer vaccines, also for patients not responding to conventional immunotherapies
  • Evaxion plans to select a lead ERV precision vaccine candidate during the second half of 2025

COPENHAGEN, Denmark, December 12, 2024 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, obtains preclinical Proof-of-Concept (PoC) for its precision cancer vaccine concept targeting non-conventional ERV (endogenous retrovirus) tumor antigens shared across patients.

New data confirming the preclinical PoC is presented at the ESMO Immuno-Oncology Congress, currently taking place in Geneva, Switzerland.

Evaxion’s AI-Immunology™ platform can identify and select vaccine targets from ERVs expressed in the cancer cells, enabling the design of precision cancer vaccines for multiple specific cancer types.

This precision vaccine concept leverages our unique data insights and expertise in identifying vaccine targets compatible with the diversity of the immune system. By selecting ERV fragments, so-called hotspots, that match a broad spectrum of immune system profiles, these vaccines have the potential to be effective across a wide range of patients. The new data prove that the AI-Immunology™ platform can identify functional and potent ERV antigenic hotspots. This warrants further development towards clinical application.

“We are excited to have obtained preclinical PoC for our innovative concept for ERV-based precision cancer vaccines, thereby achieving another company milestone. This is a tremendous example of how AI-Immunology™ enables us to apply completely novel approaches to vaccine development, potentially leading to improved treatment options. ERVs hold a big therapeutic potential and with AI-Immunology™ we can design broadly applicable precision vaccines harnessing this potential. We are looking forward to continuing the development and aim at selecting a lead vaccine candidate in the second half of 2025,” says Christian Kanstrup, CEO of Evaxion.

The new data stems from studies in human cell and mouse models. Stimulation with ERV precision vaccine targets induced ERV-specific T-cell responses in human immune cells from several donors. Further, AI-Immunology™ designed mouse ERV precision vaccines induced functional antigen-specific T-cells and inhibited tumor growth in mice.

Conference presentation details:

Abstract title:AI-designed cancer vaccines: antigens from the dark genome are promising cancer vaccine targets
Poster#:124P
Location:Foyer Mezzanine

About ERVs
ERVs are remnants of ancient viruses lying dormant in our genome. ERVs are often overexpressed in cancer but not in healthy tissue, making them visible to the immune system and hence promising targets for cancer vaccines. AI-Immunology™ is crucial in allowing the identification of therapeutically relevant ERV tumor antigens from genomic patient tumor data.

Contact information 
Evaxion Biotech A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion-biotech.com 

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 geopolitical 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 does the EVAX preclinical Proof-of-Concept mean for shareholders?

The preclinical PoC for Evaxion's precision cancer vaccine concept indicates a significant milestone, demonstrating the platform's potential to induce strong T-cell responses and inhibit tumor growth, which could enhance the company's market value and future prospects.

How does Evaxion's AI-Immunology™ platform work?

Evaxion's AI-Immunology™ platform identifies and selects vaccine targets from ERVs expressed in cancer cells, designing precision cancer vaccines that match diverse immune system profiles, potentially making them effective across a wide range of patients.

When will Evaxion select a lead ERV precision vaccine candidate?

Evaxion plans to select a lead ERV precision vaccine candidate during the second half of 2025.

What are the benefits of Evaxion's precision cancer vaccines?

The benefits include strong T-cell responses, tumor growth inhibition, and broader applicability for patients who do not respond to conventional immunotherapies.

What were the results of the preclinical studies for EVAX vaccines?

The preclinical studies showed that Evaxion's precision cancer vaccines induced strong T-cell responses and inhibited tumor growth in mice.

Where was Evaxion's new data on precision cancer vaccines presented?

The new data were presented at the ESMO Immuno-Oncology Congress in Geneva, Switzerland.

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