Evaxion to present new phase 2 data for AI-designed personalized cancer vaccine EVX-01 at AACR Annual Meeting

Rhea-AI Summary

Evaxion Biotech (NASDAQ: EVAX) will present new biomarker and immune data from its ongoing phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine for advanced melanoma, at the upcoming AACR Annual Meeting in Chicago (April 25-30, 2025).

The presentation will focus on T-cell immunogenicity and biomarker profiling in advanced melanoma patients receiving EVX-01 in combination with KEYTRUDA® (pembrolizumab). The trial has previously shown strong interim one-year clinical data and is on track for two-year clinical data readout in H2 2025. The study has been extended for a third year to allow for a more comprehensive assessment.

The poster presentation is scheduled for April 29, 2025, from 9am-12pm CST at the AACR Annual Meeting, highlighting the company's AI-Immunology™ powered vaccine technology.

Positive

• Strong interim one-year clinical data already achieved
• Trial extended to three years for more comprehensive assessment
• Selected by AACR scientific committee, validating scientific value
• Collaboration with major pharma company MSD (Merck) using KEYTRUDA

Negative

• Final two-year clinical data not available until H2 2025

• New biomarker and immune data from the ongoing phase 2 trial with EVX-01 will be presented at the American Association for Cancer Research (AACR) Annual Meeting 
• These data will further add to the already strong clinical data package for EVX-01
• The trial remains on track for two-year clinical efficacy data readout in the second half of 2025
  
  

COPENHAGEN, Denmark, March 25, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will present new data for its lead asset EVX-01 at a poster session at the American Association for Cancer Research (AACR) Annual Meeting taking place in Chicago April 25-30, 2025. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

Evaxion will present new biomarker and immune data obtained from the ongoing phase 2 trial. These will further add to EVX-01’s already strong clinical data package.

“We are proud to be selected by the AACR’s scientific committee to present new data at this very renowned and important scientific meeting. This is a testament of the high scientific value of the EVX-01 clinical program, and we are excited to get the chance to present and discuss the data with a big audience in the field of melanoma research”, says Birgitte Rønø, Chief Scientific Officer of Evaxion.

The trial previously yielded strong interim one-year clinical data and remains on track for readout of two-year clinical data in the second half of 2025. Additionally, the trial has been extended with a third year, allowing for a more comprehensive assessment of the full potential of EVX-01.

AACR presentation details:
Abstract title:        T-cell immunogenicity and biomarker profiling in advanced melanoma patients receiving the personalized vaccine EVX-01 in combination with pembrolizumab
Abstract#:        4538
Poster#:        9
Session (category):        Immune responses to therapies including chemotherapy and radiotherapy (Clinical research)
Location:        Poster section 28
Date/Time:        April 29, 2025, at 9am-12pm CST/16-19 CET                 
Presenter:         Mads Lausen Nielsen, PhD, Project Manager at Evaxion

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. 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 cancers. It is Evaxion’s lead clinical asset.

EVX-01 is designed with our AI-Immunology™ platform 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.

In clinical trials, EVX-01 has demonstrated 69% and 67% Overall Response Rates in patients with advanced melanoma. Further, significant correlations between clinical responses and AI-Immunology™ predictions have been observed, underlining the predictive power of the platform.

Contact information 
Evaxion Biotech A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96

mak@evaxion.ai 

About EVAXION
Evaxion Biotech A/S is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine 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 geo-political 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

When will Evaxion (EVAX) release the two-year clinical data for EVX-01 cancer vaccine?

Evaxion will release the two-year clinical data for EVX-01 in the second half of 2025.

What is EVX-01 being tested for in Evaxion's (EVAX) phase 2 trial?

EVX-01 is being tested as a treatment for advanced melanoma (skin cancer) in combination with KEYTRUDA® (pembrolizumab).

What will Evaxion (EVAX) present at the AACR Annual Meeting 2025?

Evaxion will present new biomarker and immune data from the ongoing phase 2 trial of EVX-01 at AACR.

How is Evaxion's (EVAX) EVX-01 vaccine personalized for each patient?

Each patient receives a unique vaccine designed and manufactured based on their individual biology using Evaxion's AI-Immunology™ platform.