Evaxion extends phase 2 trial with personalized cancer vaccine EVX-01 to further enhance clinical data package

Rhea-AI Summary

Evaxion Biotech (NASDAQ: EVAX) has announced an extension of its Phase 2 trial for EVX-01, a personalized cancer vaccine for advanced melanoma, from two to three years. This extension will allow the company to collect additional clinical outcome data and potentially demonstrate enhanced treatment effects and immune response durability.

The trial, which has already yielded convincing one-year data, will offer active participants the opportunity to receive additional EVX-01 doses as monotherapy after completing the initial two-year protocol. The two-year data readout remains on track for the second half of 2025.

Interim one-year data presented at the ESMO Congress in September 2024 showed promising results:

• 69% Overall Response Rate
• Reduction in tumor target lesions in 15 out of 16 patients
• Positive correlation between AI-Immunology™ platform predictions and immune responses
• 79% of vaccine targets triggered a targeted immune response

EVX-01 is designed using Evaxion's AI-Immunology™ platform and is being tested in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).

Positive

• 69% Overall Response Rate in one-year data
• Reduction in tumor target lesions in 15 out of 16 patients
• 79% of vaccine targets triggered immune responses
• Positive correlation between AI platform predictions and immune responses (p=0.00013)
• Trial extension may demonstrate enhanced treatment effects and durability
• All active patients achieved reduction in tumor target lesions

Negative

• Extended timeline pushes complete data availability to 2026

• Originally planned as a two-year study, the trial has been extended by an additional year to collect three-year clinical outcome data 
• The additional third year of EVX-01 dosing may provide further insights into potential enhanced treatment effects and durability of induced immune response
• The trial already yielded convincing one-year data and remains on track for two-year data readout in the second half of 2025
  
  

COPENHAGEN, Denmark, February 25, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will further enhance the data package from its ongoing phase 2 trial with the company’s lead asset EVX-01 by extending the trial from two to three years. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine being developed as a treatment for advanced melanoma (skin cancer).

Active participants in the trial will be given the opportunity to enter the one-year extension after completing the two-year protocol. They will receive additional EVX-01 doses as monotherapy, with close monitoring to assess clinical response duration and immune activation. In the first two years of the trial, patients received EVX-01 in combination with standard anti-PD-1 therapy.

The trial is progressing according to plan, with two-year data readout expected in the second half of 2025. All trial active patients have achieved reduction in tumor target lesions and are faring well, which should allow for a seamless transition into the extension of the trial.

“We are very pleased with how this trial has been progressing and the encouraging data obtained so far. Patients are responding positively to the therapy, which is generally well tolerated. We are happy to support patients further by offering additional EVX-01 treatment. Extending the trial also allows us to collect even more data and further enhance the data package for this promising new potential treatment option for advanced melanoma. Adding another year might allow us to document even better effects of the treatment than what will be observed after one and two years”, says Birgitte Rønø, Chief Scientific Officer of Evaxion.

EVX-01 is designed with Evaxion’s AI-Immunology™ platform and tailored to target the unique tumor profile and immune characteristics of each individual patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors.

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.

Convincing one-year phase 2 data
Convincing interim one-year data from the trial was presented at the European Society for Medical Oncology (ESMO) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology™ platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Further, 79% of EVX-01’s vaccine targets triggered a targeted immune response, which compares very favorably to what is seen with other approaches.

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 a personalized therapy 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 the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology™ predictions was 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 U.S. 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 are the key results from Evaxion's EVX-01 Phase 2 trial for melanoma?

The interim one-year data showed a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and 79% of vaccine targets triggered an immune response. There was also a positive correlation between AI-Immunology™ platform predictions and immune responses induced by the individual neoantigens.

How is Evaxion's EVX-01 cancer vaccine personalized for each patient?

EVX-01 is designed using Evaxion's AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each individual patient. Each patient enrolled in the trial receives a unique vaccine designed and manufactured based on their individual biology.

When will Evaxion Biotech (EVAX) release the two-year data for its EVX-01 melanoma vaccine?

Evaxion Biotech expects to release the two-year data readout for the EVX-01 melanoma vaccine in the second half of 2025, as stated in their announcement.

Why is Evaxion (EVAX) extending its Phase 2 trial for EVX-01 from two to three years?

Evaxion is extending the trial to collect three-year clinical outcome data, provide further insights into potential enhanced treatment effects, and assess the durability of induced immune responses. This extension will enhance the overall data package for EVX-01 as a potential treatment for advanced melanoma.

What treatment will patients receive during the third year of Evaxion's EVX-01 trial?

During the third year extension, active participants will receive additional EVX-01 doses as monotherapy, with close monitoring to assess clinical response duration and immune activation. This differs from the first two years where patients received EVX-01 in combination with standard anti-PD-1 therapy.