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
Insights
Evaxion Biotech's decision to extend its Phase 2 EVX-01 trial by an additional year represents a strategic enhancement of its clinical data package that could significantly strengthen the company's position in the competitive personalized cancer vaccine landscape.
The extension comes after impressive one-year data showing a 69% Overall Response Rate and tumor reduction in 15 of 16 patients - metrics that compare favorably to standard-of-care outcomes in advanced melanoma. The statistical correlation (p=0.00013) between AI predictions and actual immune responses validates Evaxion's technological approach and differentiates it from competitors like BioNTech and Moderna, whose personalized cancer vaccines typically show lower neoantigen response rates in the 20-60% range.
What's particularly noteworthy is the transition to EVX-01 monotherapy in year three, following combination therapy with pembrolizumab in years one and two. This design could answer a critical question that impacts commercial potential: can EVX-01 maintain durable responses without concurrent checkpoint inhibition? Positive results here would substantially increase the vaccine's value proposition and potentially position it as a maintenance therapy after initial combination treatment.
For a micro-cap biotech with a market capitalization of just $15.3 million, this trial extension represents a calculated risk. While it will require additional capital allocation, the enhanced data package could significantly improve partnership and licensing opportunities. The melanoma immunotherapy market is projected to reach $7.5 billion by 2027, and robust three-year data could position Evaxion to capture meaningful market share.
Investors should note that this extension doesn't delay the planned two-year data readout in H2 2025, maintaining near-term catalysts while adding potential long-term value. The extension also suggests management confidence in both the existing data and patient tolerability, as dropout rates would typically make such extensions challenging if the treatment weren't well-tolerated.
The 79% target-specific immune response rate is particularly significant, as it suggests Evaxion's AI platform may be more precise at identifying immunogenic neoantigens than competing approaches. This technical advantage could translate to superior efficacy and potentially broader applications across multiple tumor types, expanding the addressable market beyond melanoma.
While this extension adds complexity to Evaxion's clinical timeline, it demonstrates a commitment to generating comprehensive data that could ultimately accelerate regulatory discussions and commercial partnerships, potentially transforming this undervalued biotech into a significant player in the personalized cancer vaccine space.
- 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
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 (
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
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FAQ
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