New phase 2 data highlight the strength of the immune response induced by personalized cancer vaccine EVX-01

Previously presented three-year follow-up showed sustained clinical and T-cell responses in the advanced melanoma trial.

Rhea-AI Summary

Evaxion (NASDAQ: EVAX) announced new phase 2 biomarker data showing immune responses to its personalized cancer vaccine EVX-01 in advanced melanoma.

Vaccine-target-specific T cells were detected directly ex vivo, meaning outside the body without prior laboratory expansion. Responses were dominated by CD4+ T cells; CD8+ responses occurred in half of patients. AI-Immunology predictions were associated with actual T-cell responses (p<0.001).

Previously presented results showed 89% of vaccine targets triggered tumor-specific immune responses. At two years, 12 of 16 patients had objective clinical responses, a 75% response rate, including four complete responses. Clinical and T-cell responses were sustained at three years. Patients received EVX-01 with pembrolizumab during the first two years. The new findings are being presented at SITC 2026.

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Positive

• Moderate pointTwo-year objective response rate was 75%: 12 of 16 patients responded, including four complete responses.
• Minor pointEVX-01-induced target-specific T cells were detected directly ex vivo, with responses dominated by CD4+ T cells.
• Minor pointCD8+ T-cell responses were observed in half of patients.
• Minor pointAI-Immunology predictions were associated with actual T-cell responses at p<0.001.
• Minor point89% of EVX-01 targets triggered tumor-specific immune responses.
• Minor pointClinical and T-cell responses were sustained at three-year follow-up.

Negative

• None.

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Key Figures

AI prediction association: p<0.001 CD8+ T-cell responses: Half of patients Vaccine target precision: 89% +2 more

AI prediction association

p<0.001

Association between AI-Immunology predictions and actual T-cell responses

CD8+ T-cell responses

Half of patients

Phase 2 EVX-01 biomarker findings

Vaccine target precision

89%

Previously reported three-year phase 2 data

Objective response rate

75% (12 of 16 patients)

Phase 2 trial at two-year follow-up

Complete responses

4 patients

Phase 2 trial at two-year follow-up

Previous Clinical trial Reports

2 past events · Latest: Oct 23

Same Type 2 events

1. Oct 23

   Phase 2 results

   24h Move

   +1.4%

   Reported 89% target immunogenicity and sustained three-year immune and clinical responses.

2. Oct 19

   Phase 2 results

   24h Move

   +17.7%

   Reported maintained clinical responses through year three without tumor progression.

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

Key Terms

neoantigen-specific t-cells, ex vivo, cd4+ t-cells, cd8+ t-cell responses, +1 more

5 terms

neoantigen-specific t-cells medical

"detection of EVX-01 induced neoantigen-specific T-cells directly ex vivo"

T cells whose receptors specifically recognize neoantigens — short peptide fragments produced by tumor-specific mutations and presented on a cell’s major histocompatibility complex (MHC). These T cells can be CD8+ (cytotoxic) or CD4+ (helper) and act by binding the mutant peptide–MHC complex through their T‑cell receptor (TCR), triggering immune responses against cells displaying the neoantigen; identification of neoantigen-specific T cells underpins therapies such as personalized cancer vaccines and adoptive T‑cell transfer. Neoantigens are absent from normal tissues, giving this specificity, but their detection and durable presentation can be limited by factors like prediction accuracy, tumor heterogeneity, and loss of antigen or MHC expression.

ex vivo medical

"neoantigen-specific T-cells directly ex vivo"

Ex vivo describes tests or treatments performed on living cells, tissues, or organs that have been removed from the body and studied in an external environment. For investors, ex vivo work sits between basic lab dish tests and whole‑animal or human studies, offering a more realistic preview of how a therapy or diagnostic might behave in real tissue — like running an engine on a test stand before putting it back into a car — which can reduce scientific risk and inform development milestones.

cd4+ t-cells medical

"Ex vivo responses were dominated by CD4+ T-cells"

A subtype of white blood cell (T lymphocyte) that expresses the CD4 surface protein and helps coordinate the immune response. CD4+ T-cells recognize peptide antigens presented on MHC class II molecules and activate other immune cells — for example, by releasing signaling proteins (cytokines) and providing help to B cells and macrophages. They are a functional class (helper T cells) distinct from CD8+ cytotoxic T cells; clinical measurements of CD4+ T-cell count are commonly used as a marker of immune-system status but do not by themselves indicate specific infections or outcomes.

cd8+ t-cell responses medical

"while CD8+ T-cell responses were observed in half of patients"

CD8+ T-cell responses are the activity of a subset of immune cells (CD8-positive T lymphocytes) that recognize fragments of infected, abnormal, or foreign proteins presented on a cell's MHC class I molecules and kill or suppress those cells. In clinical and trial reports this phrase describes the presence, strength, or characteristics of those antigen-specific cytotoxic T cells—often measured by laboratory assays that count responding cells, detect their inflammatory signals (for example interferon‑gamma), or demonstrate their ability to proliferate or kill target cells—where magnitude, breadth (which antigens they target) and durability are the main attributes reported.

objective response rate medical

"the trial demonstrated an Objective Response Rate (ORR) of 75%"

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.

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• Detection of neoantigen-specific T cells directly ex vivo indicates strong EVX-01-induced immune responses
• Data further underlines the strong predictive performance of Evaxion’s AI-Immunology™ platform
• The new biomarker data supplements recently published three-year data showing 89% vaccine target precision and sustained T-cell and clinical responses
  

COPENHAGEN, Denmark, November 6, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology™ platform, announces new biomarker data from its phase 2 trial with personalized cancer vaccine EVX-01 in patients with advanced melanoma (skin cancer).

The data demonstrate potent EVX-01 induced immune responses and further underline the strong predictive performance of Evaxion’s AI-Immunology™ platform. It will be presented in both an oral and a poster session today and tomorrow respectively at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting, taking place in Phoenix, Arizona.

“It is exciting to announce yet another set of new and promising data providing insights into the magnitude, quality and systemic impact of EVX-01-induced immunity in advanced melanoma. The data provide a clear demonstration of the very strong immune responses induced by EVX-01 and also validates our AI-Immunology™ platform further. We are looking forward to sharing and discussing this data with both scientific stakeholders and potential business partners at the important SITC meeting”, says Birgitte Rønø, CSO and COO of Evaxion.

Comprehensive data package
The new data adds to EVX-01’s already comprehensive data package which includes three-year clinical response and immune data presented at the European Society for Medical Oncology (ESMO) Congress 2026 held in October. These data showed 89% vaccine target precision and sustained T-cell and clinical responses at three-year follow-up in the phase 2 trial.

New findings include detection of EVX-01 induced neoantigen-specific T-cells directly ex vivo, which is a clear testament to the magnitude of the vaccine-induced immune responses. Ex vivo responses were dominated by CD4+ T-cells, while CD8+ T-cell responses were observed in half of patients.   

The data also documents a significant association (p<0.001) between predictions by AI-Immunology™ and actual T-cell responses, confirming the strong predictive performance of the platform. Essentially, the platform predicts, with very high precision, which neoantigens will illicit the strongest immune responses allowing for selection of these as optimal vaccine targets.

SITC oral and poster presentation details:

• Abstract title: EVX-01 personalized AI-designed vaccine plus pembrolizumab induce neoantigen-specific T-cell responses and systemic immune modulation in advanced melanoma
• Abstract#: 502

Oral presentation:

• Session: 105b: Rapid Oral - Clinical 1
• Location: Phoenix Convention Center, West Building-300 Level - 301BC
• Date/Time: Friday, November 6, 2026, 12:30-1:30pm MT / 20.30-21.30 CET
• Presenter:  Mads Lausen, Senior Scientist at Evaxion

Poster presentation:

• Session: Poster Session
• Location: Phoenix Convention Center, North Building-Lower Level - Exhibition Halls 4-6
• Date/Time: Saturday, November 7, 2026, 12:30-1:30pm & 6:40-8:10pm MT / 20:30-21:30 CET & 02:40-04:10 CET (Sunday, November 8)
• Presenter: Mads Lausen, Senior Scientist at Evaxion

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

At two-year follow-up, the trial demonstrated an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. Clinical and T-cell responses were sustained at three-year follow-up. 89% of the EVX-01 neoantigen targets triggered a tumor-specific immune response in the patients.

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). In the third year, a subset of patients received EVX-01 as stand-alone therapy. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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 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 new EVX-01 phase 2 biomarker data show?

The data showed vaccine-target-specific T cells detected directly ex vivo, with CD4+ T cells dominating responses and CD8+ responses observed in half of patients. AI-Immunology predictions were associated with actual T-cell responses at p<0.001.

What clinical response rate did Evaxion report for EVX-01 in advanced melanoma?

At two-year follow-up, 12 of 16 patients had objective clinical responses, yielding a 75% objective response rate, including four complete responses. Patients received EVX-01 with pembrolizumab during the first two years. Clinical and T-cell responses were sustained at three-year follow-up.

Did patients receive Evaxion's EVX-01 alone during the third year of the trial?

A subset of patients received EVX-01 as stand-alone therapy in the third year. During the first two years, patients received EVX-01 in combination with KEYTRUDA, also known as pembrolizumab.