Copenhagen, 16 January 2025 – Evaxion Biotech A/S (NASDAQ: EVAX), a Danish clinical-stage biotech applying artificial intelligence to immunology, announced today the successful completion of patient dosing in its Phase II clinical trial of EVX-01, a personalized cancer vaccine developed for advanced melanoma.

The trial enrolled 16 patients across multiple clinical sites, all of whom have now received their individualized vaccine doses. According to the company, one patient has already completed the full schedule of visits and reached the end of the study protocol, while follow-up assessments continue for the remaining participants. A comprehensive data readout is expected in the second half of 2025, a timeline that positions Evaxion for a potentially pivotal year in demonstrating the viability of personalized, AI-driven vaccines in oncology.

How EVX-01 Works

EVX-01 is not a one-size-fits-all therapy. Instead, it represents a tailored immunotherapy approach, leveraging Evaxion’s proprietary AI-Immunology™ platform to identify neoantigens—unique protein fragments arising from a patient’s own tumor mutations. These neoantigens are then encoded into a custom-designed vaccine, intended to train the immune system to specifically recognize and attack the patient’s cancer cells.

This strategy builds on the growing recognition that tumor heterogeneity and immune escape often limit the effectiveness of standard immunotherapies, such as checkpoint inhibitors. By integrating patient-specific mutational signatures, EVX-01 could potentially enhance response rates and sustain durable remissions in patients who otherwise have limited treatment options.

The Broader Landscape: Personalized Cancer Vaccines

The concept of personalized cancer vaccines has gained renewed attention following promising early-stage data from multiple biotech players. High-profile programs in melanoma and other solid tumors—such as those from Moderna, BioNTech, and Genentech—have already demonstrated encouraging immunogenicity and efficacy signals when combined with checkpoint blockade.

What differentiates Evaxion is its deep integration of artificial intelligence into vaccine design. By using AI models trained on vast datasets of tumor and immune system interactions, the company aims to dramatically shorten vaccine development timelines while improving the precision of neoantigen selection. This could prove to be a critical edge as the field moves toward larger, randomized clinical trials where efficacy must be demonstrated at scale.

Operational Significance of Dosing Completion

The completion of dosing in a Phase II study may appear procedural, but it is in fact a major operational milestone. It signals that the company has successfully recruited and retained patients in what is typically a challenging clinical population—patients with advanced melanoma who may already be heavily pretreated. It also demonstrates that EVX-01 has cleared practical hurdles such as manufacturing individualized vaccines at scale, a logistical challenge often underestimated in personalized medicine.

With patients now fully dosed, Evaxion can focus resources on data analysis, immune monitoring, and preparation for regulatory discussions. The anticipated readout in the second half of 2025 will be critical for determining whether EVX-01 can justify progression to a pivotal Phase III trial.

What’s Next for Evaxion

Beyond EVX-01, Evaxion is advancing a pipeline of AI-designed vaccines and immunotherapies that span oncology and infectious diseases. Success in melanoma could serve as a proof-of-concept not only for the company’s platform but also for the broader field of computational drug design, where algorithms are increasingly being used to guide therapeutic development.

If EVX-01’s upcoming results demonstrate strong efficacy—particularly in improving response rates in combination with checkpoint inhibitors—Evaxion could position itself as a key player in the next generation of immuno-oncology therapies. Moreover, the data will likely inform investor sentiment and potential partnership opportunities with larger pharma companies seeking to enter or expand in the personalized oncology vaccine space.

Conclusion

The dosing completion milestone in Evaxion’s Phase II trial of EVX-01 is more than just a procedural update—it represents tangible progress in a field striving to harness AI, precision medicine, and immunotherapy into one cohesive treatment strategy. As the biotech world waits for late-2025 data, EVX-01 stands as both a scientific experiment and a test case for how artificial intelligence can transform not only drug discovery but also the very personalization of cancer therapy.