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Evaxion to present broad biomarker data from phase 2 trial with personalized cancer vaccine EVX-01 at the SITC 2026 Annual Meeting

The biomarker analyses examine systemic immune effects beyond vaccine-specific T-cell responses in advanced melanoma.

(Moderate)

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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.

Evaxion (NASDAQ: EVAX) will present phase 2 EVX-01 cancer vaccine biomarker data at the SITC annual meeting on November 6–7, 2026. The oral and poster presentations examine EVX-01 plus pembrolizumab in advanced melanoma, including systemic immune effects beyond vaccine-specific T-cell responses. Longitudinal profiling, which tracks immune responses over time, assessed the magnitude, quality and durability of those responses.

Previously reported trial results showed a 75% objective response rate, meaning measurable tumor responses, at two-year follow-up: 12 of 16 patients responded, including four complete responses. Clinical and T-cell responses were sustained at three-year follow-up. 89% of EVX-01 neoantigen targets—tumor-specific targets selected for the vaccine—triggered a tumor-specific immune response. Each patient received a personalized vaccine designed using Evaxion’s AI-Immunology platform.

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Positive

  • Moderate pointEVX-01 trial showed a 75% objective response rate at two years, with 12 of 16 patients responding.
  • Minor pointComplete responses occurred in four patients in the phase 2 advanced melanoma trial.
  • Minor pointClinical and T-cell responses were sustained at three-year follow-up.
  • Minor point89% of EVX-01 neoantigen targets triggered a tumor-specific immune response in patients.

Negative

  • None.
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Market Reaction – EVAX

$2.91 – $3.19 Day Range
$26.88M Mkt Cap at Last Price

On Nov 3, the day this news came out, the latest delayed price for EVAX is 2.05% above the previous close. Our momentum scanner has recorded 2 alerts for this stock so far that day. The latest delayed price is $2.98.

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Key Figures

Objective response rate: 75% (12 of 16 patients) Complete responses: 4 patients Neoantigen targets triggering tumor-specific immune response: 89%
Objective response rate
75% (12 of 16 patients)
Two-year phase 2 results
Complete responses
4 patients
Two-year phase 2 results
Neoantigen targets triggering tumor-specific immune response
89%
Phase 2 trial

Previous Clinical trial Reports

1 past event · Latest: Oct 23
Same Type 1 event
  1. Oct 23

    Phase 2 results

    24h Move
    +1.4%

    Three-year follow-up reported sustained T-cell responses and 89% vaccine-target immune response.

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, neoantigen, immunomodulatory
3 terms
objective response rate medical
"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.
neoantigen medical
"89% of the EVX-01 neoantigen targets triggered a tumor-specific immune response"
A neoantigen is a new, abnormal protein piece that appears on a cancer cell because of a mutation and is not found on healthy cells; think of it as a unique fingerprint the immune system can recognize. It matters to investors because medicines that target neoantigens—such as personalized vaccines or immune therapies—can be highly specific, potentially more effective and safer, and therefore can shape clinical success, regulatory value and commercial potential for oncology drugs.
immunomodulatory medical
"analysis of broad systemic immunomodulatory effects"
Immunomodulatory describes a drug, therapy, or compound that changes how the immune system responds—either boosting, calming, or redirecting its activity. For investors, immunomodulatory products matter because they target many large markets (autoimmune diseases, infections, cancer) and carry distinct safety, trial-design and regulatory risks; think of them as a thermostat for the immune system, where small adjustments can strongly affect effectiveness, side effects and approval chances.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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  • New data from the phase 2 trial with EVX-01 to be presented in both an oral and poster session

COPENHAGEN, Denmark, November 3, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology™ platform, will present new biomarker data from its phase 2 trial with personalized cancer vaccine EVX-01 at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting, taking place in Phoenix, Arizona, November 4-8, 2026.

The new data includes analysis of broad systemic immunomodulatory effects of EVX-01 plus pembrolizumab beyond vaccine-specific T-cell responses. It will be presented in both an oral and poster session at the SITC meeting.

To further understand the immunological mechanisms underlying EVX-01 activity, we performed longitudinal immune profiling of treated patients. The analyses included characterization of vaccine-specific T-cell responses together with profiling of systemic, treatment-associated immune responses. These data provide insights into the magnitude, quality, durability, and systemic impact of EVX-01-induced immunity in advanced melanoma.

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Evaxion’s phase 2 EVX-01 melanoma trial show?

At two-year follow-up, the trial showed a 75% objective response rate, with 12 out of 16 patients having objective clinical responses and four obtaining a complete response. Clinical and T-cell responses were sustained at three-year follow-up.

Was EVX-01 given alone or with pembrolizumab in Evaxion’s phase 2 trial?

Patients received EVX-01 with pembrolizumab during the first two years, while a subset received EVX-01 as stand-alone therapy in the third year. Pembrolizumab is MSD’s anti-PD-1 therapy marketed as KEYTRUDA.

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