On October 19, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology platform, reported new three-year clinical outcome data for personalized cancer vaccine EVX-01 in patients with advanced melanoma.

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All patients at three-year follow-up in the phase 2 trial maintained the clinical responses observed at two-year follow-up, with no tumor progression observed. In the third year of treatment, patients received EVX-01 as stand-alone therapy. The data, coupled with new immune data, will be presented in a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 to be held in Madrid, Spain, from October 23-27, 2026.

The new findings supplement the unprecedented two-year data presented at ESMO (Free ESMO Whitepaper) in 2025, showing a 75% Objective Response Rate with 25% of patients obtaining a complete response.

"We are highly excited by the new data reflecting a long durability of clinical responses in this hard-to-treat patient population. This is another strong confirmation of the clinical potential of personalized cancer vaccines in general, and EVX-01 in particular, which we are looking forward to sharing and discussing at the important ESMO (Free ESMO Whitepaper) Congress. The new data further adds to EVX-01’s strong data package as a good foundation for potential partnership discussions," says Birgitte Rønø, CSO and COO of Evaxion.

Building on convincing two-year results
In addition to promising response rates, the two-year data from the trial also showed a durable clinical benefit, with 92% of patients still responding at two years of follow-up and no relapses observed.

54% of patients had a deepened response following initiation of EVX-01 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 induced an immune response in all patients, with 86% of the vaccine neoantigens generating potent specific T-cell responses as measured at the two-year follow-up.

About the phase 2 trial
The phase 2 trial investigated EVX-01 in patients with advanced melanoma. Each patient enrolled in the trial received a unique vaccine designed with Evaxion’s unique AI-Immunology prediction platform and manufactured based on their individual biology.

In the first two-years, patients received EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab). KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Six out of 12 responders continued in the trial’s one-year extension, where they received EVX-01 as stand-alone therapy.

Webinar on October 29, 2026
Evaxion will host a webinar featuring key opinion leader and trial investigator, Professor Muhammad Adnan Khattak, on October 29, 2026, at 15.30 CET/10.30am EDT.

The webinar can be attended through registration via this link.

In the webinar, Professor Khattak will present the three-year clinical and immune data from the EVX-01 phase 2 trial in patients with advanced melanoma. The presentation will highlight clinical outcomes, durability of responses and vaccine-induced immune responses following three years of follow-up. The presentation will be followed by a Q&A session, with participants encouraged to submit questions.

Poster presentation details
Poster title: EVX-01, a personalized cancer vaccine, induces sustained T-cell responses and durable disease control in advanced melanoma after three-year of follow-up
Presentation#: 2006P
Location: Poster Area – Hall 5
Topic: Investigational immunotherapy
Date/Time: October 24, 2026, at 12:00 – 12:45 CET
Presenter: Professor Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancer tumors. It is currently being evaluated as a treatment of advanced melanoma and is Evaxion’s lead clinical asset.

Designed with our AI-Immunology platform, EVX-01 is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumor-specific neoantigens.

(Press release, Evaxion, OCT 19, 2026, View Source [SID1234673556])