Strong validation of Evaxion’s AI-Immunology™ platform in multiple clinical trials

Rhea-AI Summary

Evaxion Biotech A/S (NASDAQ: EVAX) has reported strong validation of its AI-Immunology™ platform in multiple clinical trials. The company, specializing in AI-powered vaccine development, has gathered evidence from three separate clinical trials demonstrating the platform's ability to select clinically relevant vaccine targets.

Key findings include:

• Statistically significant correlation between AI-Immunology™ prediction scores and immunological responses in patients
• Strongest outcomes generated by top-ranked AI-Immunology™ vaccine targets
• In one trial, a statistically significant correlation between AI-Immunology™ prediction scores and Progression Free Survival (PFS)

The data supports the platform's potential in selecting effective vaccine targets and allows for continuous refinement of AI-Immunology™, broadening its commercial potential. Evaxion's CEO, Christian Kanstrup, emphasized the importance of generating relevant clinical data for the ongoing development of the platform.

Positive

• Strong validation of AI-Immunology™ platform in multiple clinical trials
• Statistically significant correlation between AI prediction scores and immunological responses
• Correlation between AI prediction scores and Progression Free Survival in one trial
• Ongoing clinical data generation allows for continuous refinement of the AI platform
• Broadening commercial potential of the AI-Immunology™ platform

Negative

• None.

Insights

Medical Research Analyst

The clinical validation of Evaxion's AI-Immunology™ platform across three separate trials is a significant development in personalized cancer vaccine research. The platform's ability to predict effective vaccine targets (neoantigens) with a high degree of accuracy, as evidenced by the statistically significant correlations between AI prediction scores and patient immune responses, is particularly noteworthy.

Key points of impact:

• Strong correlation between AI-predicted targets and actual immune responses in patients
• Statistically significant link between prediction scores and Progression Free Survival in one trial
• Validation across multiple clinical trials (EVX-01, EVX-02 and EVX-03)
• Potential for continuous refinement of the AI platform through ongoing data generation

This validation could accelerate the development of more effective personalized cancer vaccines, potentially improving treatment outcomes for cancer patients. However, it's important to note that while these results are promising, larger phase 2 and 3 trials will be necessary to fully establish the clinical efficacy and safety of this approach.

Financial Analyst

From an investor's perspective, this news is potentially significant for Evaxion Biotech (NASDAQ: EVAX). The validation of their AI-Immunology™ platform across multiple clinical trials strengthens the company's technological moat and could lead to increased interest from potential partners or acquirers in the pharmaceutical industry.

Key financial implications:

• Potential for accelerated development timelines, reducing R&D costs
• Increased likelihood of successful clinical outcomes, possibly leading to higher valuation
• Enhanced competitive position in the personalized cancer vaccine market
• Possibility of licensing opportunities or partnerships with larger pharmaceutical companies

However, investors should be cautious as Evaxion is still a clinical-stage company with no approved products. The market cap of $15.78 million suggests it's a micro-cap stock, which typically carries higher risk. While this news is positive, the company's financial position, cash runway and ability to fund future clinical trials remain critical factors to monitor.

• Data from three separate clinical trials documents the strong ability of the AI-Immunology™ platform to select clinically relevant vaccine targets
• Strongest outcomes are generated by the top-ranked AI-Immunology™ vaccine targets, thereby linking AI-vaccine design with real-world evidence
• This underscores the platform’s unique potential in selecting effective vaccine targets
• The ongoing generation of relevant clinical data allows for continuous refinement of AI-Immunology™ thereby broadening the commercial potential of the platform

COPENHAGEN, Denmark, October 9, 2024 – Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has now evidence from three different clinical trials validating the vaccine target predictions of its AI platform.

Evaxion has developed three personalized cancer vaccine candidates with the use of its AI-Immunology™ platform. Two of these – EVX-01 and EVX-02 – have completed clinical phase 1 testing and EVX-01 is currently in phase 2, while the third – EVX-03 – is an IND-ready vaccine candidate.

The AI-Immunology™ platform identifies cancer vaccine targets, so called neoantigens, and assigns a prediction score reflecting the likelihood of each vaccine target to elicit a specific immune response against the tumor. In all three clinical trials, a statistically significant correlation was observed between the AI-Immunology™ prediction scores and the immunological responses measured in the patients, with the most robust responses being generated by vaccine targets with the highest AI-Immunology™ prediction scores.

Further, in the one trial where it was assessed, a statistically significant correlation was demonstrated between AI-Immunology™ prediction scores and Progression Free Survival (PFS) in patients, underscoring the platform's ability to identify vaccine targets with meaningful clinical impact.

“We are proud to have collected such strong clinical data documenting the unique predictive capabilities of the AI-Immunology™ platform across several clinical trials. The correlation between the platform’s prediction score and clinical outcome is unique and provides very solid guidance for the further development of personalized cancer vaccines based upon AI-Immunology™. Generating highly relevant clinical data is very important for our ability to apply constant learning loops, allowing for the continuous development of AI-Immunology™,” says Christian Kanstrup, CEO of Evaxion.

About AI-Immunology™
AI-Immunology™ is a scalable and adaptable artificial intelligence technology platform at the forefront of vaccine discovery for infectious diseases and cancers. By integrating the collective power of proprietary AI models PIONEER™, EDEN™, RAVEN™, and ObsERV™, the platform can model the complexity of the patient’s immune system. AI-Immunology™ advanced computational modeling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionizing the landscape of immunotherapy by offering a holistic and personalized approach to combat fast-evolving pathogens and malignant cells.

Contact information 
Evaxion Biotech A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion-biotech.com 

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 the worldwide ongoing COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia and the Middle East; 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 clinical trials has Evaxion Biotech (EVAX) conducted for its AI-Immunology™ platform?

Evaxion Biotech has conducted three clinical trials for personalized cancer vaccine candidates developed using its AI-Immunology™ platform. Two candidates, EVX-01 and EVX-02, have completed phase 1 testing, with EVX-01 currently in phase 2. The third candidate, EVX-03, is IND-ready.

How does Evaxion's AI-Immunology™ platform select cancer vaccine targets?

Evaxion's AI-Immunology™ platform identifies cancer vaccine targets (neoantigens) and assigns prediction scores reflecting the likelihood of each target to elicit a specific immune response against the tumor. Higher prediction scores correlate with stronger immunological responses in patients.

What significant correlations were observed in Evaxion's (EVAX) clinical trials?

Evaxion's clinical trials showed statistically significant correlations between AI-Immunology™ prediction scores and immunological responses in patients. In one trial, a statistically significant correlation was also observed between prediction scores and Progression Free Survival (PFS).

How does the clinical data benefit the development of Evaxion's (EVAX) AI-Immunology™ platform?

The clinical data allows Evaxion to apply constant learning loops, enabling continuous development and refinement of the AI-Immunology™ platform. This ongoing improvement broadens the commercial potential of the platform and provides guidance for further development of personalized cancer vaccines.