Evaxion to Present New Positive Data from Ongoing Phase 2 Study on Lead Vaccine Candidate EVX-01 at the American Society of Clinical Oncology Annual Meeting 2024
Evaxion Biotech announces positive data from its ongoing Phase 2 study of the personalized cancer vaccine EVX-01 at the American Society of Clinical Oncology (ASCO) Annual Meeting. The study, which combines EVX-01 with anti-PD1 therapy for advanced melanoma patients, reveals that EVX-01 induces strong and specific immune responses mediated by both CD4+ and CD8+ T-cells. Booster shots further enhance these responses without safety concerns. The vaccine demonstrated a good tolerance profile with only minor adverse events. These findings support the potential clinical benefits of EVX-01 and the precision of Evaxion’s AI-Immunology™ platform in selecting effective vaccine targets.
- EVX-01 showed strong and specific immune responses in all assessed patients.
- Both CD4+ and CD8+ T-cells mediated the immune responses induced by EVX-01.
- Booster immunizations enhanced immune responses without safety concerns.
- EVX-01 was well-tolerated with only grade 1 and 2 adverse events.
- Ongoing Phase 2 study confirms findings from previous Phase 1 study.
- Evaxion's AI-Immunology™ platform effectively selects therapeutic vaccine targets.
- The data presented is interim and final clinical efficacy is not yet confirmed.
- Only minor adverse events were reported, but no long-term safety data is available.
- Commercialization and market adoption of EVX-01 still face uncertainty.
Insights
The announcement of positive data from Evaxion's Phase 2 study on their lead vaccine candidate EVX-01 is significant. The fact that the vaccine induced clinically relevant immune responses in all assessed patients, mediated by both CD4+ and CD8+ T-cells, is noteworthy. This points to a strong and specific immune activation, which is critical for the efficacy of cancer immunotherapies.
Moreover, the booster immunizations appear to enhance these responses without raising safety concerns, indicating a potentially favorable risk-benefit profile. This aligns with prior Phase 1 findings and strengthens confidence in their AI-Immunology™ platform's ability to design personalized vaccines effectively.
From a long-term perspective, this progress could place Evaxion at the forefront of personalized cancer vaccine development. However, it's essential to wait for more comprehensive efficacy and safety data before drawing definitive conclusions on the vaccine's clinical benefits.
The announcement has potential financial implications for Evaxion Biotech A/S. Positive clinical data typically boosts investor confidence, which often translates into a
The company's focus on leveraging AI to develop personalized vaccines could attract strategic investments and partnerships. This innovative approach may also position Evaxion as a key player in the competitive biotech space, potentially driving future revenue growth.
However, it's vital to consider the uncertainties inherent in clinical trials. While current data is promising, the final outcome of the Phase 2 study and subsequent Phase 3 trials will be decisive in determining the vaccine's market viability and financial impact.
- EVX-01 induced positive clinically relevant immune responses in all assessed patients
- Booster immunizations tended to increase the immune response
- The observed immune responses were mediated by both CD4+ and CD8+ T-cells
COPENHAGEN, Denmark, May 23, 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, today announces its participation in the American Society of Clinical Oncology (ASCO) Annual Meeting, where it will present positive immune data form its ongoing EVX-01 Phase 2 study. The study assesses the personalized cancer vaccine EVX-01 in combination with anti-PD1 therapy in patients with advanced melanoma. The conference will take place in Chicago, IL, from May 31 – June 4, 2024.
“We continue to see encouraging results from our ongoing Phase 2 study with EVX-01. The immune signatures induced by EVX-01 are both specific and strong, with booster immunizations pointing to further increased immune responses. The data makes us optimistic about the potential clinical benefit of EVX-01, and we eagerly await further data readouts on this novel personalized cancer vaccine. With our AI-Immunology™ platform, we can precisely select vaccine targets and design personalized vaccines that match each patient’s unique tumor signature and immune characteristics. This represents a novel approach to addressing an unmet medical need that remains dire, and we are excited about the interest we are seeing in the EVX-01 program,” said Christian Kanstrup, CEO at Evaxion.
This ongoing Phase 2 study currently confirms findings from the previous Phase 1 study, reaffirming the ability of Evaxion’s AI-Immunology™ platform to precisely select therapeutically relevant vaccine targets and generate new valuable insights. Key highlights from the Phase 2 study are:
- Analyses of patient samples demonstrated EVX-01 vaccine-induced specific and robust immune responses, mediated by both CD4+ and CD8+ T-cells
- Booster immunizations tended to increase the immune response and did not impose any safety concerns
- The EVX-01 vaccine candidate was found to be well-tolerated with only grade 1 and 2 adverse events
Poster Details:
| Abstract Title: | “Immunogenicity of an AI-designed personalized neoantigen vaccine, EVX-01, in combination with anti-PD-1 therapy in patients with metastatic melanoma” |
| Abstract #: | 9561 |
| Poster Bd #: | 345 |
| Track: | Melanoma/Skin Cancers |
| Location: | Hall A – McCormick Place |
| Date/Time: | Saturday, June 1, 1:30 – 4:30 p.m. CDT |
| Presenter: | Mads Lausen Nielsen, Senior Scientist |
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 that, 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
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