Evaxion Publishes Data, Showing 67% Objective Response Rate in Metastatic Melanoma for the AI-Designed Personalized Cancer Vaccine EVX-01, in Leading Medical Journal
Evaxion has published Phase 1 study data for its AI-designed personalized cancer vaccine, EVX-01, in the Journal for ImmunoTherapy of Cancer. The study showed a 67% objective response rate (ORR) in patients with metastatic melanoma, with eight out of 12 patients showing clinical responses — six partial and two complete. EVX-01, co-administered with anti-PD-1 therapy, did not cause serious vaccine-related adverse events. The results validate the precision of Evaxion's AI-Immunology™ platform.
Phase 2 of the EVX-01 program is underway, with 71% of administered neoantigens inducing specific T-cell responses, as presented at ASCO. The one-year efficacy readout is expected in Q3 2024. CEO Christian Kanstrup expressed optimism about these promising results.
- 67% objective response rate (ORR) in Phase 1 for EVX-01.
- Six partial and two complete responses among 12 metastatic melanoma patients.
- No serious vaccine-related adverse events in Phase 1.
- 71% of administered neoantigens in Phase 2 induced specific T-cell responses.
- Phase 2 study progressing with one-year efficacy readout on track for Q3 2024.
- Validation of AI-Immunology™ platform's precision and predictive power.
- Only 12 patients were involved in Phase 1, limiting the robustness of data.
- Long wait until Q3 2024 for Phase 2 one-year efficacy readout.
- Results are yet to be validated in a larger, more diverse patient population.
Insights
67% objective response rate (ORR) in metastatic melanoma patients is notable. For context, the ORR measures the percentage of patients whose cancer shrinks or disappears after treatment. In comparison, historical data for standard anti-PD-1 therapies typically show an ORR around
The EVX-01 vaccine's ability to elicit a 67% ORR combined with no serious vaccine-related adverse events suggests it might be an effective and safer alternative. However, these results are from a small Phase 1 trial and larger Phase 2 trials will provide more definitive data.
This treatment targets neoantigens, unique to each patient's tumor, offering a personalized approach. The Phase 2 study's immune data showing a positive correlation between AI-predicted neoantigen scores and T-cell responses further supports the vaccine's efficacy. If Phase 2 results align with Phase 1, it could revolutionize metastatic melanoma treatment, traditionally challenging due to high mutation rates in these cancers.
Evaxion's Phase 1 results could significantly impact investor sentiment. The 67% ORR positions EVX-01 favorably against existing treatments, potentially increasing market interest and boosting stock prices.
However, clinical trial progression is inherently risky. While Phase 1 results are promising, the Phase 2 study's results, expected in Q3 2024, will be critical. Success in Phase 2 could lead to higher valuations and investor confidence, but failure might negatively impact stock performance.
Furthermore, the absence of serious adverse events is a positive indicator, potentially reducing regulatory hurdles. The technology behind Evaxion’s AI-Immunology platform also adds a compelling narrative by leveraging AI in personalized medicine, a growing sector.
The publication in a leading journal and the presented data at ASCO highlight the credibility of Evaxion’s research. Journals like the Journal for ImmunoTherapy of Cancer are prestigious, indicating rigorous peer review. This publication solidifies the scientific community's recognition of EVX-01's potential.
Additionally, strong immune readouts from Phase 2 studies enhance the vaccine’s profile. The ongoing Phase 2 study's results, especially the 71% neoantigen-specific T-cell response, corroborate the Phase 1 findings and demonstrate consistent efficacy. This consistent performance across different trial phases is important for regulatory approval and future market adoption.
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67% objective response rate (ORR) is reported in the publication summarizing results from the Phase 1 study assessing Evaxion’s personalized cancer vaccine, EVX-01, in patients with metastatic melanoma
- The findings also demonstrate strong and clinically relevant immune responses after EVX-01 administration to metastatic melanoma patients co-treated with anti-PD-1 standard of care
- The clinical study results substantiate the precision and predictive power of Evaxion’s AI-Immunology™ platform
- Evaxion has advanced the EVX-01 program into a Phase 2 study, and strong immune data readouts from the ongoing study were presented at ASCO in early June. The one-year clinical efficacy readout from the Phase 2 study is on track for Q3 2024
COPENHAGEN, Denmark, June 17, 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, announces publication of data from its Phase 1 dose escalation study of its lead personalized cancer vaccine candidate, EVX-01, for metastatic melanoma. The study results, published in the Journal for ImmunoTherapy of Cancer, demonstrated that eight out of 12 patients (
The EVX-01 cancer vaccine is designed to target neoantigens - antigenic sequences derived from cancer mutations - that are displayed on the surface of cancer cells, allowing the immune system to recognize, attack and eliminate the malignant cells. Since the neoantigen tumor profiles vary from one cancer patient to another, the EVX-01 cancer vaccine is truly personalized and tailored to the unique characteristics of each patient’s tumor and immune system profile. This represents a novel treatment paradigm with potential broad application in cancer therapy.
At this year’s ASCO annual meeting, the Company presented comprehensive immune data from its ongoing EVX-01 Phase 2 study, with
“This publication provides a clear conclusion to our Phase 1 study, with peer-reviewed validation of our reported outcomes. We are very impressed with EVX-01 achieving a
For more information about the recent EVX-01 Phase 2 immune data presented at ASCO, please visit our recent press release.
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.
FAQ
What is the objective response rate (ORR) achieved by Evaxion's EVX-01 in Phase 1?
How many patients showed clinical responses to EVX-01 in the Phase 1 study?
Were there any serious vaccine-related adverse events in the Phase 1 study of EVX-01?
What is the timeline for the Phase 2 study readout for EVX-01?
How effective were the administered neoantigens in the Phase 2 study of EVX-01?
