Evaxion Presents Positive Phase 2 Data for AI-Designed EVX-01 Vaccine at ASCO 2024

Evaxion Biotech A/S, a clinical-stage TechBio firm based in Copenhagen, Denmark, has released promising data from its ongoing Phase 2 study of EVX-01, an AI-designed personalized cancer vaccine. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024, these findings underscore the vaccine's potential in treating metastatic melanoma by leveraging Evaxion's proprietary AI-Immunology™ platform.

EVX-01, the company's leading clinical asset, is a peptide-based personalized cancer vaccine targeting neoantigens—antigenic sequences originating from cancer mutations. These neoantigens are displayed on cancer cell surfaces, enabling the immune system to recognize and attack the malignant cells. The Phase 2 trial involved patients with metastatic or unresectable stage III or IV melanoma, treated with a combination of EVX-01 and an anti-PD1 inhibitor, pembrolizumab (KEYTRUDA®).

The study revealed several key findings:
- The vaccine induced specific, tumor-targeted immune responses in all melanoma patients assessed, with 71% of administered neoantigens eliciting a T-cell response.
- These immune responses were mediated by both CD4+ and CD8+ T-cells.
- Booster immunizations with EVX-01 tended to enhance immune responses without raising safety concerns.
- A statistically significant positive correlation was observed between neoantigen quality, as predicted by AI-Immunology™, and the vaccine-induced immune response.
- The EVX-01 vaccine was well-tolerated, with only grade 1 and 2 adverse events reported.

Evaxion's CEO, Christian Kanstrup, expressed optimism about the data, emphasizing that it reaffirms the precision and predictive power of their AI-Immunology™ platform. He highlighted the potential of EVX-01 to develop life-saving treatments and noted the company's anticipation for the one-year clinical readout in the third quarter of 2024.

The ongoing Phase 2 clinical trial is a multi-center, open-label, single-arm study conducted in collaboration with Merck Sharp & Dohme LLC, and involves leading principal investigators and research centers from Italy and Australia. The trial aims to evaluate the efficacy and safety of EVX-01 in combination with pembrolizumab in treatment-naive melanoma patients. Further details on the trial can be found under clinical trial ID NCT05309421.

Evaxion Biotech A/S is at the forefront of integrating artificial intelligence with immunology to create novel immunotherapies for cancer, bacterial diseases, and viral infections. The company's AI-Immunology™ platform is designed to decode the human immune system and has led to the development of a clinical-stage oncology pipeline of personalized vaccines, as well as a preclinical pipeline for infectious diseases with high unmet medical needs. Evaxion is dedicated to transforming patient care through innovative and targeted treatment options.

In summary, the recent data from the EVX-01 Phase 2 study highlight the vaccine's ability to induce targeted immune responses in melanoma patients, validating Evaxion's AI-driven approach to vaccine development. The ongoing study continues to provide valuable insights, reinforcing the potential of AI-Immunology™ in creating effective cancer therapies.