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Evaxion to present three-year clinical efficacy data for personalized cancer vaccine EVX-01 at the ESMO Congress 2026

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Evaxion (NASDAQ: EVAX) will present three-year clinical efficacy data from its phase 2 trial of personalized cancer vaccine EVX-01 in advanced melanoma at the ESMO Congress 2026 in Madrid, October 23-27, 2026. The third-year extension evaluates EVX-01 as stand-alone therapy in a subset of patients, offering insight into effects without anti-PD-1 combination.

According to Evaxion, prior two-year data from the same trial showed a 75% Objective Response Rate (12/16 patients), including four complete responses, 92% of patients still responding at two years with no relapses, tumor reduction in 15/16 patients, and EVX-01-induced immune responses in all patients, with 86% of targeted neoantigens generating specific T-cell responses.

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Positive

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Negative

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Market Context

With short interest data indicating relatively low bearish positioning and peers showing mixed same-...
Analysis

With short interest data indicating relatively low bearish positioning and peers showing mixed same-day moves, this EVX-01 update slots into a pattern of R&D-driven headlines. Investors may watch whether future data or financing steps shift the historically uneven price responses to such news.

Key Figures

Objective Response Rate: 75% Responders: 12 of 16 patients Complete responses: 4 patients +5 more
8 metrics
Objective Response Rate 75% Two-year phase 2 data in advanced melanoma
Responders 12 of 16 patients Objective clinical responses at two years
Complete responses 4 patients Complete response rate within 16-patient phase 2 trial
Durable responders 92% of patients Still responding at two-year follow-up with no relapses
Deepened responses 54% of patients Improved from stable/partial to partial/complete response during treatment
Tumor reduction 15 of 16 patients Target lesion reduction in phase 2 melanoma trial
Neoantigen T-cell responses 86% of targeted neoantigens Generated potent specific T-cell responses in all patients
Sample size 16 patients Phase 2 EVX-01 advanced melanoma trial

Historical Context

5 past events · Latest: Jul 12 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 12 Preclinical data update Positive -4.7% New preclinical CMV vaccine EVX‑V1 data presented at herpesvirus workshop.
Jul 01 Data presentation notice Positive +3.2% Announcement of upcoming EVX‑V1 CMV preclinical data presentation in Montreal.
Jun 12 Award recognition Positive +5.3% AI‑Immunology platform received 2026 Prix Galien UK digital health award.
Jun 11 Preclinical data update Positive -4.8% New preclinical data for EVX‑04 AML vaccine candidate reported via 6‑K.
May 12 Data presentation notice Positive -1.3% Plan to present new EVX‑04 AML data at EHA 2026 Congress.

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

Pattern Detected

Recent Evaxion news has drawn mixed price reactions, with positive R&D updates more often met by divergence than by supportive follow-through.

Key Terms

objective response rate, neoantigens, anti-pd-1 therapy, t-cell responses
4 terms
objective response rate medical
"The two-year data 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.
neoantigens medical
"86% 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.
anti-pd-1 therapy medical
"not administered in combination with anti-PD-1 therapy"
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.
t-cell responses medical
"targeted neoantigens generating potent specific T-cell responses"
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.

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

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  • Three-year data from phase 2 trial will provide additional insights into potentially enhanced treatment effects and durability of the EVX-01-induced immune response
  • Data will also offer insight into the vaccine’s effect also as stand-alone treatment of patients with advanced melanoma
  • Unprecedented two-year data from the trial presented last year showed high response rates and an impressive durability of responses

COPENHAGEN, Denmark, July 17, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will present three-year clinical efficacy data from its phase 2 trial with personalized cancer vaccine candidate EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2026 to be held in Madrid, Spain, from October 23-27, 2026.

The data stems from a one-year extension of the phase 2 trial evaluating EVX-01 in patients with advanced melanoma (skin cancer). In the third year, patients received EVX-01 as stand-alone therapy, meaning the data will offer insight into the vaccine’s effect also when not administered in combination with anti-PD-1 therapy. Further, the data may also provide additional insights into potentially enhanced treatment effects and durability of the EVX-01-induced immune response.

“We are looking forward to presenting the data on EVX-01 at the important ESMO Congress. This will be an excellent opportunity for us to also discuss the data with stakeholders and potential business partners at a time when pivotal late-stage clinical data are continuing to emerge across the personalized cancer vaccine field,” says Birgitte Rønø, CSO & COO of Evaxion.

Convincing results
The three-year data will add to already convincing results from the phase 2 trial. The two-year data 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. 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 86% of the targeted neoantigens generating potent specific T-cell responses.

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). 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.

Presentation details
Abstract 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: Dr. 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 cancers. It is Evaxion’s lead clinical asset.

Designed with our AI-Immunology™ platform, EVX-01 and 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 tumors.

About melanoma
Melanoma accounted for approximately 1 in 5 of the 1.5 million new skin cancer cases estimated globally in 2020 with approximately 325,000 cases and 57,000 deaths. The global burden from melanoma is estimated to increase to 510,000 new cases and 96,000 deaths by 2040 (Arnold et al., JAMA Dermatology 2022). The global market for melanoma treatments is estimated to grow to $7.4 billion by 2029 (GlobalData).

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

What will Evaxion (NASDAQ: EVAX) present about EVX-01 at ESMO Congress 2026?

Evaxion will present three-year clinical efficacy data from its phase 2 EVX-01 trial in advanced melanoma. According to Evaxion, this includes results from a one-year extension assessing EVX-01 as stand-alone therapy, providing insight into treatment effects and immune-response durability without anti-PD-1 combination.

What did the two-year phase 2 data show for Evaxion’s EVX-01 cancer vaccine (EVAX)?

The two-year data showed a 75% Objective Response Rate, with 12 of 16 patients responding and four complete responses. According to Evaxion, 92% of patients were still responding at two years, no relapses occurred, and tumor reduction was seen in 15 of 16 patients.

How is EVX-01 being used in the phase 2 melanoma trial reported by Evaxion (EVAX)?

In the first two years, patients received EVX-01 plus KEYTRUDA (pembrolizumab); in year three, a subset received EVX-01 alone. According to Evaxion, each patient’s vaccine is uniquely designed and manufactured based on individual biology in this advanced melanoma study.

What immune response data has Evaxion reported for EVX-01 in advanced melanoma (NASDAQ: EVAX)?

Evaxion reported that EVX-01 induced an immune response in all enrolled patients in the phase 2 trial. According to Evaxion, 86% of targeted neoantigens generated potent, specific T-cell responses, supporting the vaccine’s personalized design and its AI-Immunology–driven neoantigen selection approach.

When and where is Evaxion’s EVX-01 poster presented at ESMO 2026, and who is the presenter?

The EVX-01 poster is scheduled for October 24, 2026, from 12:00 to 12:45 CET in Poster Area – Hall 5. According to Evaxion, the presenter is Dr. Muhammad Adnan Khattak from One Clinical Research and Edith Cowan University in Australia.

What specific clinical benefits were observed in EVaxion’s EVX-01 phase 2 trial for EVAX shareholders to note?

Evaxion observed deepening responses in 54% of patients, improving from stable or partial disease to partial or complete responses. According to Evaxion, durable benefit was seen, with 92% of patients still responding at two years and no relapses reported.