Evaxion A/S Reports Two-Year Phase 2 Data Showing Results For Its Personalized Cancer Vaccine EVX-01 In Advanced Melanoma. Study Showed A 75% Objective Response Rate With 4 Of 16 Patients Achieving Complete Responses And 92% Maintaining Durable Responses At 24 Months With No Relapses

Evaxion A/S (NASDAQ:EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new two-year unprecedented clinical efficacy data of its personalized

The two-year phase 2 data demonstrates an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. The ORR is even higher than the 69% observed after one year of treatment. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at 24 months follow-up and no relapses were observed.

54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial.

EVX-01, developed with Evaxion's AI-Immunology™ platform, is designed to target multiple neoantigens; cancer unique proteins arising from mutations.

In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology™ platform in accurately identifying neoantigens, which leads to detectable signals in patients.

Data also confirmed EVX-01 to be a well-tolerated treatment.

"We are delighted to present these two-year phase 2 data for EVX-01 demonstrating high response rates and an impressive durability of responses, whilst confirming the favorable safety profile observed in our phase 1 study. A 75% ORR is unprecedented in this hard-to-treat patient population and underscores the significant potential of EVX-01 as a new treatment option. We are looking forward to discussing the data with stakeholders and potential partners. Further clinical development, which is clearly supported by this data, will only be done in a partnership", says Birgitte Rønø, CSO and interim CEO of Evaxion.

"This study sets a new benchmark in personalized immunotherapy. The long-term efficacy and safety of EVX-01 demonstrate that Evaxion's AI-Immunology™ approach is not just innovative; it's clinically meaningful and ready to shape the future of oncology", says Professor Muhammad Adnan Khattak, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, Australia, key opinion leader and one of the trial's investigators.

Data is presented today at the European Society for Medical Oncology (ESMO) Congress 2025 to be held in Berlin, Germany. Evaxion will be available for meetings at a booth (#3035) throughout the conference to allow for interactions and discussions of the data with all interested stakeholders.

Trial endpoints

The trial's primary endpoint, measuring improved responses e.g. patients converting to a better response category, was not formally analyzed due to a reduction in number of enrolled participants compared to the original protocol. However, the 54% conversion rate (as mentioned above), would suggest the primary endpoint being met.

As the majority of patients were still responding at time of data cut-off, secondary endpoints measuring Progression Free Survival and Overall Survival could not yet be reported.