Evaxion Biotech is pioneering the use of AI in developing novel vaccines for cancer and infectious diseases. Founded in 2008 as an AI-first company, Evaxion has spent the last 15 years maturing its AI platform, AI Immunology, into a clinically validated tool for fast and effective vaccine discovery, design, and development.
AI-Driven Vaccine Development
Evaxion's AI platform significantly accelerates the vaccine development process. For instance, in infectious diseases, traditional reverse vaccinology takes approximately three years to identify a vaccine target. Evaxion's AI Immunology platform can achieve the same in just 24 hours, identifying targets that may be missed by conventional methods. This speed is crucial, especially in personalized cancer vaccines, where rapid design is essential for effective therapy.
Christian Kanstrup, CEO of Evaxion, highlighted the recent upgrade to the EDEN model, used for bacterial and infectious diseases, which now includes the ability to predict toxins, a critical target for infectious diseases.
Clinical Progress in Metastatic Melanoma
Evaxion's lead candidate, EVX-01, is a personalized neoantigen vaccine in Phase II development for metastatic melanoma. The Phase II trial presented at a conference in Barcelona showed a 69% overall response rate at the one-year readout, even better than the 67% observed in the Phase I-II trial. Notably, 15 out of 16 patients experienced a reduction in tumor size. These results underscore the potential of personalized vaccines designed for individual patients based on neoantigens.
Expanding Vaccine Modalities
EVX-B2, Evaxion's pre-clinical vaccine candidate against gonorrhea, has shown promise in an mRNA construct. In late 2023, Evaxion partnered with Atkinson Biologics to test the peptide-based EVX-B2 vaccine in an mRNA format. The pre-clinical proof of concept demonstrated that the vaccine targets work independently of the delivery modality, confirming the platform's scalability and adaptability to different partner preferences, such as mRNA, DNA, or peptide-based approaches.
Financial Strategy and Partnerships
Evaxion is strategically focused on monetizing its assets through partnerships. The company aims to generate business development income equal to its annual cash burn of approximately $14 million in 2024. This ambition is supported by strong interest from pharmaceutical companies and other potential partners in Evaxion's platform and pipeline. Merck (MSD) is not only an R&D partner but also Evaxion's largest shareholder, holding around 15% of the company.
Regulatory and Future Outlook
Evaxion has engaged in discussions with regulatory authorities, including the FDA, regarding the integration of AI in the regulatory framework. The FDA has granted fast-track designation for EVX-01, indicating a positive view of AI-derived vaccine candidates. Evaxion is focused on accelerating its business development activities, bringing in partners to advance its assets, and leveraging its AI Immunology platform to discover and develop new vaccines.
