On October 17, 2025, Evaxion A/S, a clinical-stage TechBio company excelling in AI-Immunology™, revealed groundbreaking results from their phase 2 trial of the personalized cancer vaccine EVX-01. The company reported an extraordinary 75% Objective Response Rate (ORR) in patients suffering from advanced melanoma, marking significant progress in the fight against this challenging form of cancer.

The findings, presented at the esteemed ESMO Congress, illustrated that among 16 patients treated, 12 displayed objective clinical responses, with four experiencing complete response—an exceptional achievement in a particularly hard-to-treat population. Remarkably, 92% of responders maintained their therapeutic benefits even after a full 24 months of follow-up, with no relapses observed. This durability underscores the potential for EVX-01 not only to treat but also to maintain long-term control over advanced melanoma.

Crucial to the vaccine’s success is Evaxion’s pioneering AI-Immunology™ platform, which was instrumental in designing the treatment to target multiple neoantigens—unique proteins that manifest from cancer-specific mutations. The trial highlighted a robust immune activation in all patients, with astonishingly 81% of the neoantigens targeted by the vaccine eliciting strong T-cell responses. This level of immunogenicity is particularly noteworthy when compared to historical benchmarks, suggesting that the AI-assisted approach in identifying neoantigens offers precise and effective treatment possibilities.

Furthermore, the trial demonstrated that 54% of patients had a deepened response to treatment, enhancing from stable disease or partial response to a more promising partial or complete response over the study’s duration. Notably, tumor reduction was confirmed in 15 out of the 16 patients involved, solidifying the efficacy of EVX-01.

Equally crucial is the safety profile of the treatment; the trial confirmed EVX-01 as well-tolerated, echoing findings from the earlier phase 1 study where its favorable safety was first revealed. The successful performance, both in efficacy and safety, indicates a robust potential for future clinical development.

Birgitte Rønø, Evaxion’s Chief Scientific Officer and interim CEO, expressed elation regarding these developments, emphasizing that the results set a new benchmark in personalized immunotherapy. Rønø remarked on the significant implications the findings have, indicating that EVX-01 could emerge as a serious contender in treatment options for advanced melanoma.

As a result of these compelling data, Evaxion is poised to engage more deeply with stakeholders and potential partners to further clinical development. The promise shown by EVX-01 in this trial not only highlights its innovative technology but also its capability for tangible clinical impact, setting the stage for advancements in patient care.

In anticipation of the findings’ reception, a broader discussion is scheduled for October 22, 2025, in a webinar featuring esteemed key opinion leader Professor Muhammad Adnan Khattak. This discussion will provide greater insights into the implications of EVX-01 and the pioneering work of Evaxion in the realm of personalized immunotherapy.

With such a powerful demonstration of long-term efficacy and a strong safety profile, EVX-01 has the potential to revolutionize treatment standards for advanced melanoma. The integration of AI in the immunological design of therapies may prove to be a game-changer, benefiting not only patients but also invigorating the landscape of cancer therapeutics.