Evaxion announces 89% vaccine target precision and sustained T-cell and clinical responses 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.

Rhea-AI Summary

Evaxion (EVAX) reported sustained immune and clinical responses at three-year follow-up in its phase 2 advanced melanoma trial of EVX-01. Vaccine targets generating specific T-cell responses reached 89%, versus 86% at two years; all patients developed an immune response. During the third year, T-cell responses retained their magnitude and breadth, and clinical responses were maintained without tumor progression.

Patients received EVX-01 with KEYTRUDA during the first two years. Six of 12 responders entered the one-year extension, receiving EVX-01 alone. Two-year results included a 75% objective response rate, measuring tumor shrinkage, and 25% complete responses. Tumor reduction occurred in 15 of 16 enrolled patients. Three-year findings will be presented at ESMO on October 24, 2026. Evaxion reports a cash runway extending well into the second half of 2027.

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Positive

• Moderate pointThird-year clinical responses were maintained, with no tumor progression during EVX-01 stand-alone treatment.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Evaxion reports cash runway extending well into the second half of 2027.
• Minor pointVaccine targets generating specific T-cell responses reached 89%, versus 86% at two-year follow-up.
• Minor pointEVX-01 induced an immune response in all patients in the trial.
• Minor pointThird-year T-cell responses preserved their magnitude and breadth during EVX-01 stand-alone treatment.

4 minor points

• Minor pointTwo-year objective response rate was 75%, with 25% of patients achieving complete responses.
• Minor pointTwo-year follow-up showed 92% of patients still responding, with no relapses observed.
• Minor pointResponses deepened in 54% of patients following EVX-01 initiation, improving from stable disease or partial response.
• Minor pointTumor reduction in target lesions occurred in 15 of 16 enrolled patients.

Negative

• Minor pointThe stand-alone extension included six of 12 responders, limiting the population informing third-year findings.

Key Figures

Vaccine targets inducing immune response: 89% Patients with an immune response: All patients Clinical response maintained: All patients +2 more

Vaccine targets inducing immune response

89%

Three-year EVX-01 phase 2 data

Patients with an immune response

All patients

EVX-01 phase 2 trial

Clinical response maintained

All patients

Through the third year, with no tumor progression observed

Neoantigens generating T-cell responses

86%

Two-year follow-up

Cash runway

Well into the second half of 2027

Company statement

Previous Clinical trial Reports

1 past event · Latest: Oct 19

Same Type 1 event

1. Oct 19

   Clinical data report

   24h Move

   +17.7%

   Reported maintained two-year responses with no tumor progression at three-year follow-up.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

neoantigens, monotherapy, objective response rate, anti-pd-1

4 terms

neoantigens medical

"vaccine neoantigens generating potent specific T-cell responses"

Neoantigens are new protein fragments that appear on the surface of diseased cells, most often cancer cells, because of changes in their DNA; the immune system can recognize these as foreign. For investors, neoantigens matter because they are targets for precision therapies and vaccines that aim to teach the immune system to attack only diseased cells—think of them as unique fingerprints that enable treatments to be more specific and potentially more effective, which can drive clinical and commercial value.

monotherapy medical

"the phase 2 trial in which EVX-01 was administered as monotherapy"

Monotherapy is a treatment approach that uses only one type of medicine or therapy to address a condition, instead of combining multiple options. For investors, understanding monotherapy matters because it can influence a company's development strategy, risk profile, and potential market size, especially if the single-treatment approach proves effective or faces limitations compared to combination therapies.

objective response rate medical

"showing a 75% Objective Response Rate"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

anti-pd-1 medical

"MSD’s anti-PD-1 therapy, KEYTRUDA®"

Anti-PD-1 is a type of drug that blocks a protein called PD-1 on immune cells, effectively releasing the immune system’s “brakes” so it can better recognize and attack cancer cells. For investors, these drugs matter because they can produce durable responses in multiple cancers, drive large sales if approved, and influence valuations through trial results, regulatory decisions, partnerships and competition in the oncology market.

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• EVX-01 induced an immune response in all patients in the trial with 89% of the vaccine neoantigens generating potent specific T-cell responses 
• Three-year data from the EVX-01 phase 2 trial in patients with advanced melanoma to be presented at the ESMO 2026 Congress supplementing very convincing two-year data from the trial
• The 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 23, 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 immune and clinical outcome data for personalized cancer vaccine EVX-01 in patients with advanced melanoma.

The data demonstrates EVX-01 inducing an immune response in all patients, with 89% of its personalised vaccine antigen targets inducing a tumor-specific immune response in treated patients. Further, sustained T-cell responses were observed, with preserved magnitude and breadth of the specific immune response, during the third year of the phase 2 trial in which EVX-01 was administered as monotherapy.

The new data also shows that all patients maintained their clinical response observed at two-year follow-up with no tumor progression observed through the third year of EVX-01 treatment alone. The data will be presented in a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026 held in Madrid, Spain, tomorrow.

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

“We are delighted to announce yet another set of strong immune and clinical data for EVX-01. The 89% target precision documented in the trial is another confirmation that AI-Immunology™ identifies and selects the most therapeutically relevant vaccine targets. Thus, the new data supports both EVX-01 as a promising personalized cancer vaccine and our platform as a validated technology for discovery and design of novel treatments,” says Birgitte Rønø, CSO and COO of Evaxion.

“What makes these three-year findings particularly compelling is not only the durability of clinical responses, but also the sustained strength and breadth of vaccine-induced T-cell immunity. These results offer an exciting glimpse into the future of precision oncology, where we can harness the unique biology of each patient’s tumor to train the immune system to recognize and target cancer with remarkable specificity. The prospect of translating this highly personalized immune response into long-lasting disease control represents an important step forward and offers renewed hope for patients facing advanced cancer“, 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.

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. Analyses of additional samples collected during the one-year extension phase further increased this neoantigen hit-rate to 89%.

Evaxion maintains a cash runway extending well into the second half of 2027.

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 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

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What did Evaxion's EVX-01 phase 2 trial show at three-year follow-up?

EVX-01 showed sustained T-cell and clinical responses, with no tumor progression during the third year of stand-alone treatment. Specific T-cell responses were detected against 89% of vaccine targets after analysis of additional extension-phase samples, compared with 86% at two-year follow-up.

Was EVX-01 given alone or with KEYTRUDA in Evaxion's melanoma trial?

Patients received EVX-01 with KEYTRUDA during the first two years, while the one-year extension used EVX-01 alone. Six out of 12 responders continued into that extension, so the third-year stand-alone findings concern a smaller group than the original trial population.