Evaxion Presents Positive and Validating Immune Data from Ongoing Phase 2 Trial with AI-Designed EVX-01 Vaccine at the ASCO Annual Meeting 2024
Evaxion Biotech presented promising data from their Phase 2 trial of the AI-designed cancer vaccine, EVX-01, at the ASCO Annual Meeting 2024. The vaccine, targeting neoantigens in metastatic melanoma patients, showed a specific immune response in all participants. Key findings include a 71% neoantigen-triggered T-cell response, involvement of both CD4+ and CD8+ T-cells, and no significant safety concerns. The data further validate Evaxion’s AI-Immunology™ platform's precision. CEO Christian Kanstrup highlighted the potential life-saving impact of EVX-01 and anticipates further data by Q3 2024.
- 71% of administered neoantigens elicited a T-cell response.
- Neoantigen-reactive immune responses involved both CD4+ and CD8+ T-cells.
- EVX-01 booster immunizations enhanced immune responses without safety concerns.
- Positive correlation between neoantigen quality, as predicted by AI-Immunology™, and immune response.
- Only grade 1 and 2 adverse events, indicating good tolerability.
- Continued validation of the AI-Immunology™ platform from Phase 1 to Phase 2.
- Data from Phase 2 is still ongoing, so full efficacy and safety are not yet confirmed.
- The long-term effectiveness and impact of EVX-01 remain to be seen until the one-year clinical readout.
Insights
The findings from Evaxion's Phase 2 trial underscore the potential clinical benefits of integrating AI technology into cancer vaccine development. The data showing a specific T-cell response in 71% of administered neoantigens suggests that the EVX-01 vaccine can effectively stimulate the immune system to target melanoma cells. This is important for metastatic melanoma, a condition with limited treatment options. The reported lack of severe adverse events (only grade 1 and 2) is promising for patient safety. However, it is important to await the one-year clinical readout to better understand long-term efficacy and safety. The broader clinical implications hinge on these upcoming results.
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The significance of these interim findings from Evaxion's EVX-01 Phase 2 study lies in the demonstration of the AI-Immunology™ platform's predictive power. The correlation between neoantigen quality and immune response validates the platform's utility in generating targeted cancer therapies. This could position Evaxion as a frontrunner in the emerging field of AI-powered immunotherapies. Moreover, the evidence of increased immune responses with booster immunizations, without additional safety concerns, highlights the potential for enhanced long-term treatment regimens. Investors should consider the scalability of this technology to other cancer types.
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From a financial perspective, these positive interim results could drive increased investor confidence and potentially uplift Evaxion's stock. The data presented at a prestigious platform like the ASCO Annual Meeting adds credibility and visibility, potentially attracting more institutional interest. The ongoing Phase 2 study generating further valuable insights indicates a pipeline with robust future prospects. However, it is vital to monitor the company's cash flow and funding status to ensure they can sustain research and development until commercialization. Positive patient outcomes in the third quarter could catalyze significant valuation increases.
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- Evaxion’s AI-designed cancer vaccine, EVX-01, triggered a specific and tumor-targeting immune response in all assayed melanoma patients
- Findings further confirm and validate the precision and predictive power of Evaxion’s AI vaccine target discovery and design platform, AI-Immunology™
COPENHAGEN, Denmark, June 03, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, reported data from its ongoing Phase 2 study at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. The data demonstrated vaccine-induced immune response in metastatic melanoma patients treated with the Company’s AI-Immunology™ designed personalized cancer vaccine, EVX-01, in combination with an anti-PD1 inhibitor. The EVX-01 vaccine targets neoantigens - antigenic sequences derived from cancer mutations - that are displayed on the surface of the cancer cells, allowing the immune system to recognize, attack and eliminate the malignant cells.
“We believe these positive data further confirms the precision and predictive power of our AI-Immunology™ platform. This analysis shows the potential of EVX-01 and our AI platform’s ability to develop life-saving and life-improving treatments. We look forward to the one-year clinical readout in the third quarter of 2024 and are excited about the interest we are seeing in EVX-01,” said Christian Kanstrup, CEO of Evaxion.
Key EVX-01 Phase 2 study findings presented at the meeting:
- The EVX-01 vaccine induced specific and targeted immune responses, with
71% of the administered neoantigens eliciting a T-cell response - The neoantigen-reactive immune responses were mediated by both CD4+ and CD8+ T-cells
- EVX-01 booster immunizations tended to increase the immune responses and did not impose any safety concerns
- A statistically significant positive correlation between neoantigen quality, as predicted by AI-Immunology™, and vaccine-induced immune response was demonstrated
- The EVX-01 vaccine candidate was found to be well-tolerated, with only grade 1 and 2 adverse events
The data presented from the Phase 2 study currently confirm findings from the previous EVX-01 Phase 1 study, reaffirming the ability of Evaxion’s AI-Immunology™ platform to precisely select therapeutically relevant vaccine targets. The Phase 2 study is ongoing and continues to generate new valuable insights.
About EVX-01 Phase 2 Clinical Trial
EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The ongoing Phase 2 clinical study is a self-sponsored, open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, together with leading principal investigators and research centers from Italy and Australia. It aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with the anti-PD1 treatment pembrolizumab (more commonly known as KEYTRUDA®) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.
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.
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