Evaxion reports sustained clinical responses for all patients at three-year follow-up in phase 2 trial with personalized cancer vaccine EVX-01
Six of 12 responders continued into the one-year extension, receiving EVX-01 as stand-alone therapy.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Evaxion (NASDAQ: EVAX) reported sustained clinical responses at three-year follow-up in its phase 2 trial of EVX-01 in advanced melanoma. All patients at that follow-up maintained their two-year responses, with no tumor progression observed. Six of 12 responders entered the one-year extension, receiving EVX-01 alone after two years of EVX-01 combined with KEYTRUDA.
The trial enrolled 16 patients. Two-year results included a 75% objective response rate, meaning tumor shrinkage meeting response criteria, and 25% achieving a complete response. At two years, 92% of patients were still responding, with no relapses observed; 54% had a deepened response after starting EVX-01. Immune responses occurred in all patients. New clinical and immune data will be presented at ESMO on October 24, 2026, followed by an October 29 webinar.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointThree-year follow-up showed maintained clinical responses in all patients followed, with no tumor progression observed.
- Moderate pointTwo-year objective response rate was 75%, with 25% of patients achieving a complete response.
- Minor pointTwo-year follow-up showed 92% of patients still responding, with no relapses observed.
- Minor pointResponse deepened in 54% of patients after EVX-01 initiation, improving to partial or complete response.
- Minor pointTarget-lesion tumor reduction occurred in 15 of 16 enrolled patients.
2 minor points
- Minor pointEVX-01 induced immune responses in all patients.
- Minor pointVaccine neoantigens generated specific T-cell responses in 86% of cases measured at two-year follow-up.
Negative
- Minor pointThree-year extension participation was limited to six of 12 responders from the 16-patient trial.
Key Figures
- Responses maintained
- All patients; no tumor progression
- Three-year follow-up
- Objective response rate
- 75%
- Previously reported two-year trial data
- Complete response
- 25% of patients
- Previously reported two-year trial data
- Patients still responding
- 92%
- Two-year follow-up
- Deepened response
- 54% of patients
- Following initiation of EVX-01 treatment
- Tumor reduction
- 15 out of 16 patients
- Target lesions in the phase 2 trial
- Vaccine neoantigens generating T-cell responses
- 86%
- Measured at two-year follow-up
Previous Clinical trial Reports
-
Completed the EVX-01 extension after reporting earlier response and immunogenicity findings.
-
Extended the same phase 2 EVX-01 study to three years, adding monotherapy follow-up.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
objective response rate medical
complete response medical
neoantigens medical
anti-pd-1 therapy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Three-year data from the EVX-01 phase 2 trial in patients with advanced melanoma to be presented at the ESMO 2026 Congress
- Data supplements unprecedented two-year data from the trial including a
75% Objective Response Rate with25% of patients obtaining a complete response - This new clinical and new immune data will be presented at a poster session on October 24, 2026, followed by a webinar on October 29, 2026, providing further insights into the findings
COPENHAGEN, Denmark, October 19, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology™ platform, announces new three-year clinical outcome data for personalized cancer vaccine EVX-01 in patients with advanced melanoma.
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) 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 in 2025, showing a
“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 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
EVX-01 induced an immune response in all patients, with
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.
Contact information
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai
About Evaxion
Evaxion is a pioneering clinical-stage TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer as well as infectious and autoimmune diseases.
With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development.
We have developed a pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options.
For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website.
Forward-looking statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Evaxion's EVX-01 trial show at three-year follow-up?
All patients at three-year follow-up maintained their two-year clinical responses, with no tumor progression observed. Six of 12 responders continued into the one-year extension. These patients received EVX-01 alone during the third year, after receiving EVX-01 with KEYTRUDA during the first two years.
What were the two-year response results in Evaxion's EVX-01 melanoma trial?
The trial reported a 75% objective response rate, with 25% of patients achieving a complete response. At two-year follow-up, 92% of patients were still responding, with no relapses observed. Responses deepened in 54% of patients after EVX-01 treatment began, and target-lesion tumor reduction occurred in 15 of 16 enrolled patients.