• Initial EVX-01 Phase 2 data confirms the strong Phase 1 results
  • After undergoing EVX-01 treatment, a significant and continuous tumor reduction was observed in a metastatic melanoma patient with initial progressive disease

COPENHAGEN, Denmark I October 31, 2023 I Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in the development of AI-Immunology powered vaccines, is pleased to announce initial results from the EVX-01 Phase 2 clinical trial, confirming previous successful Phase 1 findings. A comprehensive clinical update will be presented at the Society for Immunotherapy of Cancer (SITC) 38th annual meeting, taking place in San Diego, California, from November 1-5, 2023.

Key highlights of the initial Phase 2 results for the first five metastatic melanoma patients treated with EVX-01 include:

  • Phase 2 data confirm the favorable safety profile of EVX-01 observed in the Phase 1 trial
  • Promising immunological and clinical outcomes align with the Phase 1 outcomes
  • Upon EVX-01 treatment, a pronounced and ongoing tumor reduction was observed in a patient with progressive disease
  • Phase 2 data confirms Evaxion’s AI-Immunology platform’s ability to identify therapeutically relevant cancer vaccine targets

Christian Kanstrup, CEO of Evaxion, stated, “We firmly believe that our AI-Immunology platform has the potential to revolutionize the field of oncology and infectious diseases. Today’s update underscores its promise in immuno-oncology, with our EVX-01 vaccine safely eliciting robust immune responses in all patients. Notably, a pronounced tumor reduction in a metastatic patient with initial progressive disease following EVX-01 treatment offers hope for those with life-threatening cancer. We are looking forward to discussing these results with potential partners.”

Join us at the SITC meeting to explore the poster titled “Effects of an AI-generated personalized neopeptide-based immunotherapy, EVX-01, in combination with pembrolizumab in patients with metastatic melanoma. A clinical trial update”, presented on Saturday, November 4, between 9 a.m. – 8:30 p.m. PDT.

Additionally, don’t miss an in-depth presentation of Evaxion’s EVX-01 Phase 2 clinical results by joining an online webinar featuring the study’s principal investigator, Professor Adnan Khattak, held on November 8 at 11:30 a.m. EST. To register for the event, please follow this link.

Earlier this year, Evaxion reported a successful Phase 1 clinical trial for EVX-01 in combination with a checkpoint inhibitor. The trial demonstrated a 67% clinical response rate while meeting safety standards and reporting only mild adverse events. Further, high-quality neoantigens predicted by AI-Immunology were associated with longer progression-free survival. To learn more, please read here.

About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, and together with leading principal investigators and research centers from Italy and Australia aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.


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.

SOURCE: Evaxion