COPENHAGEN, Denmark — October 23, 2026
Evaxion A/S (NASDAQ: EVAX), a clinical-stage TechBio company developing immunotherapies using its AI-Immunology™ platform, announced three-year immune and clinical outcome data for EVX-01, its personalized cancer vaccine candidate for advanced melanoma. The findings show that EVX-01 induced an immune response in all patients evaluated in the Phase 2 trial, with 89% of vaccine neoantigen targets generating potent, specific T-cell responses. The company also reported sustained T-cell response magnitude and breadth during the third year of follow-up, alongside continued clinical responses and no observed tumor progression through that period among patients receiving EVX-01 monotherapy. The data will be presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain, on October 24. EVX-01 is designed individually for each patient based on the unique biological characteristics of their tumor. The new findings extend earlier results reported at ESMO 2025, when the Phase 2 trial showed a 75% objective response rate (ORR), including complete responses in 25% of patients. Evaxion said the latest results further support its approach to personalized cancer vaccine development. However, EVX-01 remains investigational, and the reported findings come from a small clinical trial rather than a large, confirmatory study.
Phase 2 Findings Show Durable Clinical and T-Cell Responses
The Phase 2 study evaluated EVX-01 in patients with advanced melanoma, with each participant receiving a personalized peptide-based vaccine designed and manufactured according to their individual tumor biology. During the first two years, EVX-01 was administered in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy. Six of the 12 responders continued into a one-year extension phase, during which they received EVX-01 as monotherapy. According to Evaxion, the new three-year data showed that patients maintained the clinical responses observed at the two-year follow-up, with no tumor progression reported through the third year among patients receiving EVX-01 alone. Earlier two-year results showed that 92% of patients were still responding, with no relapses observed at that assessment. In addition, 54% of patients experienced a deepening of response after starting EVX-01, improving from stable disease or partial response to partial or complete response. Tumor reductions in target lesions were observed in 15 of the 16 patients enrolled. The vaccine induced immune responses in all patients, while the proportion of vaccine neoantigens generating potent, specific T-cell responses increased from 86% at the two-year assessment to 89% following analysis of additional samples collected during the extension phase. These findings indicate sustained vaccine-targeted immune activity in the patients studied, although the small cohort and study design limit conclusions about broader clinical effectiveness.
AI-Immunology Platform Supports Personalized Vaccine Design
EVX-01 is Evaxion’s lead clinical-stage asset and is being developed as a personalized cancer vaccine for advanced melanoma and potentially other advanced solid tumors. The peptide-based vaccine is designed using the company’s proprietary AI-Immunology™ platform, which analyzes individual tumor profiles and immune characteristics to identify tumor-specific neoantigens that may be recognized by the patient’s immune system. The intended mechanism is to stimulate targeted T-cell responses against these tumor-specific antigens. Evaxion reported that the 89% neoantigen response rate demonstrates the platform’s ability to identify and select vaccine targets capable of generating specific immune responses. Birgitte Rønø, chief scientific officer and chief operating officer of Evaxion, said the findings support continued development of EVX-01 and the company’s AI-based approach to target discovery and vaccine design. Professor Muhammad Adnan Khattak, an investigator in the trial and oncology specialist affiliated with One Clinical Research, Hollywood Private Hospital and Edith Cowan University in Australia, highlighted the persistence and breadth of T-cell responses alongside the durability of the clinical findings. The data provide further evidence of biological activity in the study population, but additional clinical evaluation will be needed to establish the vaccine’s benefit, determine which patients may benefit most and assess how results compare with other treatment approaches.
Advertisement
ESMO Presentation and Upcoming Webinar
Evaxion will present the three-year findings in a poster titled “EVX-01, a personalized cancer vaccine, induces sustained T-cell responses and durable disease control in advanced melanoma after three-year of follow-up.” The presentation is scheduled for October 24, 2026, from 12:00 to 12:45 p.m. Central European Time, in Poster Area – Hall 5, under the investigational immunotherapy topic. The poster presentation number is 2006P, and Professor Khattak will present the data. The company will also host a webinar on October 29, 2026, at 15:30 CET (10:30 a.m. EDT), featuring Professor Khattak discussing the three-year clinical and immune results, response durability and vaccine-induced T-cell activity, followed by a question-and-answer session. Evaxion said its cash runway extends well into the second half of 2027. The company is developing personalized and off-the-shelf cancer vaccine candidates, as well as prophylactic vaccine candidates for infectious diseases, using its AI-Immunology platform. The EVX-01 findings add longer-term follow-up to the company’s clinical evidence base, while further studies will be important to clarify the vaccine’s potential role in treating advanced melanoma and other cancers.
Source: Evaxion,, press release
