Evaxion announces last patient visit in one-year extension of phase 2 trial with personalized cancer vaccine EVX-01

Evaxion (NASDAQ: EVAX) completed the one-year extension of its phase 2 trial of personalized cancer vaccine EVX-01, with the last patient visit on April 7, 2026.

Rhea-AI Summary

Evaxion (NASDAQ: EVAX) completed the one-year extension of its phase 2 trial of personalized cancer vaccine EVX-01, with the last patient visit on April 7, 2026.

First-two-year results showed a 75% Objective Response Rate (12/16), four complete responses, 92% still responding at two years, and high immunogenicity (81% neoantigen response). Three-year efficacy data are expected in the second half of 2026.

Positive

• Objective Response Rate 75% (12 of 16 patients)
• Four complete responses among 16 patients
• 92% durable response at two-year follow-up
• 81% neoantigen immunogenicity induced by EVX-01
• Tumor reduction in 15 of 16 patients

Negative

• Small trial cohort: 16 patients limits broad generalizability
• Key three-year efficacy data pending in H2 2026

Argus Apr 7 session

+2.01% close to close Open Argus

Details

News Market Reaction – EVAX

On Apr 7, the day this news came out, EVAX closed 2.01% above the previous close.

Data tracked by StockTitan Argus for the Apr 7 session.

Market Context

This announcement confirms completion of the one-year extension of Evaxion’s phase 2 EVX-01 trial, w...

Analysis

This announcement confirms completion of the one-year extension of Evaxion’s phase 2 EVX-01 trial, with a reported 75% Objective Response Rate and durable responses in 92% of patients at two years. The news advances a multi-year clinical story where earlier EVX-01 updates already showed high immunogenicity and tumor reduction in 15 of 16 patients. Investors would typically watch for the planned three-year data in 2H 2026 and how it shapes the program’s competitive profile and partnering prospects.

Key Figures

Objective Response Rate: 75% Responders: 12 of 16 patients Complete responses: 4 patients +5 more

Objective Response Rate

75%

Phase 2 EVX-01 trial, first two years

Responders

12 of 16 patients

Objective clinical responses in EVX-01 phase 2

Complete responses

4 patients

Complete response rate among 16 treated

Durable responders

92%

Patients still responding at two-year follow-up

Deepened responses

54% of patients

Improved from stable/partial to partial/complete response

Tumor reduction

15 of 16 patients

Target lesion reduction in EVX-01 phase 2

Immunogenic targets

81% of targeted neoantigens

Generated potent specific T-cell responses

Patients in trial

16 patients

EVX-01 phase 2 advanced melanoma trial size

Previous Clinical trial Reports

5 past events · Latest: Feb 25

Same Type 5 events

1. Feb 25

   EVX-01 trial extension

   24h Move

   -11.1%

   Extended EVX-01 phase 2 to three years for more outcome data.

2. Jan 15

   EVX-01 dosing complete

   24h Move

   -12.9%

   Completed dosing of all 16 patients in EVX-01 phase 2 trial.

3. Nov 12

   EVX-V1 preclinical data

   24h Move

   -1.6%

   Reported positive preclinical data for CMV vaccine EVX-V1.

4. Sep 09

   EVX-01 efficacy update

   24h Move

   -5.8%

   Announced 69% Overall Response Rate in EVX-01 phase 2 trial.

5. Apr 17

   EVX-01 dosing milestone

   24h Move

   +1.7%

   First patient completed dosing in EVX-01 phase 2 trial.

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, anti-pd-1 therapy, pembrolizumab, monotherapy, +4 more

8 terms

objective response rate medical

"two-year data including 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 therapy medical

"in combination with MSD’s ... anti-PD-1 therapy, Keytruda®"

Anti-PD-1 therapy are drugs that block the PD-1 protein on immune cells, effectively releasing the “brakes” that can prevent the body from attacking cancer cells; think of it like removing a safety lock so security guards can better recognize intruders. Investors care because these therapies can transform treatment outcomes, drive significant sales if approved for multiple cancers, and carry regulatory, patent and competitive risks that affect a company’s valuation.

pembrolizumab medical

"Keytruda® (pembrolizumab). In the third year, patients received"

A cancer immunotherapy drug that helps the body’s immune system recognize and attack tumor cells by blocking a molecular “brake” that tumors use to hide. Investors watch it because regulatory approvals, clinical trial results, dosing rules, and competition directly affect potential sales, profit forecasts, and the valuation of companies that sell or license the drug—think of trial outcomes as checkpoint signs that can open or close a revenue road.

monotherapy medical

"In the third year, patients received EVX-01 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.

neoantigens medical

"81% of the targeted 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.

t-cell responses medical

"neoantigens generating potent specific T-cell responses. This high"

T-cell responses are the actions of a type of immune cell (T cells) that identify and destroy infected or abnormal cells and coordinate the wider immune reaction. For investors, stronger or longer-lasting T-cell responses after a vaccine or therapy suggest better protection or treatment durability, which can affect clinical success, regulatory approval and market value — think of T cells as security guards that patrol and remove threats, not just a lock that blocks them.

advanced melanoma medical

"evaluated as a treatment for advanced melanoma (skin cancer). In the"

Advanced melanoma is a form of skin cancer that has grown beyond the original spot or cannot be removed with surgery, often spreading to other parts of the body. For investors, it matters because this stage drives demand for more complex treatments, ongoing drug development, clinical trial results, and regulatory decisions—similar to how a house fire that spreads beyond one room requires a different, more costly response than a small contained blaze.

immune response medical

"EVX-01 induced an immune response in all patients, with 81%"

The immune response is the body's defense system reacting to a foreign substance—like a virus, bacteria, or a drug—by mobilizing cells and molecules to neutralize or remove the threat. For investors, the strength and type of that response determine whether a medicine or vaccine works, how safe it is, and the likelihood of regulatory approval or market uptake, much like how a safety test decides whether a product can be sold widely.

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

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• Trial extension completed as planned with three-year clinical efficacy data expected to be presented in the second half of 2026
• The trial has already yielded encouraging one- and two-year data including a 75% Objective Response Rate

COPENHAGEN, Denmark, April 7, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, has successfully completed the one-year extension of its phase 2 trial with personalized cancer vaccine EVX-01 with the last patient having now had last physician visit. Patients in the trial will continue to be monitored and data prepared for expected presentation in the second half of 2026.

Designed with AI-Immunology™, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). In the first two years of the phase 2 trial, patients were treated with EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, Keytruda® (pembrolizumab).

In the third year, patients received EVX-01 as monotherapy, allowing an evaluation of the vaccine’s effect both as stand-alone and combination treatment. Further, the three-year data may provide additional insights into potential enhanced treatment effects and durability of induced immune response.

“We are pleased to have carried through the extension of the trial as planned and are looking forward to collecting, analysing and presenting the data. EVX-01 already has a very strong data package demonstrating the unique capabilities of AI-Immunology™ in cancer vaccine design. We hope to further enhance the data package with the three-year results,” says Birgitte Rønø, CSO of Evaxion.

Encouraging data
Data from the first two years of the trial demonstrated an Objective Response Rate of 75%, as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at two years follow-up and no relapses were observed.

54% of patients had a deepened response during 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.

In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology™ platform in accurately identifying neoantigens, which leads to detectable signals in patients.

Data also confirmed EVX-01 to be a well-tolerated treatment.

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 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 vaccine candidates for cancer and infectious 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 clinical 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 (EVAX) report about the EVX-01 phase 2 trial on April 7, 2026?

Evaxion reported completion of the one-year extension with the last patient visit on April 7, 2026. According to the company, two-year results include a 75% Objective Response Rate, four complete responses, 92% still responding at two years, and high immunogenicity.

How strong were EVX-01 efficacy results reported by Evaxion (EVAX) through two years?

EVX-01 showed a 75% Objective Response Rate and four complete responses in 16 patients. According to the company, 92% of patients were still responding at two years and tumor reduction occurred in 15 of 16 patients.

What immunogenicity did Evaxion (EVAX) report for personalized vaccine EVX-01?

EVX-01 induced immune responses in all patients, with 81% of targeted neoantigens eliciting T-cell responses. According to the company, this high immunogenicity supports the AI-Immunology platform's neoantigen selection precision.

When will Evaxion (EVAX) present the three-year clinical efficacy data for EVX-01?

Evaxion expects to present three-year efficacy data in the second half of 2026. According to the company, patients will continue to be monitored while data are prepared for presentation in H2 2026.

What are the main limitations investors should note about Evaxion's (EVAX) EVX-01 results?

Results are from a small phase 2 cohort of 16 patients and are early-stage findings. According to the company, three-year data are pending, so broader efficacy and durability conclusions remain conditional on upcoming results.